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IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION AND INDICATIONS
SERIOUS INFECTIONS
Patients treated with XELJANZ/XELJANZ XR are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.
If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled.
Reported infections include:
• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ/XELJANZ XR use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ/XELJANZ XR use.
• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis.
Avoid use of XELJANZ/XELJANZ XR in patients with an active, serious infection, including localized infections, or with chronic or recurrent infection.
In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily.
The risks and benefits of treatment with XELJANZ/XELJANZ XR should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ/XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.
MORTALITY
Rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.
Consider the risks and benefits of XELJANZ/XELJANZ XR treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing XELJANZ/XELJANZ XR in patients who develop a malignancy.
Malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily dosing in the UC long-term extension study.
Other malignancies were observed in clinical studies and the post-marketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
THROMBOSIS
Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, have occurred in patients treated with XELJANZ and other Janus kinase inhibitors used to treat inflammatory conditions. RA patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study had an observed increase in incidence of these events.​​​​​ Many of these events were serious and some resulted in death. Avoid XELJANZ/XELJANZ XR in patients at risk. Discontinue XELJANZ/XELJANZ XR and promptly evaluate patients with symptoms of thrombosis. For patients with UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. In a long-term extension study in UC, four cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice daily, including one death in a patient with advanced cancer.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in XELJANZ clinical trials, although the role of JAK inhibition is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There was no discernable difference in frequency of gastrointestinal perforation between the placebo and the XELJANZ arms in clinical trials of patients with UC, and many of them were receiving background corticosteroids. XELJANZ/XELJANZ XR should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs).
HYPERSENSITIVITY
Angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving XELJANZ/XELJANZ XR and some events were serious. If a serious hypersensitivity reaction occurs, promptly discontinue tofacitinib while evaluating the potential cause or causes of the reaction.
LABORATORY ABNORMALITIES
Lymphocyte Abnormalities: Treatment with XELJANZ was associated with initial lymphocytosis at one month of exposure followed by a gradual decrease in mean lymphocyte counts. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a count less than 500 cells/mm3. In patients who develop a confirmed absolute lymphocyte count less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Monitor lymphocyte counts at baseline and every 3 months thereafter.
Neutropenia: Treatment with XELJANZ was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with an ANC less than 1000 cells/mm3. For patients who develop a persistent ANC of 500-1000 cells/mm3, interrupt XELJANZ/XELJANZ XR dosing until ANC is greater than or equal to 1000 cells/mm3. In patients who develop an ANC less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Monitor neutrophil counts at baseline and after 4-8 weeks of treatment and every 3 months thereafter.
Anemia: Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a hemoglobin level less than 9 g/dL. Treatment with XELJANZ/XELJANZ XR should be interrupted in patients who develop hemoglobin levels less than 8 g/dL or whose hemoglobin level drops greater than 2 g/dL on treatment. Monitor hemoglobin at baseline and after 4-8 weeks of treatment and every 3 months thereafter.
Liver Enzyme Elevations: Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation compared to placebo. Most of these abnormalities occurred in studies with background DMARD (primarily methotrexate) therapy. If drug-induced liver injury is suspected, the administration of XELJANZ/XELJANZ XR should be interrupted until this diagnosis has been excluded. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury.
Lipid Elevations: Treatment with XELJANZ was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Maximum effects were generally observed within 6 weeks. There were no clinically relevant changes in LDL/HDL cholesterol ratios. Manage patients with hyperlipidemia according to clinical guidelines. Assessment of lipid parameters should be performed approximately 4-8 weeks following initiation of XELJANZ/XELJANZ XR therapy.
VACCINATIONS
Avoid use of live vaccines concurrently with XELJANZ/XELJANZ XR. The interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.
PATIENTS WITH GASTROINTESTINAL NARROWING
Caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non-deformable extended release formulation.
HEPATIC and RENAL IMPAIRMENT
Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.
For patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 5 mg twice daily, reduce to XELJANZ 5 mg once daily.
For UC patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 10 mg twice daily, reduce to XELJANZ 5 mg twice daily.
ADVERSE REACTIONS
The most common serious adverse reactions were serious infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical trials in patients with RA with XELJANZ 5 mg twice daily and placebo, respectively, (occurring in greater than or equal to 2% of patients treated with XELJANZ with or without DMARDs) were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension. The safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in RA patients.
Adverse reactions reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials for UC were: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.
