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Xospata

Name of the generic: gilteritinib GIL-te-RI-tib GIL-te-RI’-ti-nib [ GIL-te-RI-tib
Drug class: multikinase inhibitors

What is Xospata?

The medicine Xospata can be prescribed and is used to treat acute myeloid leukaemia (AML) in adult patients who have an unnormal FLT3 gene. Your doctor will conduct a test to determine if you have this gene.

Xospata is prescribed when other treatments for cancer fail or end up failing.

It isn't clear whether Xospata is safe and effective for children.

Warnings

Do not use Xospata if you are sensitive to gilteritinib, as well as any inactive ingredients that comprise hydroxypropyl cellulose, mannitol low-substituted hydroxypropylcellulose, magnesium stearate, hypromellose polyethylene glycol, talc ferric oxide, and titanium dioxide.

Xospata could trigger a condition known as differentiation syndrome. It can cause blood cells to become damaged, which can be fatal if not addressed. The condition can manifest in the 2nd to 3rd months after starting to take Xospata.Get medical attention immediately. If you are suffering from indications of differentiation syndrome, such as symptoms like cough, fever, and breathing problems, bone pain, rapid weight gain, and swelling of your legs, arms, groyne, or neck,

Before you take this drug

It is not recommended to use Xospata if you have an allergy to gilteritinib.

To ensure that Xospata is safe for you, ask your doctor if you've ever experienced:

  • Heart issues;
  • Lengthy qt syndrome (in either you (or a relative)
  • An electrolyte imbalance (such as low levels of magnesium, potassium, or magnesium in the blood).

Before you start taking this medicine, the function of your heart may need to be assessed with an electrocardiogram, or ECG (sometimes known as the EKG).

Gilteritinib could cause harm to an unborn baby and cause a birth defect if the father or mother is taking this medication.

  • If you're female, do not use xospata when you are expecting. It is possible that you will need to undergo an unconfirmed pregnancy test prior to taking this medication. Make sure you are using effective birth control to avoid pregnancy while taking this medicine and for at least six months following your last dose.
  • If you're male, use effective birth control when your partner is capable of becoming pregnant. Use birth control for a minimum of 4 months following your last dose.
  • Inform your doctor immediately. If you become pregnant when one of the mothers or fathers is taking xospata,

Don't breastfeed during the course of this medication or for at least two months following the last dose.

Similar/related drugs

Ventoclax, Venclexta, Azacitidine, Vincristine, Cytarabine, and Ivosidenib

How to take Xospata?

Use Xospata exactly as directed by your physician. Follow the directions on the prescription label and go through all medication guides and instruction sheets.

There is a possibility that you will require regular medical tests to make sure the medication isn't producing harmful negative effects. Your treatment for cancer could be delayed, depending on the results.

Xospata is typically prescribed every day. It is taken with a full glass of water at the exact same time every day.You can consume Xospata in combination with food or not.Do not chew, crush, or break a Xospata tablet. Suck the tablet completely.

It could take a few months before you get the full benefit from taking this medication. Your doctor will decide the time frame for treatment with this medication.Do not alter the dose or discontinue taking this medication without consulting your physician.Keep this medicine in its original container at room temperature, away from heat and moisture.

Details on dosage

Usual Adult Dose for Acute Myeloid Leukaemia:

120 mg orally every day, until the disease progresses or becomes unacceptably toxic.
Comments:
The response may take a while. In the absence of progress or unacceptable toxic effects, patients should be treated for at least six months to allow for a clinical reaction.
Select patients to be treated for AML by this medication in accordance with their presence of FLT3 mutations in bone marrow or blood.
Use: To treat patients in adulthood who have an acute myeloid leukaemia (AML) with an FMS-related tyrosine kinase 3 (FLT3) variant that is confirmed by an FDA-approved test.

What happens if I miss a dose?

You should take the missed dose the day you first remember it. Do not take any missed doses if the next dose falls within less than 12 hours. Don't take two doses in a 12-hour time frame.

What happens if I overdose?

Get medical attention in an emergency or contact the Poison Help line toll-free at 1-800-222-1222.

What can you do to

Follow your doctor's advice regarding any restrictions on your food, drink, or activity.

Side effects of Xospata

See a doctor immediately. If you are experiencing symptoms of an allergy reaction, Xospata: hives, breathing problems, or swelling of your lips, face, or tongue,

Gilteritinib may cause a condition known as differentiation syndrome. This condition affects blood cells and can be fatal if not addressed. The condition can manifest in the 2nd to 3rd months after starting to take Xospata.

Take immediate medical advice when you experience the following symptoms:

  • Trouble breathing;
  • Bone pain;
  • Rapid weight increase and
  • Swelling in your legs, arms, or underarms. It can also affect your groyne or neck.

See your doctor right away if you are suffering from:

  • Headache, confusion, change in mental status, vision loss, seizure (convulsions);
  • Colds, fever, cough with chest pain and mucus;
  • Flu symptoms, including throat and mouth ulcers;
  • Extreme abdominal pain expanding to your back, nausea, and even vomiting;
  • An uneasy feeling that you're in the process of passing out
  • Rapid or pounding heartbeats, chest flutters, breathlessness, and abrupt fainting (like you're about to pass out).

The treatment for cancer may be delayed or completely stopped in the event of certain adverse effects.

Common Xospata adverse reactions could include:

  • Nausea, vomiting, diarrhea, and  constipation;
  • Sores or pain in the throat or mouth;
  • Shortness of breath, cough;
  • Headache, dizziness;
  • Eye issues;
  • Joint or muscle pain;
  • Low blood pressure;
  • The swelling of your arms and legs;
  • Fever, tiredness;
  • Reduced urination
  • The rash
  • Abnormal tests of liver function.

This is not a comprehensive list of all the side effects. Other side effects could occur. Consult your physician to seek medical advice on the effects. If you experience any side reactions to the FDA by calling 1-800-FDA-1088.

Interaction with other drugs

Other medications may be incompatible with gilteritinib, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your physician about the medicines you are currently taking as well as any medications you are about to start or stop taking.

 

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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