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Introduction About STAURINZ 25MG SOFT GELATIN CAPSULE
STAURINZ 25MG SOFT GELATIN CAPSULE is used to manage acute myeloid leukaemia (AML) in adults who have a defect in a gene called FLT3. It is also used in adults to manage aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL). These are disorders in which the body produces too many mast cells (a type of white blood cell).
STAURINZ 25MG SOFT GELATIN CAPSULE contains Midostaurin which belongs to the group of medicines called Protein kinase inhibitors which blocks the action of some enzymes (kinases) in the cancerous cells and stops their division and growth.
Your doctor will perform regular blood tests during treatment with STAURINZ 25MG SOFT GELATIN CAPSULE in order to monitor the amount of blood cells (white blood cells, red blood cells and platelets) and electrolytes (e.g. calcium, potassium, magnesium) in your body. Your heart and lung function will also be checked regularly.
Before taking STAURINZ 25MG SOFT GELATIN CAPSULE, inform your doctor if you have any infections, heart or lung problems. It should be used with caution in patients with liver problems due to alcohol to manage the risk of liver damage.
STAURINZ 25MG SOFT GELATIN CAPSULE is not recommended for use in pregnant and breastfeeding women. STAURINZ 25MG SOFT GELATIN CAPSULE is not recommended for use in children and adolescents less than 18 years of age.
The most common side effects of taking STAURINZ 25MG SOFT GELATIN CAPSULE include red or purple, flat, pinhead spots under the skin, problems falling asleep, headache, dizziness, shortness of breath, respiratory infections, mouth sores, nausea, vomiting, upper abdominal pain, piles, excessive sweating, thirst, back pain, joint pain, neck pain, muscle pain, high urine output, dark urine, dry flushed skin, abnormal heart rhythm, swelling of the eyelid and weight gain. Consult your doctor if any symptoms worsens.
Uses Of STAURINZ 25MG SOFT GELATIN CAPSULE
Management of blood cancer and other blood disorders like:
- Acute myeloid leukaemia (AML) in adults who have a defect in a gene called FLT3.
- Aggressive systemic mastocytosis (ASM)
- Systemic mastocytosis with associated haematological neoplasm (SM-AHN)
- Mast cell leukaemia (MCL)
How STAURINZ 25MG SOFT GELATIN CAPSULE Works
STAURINZ 25MG SOFT GELATIN CAPSULE contains Midostaurin which works by blocking certain proteins (called kinases) that are involved in the growth and survival of cancer cells. Specifically, it targets abnormal proteins in blood cells that lead to uncontrolled cell growth, as seen in some types of leukemia. By inhibiting these proteins, midostaurin helps to slow down or stop the growth of cancer cells.
How to use STAURINZ 25MG SOFT GELATIN CAPSULE
Take STAURINZ 25MG SOFT GELATIN CAPSULE with food or as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and severity of the condition.