USE IN PREGNANCY
Available data with XELJANZ/XELJANZ XR use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal studies, tofacitinib at 6.3 times the maximum recommended dose of 10 mg twice daily demonstrated adverse embryo-fetal findings. The relevance of these findings to women of childbearing potential is uncertain. Consider pregnancy planning and prevention for females of reproductive potential.
INDICATIONS
Rheumatoid Arthritis
• XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
• Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Psoriatic Arthritis
• XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
• Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Ulcerative Colitis
• XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
• Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information}. New York, NY: Pfizer Inc.; December 2019.
2. Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736, 1-77. doi:10.1056/NEJMoa1606910.
3. Data on file. Pfizer Inc., New York, NY.
4. US Department of Health and Human Services. Clinical trial imaging endpoint process standards: guidance for industry. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm268555.pdf. Published April 2018. Accessed June 1, 2018.
5. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710.
6. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353(23):2462-2476.
7. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomized controlled trial. Gut. 2011;60(6):780-787.
8. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2014;146:85-95.
9. Dhanda AD, Creed TJ, Greenwood R, Sands BE, Probert CS. Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials? Inflamm Bowel Dis. 2012;18(11):2056-2062.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. Data on file. Pfizer Inc., New York, NY.
2. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
3. Danese S, Grisham M, Hodge J, Telliez JB. JAK inhibition using tofacitinib for inflammatory bowel disease treatment: a hub for multiple inflammatory cytokines. Am J Physiol Gastrointest Liver Physiol. 2016;310(3):G155-G162.
4. Hodge JA, Kawabata TT, Krishnaswami S, et al. The mechanism of action of tofacitinib—an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2016;34(2):318-328.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
TERMS & CONDITIONS
CO-PAY CARD TERMS & CONDITIONS
By using the XELJANZ/XELJANZ XR Co-Pay Savings Card (the "Card"), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
  • Patients are not eligible to use this card if they are enrolled in a state and federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Patient must have private insurance. Offer is not valid for cash paying patients.
  • You will receive a maximum benefit of $15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, and may pay as little as $0 per month co-pay. After a maximum of $15,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
  • You must deduct the value of this card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
  • You must be 18 years of age or older to redeem the Card.
  • The Card is not valid where prohibited by law.
  • The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • The Card is not health insurance.
  • Offer good only in the U.S. and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • The Card may be used once per month for the life of the program.
  • No other purchase is necessary.
  • Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke, or amend the program without notice.
  • Card and Program expires 12/31/2021.
If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.
INTERIM CARE RX PROGRAM TERMS & CONDITIONS
  • Interim Care Rx is not health insurance and is available for eligible, commercially insured patients only.
  • Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ/XELJANZ XR.
  • No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party payer.
  • Not available to patients covered under government plans such as Medicaid, Medicare or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts, Michigan, Minnesota, Missouri, Ohio, or Rhode Island.
  • Available in 30-day supply. Refills are subject to limitations.
  • Interim Care Rx offer does not require, nor will be made contingent on, purchase requirements of any kind.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Interim Care Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed and a delay occurs in the prior authorization or appeals process.
  • Offer good only in the U.S. and Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the U.S. or Puerto Rico.
  • Continued eligibility for the program requires the submission of two appeals within 180 days of enrollment. After 12 months of program enrollment an updated prescription and benefits investigation is required to confirm continued eligibility.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.
PATIENT ASSISTANCE PROGRAM/PFIZER PATIENT ASSISTANCE PROGRAM FOR UNDERINSURED PATIENTS TERMS & CONDITIONS
  • The Pfizer Patient Assistance Program is not health insurance and is available for eligible uninsured/underinsured patients only.
  • Offer is only available to patients who meet financial and other criteria.
  • This offer does not require, nor will it be made contingent on, purchase requirements of any kind.
  • No claim for reimbursement or credit for any costs associated with the medicine(s) may be submitted to any prescription insurance provider or payer, including Medicare Part D plans.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Offer good only in the US and Puerto Rico.
  • Patient must be a resident of the United States or Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
  • Patient must be treated in the outpatient setting of care.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
TERMS & CONDITIONS
CO-PAY CARD TERMS & CONDITIONS
By using the XELJANZ XR/XELJANZ Co-pay Savings Card (the "Card"), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
  • Patients are not eligible to use this card if they are enrolled in a state and federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Patient must have private insurance. Offer is not valid for cash paying patients.
