Gaxenim
Gaxenim helps treat multiple sclerosis (MS) by reducing flare-ups and slowing down the development of physical problems caused by the disease.
Form
kapseli, kova
Strength
0.5 mg
Active Ingredient
Fingolimod hydrochloride
Manufacturer
Bausch Health Ireland Limited
How to Use
Dosage
Adults take one 0.5 mg capsule once daily. Children and adolescents weighing 40 kg or less take one 0.25 mg capsule once daily. Children and adolescents weighing over 40 kg take one 0.5 mg capsule once daily.
Method
Swallow the capsule whole with a glass of water, do not open it. You can take the medicine with or without food.
Important
Do not exceed the dose prescribed by your doctor, usually one 0.5 mg capsule daily for adults and children over 40 kg. For children and adolescents weighing 40 kg or less, the maximum is one 0.25 mg capsule daily.
Possible Side Effects
COMMON
- •Cough with mucus, chest discomfort, fever (signs of lung problems)
- •Herpes virus infection (shingles), with blisters, burning, itching, or pain on skin, typically upper body or face. May also include fever, weakness, numbness, or red patches.
- •Slow heart rate (bradycardia), irregular heartbeat
- •Type of skin cancer called basal cell carcinoma, often appearing as pearly bumps.
- •Depression and anxiety (more common in MS patients, also reported in children taking fingolimod)
- •Weight loss
- •Flu-like infection, with symptoms like tiredness, chills, sore throat, joint or muscle pain, fever.
- •Feeling of pressure or pain in cheeks and forehead (sinus infection)
- •Headache
- •Diarrhea
- •Back pain
- •Increased liver enzyme levels in blood tests
- •Cough
- •Ringworm, skin fungal infection
- •Dizziness
- •Severe headache, often with nausea, vomiting, and sensitivity to light (migraine)
- •Low white blood cell count (lymphocytes, leukocytes)
- •Feeling weak
- •Itchy, red, burning rash (eczema)
- •Itching
- •Increased blood fat levels (triglycerides)
- •Hair loss
- •Shortness of breath
- •High blood pressure
- •Muscle pain
- •Joint pain
RARE
- •Pneumonia, with symptoms like fever, cough, breathing difficulties
- •Macular edema (swelling in the back of the eye), with symptoms like shadows or blind spots in central vision, blurred vision, difficulty distinguishing colors or details.
- •Low platelet count, increasing risk of bleeding or bruising
- •Melanoma (a type of skin cancer that usually starts from an unusual mole), with moles that change in size, shape, height, or color, or new moles. Moles may itch, bleed, or become sore.
- •Seizures (more common in children and adolescents than adults)
- •Low level of certain white blood cells (neutrophils) in the blood
- •Depressed mood
- •Nausea
- •Posterior Reversible Encephalopathy Syndrome (PRES), with sudden severe headache, confusion, seizures, and/or vision problems.
- •Lymphoma (a type of cancer affecting the lymphatic system)
- •Squamous cell carcinoma (a type of skin cancer that can appear as a firm red lump, a scaly sore, or a new sore on an old scar).
- •Abnormal heart electrical activity (T-wave inversion)
- •Tumor linked to human herpesvirus 8 infection (Kaposi's sarcoma)
- •Allergic reactions, including rash, itchy hives, swelling of the lips, tongue, or face.
- •Signs of liver disease (including liver failure), such as yellow skin or eyes, nausea, vomiting, pain in the upper right abdomen, dark urine, less appetite, tiredness, and abnormal liver function tests. In rare cases, liver failure can lead to transplant.
- •Risk of rare brain infection, Progressive Multifocal Leukoencephalopathy (PML). Symptoms can be similar to MS flare-ups.
- •Inflammatory disorder after stopping Gaxenim treatment (known as Immune Reconstitution Inflammatory Syndrome or IRIS)
- •Cryptococcal infections (a type of fungal infection), including meningitis caused by cryptococcus, with symptoms like headache, stiff neck, sensitivity to light, nausea, and/or confusion.
- •Merkel cell carcinoma (a type of skin cancer), which can appear as a flesh-colored or purplish, painless lump, often on the face, head, or neck.
- •MS symptoms may return and be worse after stopping Gaxenim.
- •Autoimmune anemia (decreased red blood cells), where red blood cells are destroyed (autoimmune hemolytic anemia).
- •Swelling in the limbs (peripheral edema)
Important Warnings
- Do not take Gaxenim if your immune system is weak due to illness or other medicines.
- Do not take Gaxenim if you have a severe active infection, like hepatitis or tuberculosis, or an active chronic infection.
- Do not take Gaxenim if you have active cancer.
- Do not take Gaxenim if you have severe liver disease. Your doctor will do blood tests to check your liver function.
- Do not take Gaxenim if you have had a heart attack, chest pain (angina), stroke, or certain types of heart failure in the last 6 months.
Show 14 more warnings
- Do not take Gaxenim if you have an irregular heartbeat (arrhythmia) or a long QT interval shown on an ECG before starting treatment.
- Do not take Gaxenim if you are currently using or have recently used medicines for irregular heartbeats (antiarrhythmics like quinidine, disopyramide, amiodarone, or sotalol).
- Do not take Gaxenim if you are pregnant or could become pregnant and are not using effective birth control. Gaxenim can harm an unborn baby.
- Do not take Gaxenim if you are allergic to fingolimod or any other ingredient in this medicine.
- Tell your doctor if you feel dizzy or tired, if your heart beats slower, or if your blood pressure drops, as you may need urgent care.
- Gaxenim may not be suitable if you have or are at risk for irregular heartbeat, abnormal ECG results, heart disease, or heart failure.
- If you have never had chickenpox, your doctor will check your immunity and you may need to get vaccinated before starting Gaxenim.
- Gaxenim lowers white blood cell counts, making you more prone to infections. Contact your doctor immediately if you suspect an infection, especially if you have fever or flu-like symptoms.
- HPV infections, including warts and HPV-related cancers, have been reported in patients taking fingolimod. Your doctor may recommend HPV vaccination and screening.
- PML is a rare and serious brain infection that can cause severe disability or death. Your doctor will monitor you for PML before and during treatment.
- Tell your doctor right away if your MS seems to worsen or if you notice new symptoms like mood changes, weakness on one side, vision problems, confusion, memory loss, or speech difficulties, as these could be signs of PML.
- Gaxenim can cause swelling in the eye (macular edema), which may lead to vision problems. Report any vision changes to your doctor immediately.
- Gaxenim can cause a slight increase in blood pressure, so your doctor may check it regularly.
- Do not stop taking Gaxenim or change your dose without first talking to your doctor.