Side Effects Of STAURINZ 25MG SOFT GELATIN CAPSULE
Common
- infection at catheter site
- red or purple, flat, pinhead spots under the skin (petechiae)
- problems falling asleep (insomnia)
- headache, dizziness, fainting
- shortness of breath, nose bleeds, throat pain, runny nose, fever
- mouth sores (stomatitis)
- nausea, vomiting, upper abdominal pain
- haemorrhoids (piles), rectal pain and anal discomfort
- excessive sweating
- back pain, joint pain, neck pain, limb pains
- thirst, high urine output, dark urine, dry flushed skin
- muscle spasms, weakness and twiching
- abnormal heart rhythm
- bruising and bleeding (defect in blood clotting)
- hypocalcemia
- swelling of the eyelid
- eye pain, blurred vision, intolerance to light (keratitis)
- increased weight
Stop taking STAURINZ 25MG SOFT GELATIN CAPSULE and contact your doctor immediately if you experience any of the following side effects:
- allergic reaction (swelling of the hands, feet, ankles, face, lips or throat which may cause trouble swallowing or breathing, an itchy, lumpy rash or nettle rash, runny nose)
- weakness, spontaneous bleeding or bruising, frequent infections with signs such as fever, chills, sore throat or mouth ulcers (signs of a low level of blood cells)
- fever, cough with or without mucus, chest pain, trouble breathing or shortness of breath (signs of non-infectious interstitial lung disease or pneumonitis)
- severe shortness of breath, laboured and unusually rapid breathing, dizziness, light-headedness, confusion and extreme tiredness (signs of acute respiratory distress syndrome)
- infections, fever, low blood pressure, decreased urination, rapid pulse, rapid breathing (signs of sepsis or neutropenic sepsis)
Warning & Precautions
Pregnancy
ContraindicatedSTAURINZ 25MG SOFT GELATIN CAPSULE is not recommended for use in pregnant women as it can harm the unborn baby. Your doctor will ask you to take a pregnancy test before you start treatment to make sure you are not pregnant. You must use an effective method of contraception during and at least 4 months after you have stopped taking it. It also reduces fertility. Consult your doctor before taking STAURINZ 25MG SOFT GELATIN CAPSULE.
Breastfeeding
ContraindicatedSTAURINZ 25MG SOFT GELATIN CAPSULE is not recommended in breastfeeding women as it can harm the baby. You should not breast-feed during treatment with STAURINZ 25MG SOFT GELATIN CAPSULE and for at least 4 months after stopping the treatment. Consult your doctor before taking it.
Driving and Using Machines
Use with CautionSTAURINZ 25MG SOFT GELATIN CAPSULE can cause dizziness and vertigo hence be cautious while driving or using heavy machines.
Allergy
ContraindicatedDo not take STAURINZ 25MG SOFT GELATIN CAPSULE if you are allergic to Midostaurin or any other ingredients of this medicine.
Lungs
Use with CautionSTAURINZ 25MG SOFT GELATIN CAPSULE should be used with caution in patients with lungs or breathing problems. Consult your doctor before taking it.
Heart Disease
Use with CautionSTAURINZ 25MG SOFT GELATIN CAPSULE should be used with caution in patients with heart disorders. Consult your doctor before taking it.
Use In Pediatrics
ContraindicatedSTAURINZ 25MG SOFT GELATIN CAPSULE is not recommended for use in children and adolescents less than 18 years of age who are also receiving other chemotherapy, because it could cause a severe reduction of certain types of blood cells. Consult your child’s doctor for advice.
Use In Geriatrics
Use with CautionSTAURINZ 25MG SOFT GELATIN CAPSULE should be used with caution in elderly patients. Consult your doctor before taking it.
Others
Before taking STAURINZ 25MG SOFT GELATIN CAPSULE, inform your doctor if you:
- have any infections
Interactions
A. Drug-Drug interactions:
Before taking STAURINZ 25MG SOFT GELATIN CAPSULE, inform your doctor if you are taking any of the following medicines:
- Anti tuberculosis (Ex. Rifampicin)
- Anti epilepsy (Ex. carbamazepine or phenytoin)
- Anti-cancer (Ex. Enzalutamide)
- Antidepressants (Ex. St. John’s Wort, nefazodone or bupropion)
- Anti-infective such as ketoconazole or clarithromycin
- anti-HIV, such as ritonavir or efavirenz
- some medicines used to control levels of fat in your blood, such as atorvastatin or rosuvastatin
- muscle relaxants like tizanidine and chlorzoxazone
Overdosage:
If you or anyone else accidentally takes too much of STAURINZ 25MG SOFT GELATIN CAPSULE, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Midostaurin |
| Pharmacological Category | : | Protein kinase inhibitors |
| Therapeutic Indication | : | Acute myeloid leukaemia (AML), aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL) |
| Dosage Forms | : | Capsule |
More Information
Storage
- Keep STAURINZ 25MG SOFT GELATIN CAPSULE out of reach of children
- Store below 25°C
FAQs About STAURINZ 25MG SOFT GELATIN CAPSULE
Q: What does STAURINZ 25MG SOFT GELATIN CAPSULE contain?
