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Inflitza 25 Softgel Capsule is also used to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL). It 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. This medicine is not recommended for children as safety and effectiveness have not been established.

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Written By Santoshini Reddy G , M Pharmacy
Reviewed By Dr. Lakshmithulasi Yarragunta , PharmD (PB)
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More about the Product

Composition :

MIDOSTAURIN-25MG

Manufacturer/Marketer :

Intas Pharmaceuticals Ltd

Consume Type :

Oral

Expires on or after :

Jan-27

Return Policy :

Not Returnable

About Inflitza 25 Softgel Capsule

Inflitza 25 Softgel Capsule is a prescription medicine used to treat specific types of blood and bone marrow cancers, such as newly diagnosed acute myeloid leukemia (AML) that has a specific abnormal gene called FLT3. It is also prescribed for adults with rare blood disorders called advanced systemic mastocytosis, which includes aggressive systemic mastocytosis and mast cell leukemia. This medicine works by targeting and blocking specific proteins that cause cancer cells to grow and multiply.

You will typically take Inflitza 25 Softgel Capsule twice a day, and it is highly important to take it at the same times every day to keep a constant level of the medicine in your body. Always take this medicine with food to help prevent severe stomach upset and nausea. Along with taking this medicine, staying well-hydrated and eating small, frequent meals can help manage treatment-related digestive side effects.

Some common side effects of Inflitza 25 Softgel Capsule include nausea, vomiting, diarrhoea, feeling very tired, and headache. It is vital to watch for serious side effects like severe lung issues, unusual bruising or bleeding, or signs of infection such as a fever, and contact your doctor immediately if these occur.

Before starting Inflitza 25 Softgel Capsule, tell your doctor if you have a history of lung or breathing problems, heart conditions, or liver disease. Do not take this if you are pregnant, planning to become pregnant, or breastfeeding, as this medicine can harm an unborn baby or newborn.

Inflitza 25 Softgel Capsule can interact with many other medicines, including certain antibiotics, heart medications, and herbal supplements, which can either increase the risk of side effects or make this treatment less effective. Avoid drinking alcohol or smoking while taking this medication, as they can worsen liver strain and stomach irritation. If you are an older adult, or if you have pre-existing kidney or liver conditions, your doctor will monitor you closely during treatment.

Uses of Inflitza 25 Softgel Capsule

Your doctor may prescribe Inflitza 25 Softgel Capsule to treat the following conditions and help control the growth of abnormal cells:

  • Acute Myeloid Leukemia (AML): Used in combination with chemotherapy to treat newly diagnosed AML in adults whose cancer cells have a specific abnormal gene mutation (FLT3). It helps by blocking the signals that tell these leukemia cells to grow.
  • Advanced Systemic Mastocytosis (ASM): Helps manage this rare disorder where too many mast cells (a type of immune cell) build up in the body's tissues. It blocks the abnormal proteins that cause these cells to multiply excessively.
  • Systemic Mastocytosis with Associated Hematological Neoplasm (SM-AHN): Helps reduce the number of abnormal mast cells and controls the symptoms caused by the co-existing blood disorder.
  • Mast Cell Leukemia (MCL): Helps slow down the rapid progression of this highly aggressive form of mast cell cancer by stopping the division of cancerous mast cells.

Key Benefits

Using Inflitza 25 Softgel Capsule as prescribed helps control the growth of abnormal cells and improve treatment outcomes. Here are the key benefits you can expect:

  • Slows cancer progression: By targeting the specific root causes of cancer cell growth, Inflitza 25 Softgel Capsule helps slow down or halt the spread of abnormal cells in the blood and bone marrow. This can lead to a period of disease stability.
  • Enhances chemotherapy success: When used alongside standard chemotherapy for AML, it works in tandem to increase the likelihood of clearing cancer cells from the body, helping patients achieve better treatment outcomes.
  • Relieves mast cell symptoms: For people with systemic mastocytosis, Inflitza 25 Softgel Capsule helps reduce the severe symptoms caused by mast cell buildup, such as organ damage, severe skin flushing, and digestive issues, leading to improved daily comfort.

Directions for Use

  • Recommended to take Inflitza 25 Softgel Capsule with food to prevent stomach upset.
  • Recommended to take twice daily or as advised by your doctor.
  • Swallow the medicine as a whole with a glass of water.
  • Do not crush, break, or chew it.