  • You will receive a maximum benefit of $15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, and may pay as little as $0 per month co-pay. After a maximum of $15,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
  • You must deduct the value of this card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
  • You must be 18 years of age or older to redeem the Card.
  • The Card is not valid where prohibited by law.
  • The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • The Card is not health insurance.
  • Offer good only in the U.S. and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • The Card may be used once per month for the life of the program.
  • No other purchase is necessary.
  • Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke, or amend the program without notice.
  • Card and Program expires 12/31/2021.
If you have questions or are in need of additional support call 1-844-935-5269 or visit www.XELJANZ.com
XSAVINGS Mobile Text Program Terms & Conditions
User texts "XPROGRAM" to short code 50336.
Text HELP for help, STOP to opt out.
Patients may receive up to 10 messages per month.
Message and data rates may apply.
  1. By opting into the XSAVINGS mobile texting program (Program), you consent to receive up to 10 text messages and/or push notifications from Pfizer Inc. Such messages may be marketing or non-marketing messages and may include co-pay related information, fill confirmation, website information, etc. Messages may be delayed or undelivered for various factors. TrialCard, carriers (including, but not limited to, T-Mobile) and any service providers utilized by TrialCard to send messages are not liable for delayed or undelivered messages.
  2. To stop receiving text messages, text STOP to 50336. DOING SO WILL ONLY OPT YOU OUT OF THIS PROGRAM; you will remain opted in to any other Pfizer Inc text message program(s) into which you opted separately.
  3. To request more information or to obtain help, text HELP to 50336. You can also call customer service at 1-844-935-5269.
  4. You represent that you are the account holder for the mobile telephone number(s) that you provide to opt into the Program. You are responsible for notifying Pfizer Inc immediately if you change your mobile telephone number. You may notify Pfizer Inc of a number change by calling 1-844-935-5269.
  5. Message and data rates may apply to each text message sent or received in connection with the texting program, as provided in your mobile telephone service rate plan (please contact your mobile telephone carrier for pricing plans). Applicable roaming charges may apply. Charges are both billed and payable to your mobile service provider or deducted from your prepaid account. Pfizer Inc does not impose a separate fee for sending text messages.
  6. Data obtained from you in connection with this Program may include your telephone number, your carrier's name, and details of the message (date, time, and content). Pfizer Inc may use this information to contact you and to provide the services you request.
  7. For information on data collection and use, please read our full corporate Privacy Policy (https://www.pfizer.com/Privacy), which is incorporated by reference into these Terms.
  8. Pfizer Inc will not be liable for any delays in the receipt of any SMS messages, as delivery is subject to effective transmission from your network operator.
  9. This Program is available only on these US participating mobile carriers: Verizon Wireless, Sprint, Boost Mobile, T-Mobile, AT&T, Atlantic Tele-Network International (ATNI), Alaska Communications Systems (ACS), ASTAC, Bandwidth.com (includes Republic Wireless), Blue Wireless, Bluegrass Cellular, Breakaway Wireless, Brightlink, C Spire Wireless (aka Cellular South), Carolina West Wireless, CellCom, Cellone Nation, Cellular One of N.E. Arizona, Chariton Valley Cellular, Chat Mobility, Copper Valley Telecom, Cordova Wireless, Cross Wireless, CTC, Custer Telephone, East Kentucky Network (Appalachian Wireless), Enflick, GCI Communications, Google Voice, Illinois Valley Cellular, Inland Cellular, Inteliquent, iWireless, Leaco Rural Telephone Cooperative, Limitless Mobile, Mid-Rivers Communications, MobileNation/SI Wireless, MTA Wireless/Matanuska Kenai, Nemont CDMA, Nemont US UMTS, NewCore Wireless, Nex-Tech Wireless, NNTC Wireless, Northwest Missouri Cellular, Pine Belt Wireless, Pine Cellular, Pioneer Cellular, PTCI, Shelcomm, Silver Star PCS, Snake River PCS, SouthernLINC, SouthernLINC LTE, SRT, STRATA Networks, Standing Rock (SRTI), Thumb Cellular, Triangle Wireless, Union Wireless, U.S. Cellular, United Wireless, Viaero Wireless, Virgin Mobile, West Central Wireless.
  10. You agree to indemnify Pfizer Inc and any third parties texting on its behalf in full for all claims, expenses, and damages related to or caused, in whole or in part, by your failure to immediately notify us if you change your telephone number, including but not limited to all claims, expenses, and damages related to or arising under the Telephone Consumer Protection Act.
  11. Pfizer Inc may immediately suspend or terminate your participation in the Program if it believes you are in breach of these SMS Terms and Conditions. Your participation in this Program is also subject to termination in the event that your mobile telephone service terminates or lapses. Pfizer Inc reserves the right to modify or discontinue, temporarily or permanently, all or any part of the Program, with or without notice.
  12. Pfizer Inc may revise, modify, or amend these SMS Terms and Conditions at any time. Any such revision, modification, or amendment shall take effect when it is posted to Pfizer Inc's website. You agree to review these SMS Terms and Conditions periodically to ensure that you are aware of any changes. Your continued consent to receive text messages will indicate your acceptance of those changes.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
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INDICATION AND LIMITATIONS OF USE
Ulcerative Colitis
• XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
• Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Clinical Information List