A: STAURINZ 25MG SOFT GELATIN CAPSULE contains Midostaurin which belongs to the group of medicines called Protein kinase inhibitors.
Q: What is the use of STAURINZ 25MG SOFT GELATIN CAPSULE?
A: STAURINZ 25MG SOFT GELATIN CAPSULE is used to manage acute myeloid leukaemia (AML) in adults who have a defect in a gene called FLT3. It is also used in adults to manage aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL). These are disorders in which the body produces too many mast cells (a type of white blood cell).
Q: Do we need to perform any tests before starting the treatment?
A: Your doctor will perform regular blood tests during treatment with STAURINZ 25MG SOFT GELATIN CAPSULE in order to monitor the amount of blood cells (white blood cells, red blood cells and platelets) and electrolytes (e.g. calcium, potassium, magnesium) in your body. Your heart and lung function will also be checked regularly.
Q: What are the precautions to be followed before taking STAURINZ 25MG SOFT GELATIN CAPSULE?
A: Before taking STAURINZ 25MG SOFT GELATIN CAPSULE, inform your doctor if you have any infections, heart or lung problems. It should be used with caution in patients with liver problems due to alcohol to manage the risk of liver damage.
Q: Can STAURINZ 25MG SOFT GELATIN CAPSULE be used during pregnancy?
A: STAURINZ 25MG SOFT GELATIN CAPSULE is not recommended for use in pregnant women as it can harm the unborn baby. Your doctor will ask you to take a pregnancy test before you start treatment to make sure you are not pregnant. You must use an effective method of contraception during and at least 4 months after you have stopped taking it. It also reduces fertility. Consult your doctor before taking STAURINZ 25MG SOFT GELATIN CAPSULE.
Q: Can STAURINZ 25MG SOFT GELATIN CAPSULE be used in children?
A: STAURINZ 25MG SOFT GELATIN CAPSULE is not recommended for use in children and adolescents less than 18 years of age.
Q: What are the side effects of taking STAURINZ 25MG SOFT GELATIN CAPSULE?
A: The most common side effects of taking STAURINZ 25MG SOFT GELATIN CAPSULE include red or purple, flat, pinhead spots under the skin, problems falling asleep, headache, dizziness, shortness of breath, respiratory infections, mouth sores, nausea, vomiting, upper abdominal pain, piles, excessive sweating, thirst, back pain, joint pain, neck pain, muscle pain, high urine output, dark urine, dry flushed skin, abnormal heart rhythm, swelling of the eyelid and weight gain. Consult your doctor if any symptoms worsen.
Q: How does STAURINZ 25MG SOFT GELATIN CAPSULE work?
A: STAURINZ 25MG SOFT GELATIN CAPSULE contains Midostaurin which works by blocking certain proteins (called kinases) that are involved in the growth and survival of cancer cells. Specifically, it targets abnormal proteins in blood cells that lead to uncontrolled cell growth, as seen in some types of leukemia. By inhibiting these proteins, midostaurin helps to slow down or stop the growth of cancer cells.
References
1. Tilo Grosser, Emer Smyth and Garret A. FitzGerald. Anti-cancer agents; Pharmacotherapy of gout. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page-693.
2. Molly Megan Gallogly and Hillard M Lazarus. Midostaurin: an emerging treatment for acute myeloid leukemia patients. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. April 2016. [Accessed on 30th August 2024] Midostaurin: an emerging treatment for acute myeloid leukemia patients - PMC (nih.gov)
3. Rydapt® 25 mg soft capsules midostaurin. Novartis Pharmaceuticals UK Limited. EMC.UK. [Revised in July 2024]. [Accessed on 11th September 2024] https://www.medicines.org.uk/emc/files/pil.9134.pdf
Useful Diagnostic Tests
- Complete blood count (CBC)
- Lung function test
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