Fingolimod Tillomed
Fingolimod helps reduce MS flare-ups and slow down the worsening of physical problems, but it does not cure the disease.
Form
kapseli, kova
Strength
0.5 mg
Active Ingredient
Fingolimod hydrochloride
Manufacturer
Tillomed Pharma GmbH
How to Use
Dosage
Adults: One 0.5 mg capsule once a day. Children and adolescents (10 years and older): Dose depends on body weight. For those weighing 40 kg or less: 0.25 mg once a day. For those weighing over 40 kg: One 0.5 mg capsule once a day.
Method
Take one capsule by mouth with a glass of water once daily. Swallow the capsule whole; do not open it. You can take it with or without food.
Important
Do not exceed one 0.5 mg capsule per day for adults and children weighing over 40 kg, or one 0.25 mg capsule per day for children weighing 40 kg or less.
Possible Side Effects
COMMON
- •Flu-like symptoms (tiredness, chills, sore throat, joint or muscle pain, fever)
- •Sinusitis (feeling of pressure or pain in cheeks and forehead)
- •Headache
- •Diarrhea
- •Back pain
- •Increased liver enzyme levels in blood tests
- •Cough
- •Skin fungal infection (ringworm)
- •Dizziness
- •Migraine (severe headache often with nausea, vomiting, and sensitivity to light)
- •Low white blood cell count (lymphocytes, leukocytes)
- •Weakness (feeling of fatigue)
- •Rash (itchy, red, burning eczema)
- •Itching
- •High blood fat levels (triglycerides)
- •Hair loss
- •Shortness of breath
- •Depression
- •Blurred vision
- •High blood pressure (fingolimod can cause a slight increase)
- •Muscle pain
- •Joint pain
- •Herpes virus infection (shingles), symptoms include blisters, burning, itching, or pain on the skin, usually on the upper body or face.
- •Slow heart rate (bradycardia) or irregular heart rate.
- •Skin cancer (basal cell carcinoma), often appearing as pearl-like bumps, but can also take other forms.
- •Weight loss
RARE
- •Pneumonia (symptoms can include fever, cough, difficulty breathing).
- •Macular edema (swelling at the back of the eye affecting central vision, with symptoms like shadows or blind spots, blurred vision, difficulty seeing colors or details).
- •Low platelet count (increases risk of bleeding or bruising).
- •Melanoma (a type of skin cancer that usually starts from an unusual mole, which may change in size, shape, height, or color, or new moles may develop).
- •Seizures (more common in children and adolescents than in adults).
- •Posterior Reversible Encephalopathy Syndrome (PRES), symptoms can include sudden severe headache, confusion, seizures, and/or vision problems.
- •Lymphoma (a type of cancer that affects the lymph system).
- •Squamous cell carcinoma (a type of skin cancer that can appear as a firm, small, red lump, a crusty sore, or a new sore on an existing scar).
- •Abnormal ECG (T-wave inversion, abnormal electrical activity of the heart).
- •Kaposi's sarcoma (a tumor linked to human herpesvirus 8 infection).
- •Allergic reactions, including skin rash, itchy hives, swelling of the lips, tongue, or face.
- •Liver failure (symptoms include yellowing of the skin or whites of the eyes, nausea or vomiting, pain on the right side of the stomach, dark urine, decreased appetite, tiredness, and abnormal liver function tests).
- •PML (Progressive multifocal leukoencephalopathy), a rare brain infection.
- •Inflammatory reaction after stopping treatment (Immune Reconstitution Inflammatory Syndrome or IRIS).
- •Fungal infections (like cryptococcal meningitis, with symptoms such as headache, stiff neck, light sensitivity, nausea, and/or confusion).
- •Merkel cell carcinoma (a type of skin cancer). Possible signs include a red or bluish-red, painless lump, often on the face, head, or neck.
- •Autoimmune anemia (a decreased number of red blood cells, where red blood cells are destroyed).
- •Low neutrophil count (a type of white blood cell) in the blood.
- •Depressed mood
- •Nausea
- •Swelling (peripheral edema).
Important Warnings
- Do not take this medicine if you have a weakened immune system.
- If your doctor suspects or confirms a rare brain infection called PML, you should not take this medicine.
- Do not take this medicine if you have a severe active infection, such as hepatitis or tuberculosis.
- Do not take this medicine if you have active cancer.
- Do not take this medicine if you have severe liver disease.
Show 14 more warnings
- Do not take this medicine if you have had heart problems (like a heart attack, chest pain, stroke, or heart failure) in the last 6 months.
- Do not take this medicine if you have certain irregular heartbeats or an abnormal heart rhythm shown on an ECG.
- If you are taking or have recently taken certain medicines for irregular heartbeats (like quinidine, disopyramide, amiodarone, or sotalol), do not take this medicine.
- 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 fingolimod or any other ingredient.
- Tell your doctor if you have severe breathing problems while sleeping (severe sleep apnea).
- Tell your doctor if you have symptoms of a slow heartbeat (e.g., dizziness, nausea).
- Tell your doctor if you are taking medicines that slow your heart rate.
- Tell your doctor if you have fainted before.
- Tell your doctor if you plan to get vaccinated.
- Tell your doctor if you have never had chickenpox.
- Tell your doctor if you have vision problems, eye inflammation, or diabetes.
- Tell your doctor if you have high blood pressure that is not controlled by medicine.
- Tell your doctor if you have a serious lung disease or a smoker's cough.