Induction Efficacy Results

Maintenance Efficacy Results

OCTAVE Clinical Program

Safety Profile

Dosing and Laboratory Monitoring

MOA and Other Indications

Pfizer Home
  • XELJANZ UC Home

Clinical Information

  • Induction Efficacy Results
  • Maintenance Efficacy Results
  • OCTAVE Clinical Program
  • Safety Profile
  • Dosing and Laboratory Monitoring
  • MOA and Other Indications

Support & Services

  • Co-Pay Savings Card
  • Patient Cost and Assistance Programs
  • XELSOURCE Forms and Resources
  • XELSOURCE: Patient Access

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION AND INDICATIONS
SERIOUS INFECTIONS
Patients treated with XELJANZ/XELJANZ XR are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.
If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled.
Reported infections include:
• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ/XELJANZ XR use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ/XELJANZ XR use.
• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis.
Avoid use of XELJANZ/XELJANZ XR in patients with an active, serious infection, including localized infections, or with chronic or recurrent infection.
In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily.
The risks and benefits of treatment with XELJANZ/XELJANZ XR should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ/XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.
MORTALITY
Rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.
Consider the risks and benefits of XELJANZ/XELJANZ XR treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing XELJANZ/XELJANZ XR in patients who develop a malignancy.
Malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily dosing in the UC long-term extension study.
Other malignancies were observed in clinical studies and the post-marketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
THROMBOSIS
Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, have occurred in patients treated with XELJANZ and other Janus kinase inhibitors used to treat inflammatory conditions. RA patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study had an observed increase in incidence of these events.​​​​​ Many of these events were serious and some resulted in death. Avoid XELJANZ/XELJANZ XR in patients at risk. Discontinue XELJANZ/XELJANZ XR and promptly evaluate patients with symptoms of thrombosis. For patients with UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. In a long-term extension study in UC, four cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice daily, including one death in a patient with advanced cancer.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in XELJANZ clinical trials, although the role of JAK inhibition is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There was no discernable difference in frequency of gastrointestinal perforation between the placebo and the XELJANZ arms in clinical trials of patients with UC, and many of them were receiving background corticosteroids. XELJANZ/XELJANZ XR should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs).
HYPERSENSITIVITY
Angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving XELJANZ/XELJANZ XR and some events were serious. If a serious hypersensitivity reaction occurs, promptly discontinue tofacitinib while evaluating the potential cause or causes of the reaction.
LABORATORY ABNORMALITIES
Lymphocyte Abnormalities: Treatment with XELJANZ was associated with initial lymphocytosis at one month of exposure followed by a gradual decrease in mean lymphocyte counts. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a count less than 500 cells/mm3. In patients who develop a confirmed absolute lymphocyte count less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Monitor lymphocyte counts at baseline and every 3 months thereafter.
Neutropenia: Treatment with XELJANZ was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with an ANC less than 1000 cells/mm3. For patients who develop a persistent ANC of 500-1000 cells/mm3, interrupt XELJANZ/XELJANZ XR dosing until ANC is greater than or equal to 1000 cells/mm3. In patients who develop an ANC less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Monitor neutrophil counts at baseline and after 4-8 weeks of treatment and every 3 months thereafter.
Anemia: Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a hemoglobin level less than 9 g/dL. Treatment with XELJANZ/XELJANZ XR should be interrupted in patients who develop hemoglobin levels less than 8 g/dL or whose hemoglobin level drops greater than 2 g/dL on treatment. Monitor hemoglobin at baseline and after 4-8 weeks of treatment and every 3 months thereafter.
