|
VIIBRYD (vilazodone hydrochloride) tablets
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VIIBRYD ® safely and effectively. See full prescribing information for VIIBRYD.
VIIBRYD (vilazodone hydrochloride) tablets, for oral use
Initial U.S. Approval: 2011
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
-
Antidepressants increase the risk of suicidal thoughts and behaviors in patients aged 24 years and younger (5.1).
-
Monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1).
-
Safety and effectiveness of VIIBRYD have not been established in pediatric patients (8.4).
RECENT MAJOR CHANGES
|
Dosage and Administration (2) |
03/2015 |
|
Warnings and Precautions (5.2) |
04/2014 |
|
Warnings and Precautions (5.7) |
07/2014 |
INDICATIONS AND USAGE
VIIBRYD is indicated for the treatment of major depressive disorder (MDD) (1).
DOSAGE AND ADMINISTRATION
-
Recommended target dosage: 20 mg to 40 mg once daily with food (2.1, 12.3)
-
To titrate: start with initial dosage of 10 mg once daily for 7 days, followed by 20 mg once daily. The dose may be increased up to 40 mg once daily after a minimum of 7 days between dosage increases (2.1)
-
Prior to initiating VIIBRYD, screen for bipolar disorder (2.2, 5.4)
-
When discontinuing VIIBRYD, reduce dosage gradually (2.4, 5.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
-
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4)
WARNINGS AND PRECAUTIONS
-
Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue VIIBRYD and initiate supportive treatment (5.2)
-
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.3)
-
Activation of Mania/Hypomania: Screen patients for bipolar disorder (5.4).
-
Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder (5.6).
-
Angle Closure Glaucoma: Avoid use of antidepressants, including VIIBRYD, in patients with untreated anatomically narrow angles. (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia (6).
To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories, LLC. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
-
CYP3A4 Inhibitors: The VIIBRYD dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors (2.4, 7).
-
CYP3A4 Inducers: Consider increasing VIIBRYD dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days (2.4, 7).
USE IN SPECIFIC POPULATIONS
-
Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the newborn (8.1).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Treatment of Major Depressive Disorder
The recommended target dosage for VIIBRYD is 20 mg to 40 mg orally once daily with food [see Clinical Pharmacology (12.3), Clinical Studies (14)]. To achieve the target dosage, titrate VIIBRYD as follows:
-
Start with an initial dosage of 10 mg once daily with food for 7 days,
-
Then increase to 20 mg once daily with food.
-
The dose may be increased up to 40 mg once daily with food after a minimum of 7 days between dosage increases.
If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.
2.2 Screen for Bipolar Disorder Prior to Starting VIIBRYD
Prior to initiating treatment with VIIBRYD or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)].
2.3 Switching to or from a Monoamine Oxidase Inhibitor Antidepressant
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of VIIBRYD. In addition, at least 14 days must elapse after stopping VIIBRYD before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].
2.4 Dosage Adjustments with CYP3A4 Inhibitors or Inducers
Patients receiving concomitant CYP3A4 inhibitors:
During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the VIIBRYD dose should not exceed 20 mg once daily. The original VIIBRYD dose level, can be resumed when the CYP3A4 inhibitor is discontinued [see Drug Interactions (7)].
Patients receiving concomitant CYP3A4 inducers:
Based on clinical response, consider increasing the dosage of VIIBRYD by 2-fold, up to a maximum 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for greater than 14 days. If CYP3A4 inducers are discontinued, gradually reduce the VIIBRYD dosage to its original level over 1 to 2 weeks [see Drug Interactions (7)].
2.5 Discontinuing Treatment with VIIBRYD
Adverse reactions may occur upon discontinuation of VIIBRYD [see Warnings and Precautions (5.5)]. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. VIIBRYD should be down tapered from the 40 mg once daily dose to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Patients taking VIIBRYD 20 mg once daily should be tapered to 10 mg once daily for 7 days.
3 DOSAGE FORMS AND STRENGTHS
VIIBRYD Tablets are available as 10 mg, 20 mg and 40 mg film-coated tablets.
-
-
10 mg pink, oval tablet, debossed with 10 on one side
-
-
20 mg orange, oval tablet, debossed with 20 on one side
-
-
40 mg blue, oval tablet, debossed with 40 on one side
4 CONTRAINDICATIONS
VIIBRYD is contraindicated in:
-
Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].
5 WARNINGS AND PRECAUTIONS
|
|
