About MIDOSTAURIN
MIDOSTAURIN belongs to the group of medicines called protein kinase inhibitors used to treat acute myeloid leukaemia (AML). It is sometimes, also used to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
MIDOSTAURIN contains Midostaurin, which works by blocking the action of kinase enzymes in abnormal cells and stops their division and growth. Thereby, it helps prevent the spread of cancer and mast cells.
MIDOSTAURIN may cause certain side effects such as nausea, vomiting, headache, fever, musculoskeletal pain, and upper abdominal pain. Most of these side effects may not require medical attention and resolve gradually over time. Do not be reluctant to talk with your doctor if any of the side effects persist or worsen. Take MIDOSTAURIN as prescribed by your doctor.
Discontinue taking MIDOSTAURIN and inform your physician if you observe any allergic reactions. Inform the doctor about your health condition and medications to rule out any side effects. Do not take MIDOSTAURIN if you are pregnant or breastfeeding. This medicine is not recommended for children as safety and effectiveness have not been established.
Uses of MIDOSTAURIN
Acute myeloid leukaemia (AML), aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
Medicinal Benefits
MIDOSTAURIN belongs to the group of medicines called protein kinase inhibitors used to treat acute myeloid leukaemia (AML) in patients who are FLT3 mutation-positive. It is also used to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL). MIDOSTAURIN contains Midostaurin, which works by blocking the action of kinase enzymes in abnormal cells and stops their division and growth. Thereby, it helps prevent the spread of cancer and mast cells.
Directions for Use
Storage
Side Effects of MIDOSTAURIN
- Nausea
- Vomiting
- Headache
- Dizziness, light-headedness
- Upper abdominal pain
- Fever
- Joint pain
- Back pain
- Throat pain
- Mouth sores
- Nose bleeds
In-Depth Precautions and Warning
Drug Warnings
Do not take MIDOSTAURIN if you are allergic to any of its components, if you are taking medicines used to treat tuberculosis (rifampicin), epilepsy (carbamazepine or phenytoin), prostate cancer (enzalutamide), or herbal products (St. John’s Wort) or if you are pregnant or breastfeeding. Inform the doctor if you have any infections, heart disorders, lung, kidney or liver diseases. Seek immediate medical attention if you experience symptoms of low white blood cell count (fever, sore throat, mouth ulcers), lung problems (fever, chest pain, cough with or without mucous, trouble breathing or shortness of breath), or heart problems (chest pain or discomfort, fainting, dizziness, light-headedness, shortness of breath, blue discolouration of your lips, hands or feet, or swelling of your lower limbs).
Drug Interactions
Drug-Drug Interactions: Inform the doctor if you are taking medicines used to treat tuberculosis (rifampicin), epilepsy (carbamazepine or phenytoin), prostate cancer (enzalutamide), infections (ketoconazole, clarithromycin), HIV (ritonavir, efavirenz), depression (nefazodone, bupropion), control levels of fat in your blood (atorvastatin, rosuvastatin), muscle relaxant (tizanidine, chlorzoxazone), or herbal product used to treat depression (St. John’s Wort),
Drug-Food Interactions: Do not consume grapefruit and its juice during treatment with MIDOSTAURIN as it may significantly increase the blood levels of the medicine.
Drug-Disease Interactions: Inform the doctor if you have breathing or lung problems, irregular heartbeat, QT prolongation, infections, or liver or kidney disease.
Drug-Drug Interactions Checker List:
Safety Advice
Alcohol
consult your doctorIt is not known if alcohol affects MIDOSTAURIN. Please consult your doctor.
Pregnancy
unsafeMIDOSTAURIN is not recommended during pregnancy as it may harm your unborn baby. Therefore, if you are pregnant or planning for pregnancy, talk to the doctor for advice.
Breast Feeding
unsafeMIDOSTAURIN may harm the baby. Avoid breastfeeding during treatment with MIDOSTAURIN and for at least 4 months after stopping the treatment.
Driving
cautionMIDOSTAURIN may cause dizziness and vertigo. Be cautious while driving or operating machinery.
Liver
consult your doctorIf you have a pre-existing or a history of liver disease, inform your doctor before receiving MIDOSTAURIN. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Kidney
consult your doctorIf you have a pre-existing or a history of kidney disease, inform your doctor before receiving MIDOSTAURIN. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Children
cautionThe safety and effectiveness of MIDOSTAURIN in children below 18 years have not been established.
Habit Forming
Diet & Lifestyle Advise
- Eat a healthy diet and exercise regularly to maintain proper weight.
- Avoid smoking and alcohol consumption.
- Include vegetables and fruits in your diet.
- Avoid fast food, fried food, processed meats, refined carbs and added sugar.
- Get optimal sleep; rest well.
- Drink enough water to stay hydrated.
Special Advise
If you are able to become pregnant, your doctor will perform a pregnancy test within 7 days before you start the treatment.
Women of reproductive potential and males with partners who are able to become pregnant must use reliable and effective birth control pills during treatment and for four months after receiving the last dose.
Your doctor will advise regular blood tests during the treatment to monitor blood cell count, electrolytes, heart and lung functioning.
Patients Concern
Disease/Condition Glossary
Acute myeloid leukaemia: Acute myeloid leukaemia, also called acute myelogenous leukaemia or acute nonlymphocytic leukaemia, is the cancer of blood and bone marrow with excess immature white blood cells. Symptoms include fever, recurrent infections, fatigue, and easy bruising.
Aggressive systemic mastocytosis (ASM): It is a clonal mast cell disease characterised by the progressive growth of neoplastic cells in organs, leading to organopathy. Signs and symptoms include fatigue, nausea, abdominal pain, diarrhoea, bloating, skin redness, warmth, headache, low blood pressure, shortness of breath, and light-headedness.
Systemic mastocytosis with associated haematological neoplasm (SM-AHN): It is characterised by the abnormal accumulation of neoplastic mast cells in one or more organs, mainly the bone marrow, associated with another hematologic neoplasm of non-mast cell nature.
Mast cell leukaemia (MCL): It is characterised by abnormal growth and build-up of mast cells (a type of white blood cell produced by the bone marrow). Symptoms include low blood pressure, itchy skin, and rashes.