Liver Enzyme Elevations: Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation compared to placebo. Most of these abnormalities occurred in studies with background DMARD (primarily methotrexate) therapy. If drug-induced liver injury is suspected, the administration of XELJANZ/XELJANZ XR should be interrupted until this diagnosis has been excluded. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury.
Lipid Elevations: Treatment with XELJANZ was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Maximum effects were generally observed within 6 weeks. There were no clinically relevant changes in LDL/HDL cholesterol ratios. Manage patients with hyperlipidemia according to clinical guidelines. Assessment of lipid parameters should be performed approximately 4-8 weeks following initiation of XELJANZ/XELJANZ XR therapy.
VACCINATIONS
Avoid use of live vaccines concurrently with XELJANZ/XELJANZ XR. The interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.
PATIENTS WITH GASTROINTESTINAL NARROWING
Caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non-deformable extended release formulation.
HEPATIC and RENAL IMPAIRMENT
Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.
For patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 5 mg twice daily, reduce to XELJANZ 5 mg once daily.
For UC patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 10 mg twice daily, reduce to XELJANZ 5 mg twice daily.
ADVERSE REACTIONS
The most common serious adverse reactions were serious infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical trials in patients with RA with XELJANZ 5 mg twice daily and placebo, respectively, (occurring in greater than or equal to 2% of patients treated with XELJANZ with or without DMARDs) were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension. The safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in RA patients.
Adverse reactions reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials for UC were: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.
USE IN PREGNANCY
Available data with XELJANZ/XELJANZ XR use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal studies, tofacitinib at 6.3 times the maximum recommended dose of 10 mg twice daily demonstrated adverse embryo-fetal findings. The relevance of these findings to women of childbearing potential is uncertain. Consider pregnancy planning and prevention for females of reproductive potential.
INDICATIONS
Rheumatoid Arthritis
• XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
• Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Psoriatic Arthritis
• XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
• Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Ulcerative Colitis
• XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
• Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information}. New York, NY: Pfizer Inc.; December 2019.
2. Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736, 1-77. doi:10.1056/NEJMoa1606910.
3. Data on file. Pfizer Inc., New York, NY.
4. US Department of Health and Human Services. Clinical trial imaging endpoint process standards: guidance for industry. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm268555.pdf. Published April 2018. Accessed June 1, 2018.
5. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710.
6. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353(23):2462-2476.
7. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomized controlled trial. Gut. 2011;60(6):780-787.
8. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2014;146:85-95.
9. Dhanda AD, Creed TJ, Greenwood R, Sands BE, Probert CS. Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials? Inflamm Bowel Dis. 2012;18(11):2056-2062.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. Data on file. Pfizer Inc., New York, NY.
2. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
3. Danese S, Grisham M, Hodge J, Telliez JB. JAK inhibition using tofacitinib for inflammatory bowel disease treatment: a hub for multiple inflammatory cytokines. Am J Physiol Gastrointest Liver Physiol. 2016;310(3):G155-G162.
4. Hodge JA, Kawabata TT, Krishnaswami S, et al. The mechanism of action of tofacitinib—an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2016;34(2):318-328.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
TERMS & CONDITIONS
CO-PAY CARD TERMS & CONDITIONS
By using the XELJANZ/XELJANZ XR Co-Pay Savings Card (the "Card"), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
  • Patients are not eligible to use this card if they are enrolled in a state and federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Patient must have private insurance. Offer is not valid for cash paying patients.
  • You will receive a maximum benefit of $15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, and may pay as little as $0 per month co-pay. After a maximum of $15,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
