Scroll for IMPORTANT SAFETY INFORMATION and INDICATION
There are no contraindications for VIZIMPRO
Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is confirmed.
Diarrhea: Severe and fatal diarrhea occurred in patients treated with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of diarrhea. Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea.
Dermatologic Adverse Reactions: Rash and exfoliative skin reactions occurred in patients treated with VIZIMPRO. Rash occurred in 78% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 rash was reported in 21% of patients. Exfoliative skin reactions of any severity were reported in 7% of patients. Grade 3 or 4 exfoliative skin reactions were reported in 1.8% of patients. Withhold VIZIMPRO for persistent Grade 2 or any Grade 3 or 4 dermatologic adverse reaction until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of the dermatologic adverse reaction. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of VIZIMPRO, initiate use of moisturizers and appropriate measures to limit sun exposure. Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids. Initiate oral antibiotics for Grade 2 or more severe dermatologic adverse reactions.
Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VIZIMPRO and for at least 17 days after the final dose.
Adverse Reactions: The most common (>20%) adverse reactions were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). The most common (≥1%) serious adverse reactions were diarrhea (2.2%) and interstitial lung disease (1.3%).
Drug Interactions: Concomitant use with a proton pump inhibitor (PPI) decreases dacomitinib concentrations, which may reduce VIZIMPRO efficacy. Avoid the concomitant use of PPIs with VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist. Concomitant use of VIZIMPRO increases the concentration of drugs that are CYP2D6 substrates which may increase the risk of toxicities of these drugs. Avoid concomitant use of VIZIMPRO with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.
Lactation: Because of the potential for serious adverse reactions in breastfed infants from VIZIMPRO, advise women not to breastfeed during treatment with VIZIMPRO and for at least 17 days after the last dose.
Geriatric: Exploratory analyses suggest a higher incidence of Grade 3/4 adverse reactions and more frequent dose interruptions and discontinuations for adverse reactions in patients 65 years or older.
Renal Impairment: No dose modification is recommended for patients with mild or moderate renal impairment. The recommended dose of VIZIMPRO has not been established for patients with severe renal impairment (CLcr <30 mL/min).
Hepatic Impairment: No dose modification is recommended in patients with mild, moderate or severe hepatic impairment.
VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
This site is intended for U.S. health care professionals.
INDICATION: VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
VIZIMPRO is available through specific specialty pharmacies
To help your patients access the medication you’ve prescribed, Pfizer Oncology Together can identify specialty pharmacy options. If you prefer, you and your staff can also continue to work directly with specialty pharmacies.
Contact the specialty pharmacy directly to fill the prescription if one of the following applies:
Your office knows the patient’s specialty pharmacy
Your patient knows that the specialty pharmacy is covered in his/her plan and that the pharmacy is in the treatment network
Your office uses a specialty pharmacy that is in the patient’s network
Making your patients’ support needs a priority. Together.
At Pfizer Oncology Together™, patient support is at the core of everything we do. We’ve gathered resources and developed tools to help patients and their loved ones throughout VIZIMPRO treatment. From helping to identify financial assistance options to connecting patients to resources for emotional support, your patients' needs are our priority.
Patient Financial Assistance
Resources for eligible patients with commercial, private, employer, or state health insurance marketplace coverage:
†Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico. Patients may receive up to $25,000 in savings per product annually. The offer will be accepted only at participating pharmacies. This offer is not health insurance. No membership fees apply. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. For any questions, please call 1-877-744-5675, visit PfizerOncologyTogether.com/terms or write: Pfizer Oncology Together Co-Pay Savings Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.
Assistance for patients with searching for financial support that may be available from independent charitable foundations. These foundations exist independently of Pfizer and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations
Financial assistance through Extra Help, a Medicare Part D Low-Income Subsidy (LIS) program
Help finding coverage
Free medication for eligible patients through the Pfizer Patient Assistance Program
‡If support from independent charitable foundations or Medicare Extra Help is not available, Pfizer Oncology Together will provide eligible patients with medication for free through the Pfizer Patient Assistance Program. The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance FoundationTM. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.
When your patients need support for their day-to-day challenges, we want to be a place they can turn to for help. At Pfizer Oncology Together, our Care Champions, who have social work experience, can connect patients prescribed VIZIMPRO to resources that may help with some of their daily needs.§
Connections to emotional support resources such as diagnosis-specific support groups, an independent organization's helpline, and a free app to connect with loved ones
Connections to independent organizations that help eligible patients find free rides and lodging for
Educational information about physical and mental health, nutrition, and VIZIMPRO
Information to help patients prepare for leaving or returning to work
§Some services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations.