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Gilenya

Last reviewed on RxList: 4/10/2020
Gilenya Side Effects Center

What Is Gilenya?

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator used to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations and to delay physical disability.

What Are Side Effects of Gilenya?

Common side effects of Gilenya are:

Gilenya can affect your immune system's ability to fight an infection while you are taking the medication and for 2 months after your last dose. Tell your doctor right away if you develop signs of an infection such as:

  • persistent cough or sore throat,
  • difficulty breathing,
  • fever,
  • chills, or
  • cold/flu symptoms.

Dosage for Gilenya

The recommended dose for Gilenya is 0.5 mg orally once daily, with or without food.

What Drugs, Substances, or Supplements Interact with Gilenya?

Gilenya may interact with:

  • beta-blockers,
  • calcium channel blockers,
  • citalopram,
  • chlorpromazine,
  • digoxin,
  • erythromycin,
  • haloperidol,
  • ketoconazole,
  • medications to control the immune system,
  • medications for cancer,
  • heart problems, or high blood pressure, and
  • methadone

Tell your doctor all medications and supplements you use.

Gilenya During Pregnancy and Breastfeeding

Gilenya may cause fetal harm. It takes approximately 2 months for Gilenya to be eliminated from the body. Women should avoid pregnancy during treatment with Gilenya and for 2 months after treatment. It is not known if Gilenya passes into breast milk. Women and their doctors should decide whether to take Gilenya or breastfeed. Women should not do both.

Additional Information

Our Gilenya (fingolimod) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Multiple Sclerosis (MS) Symptoms and Treatment See Slideshow
Gilenya Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Fingolimod may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

  • chest pain, slow or irregular heartbeats, dizziness, tiredness;
  • shiny nodules on your skin, sores that do not heal, unusual moles that change in color or size;
  • fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light;
  • sores in your mouth and throat, cold sores, sores on your genital or anal area;
  • vision problems, blurred vision, eye pain, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking fingolimod);
  • headache, confusion, change in mental status, vision loss, seizure (convulsions);
  • shortness of breath; or
  • liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache, back pain;
  • stomach pain, diarrhea;
  • pain in your arms or legs;
  • cough, stuffy nose, flu symptoms; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gilenya (Fingolimod Capsules)

QUESTION

What kind of disease is multiple sclerosis? See Answer
Gilenya Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in labeling:

  • Bradyarrhythmia and Atrioventricular Blocks [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Progressive Multifocal Leukoencephalopathy [see WARNINGS AND PRECAUTIONS]
  • Macular Edema [see WARNINGS AND PRECAUTIONS]
  • Liver Injury [see WARNINGS AND PRECAUTIONS]
  • Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
  • Respiratory Effects [see WARNINGS AND PRECAUTIONS]
  • Fetal Risk [see WARNINGS AND PRECAUTIONS]
  • Severe Increase in Disability After Stopping GILENYA [see WARNINGS AND PRECAUTIONS]
  • Increased Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Malignancies [see WARNINGS AND PRECAUTIONS]
  • Immune System Effects Following GILENYA Discontinuation [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

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 1212 patients with relapsing forms of multiple sclerosis received GILENYA 0.5 mg. This included 783 patients who received GILENYA 0.5 mg in the 2-year placebo-controlled trials (Studies 1 and 3) and 429 patients who received GILENYA 0.5 mg in the 1-year active-controlled trial (Study 2). The overall exposure in the controlled trials was equivalent to 1716 person-years. Approximately 1000 patients received at least 2 years of treatment with GILENYA 0.5 mg. In all clinical studies, including uncontrolled extension studies, the exposure to GILENYA 0.5 mg was approximately 4119 person-years.

In placebo-controlled trials, the most frequent adverse reactions (incidence ≥ 10% and greater than placebo) for GILENYA 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 GILENYA 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 GILENYA-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 GILENYA 0.5 mg at ≥ 1% Higher Rate than for Placebo)

Adverse Drug Reactions GILENYA 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 GILENYA 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 GILENYA doses (1.25-5 mg) higher than recommended for use in MS. Similar events have been reported with GILENYA 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 GILENYA in clinical trials and in the postmarketing setting in adults [see ADVERSE REACTIONS]. In adult clinical trials, the rate of seizures was 0.9% in GILENYA-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 GILENYA, or to a combination of both.

Pediatric Patients 10 Years Of Age And Older

In the controlled pediatric trial (Study 4), the safety profile in pediatric patients receiving GILENYA 0.25 mg or 0.5 mg daily was similar to that seen in adult patients.

In the pediatric study, cases of seizures were reported in 5.6% of GILENYA-treated patients and 0.9% of interferon beta-1a-treated patients [see Use In Specific Populations].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of GILENYA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary Disorders: Liver injury [see WARNINGS AND PRECAUTIONS]

Infections: infections including cryptococcal infections [see WARNINGS AND PRECAUTIONS], progressive multifocal leukoencephalopathy [see WARNINGS AND PRECAUTIONS]

Musculoskeletal and connective tissue disorders: arthralgia, myalgia

Nervous system disorders: posterior reversible encephalopathy syndrome [see WARNINGS AND PRECAUTIONS], seizures, including status epilepticus [see ADVERSE REACTIONS]

Neoplasms, benign, malignant, and unspecified (incl cysts and polyps): melanoma, Merkel cell carcinoma, and cutaneous T cell lymphoma (including mycosis fungoides) [see WARNINGS AND PRECAUTIONS]

Skin and subcutaneous tissue disorders: hypersensitivity [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Gilenya (Fingolimod Capsules)

Related Resources for Gilenya

Read the Gilenya User Reviews »

© Gilenya Patient Information is supplied by Cerner Multum, Inc. and Gilenya Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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