Fingolimod (Page 4 of 10)

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)]

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).

Table 1 lists adverse reactions in clinical studies in adults that occurred in ≥ 1% of fingolimod-treated patients and ≥ 1% higher rate than for placebo.

Table 1: Adverse Reactions Reported in Adult Studies 1 and 3 (Occurring in ≥1% of Patients and Reported for fingolimod capsule 0.5 mg at ≥1% Higher Rate than for Placebo)

Adverse Drug Reactions Fingolimod capsule 0.5 mg N=783% Placebo N=773 %
Infections
Influenza 11 8
Sinusitis 11 8
Bronchitis 8 5
Herpes zoster 2 1
Tinea versicolor 2 ˂1
Cardiac disorders
Bradycardia 3 1
Nervous system disorders
Headache 25 24
Migraine 6 4
Gastrointestinal disorders
Nausea 13 12
Diarrhea 13 10
Abdominal pain 11 10
General disorders and administration-site conditions
Asthenia 2 1
Musculoskeletal and connective tissue disorders
Back pain 10 9
Pain in extremity 10 7
Skin and subcutaneous tissue disorders
Alopecia 3 2
Actinic keratosis 2 1
Investigations
Liver transaminase elevations (ALT/GGT/AST) 15 4
Blood triglycerides increased 3 1
Respiratory, thoracic, and mediastinal disorders
Cough 12 11
Dyspnea 9 7
Eye disorders
Vision blurred 4 2
Vascular disorders
Hypertension 8 4
Blood and lymphatic system disorders
Lymphopenia 7 ˂1
Leukopenia 2 ˂1
Neoplasms benign, malignant, and unspecified (including cysts and polyps)
Skin papilloma 3 2
Basal cell carcinoma 2 1

Adverse reactions of seizure, dizziness, pneumonia, eczema, and pruritus were also reported in Studies 1 and 3, but did not meet the reporting rate criteria for inclusion in Table 1 (difference was less than 1%).

Adverse reactions with fingolimod capsule 0.5 mg in Study 2, the 1-year active-controlled (versus interferon beta-1a) study were generally similar to those in Studies 1 and 3.

Vascular Events
Vascular events, including ischemic and hemorrhagic strokes, and peripheral arterial occlusive disease were reported in premarketing clinical trials in patients who received fingolimod doses (1.25 mg to 5 mg) higher than recommended for use in MS. Similar events have been reported with fingolimod in the postmarketing setting although a causal relationship has not been established.
Seizure
Cases of seizures, including status epilepticus, have been reported with the use of fingolimod in clinical trials and in the postmarketing setting in adults [see Adverse Reactions (6.2)]. In adult clinical trials, the rate of seizures was 0.9% in fingolimod-treated patients and 0.3% in placebo-treated patients. It is unknown whether these events were related to the effects of multiple sclerosis alone, to fingolimod, or to a combination of both.

Pediatric use information is approved for Novartis Pharmaceuticals Corporation’s GILENYA (fingolimod) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.