How Inflitza 25 Softgel Capsule Works

Inflitza 25 Softgel Capsule contains midostaurin, a kinase inhibitor that works by blocking the activity of specific enzymes called tyrosine kinases. These enzymes act as 'on-off switches' inside cells. In certain cancers, such as acute myeloid leukaemia (AML) and systemic mastocytosis, these enzymes become mutated or overactive, causing cells to grow and divide uncontrollably. Inflitza 25 Softgel Capsule blocks the activity of abnormal FLT3 and KIT proteins, cutting off the signals that cancer cells need to grow and survive. Without these signals, the abnormal cells stop dividing and eventually die, helping to control the progression of the disease.
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Alcohol

Consult your doctor

It is not known if alcohol affects Inflitza 25 Softgel Capsule. Please consult your doctor.

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Pregnancy

Unsafe

Inflitza 25 Softgel Capsule 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.

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Breast Feeding

Unsafe

Inflitza 25 Softgel Capsule may harm the baby. Avoid breastfeeding during treatment with Inflitza 25 Softgel Capsule and for at least 4 months after stopping the treatment.

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Driving

Caution

Inflitza 25 Softgel Capsule may cause dizziness and vertigo. Be cautious while driving or operating machinery.

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Liver

Consult your doctor

If you have a pre-existing or a history of liver disease, inform your doctor before receiving Inflitza 25 Softgel Capsule. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.

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Kidney

Consult your doctor

If you have a pre-existing or a history of kidney disease, inform your doctor before receiving Inflitza 25 Softgel Capsule. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.

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Children

Caution

The safety and effectiveness of Inflitza 25 Softgel Capsule in children below 18 years have not been established.

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Heart

Caution

Inflitza 25 Softgel Capsule may cause QT prolongation, a heart rhythm condition that can lead to serious complications like fainting or irregular heartbeat. If you have heart problems such as heart failure or a history of arrhythmias, your doctor will need to evaluate the risks and may monitor your heart closely during treatment.

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Geriatrics

Caution

Geriatric patients can take Inflitza 25 Softgel Capsule, but doctors usually proceed with caution due to age-related changes in metabolism and organ function. Studies suggest it can be effective and safe in older adults with AML, especially when combined with low-intensity therapies.

What if I have taken an overdose of Inflitza 25 Softgel Capsule

If you take too much of this medicine, seek emergency medical attention immediately. Overdosing can cause severe adverse reactions that require prompt medical care.

Diet & Lifestyle Advise

  • Manage nausea with food timing: Eat small, frequent meals throughout the day instead of three large ones. Take Inflitza 25 Softgel Capsule with these small meals to protect your stomach.
  • Stay well-hydrated: Drink plenty of fluids, such as water or clear broths, to prevent dehydration, especially if you experience vomiting or diarrhoea. Avoid caffeinated or sugary drinks, which can worsen diarrhoea.
  • Protect yourself from infections: Because this medicine can lower your white blood cell count, practice strict hand hygiene, avoid close contact with sick individuals, and wash fresh produce thoroughly before eating.
  • Avoid certain foods: Do not eat grapefruit or drink grapefruit juice while taking this medication. Grapefruit can increase the level of Inflitza 25 Softgel Capsule in your blood to unsafe levels, raising the risk of serious side effects.
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How Soon It Starts Working

The time required for Inflitza 25 Softgel Capsule to start to work: Inflitza 25 Softgel Capsule ideally shows its action within 1 to 3 hours after administration. The time for which the effects of Inflitza 25 Softgel Capsule last: The effect of Inflitza 25 Softgel Capsule lasts for 21 hours.

What if you forget to take Inflitza 25 Softgel Capsule

If you miss a dose of Inflitza 25 Softgel Capsule, skip the missed dose and take your next dose at your regularly scheduled time. Do not take two doses at the same time to make up for a missed one.

Storage

• Store Inflitza 25 Softgel Capsule capsules at 20°C to 25°C (68°F to 77°F) in their original blister pack. •Keep the packaging intact to protect the capsules from moisture and direct light.

