Fingolimod Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.3 )] Macular Edema [see Warnings and Precautions ( 5.4 )] Liver Injury [ see Warnings and Precautions ( 5.5 ) ] Posterior Reversible Encephalopathy Syndrome [ see Warnings and Precautions ( 5.6 ) ] Respiratory Effects [ see Warnings and Precautions ( 5.7 ) ] Fetal Risk [see Warnings and Precautions ( 5.8 )] Severe Increase in Disability After Stopping Fingolimod [see Warnings and Precautions ( 5.9 )] Tumefactive Multiple Sclerosis [see Warnings and Precautions ( 5.10 )] Increased Blood Pressure [see Warnings and Precautions ( 5.11 )] Malignancies [see Warnings and Precautions ( 5.12 ) ] Immune System Effects Following fingolimod Discontinuation [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (incidence ≥10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults In clinical trials (Studies 1, 2, and 3), a total of 1,212 patients with relapsing forms of multiple sclerosis received fingolimod capsule 0.5 mg.

This included 783 patients who received fingolimod capsule 0.5 mg in the 2-year placebo-controlled trials (Studies 1 and 3) and 429 patients who received fingolimod capsule 0.5 mg in the 1-year active-controlled trial (Study 2).

The overall exposure in the controlled trials was equivalent to 1,716 person-years .

Approximately 1,000 patients received at least 2 years of treatment with fingolimod capsule 0.5 mg.

In all clinical studies, including uncontrolled extension studies, the exposure to fingolimod capsule 0.5 mg was approximately 4,119 person-years.

In placebo-controlled trials, the most frequent adverse reactions (incidence ≥10% and greater than placebo) for fingolimod capsule 0.5 mg were headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

Adverse events that led to treatment discontinuation and occurred in more than 1% of patients taking fingolimod capsule 0.5 mg, were serum transaminase elevations (4.7% compared to 1% on placebo) and basal cell carcinoma (1% compared to 0.5% on placebo).