Fingolimod Devatis

This medicine helps reduce flare-ups and slows down the worsening of Multiple Sclerosis (MS) symptoms.

Form
kapseli, kova
Strength
0.25 mg
Active Ingredient
Fingolimod hydrochloride
Manufacturer
Devatis GmbH

How to Use

Dosage

One 0.5 mg capsule once a day.

Method

Swallow the capsule whole with water, with or without food. Taking it at the same time daily helps you remember.

Important

Do not take more than the recommended dose.

Possible Side Effects

COMMON
  • Flu-like symptoms (tiredness, chills, sore throat, muscle/joint pain, fever).
  • Headache or migraine (severe headache with sickness, vomiting, or light sensitivity).
  • Pressure or pain in your sinuses (cheeks and forehead).
  • Cough.
  • Diarrhea.
  • Back pain.
  • Higher liver enzyme levels shown in blood tests.
  • Dizziness.
  • Low white blood cell count.
  • Feeling weak.
  • Skin rash, itching, or eczema (red, burning skin).
  • Higher blood fat (triglyceride) levels.
  • Hair loss.
  • Shortness of breath.
  • Depression or feeling anxious.
  • Blurred vision.
  • High blood pressure.
  • Muscle or joint pain.
  • Herpes virus infection (shingles), which can cause blisters, burning, itching, or pain on the skin.
  • Slow or irregular heart rhythm.
  • A type of skin cancer (basal cell carcinoma), often seen as a pearly lump.
RARE
  • Pneumonia (lung infection) with fever, cough, and difficulty breathing.
  • Swelling at the back of the eye (macular edema), causing shadows, a blind spot, blurry vision, or trouble seeing colors/details.
  • Low number of platelets in your blood, increasing the risk of bleeding or bruising easily.
  • A serious type of skin cancer (malignant melanoma), often starting from an unusual mole.
  • Seizures.
  • Low number of certain white blood cells (neutrophils).
  • Depressed mood.
  • Nausea.
  • A rare brain problem called PRES, with sudden severe headache, confusion, seizures, or vision issues.
  • Lymphoma (a type of cancer that affects the lymph system).
  • Squamous cell carcinoma (another type of skin cancer that can look like a red lump or a sore).
  • Abnormal electrical activity in the heart (T-wave inversion on an ECG).
  • A tumor linked to human herpesvirus 8 (Kaposi's sarcoma).
  • Allergic reactions like rash, itchy skin bumps, or swelling of the lips, tongue, or face.
  • Signs of liver problems (yellow skin/eyes, feeling sick, throwing up, pain in the right side of the stomach, dark urine, feeling tired, or abnormal liver tests).
  • Risk of a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML).
  • An inflammatory reaction after stopping this medicine (IRIS).
  • Fungal infections, like cryptococcal meningitis (headache with stiff neck, light sensitivity, feeling sick, or confusion).
  • Merkel cell carcinoma (a type of skin cancer, often a painless lump on the face, head, or neck).
  • Swelling in the arms or legs (peripheral swelling).
  • Autoimmune anemia (your body's immune system destroys red blood cells).

Important Warnings

  • Do not take this medicine if your immune system is weak.
  • Do not take this medicine if you have a serious ongoing infection, like hepatitis or tuberculosis.
  • Do not take this medicine if you have active cancer.
  • Do not take this medicine if you have severe liver problems.
  • Do not take this medicine if you have had heart problems in the past 6 months (like a heart attack, stroke, or irregular heartbeat).
Show 4 more warnings
  • Do not take this medicine if you are taking certain heart rhythm medicines.
  • Do not take this medicine if you are pregnant or could become pregnant and are not using effective birth control.
  • Do not take this medicine if you are allergic to this medicine or its ingredients.
  • Do not take this medicine if your doctor suspects or has confirmed a rare brain infection called PML.