Drug Warnings

  • Inspect your capsules before taking: Check the blister pack and capsules before each dose; do not take any capsule that is broken, leaking, or looks damaged.
  • Monitor your body temperature: Keep a reliable thermometer at home and check your temperature if you feel unwell. A fever during cancer treatment is a medical emergency that requires immediate contact with your doctor.
  • Use effective birth control: Both men and women taking Inflitza 25 Softgel Capsule should use highly effective birth control during treatment and for at least 4 months after the last dose to prevent pregnancy.
  • Check your heart health: Keep all appointments for blood tests and heart monitoring (such as ECGs), as this medication can affect your heart rhythm.
  • Avoid sun exposure: This medicine can make your skin more sensitive to sunlight. Wear protective clothing and apply broad-spectrum sunscreen when outdoors.

Drug-Drug Interactions

verifiedApollotooltip
  • Strong CYP3A4 inhibitors (such as ketoconazole or clarithromycin): May increase the amount of Inflitza 25 Softgel Capsule in your body, raising the risk of severe side effects.
  • Strong CYP3A4 inducers (such as rifampicin, carbamazepine, or St. John's wort): May lower the levels of Inflitza 25 Softgel Capsule in your blood, making the treatment less effective.
  • Medicines that prolong the QT interval (such as certain antiarrhythmics or antipsychotics): Taking these together with Inflitza 25 Softgel Capsule can increase the risk of dangerous heart rhythm problems.

Drug-Drug Interactions

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How does the drug interact with Inflitza 25 Softgel Capsule:
Coadministration of Ziprasidone and Inflitza 25 Softgel Capsule increase the risk of abnormal heart rhythm.

How to manage the interaction:
Taking Ziprasidone with Inflitza 25 Softgel Capsule is not recommended, but it can be taken together if prescribed by a doctor. However, consult your doctor if you experience sudden dizziness, lightheadedness, fainting, shortness of breath, or heart palpitations. Do not discontinue any medications without consulting a doctor.
How does the drug interact with Inflitza 25 Softgel Capsule:
Using Moxifloxacin together with Inflitza 25 Softgel Capsule can increase the risk of an irregular heart rhythm.

How to manage the interaction:
There may be a possibility of interaction between Moxifloxacin and Inflitza 25 Softgel Capsule, but it can be taken if prescribed by a doctor. If you experience fast or irregular heartbeat, dizziness, trouble breathing, call a doctor right away. Do not stop using any medications without a doctor's advice.
How does the drug interact with Inflitza 25 Softgel Capsule:
Using chloroquine together with Inflitza 25 Softgel Capsule can increase the risk of an irregular heart rhythm.

How to manage the interaction:
Co-administration of Chloroquine with Inflitza 25 Softgel Capsule can possibly result in an interaction, but it can be taken together if prescribed by a doctor. However, consult your doctor if you experience sudden dizziness, lightheadedness, fainting, shortness of breath. Do not discontinue any medications without consulting a doctor.
How does the drug interact with Inflitza 25 Softgel Capsule:
When Inflitza 25 Softgel Capsule is taken with Ketoconazole, it may significantly increase the blood levels of Inflitza 25 Softgel Capsule. It can lead to side effects.

How to manage the interaction:
Although taking Ketoconazole and Inflitza 25 Softgel Capsule together can cause an interaction, it can be taken if a doctor has suggested it. However, if you experience paleness, fatigue, dizziness, fainting, unexpected bruising or bleeding, fever, chills, diarrhea, sore throat, muscle pains, breathing difficulty, blood in phlegm, weight loss, red or inflamed skin, body sores, or pain and burning during urination, consult the doctor. Do not discontinue any medications without a doctor's advice.
How does the drug interact with Inflitza 25 Softgel Capsule:
Coadministration of baricitinib and Inflitza 25 Softgel Capsule can raise the risk of developing serious infections.

How to manage the interaction:
Although there is an interaction, baricitinib can be taken with Inflitza 25 Softgel Capsule if prescribed by the doctor. However, if you experience fever, chills, diarrhea, sore throat, muscle aches, shortness of breath, blood in your coughing fluid, weight loss, red or irritated skin, body sores, and discomfort or burning when you urinate, consult a doctor. Do not discontinue any medication without consulting a doctor.
How does the drug interact with Inflitza 25 Softgel Capsule:
The combined use of Inflitza 25 Softgel Capsule and Hydroxychloroquine can increase the risk of an irregular heart rhythm.

