IMPORTANT SAFETY INFORMATION AND INDICATION
EFFEXOR XR is available in different dosage strengths (37.5 mg, 75 mg, and 150 mg).
Important Safety Information and Indications
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy, monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Effexor XR is not approved for use in pediatric patients.
- Effexor XR is contraindicated in patients with a known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the Effexor XR formulation
-
The use of monoamine oxidase inhibitors (MAOIs) (intended to treat psychiatric disorders) concomitantly with Effexor XR or within 7 days of discontinuing treatment with Effexor XR is contraindicated because of an increased risk of serotonin syndrome. Additionally, the use of Effexor XR within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicatedStarting Effexor XR in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome
- Adult and pediatric patients with MDD can experience worsening of their depression and/or the emergence of suicidal ideation and behavior, whether or not they are taking antidepressants. All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms
- Effexor XR is not approved for use in bipolar depression. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder
- Development of potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Effexor XR alone, but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and others, such as linezolid or intravenous methylene blue). If concomitant use of Effexor XR with other serotonergic drugs is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Patients should be made aware of the potential risk of serotonin syndrome
- In controlled trials, there were dose-related increases in systolic and diastolic blood pressure, as well as cases of sustained hypertension
- Monitor blood pressure before initiating treatment with Effexor XR and regularly during treatment. Control pre-existing hypertension before initiating treatment with Effexor XR. Use caution in treating patients with pre-existing hypertension or cardiovascular or cerebrovascular conditions that might be compromised by increases in blood pressure. Sustained blood pressure elevation can lead to adverse outcomes. Cases of elevated blood pressure requiring immediate treatment have been reported with Effexor XR. Consider dose reduction or discontinuation of treatment for patients who experienced a sustained increase in blood pressure
- SSRIs and SNRIs, including Effexor XR, may increase the risk of bleeding events, ranging from ecchymoses, hematomas, epistaxis, petechiae, and gastrointestinal hemorrhage to life-threatening hemorrhage. Concomitant use of aspirin, NSAIDs, and warfarin, and other anti- coagulants or other drugs known to affect platelet function may add to this risk
- The pupillary dilation that occurs following use of many antidepressant drugs including Effexor XR may trigger an angle closure attack in a patient with anatomically narrow angles (Angle Closure Glaucoma) who does not have a patent iridectomy
- As with all antidepressants, Effexor XR should be used cautiously in patients with a history or family history of mania or hypomania
- Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually
- Effexor XR, like many antidepressants, should be used cautiously in patients with a history of seizures and should be discontinued in any patient who develops seizures
- Hyponatremia can occur as a result of treatment with SSRIs and SNRIs, including Effexor XR. Consider discontinuation of Effexor XR in patients with symptomatic hyponatremia
- Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy have been rarely reported
- The most commonly observed adverse reactions in Effexor XR-treated patients in MDD, GAD, SAD, and PD (incidence ≥ 5% and at least twice the rate of placebo) were nausea (30.0%), somnolence (15.3%), dry mouth (14.8%), sweating (11.4%), abnormal ejaculation (9.9%), anorexia (9.8%), constipation (9.3%), impotence (5.3%), and decreased libido (5.1%)
- As with any psychotropic drug, Effexor XR may impair judgment, thinking, or motor skills; patients should be advised to exercise caution until they have adapted to therapy
Indications
Effexor XR extended-release capsules are indicated for the treatment of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia.
Please see Full Prescribing Information, including BOXED WARNING, and Medication Guide.
EFFEXOR XR Savings Card Terms and Conditions
By participating in the EFFEXOR XR Savings Offer Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- This Savings Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, Tricare, or other federal or state healthcare programs (including any state prescription drug assistance programs) and the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”)
- You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- Eligible patients will pay a minimum of $4 per prescription fill. By using the Savings Offer, eligible patients will receive a savings of up to $150 per fill off their co-pay or out-of-pocket costs. The Savings Offer is good for a maximum savings of $1,800 per year ($150 per month x 12 months). The Savings Offer limits your prescription cost to $4, subject to a maximum $150 monthly benefit. Thus, if your co-pay or out-of-pocket cost is more than $150, you will save $150 off of your co-pay or total out-of-pocket costs. [Example: If your co-pay or out-of-pocket costs are $175, you will pay $25 ($175 – $150 = $25)]. If your co-pay or out-of-pocket costs are no more than $150, you pay $4. For a mail-order 3-month prescription, your total maximum savings will be $450 ($150 x 3)
- This Savings Offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs
- The Savings Offer is not valid for Massachusetts residents whose prescriptions are covered, in whole or in part, by third-party insurance
- This Savings Offer is not valid where prohibited by law
- The Savings Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
- The Savings Offer may not be redeemed more than once per month per patient
- The Savings Offer will be accepted only at participating pharmacies
- The Savings Offer is not health insurance
- This Savings Offer is good only in the U.S. and Puerto Rico
- The Savings Offer is limited to 1 per person during this offering period and is not transferable
- Pfizer reserves the right to rescind, revoke, or amend the program without notice
- No membership fees. The Savings Offer and Program expire on 12/31/2020
For reimbursement when using a nonparticipating pharmacy/mail order: Pay for your EFFEXOR XR prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: EFFEXOR XR Savings Offer, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the front of your Savings Card, your name, and mailing address.
