lock or sick sinus syndrome, unless patient has a pacemaker (4)
•Baseline QTc interval ≥500 ms (4)
•Treatment with Class Ia or Class III anti-arrhythmic drugs (4)
WARNINGS AND PRECAUTIONS
•Decrease in heart rate and/or atrioventricular conduction after first dose of GILENYA: Monitor patients (2, 5.1)
•Infections: GILENYA may increase the risk of infections. A recent CBC should be available before initiating treatment with GILENYA. Monitor for signs and symptoms of infection during treatment and for two months after discontinuation. Do not start GILENYA treatment in patients with active acute or chronic infections. (5.2)
•Macular edema: Can occur with or without visual symptoms. An ophthalmologic eva luation should be performed before starting GILENYA and at 3-4 months after treatment initiation. Monitor visual acuity at baseline and during routine eva luations of patients. Patients with diabetes mellitus or a history of uveitis are at increased risk and should have regular ophthalmologic eva luations. (5.3)
•Decrease in pulmonary function tests with GILENYA: Obtain spirometry and diffusion lung capacity for carbon monoxide (DLCO) when clinically indicated. (5.4)
•Hepatic effects: GILENYA may increase liver transaminases. Recent liver enzyme results should be available before starting GILENYA. Assess liver enzymes if hepatic injury is suspected. Discontinue GILENYA if significant liver injury occurs (5.5)
•Fetal risk: Women of childbearing potential should use effective contraception during and for 2 months after stopping GILENYA (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥10% and > placebo): Headache, influenza, diarrhea, back pain, liver transaminase elevations and cough. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•Ketoconazole: Monitor patients closely, as GILENYA exposure is increased by 70% during concomitant use with systemic ketoconazole, and risk of adverse reactions is greater. (7, 12.3)
•Vaccines: Avoid live attenuated vaccines during, and for 2 months after stopping GILENYA treatment, due to risk of infection. (5.2, 7)
USE IN SPECIFIC POPULATIONS
•Pregnancy: Based on animal data, may cause fetal harm. Pregnancy registry available. (8.1)
•Pediatric patients: Safety and effectiveness not established. (8.4)
•Hepatic impairment: Monitor patients with severe hepatic impairment closely, as GILENYA exposure is doubled, and risk of adverse reactions is greater. (5.5, 8.6, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 05/2012
Back to Highlights and Tabs
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Bradyarrhythmia and Atrioventricular Blocks
5.2 Infections
5.3 Macular Edema
5.4 Respiratory Effects
5.5 Hepatic Effects
5.6 Fetal Risk
5.7 Blood Pressure Effects
5.8 Immune System Effects Following GILENYA Discontinuation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
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