How to manage the interaction:
Co-administration of Inflitza 25 Softgel Capsule and Hydroxychloroquine can lead to an interaction, it can be taken if advised by your doctor. However, if you experience any symptoms like dizziness, lightheadedness, fainting, shortness of breath, or heart palpitations, consult the doctor immediately. Do not stop using any medications without a doctor's advice.
How does the drug interact with Inflitza 25 Softgel Capsule:
Inflitza 25 Softgel Capsule blood levels may be significantly raised by combining itraconazole and Inflitza 25 Softgel Capsule.

How to manage the interaction:
Although there is a possible interaction between Inflitza 25 Softgel Capsule and Itraconazole, they can be taken in case a doctor prescribes it. Consult a doctor if you notice any of the following symptoms: paleness, tiredness, dizziness, fainting, unusual bruising or bleeding, fever, chills, diarrhoea, sore throat, aches in the muscles, shortness of breath, blood in the phlegm, red or irritated skin, body sores, or pain or burning when urinating. Never stop taking any medications without talking to a doctor.

Drug-Food Interactions

verifiedApollotooltip
  • Grapefruit and grapefruit juice: Can significantly block the enzymes that break down Inflitza 25 Softgel Capsule in your body, leading to toxic levels of the drug.
No Drug - Food interactions found in our database. Some may be unknown. Consult your doctor for what to avoid during medication.

Drug-Food Interactions

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Habit Forming

No

Therapeutic Class

[KINASE INHIBITORS]

FAQs

Inflitza 25 Softgel Capsule is used to treat Acute myeloid leukaemia (AML), aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), and mast cell leukaemia (MCL).
Inflitza 25 Softgel Capsule 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.
If you miss a dose of Inflitza 25 Softgel Capsule, take your next dose at the scheduled time. Avoid taking an extra dose to make up for the missed dose.
Continue taking Inflitza 25 Softgel Capsule even if you feel well. Do not stop taking Inflitza 25 Softgel Capsule without talking to the doctor.
No, you must swallow Inflitza 25 Softgel Capsule capsules whole. Do not open, crush, or chew them, as this can affect how the medicine is absorbed and may irritate your mouth or throat. If you have trouble swallowing pills, talk to your doctor or pharmacist.
If you vomit after taking your dose, do not take an extra capsule to replace it. Simply wait and take your next scheduled dose at your usual time. Talk to your doctor if you experience persistent vomiting.
It is highly recommended to avoid alcohol while taking Inflitza 25 Softgel Capsule. Alcohol can worsen stomach irritation, increase nausea, and place extra stress on your liver, which is already processing this medication. Talk to your doctor.
Hair loss is not a direct common side effect of Inflitza 25 Softgel Capsule itself, but because it is often prescribed alongside traditional chemotherapy for leukaemia, you may experience hair thinning or loss due to the other treatments. Talk to your doctor.
Grapefruit contains natural compounds that block the enzymes responsible for breaking down Inflitza 25 Softgel Capsule in your liver. This can cause the drug to build up to dangerous levels in your bloodstream, increasing your risk of severe side effects. Talk to your doctor.
No, you should not take Inflitza 25 Softgel Capsule if you are planning to become pregnant or father a child. This medicine can cause severe harm to a developing baby, so effective birth control must be used during treatment and for several months afterward. Talk to your doctor.
Yes, Inflitza 25 Softgel Capsule can lower your white blood cell count, making it harder for your body to fight off infections. You will need regular blood tests to monitor your immune cell levels. Talk to your doctor.

Disclaimer

While we strive to provide complete, accurate, and expert-reviewed content on our 'Platform', we make no warranties or representations and disclaim all responsibility and liability for the completeness, accuracy, or reliability of the aforementioned content. The content on our platform is for informative purposes only, and may not cover all clinical/non-clinical aspects. Reliance on any information and subsequent action or inaction is solely at the user's risk, and we do not assume any responsibility for the same. The content on the Platform should not be considered or used as a substitute for professional and qualified medical advice. Please consult your doctor for any query pertaining to medicines, tests and/or diseases, as we support, and do not replace the doctor-patient relationship.

Country of origin

India

Manufacturer/Marketer address

Chinubhai Centre, Off. Nehru Bridge, Ashram Road, Ahmedabad - 380009. Gujarat. India.
Other Info - INF0386
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