Staurinz 25mg capsule contains the active substance midostaurin. It is an anti-cancer medicine that belongs to the class of medications called tyrosine kinase inhibitors. It is combined with other chemotherapy medications to treat acute myeloid leukemia (AML) in adults with a defect in a gene called FLT3. Acute myeloid leukemia is a form of cancer that starts in certain WBC called myeloid cells in which the body overproduces these cells abnormally. The medicine is also used in adults to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).  

Do not take Staurinz 25mg capsule if you are allergic to Midostaurin or any other ingredients of this medicine. Inform your healthcare professional if you have any symptoms of an infection, heart disorder, lung problems, or problems with breathing. If you experience any of these symptoms, such as fever, sore throat, mouth ulcers, cough with or without mucous, chest pain, difficulty breathing, or swelling in the body parts after taking the medicine, immediately report it to your doctor. 

This medicine is not recommended for children and adolescents below 18 years of age. Inform your physician if you are pregnant, breastfeeding, or planning for pregnancy before initiating the therapy. Staurinz 25mg capsule may reduce fertility in men and women; discuss this with your doctor before starting the therapy. This medicine's most common side effects are fever with reduced blood cell counts, nausea, vomiting, headache, musculoskeletal pain, increased blood glucose levels, and respiratory tract infection.

• Acute myeloid leukemia (AML)
• Aggressive systemic mastocytosis (ASM)
• Systemic mastocytosis with associated hematological neoplasm (SM-AHN)
• Mast cell leukemia (MCL)

Staurinz 25mg capsule is a kinase inhibitor that potently inhibits multiple receptor tyrosine kinases. It blocks the action of the kinases in the abnormal cells that express FLT3 mutant genes and stops their division and growth. 

Inform your healthcare provider about all the medicines you are taking, including prescription medications, over-the-counter medications, vaccinations, nutritional and vitamin supplements, and herbal products. Certain medications may interact with the effects of Staurinz 25mg capsule and reduce its effectiveness by causing undesirable side effects.

• Store Staurinz 25mg capsule at room temperature (25°C)
• keep the capsule away from the reach of children and pets.
• If you miss a dosage, take it as soon as you remember. If it is almost time for the next dose, skip the missing dose.
• Do not take a double dose to compensate for a missed dose.

Your doctor will decide the dose and duration of the treatment based on your disease condition, severity, and other factors. Take the Staurinz 25mg capsule as prescribed by your doctor. Do not open, break, crush, or chew the capsules. Swallow the capsule whole with a glass of water. Take the capsules with food at the same time each day. 

Side effects are unwanted symptoms caused by medicines. Even though all drugs cause side effects, not everyone gets them. 

 Common 

• Swelling in the lower limbs
• Skin rash
• Increased blood sugar levels
• Abdominal pain
• Constipation, diarrhea
• Nausea, vomiting
• Musculoskeletal pain
• Headache
• Bleeding from nose
• Upper respiratory infection
• Tiredness
• Fever

Serious  

• Heart failure
• GI bleeding
• Fever with decreased blood cell counts
• Hypersensitivity reactions
• Kidney problems
• Pneumonia
• Blood infection

Do not breastfeed during the treatment with Staurinz 25mg capsule and for at least 4 months after the last dose. Avoid grapefruit juice during the treatment with this medicine. If you vomit after taking this medicine, do not take another capsule to make up the dose. If you are a male patient with a female partner with reproducing potential, use effective contraception during the treatment and for 4 months after the last dose. Your doctor will perform regular blood tests during the treatment to monitor the number of blood cells and electrolytes in your body. Your heart and lung function will also be checked regularly. This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury.

1. Novartis Pharmaceuticals, Electronic Medicines Compendium (EMC), www.medicines.org.uk. [revised on 2022] [cited 2023 Apr 13]. Available from: https://www.medicines.org.uk/emc/product/9134/smpc
2. Novartis Pharmaceuticals, Highlights Of Prescribing Information, Midostaurin, [revised on 2017] [cited 2023 Apr 13]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf
3. Anton Wellstein, Giuseppe Giaccone, Michael B. Atkins, and Edward A. Sausville, Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules, Goodman & Gilman’s Pharmacological Basis of Therapeutics, 13th Edition, 2018, 1203-1236.