Gilenya
New Pill May Reduce Relapses in MS Patients »
"Oct. 5, 2011 -- People with multiple sclerosis (MS) may soon have a second needle-free option to control their disease.
Last year, the FDA approved the first disease-modifying pill, a drug called Gilenya, to treat MS.
Now "...
Read the New Pill May Reduce Relapses in MS Patients article »
Gilenya
Gilenya Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Gilenya (fingolimod) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations and to delay physical disability. Most common side effects with the use of Gilenya are headache, influenza, diarrhea, back pain, liver transaminase elevations, and cough.
The recommended dose for Gilenya is 0.5 mg orally once daily, with or without food. 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 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.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Gilenya in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- slow heart rate, dizziness, feeling very weak or tired;
- chest pain, pounding heartbeats or fluttering in your chest;
- sudden numbness or weakness, severe headache, problems with speech or walking;
- wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;
- fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;
- swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- vision problems, blurred vision, eye pain, increased sensitivity to light, 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).
Less serious side effects may include:
- headache, tired feeling;
- back pain;
- diarrhea; or
- stuffy nose, sinus pain, or cough.
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Gilenya Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication 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. You may be more likely to get a serious infection (such as bronchitis, pneumonia). Tell your doctor right away if you develop any signs of an infection such as persistent cough/sore throat, difficulty breathing, fever/chills, or cold/flu symptoms. Do not start fingolimod if you have a current infection.
Get medical help right away if you have any very serious side effects, including: shortness of breath, chest pain, severe dizziness/fainting, slow/irregular/fast heartbeat, unusual tiredness/weakness, eye pain/sensitivity to light, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes).
This medication may rarely cause serious liver problems. Tell your doctor right away if you experience: yellowing eyes/skin, dark urine, stomach/abdominal pain, persistent nausea.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Gilenya (Fingolimod Capsules)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Gilenya FDA Prescribing Information: Side Effects
(Adverse Reactions)
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]
- Macular edema [see WARNINGS AND PRECAUTIONS]
- Respiratory effects [see WARNINGS AND PRECAUTIONS]
- Hepatic effects [see WARNINGS AND PRECAUTIONS]
The most frequent adverse reactions (incidence ≥ 10% and > placebo) for GILENYA 0.5 mg were headache, influenza, diarrhea, back pain, liver enzyme elevations, and cough. The only adverse event leading to treatment interruption reported at an incidence > 1% for GILENYA 0.5 mg was serum transaminase elevations (3.8%).
Clinical Trials Experience
A total of 1703 patients on GILENYA (0.5 or 1.25 mg once daily) constituted the safety population in the 2 controlled studies in patients with relapsing remitting MS (RRMS) [see Clinical Studies].
Study 1 was a 2-year placebo-controlled clinical study in 1272 MS patients treated with GILENYA 0.5 mg (n=425), GILENYA 1.25 mg (n=429) or placebo (n= 418).
Table 1 : Adverse Reactions in
Study 1 (occurring in ≥ 1% of patients, and reported for GILENYA 0.5 mg at
≥ 1% higher rate than for placebo)
| Placebo N=418 % |
||
| Infections | ||
| Influenza viral infections | 13 | 10 |
| Herpes viral infections | 9 | 8 |
| Bronchitis | 8 | 4 |
| Sinusitis | 7 | 5 |
| Gastroenteritis | 5 | 3 |
| Tinea infections | 4 | 1 |
| Bradycardia | 4 | 1 |
| Headache | 25 | 23 |
| Dizziness | 7 | 6 |
| Paresthesia | 5 | 4 |
| Migraine | 5 | 1 |
| Diarrhea | 12 | 7 |
| General disorders and administration site conditions | ||
| Asthenia | 3 | 1 |
| Back pain | 12 | 7 |
| Alopecia | 4 | 2 |
| Eczema | 3 | 2 |
| Pruritus | 3 | 1 |
| ALT/AST increased | 14 | 5 |
| GGT increased | 5 | 1 |
| Weight decreased | 5 | 3 |
| Blood triglycerides increased | 3 | 1 |
| Cough | 10 | 8 |
| Dyspnea | 8 | 5 |
| Depression | 8 | 7 |
| Vision blurred | 4 | 1 |
| Eye pain | 3 | 1 |
| Hypertension | 6 | 4 |
| Lymphopenia | 4 | 1 |
| Leukopenia | 3 | < 1 |
Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a, n=431) study including 849 patients with MS treated with fingolimod, were generally similar to those in Study 1.
Vascular Events
Vascular events, including ischemic and hemorrhagic strokes, peripheral arterial occlusive disease and posterior reversible encephalopathy syndrome were reported in premarketing clinical trials in patients who received GILENYA doses (1.25-5 mg) higher than recommended for use in MS. No vascular events were observed with GILENYA 0.5 mg in the premarketing database.
Lymphomas
Cases of lymphoma (cutaneous T-cell lymphoproliferative disorders or diffuse B-cell lymphoma) were reported in premarketing clinical trials in MS patients receiving GILENYA at, or above, the recommended dose of 0.5 mg. Based on the small number of cases and short duration of exposure, the relationship to GILENYA remains uncertain.
Read the entire FDA prescribing information for Gilenya (Fingolimod Capsules) »
Additional Gilenya Information
Gilenya - User Reviews
Gilenya User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Gilenya sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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