Fingolimod Krka

Fingolimod Krka helps manage multiple sclerosis (MS) by reducing flare-ups and slowing down physical problems, but it does not cure the disease.

Form
kapseli, kova
Strength
0.5 mg
Active Ingredient
Fingolimod hydrochloride
Manufacturer
KRKA d.d. Novo mesto

How to Use

Dosage

For adults and adolescents over 40 kg, the usual dose is one 0.5 mg capsule once daily. For adolescents 10 years and older weighing 40 kg or less, the dose is one 0.25 mg capsule once daily.

Method

Take one capsule orally once a day with a glass of water. Swallow the capsule whole, do not open it. You can take it with or without food.

Important

Do not exceed the recommended daily dose.

Possible Side Effects

COMMON
  • Flu-like infection (tiredness, chills, sore throat, joint/muscle pain, fever).
  • Sinus pain or pressure (sinus infection).
  • Headache.
  • Diarrhea.
  • Back pain.
  • Increased liver enzymes (shown in blood tests).
  • Cough.
  • Herpes infection (shingles), with blisters, burning, itching, or pain on skin.
  • Slow or irregular heartbeat.
  • Basal cell carcinoma (a type of skin cancer), often appearing as shiny bumps.
  • Depression and anxiety.
  • Weight loss.
  • Ringworm (fungal skin infection).
  • Dizziness.
  • Migraine (severe headache, nausea, vomiting, light sensitivity).
  • Low white blood cell count.
  • Weakness.
  • Eczema (itchy, red rash).
  • Itching.
  • High blood fat levels.
  • Hair loss.
  • Shortness of breath.
  • High blood pressure.
  • Muscle pain.
  • Joint pain.
RARE
  • Pneumonia (fever, cough, difficulty breathing).
  • Macular edema (swelling in the back of the eye), with symptoms like shadows, blind spots, blurred vision, or difficulty distinguishing colors.
  • Low platelet count, increasing risk of bleeding or bruising.
  • Melanoma (a type of skin cancer usually starting from an abnormal mole) which can change in size, shape, color, or bleed.
  • Seizures (more common in children and adolescents).
  • Posterior reversible encephalopathy syndrome (PRES), with symptoms like sudden severe headache, confusion, seizures, and/or vision problems.
  • Lymphoma (a type of cancer affecting the immune system).
  • Squamous cell carcinoma (a type of skin cancer) that can appear as a firm red lump, scaly sore, or new sore on an old scar.
  • Abnormal heart electrical activity (T-wave inversion on ECG).
  • Tumor linked to human herpesvirus 8 infection (Kaposi's sarcoma).

Important Warnings

  • Do not take if your immune system is weak (due to disease or other medicines).
  • Do not take if you have a severe active or chronic infection, like hepatitis or tuberculosis.
  • Do not take if you have active cancer.
  • Do not take if you have severe liver disease.
  • Do not take if you have had a heart attack, chest pain, stroke, or certain types of heart failure in the last 6 months.
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  • Do not take if you have certain types of irregular heartbeats or if an ECG showed a long QT interval before starting this medicine.
  • Do not take if you are using or have recently used medicines for irregular heartbeats like quinidine, disopyramide, amiodarone, or sotalol.
  • Do not take if you are pregnant or could become pregnant and are not using effective birth control.
  • This medicine can make your heart beat slower or irregularly, especially at the start. Your doctor will monitor your heart. Tell your doctor if you feel dizzy or tired.
  • This medicine can lower your white blood cells, making you more prone to infections. Contact your doctor immediately if you have fever, flu-like symptoms, or unusual signs of infection.
  • This medicine can cause swelling in the back of your eye (macular edema), affecting your vision. Your doctor will check your eyes regularly. Report any vision changes.
  • This medicine can affect your liver. Your doctor will do blood tests. If you notice yellow skin/eyes, dark urine, stomach pain, or feel very tired, contact your doctor right away.
  • Women must use effective birth control during treatment and for 2 months after stopping, as it can harm an unborn baby.