  • You must deduct the value of this card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
  • You must be 18 years of age or older to redeem the Card.
  • The Card is not valid where prohibited by law.
  • The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • The Card is not health insurance.
  • Offer good only in the U.S. and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • The Card may be used once per month for the life of the program.
  • No other purchase is necessary.
  • Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke, or amend the program without notice.
  • Card and Program expires 12/31/2021.
If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.
INTERIM CARE RX PROGRAM TERMS & CONDITIONS
  • Interim Care Rx is not health insurance and is available for eligible, commercially insured patients only.
  • Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ/XELJANZ XR.
  • No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party payer.
  • Not available to patients covered under government plans such as Medicaid, Medicare or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts, Michigan, Minnesota, Missouri, Ohio, or Rhode Island.
  • Available in 30-day supply. Refills are subject to limitations.
  • Interim Care Rx offer does not require, nor will be made contingent on, purchase requirements of any kind.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Interim Care Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed and a delay occurs in the prior authorization or appeals process.
  • Offer good only in the U.S. and Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the U.S. or Puerto Rico.
  • Continued eligibility for the program requires the submission of two appeals within 180 days of enrollment. After 12 months of program enrollment an updated prescription and benefits investigation is required to confirm continued eligibility.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.
PATIENT ASSISTANCE PROGRAM/PFIZER PATIENT ASSISTANCE PROGRAM FOR UNDERINSURED PATIENTS TERMS & CONDITIONS
  • The Pfizer Patient Assistance Program is not health insurance and is available for eligible uninsured/underinsured patients only.
  • Offer is only available to patients who meet financial and other criteria.
  • This offer does not require, nor will it be made contingent on, purchase requirements of any kind.
  • No claim for reimbursement or credit for any costs associated with the medicine(s) may be submitted to any prescription insurance provider or payer, including Medicare Part D plans.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Offer good only in the US and Puerto Rico.
  • Patient must be a resident of the United States or Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
  • Patient must be treated in the outpatient setting of care.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
TERMS & CONDITIONS
CO-PAY CARD TERMS & CONDITIONS
By using the XELJANZ XR/XELJANZ Co-pay Savings Card (the "Card"), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
  • Patients are not eligible to use this card if they are enrolled in a state and federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Patient must have private insurance. Offer is not valid for cash paying patients.
  • You will receive a maximum benefit of $15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, and may pay as little as $0 per month co-pay. After a maximum of $15,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
  • You must deduct the value of this card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
  • You must be 18 years of age or older to redeem the Card.
  • The Card is not valid where prohibited by law.
  • The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • The Card is not health insurance.
  • Offer good only in the U.S. and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • The Card may be used once per month for the life of the program.
  • No other purchase is necessary.
  • Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke, or amend the program without notice.
  • Card and Program expires 12/31/2021.
If you have questions or are in need of additional support call 1-844-935-5269 or visit www.XELJANZ.com
XSAVINGS Mobile Text Program Terms & Conditions
User texts "XPROGRAM" to short code 50336.
Text HELP for help, STOP to opt out.
Patients may receive up to 10 messages per month.
Message and data rates may apply.
  1. By opting into the XSAVINGS mobile texting program (Program), you consent to receive up to 10 text messages and/or push notifications from Pfizer Inc. Such messages may be marketing or non-marketing messages and may include co-pay related information, fill confirmation, website information, etc. Messages may be delayed or undelivered for various factors. TrialCard, carriers (including, but not limited to, T-Mobile) and any service providers utilized by TrialCard to send messages are not liable for delayed or undelivered messages.
  2. To stop receiving text messages, text STOP to 50336. DOING SO WILL ONLY OPT YOU OUT OF THIS PROGRAM; you will remain opted in to any other Pfizer Inc text message program(s) into which you opted separately.
  3. To request more information or to obtain help, text HELP to 50336. You can also call customer service at 1-844-935-5269.
  4. You represent that you are the account holder for the mobile telephone number(s) that you provide to opt into the Program. You are responsible for notifying Pfizer Inc immediately if you change your mobile telephone number. You may notify Pfizer Inc of a number change by calling 1-844-935-5269.
  5. Message and data rates may apply to each text message sent or received in connection with the texting program, as provided in your mobile telephone service rate plan (please contact your mobile telephone carrier for pricing plans). Applicable roaming charges may apply. Charges are both billed and payable to your mobile service provider or deducted from your prepaid account. Pfizer Inc does not impose a separate fee for sending text messages.
  6. Data obtained from you in connection with this Program may include your telephone number, your carrier's name, and details of the message (date, time, and content). Pfizer Inc may use this information to contact you and to provide the services you request.
  7. For information on data collection and use, please read our full corporate Privacy Policy (https://www.pfizer.com/Privacy), which is incorporated by reference into these Terms.
  8. Pfizer Inc will not be liable for any delays in the receipt of any SMS messages, as delivery is subject to effective transmission from your network operator.
  9. This Program is available only on these US participating mobile carriers: Verizon Wireless, Sprint, Boost Mobile, T-Mobile, AT&T, Atlantic Tele-Network International (ATNI), Alaska Communications Systems (ACS), ASTAC, Bandwidth.com (includes Republic Wireless), Blue Wireless, Bluegrass Cellular, Breakaway Wireless, Brightlink, C Spire Wireless (aka Cellular South), Carolina West Wireless, CellCom, Cellone Nation, Cellular One of N.E. Arizona, Chariton Valley Cellular, Chat Mobility, Copper Valley Telecom, Cordova Wireless, Cross Wireless, CTC, Custer Telephone, East Kentucky Network (Appalachian Wireless), Enflick, GCI Communications, Google Voice, Illinois Valley Cellular, Inland Cellular, Inteliquent, iWireless, Leaco Rural Telephone Cooperative, Limitless Mobile, Mid-Rivers Communications, MobileNation/SI Wireless, MTA Wireless/Matanuska Kenai, Nemont CDMA, Nemont US UMTS, NewCore Wireless, Nex-Tech Wireless, NNTC Wireless, Northwest Missouri Cellular, Pine Belt Wireless, Pine Cellular, Pioneer Cellular, PTCI, Shelcomm, Silver Star PCS, Snake River PCS, SouthernLINC, SouthernLINC LTE, SRT, STRATA Networks, Standing Rock (SRTI), Thumb Cellular, Triangle Wireless, Union Wireless, U.S. Cellular, United Wireless, Viaero Wireless, Virgin Mobile, West Central Wireless.
  10. You agree to indemnify Pfizer Inc and any third parties texting on its behalf in full for all claims, expenses, and damages related to or caused, in whole or in part, by your failure to immediately notify us if you change your telephone number, including but not limited to all claims, expenses, and damages related to or arising under the Telephone Consumer Protection Act.
  11. Pfizer Inc may immediately suspend or terminate your participation in the Program if it believes you are in breach of these SMS Terms and Conditions. Your participation in this Program is also subject to termination in the event that your mobile telephone service terminates or lapses. Pfizer Inc reserves the right to modify or discontinue, temporarily or permanently, all or any part of the Program, with or without notice.
  12. Pfizer Inc may revise, modify, or amend these SMS Terms and Conditions at any time. Any such revision, modification, or amendment shall take effect when it is posted to Pfizer Inc's website. You agree to review these SMS Terms and Conditions periodically to ensure that you are aware of any changes. Your continued consent to receive text messages will indicate your acceptance of those changes.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.
 
References
1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; December 2019.
2. Data on file. Pfizer Inc., New York, NY.

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