Gilternib 40mg (Gilteritinib)

Gilternib 40mg is a medicine made from the main ingredient Gilteritinib. Gilternib 40mg is indicated for the treatment of relapsed or refractory acute myeloid leukemia. The drug is manufactured by Everest Pharma Ltd, Bangladesh.

Dosage forms

• Tablets.

What is acute myeloid leukemia?

• Acute myeloid leukemia is a type of cancer that causes the soft tissue inside bones to cause abnormalities in myeloblasts, platelets or red blood cells. Some cases of the disease will spread to other parts of the body such as lymph nodes, liver, spinal cord, brain, and spleen.

Uses - Indications of Gilternib 40mg

• Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations.

How to use – dosage of Gilternib 40mg

• How to use: The drug is taken orally.

• Dosage: The recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily.

Contraindications of Gilternib 40mg

• People who are sensitive to the ingredients of the drug.

Notes when using Gilternib 40mg

• Gilternib can cause a condition called dedifferentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 2 days to 3 months after you start taking Xospata.

• Seek medical help immediately if you have symptoms of dedifferentiation syndrome: fever, cough, difficulty breathing, bone pain, rapid weight gain, or swelling in your arms, legs, armpits, groin, or neck.

• To make sure Gilternib is safe for you, tell your doctor if you have ever had: Heart problems; long QT syndrome (in you or a family member); or an electrolyte imbalance (such as low blood levels of potassium or magnesium).

• Before taking this medication, your heart function may need to be tested with an electrocardiogram or ECG (sometimes called an EKG).

Use for pregnant or breastfeeding women

• Pregnant women: Gilteritinib may harm the fetus when administered to pregnant women. There are no or limited data on the use of gilteritinib in pregnant women. Reproduction studies in rats have shown that gilteritinib causes inhibition of fetal growth, embryolethality, and teratogenicity. Gilternib is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

• Breastfeeding women: 

  • It is not known whether gilteritinib or its metabolites are excreted in human milk. Available animal data indicate excretion of gilteritinib and its metabolites in the milk of lactating rats and distribution into tissues of newborn rats via milk.

  • A risk to the nursing infant cannot be excluded. Breast-feeding should be discontinued during treatment with Gilternib and for at least two months after the final dose.

For use by drivers and machine operators

• Consult your doctor.

Side effects of Gilternib 40mg

• Some side effects that may occur when using the drug: Nausea, vomiting, diarrhea, constipation; pain or sores in the mouth or throat, cough, difficulty breathing, headache, dizziness, muscle or joint pain, low blood pressure, swelling of the hands or feet, etc. 

Interact

• CYP3A/P-gp Inducers: Coadministration of Gilteritinib with strong CYP3A/P-gp inducers (e.g., phenytoin, rifampin, and St. John's Wort) should be avoided as they may decrease gilteritinib concentrations in plasma. In healthy subjects, coadministration of rifampicin (600 mg), a strong CYP3A/P-gp inducer, to steady state with a single 20 mg dose of gilteritinib decreased the mean gilteritinib Cmax to 27 % and mean AUCinf by 70%, respectively, compared to subjects receiving a single dose of gilteritinib.

• CYP3A, P-gp and/or BCRP Inhibitors: Strong CYP3A, P-gp and/or BCRP inhibitors (e.g., voriconazole, itraconazole, posaconazole, clarithromycin, erythromycin, captopril, carvedilol, ritonavir, azithromycin) may may increase gilteritinib plasma concentrations. A single 10 mg dose of gilteritinib administered concomitantly with itraconazole (200 mg once daily for 28 days), a potent inhibitor of CYP3A, P-gp and BCRP, in healthy subjects resulted in a mean increase in Cmax of approximately 20% and 2.2-fold increase in mean AUCinf compared to subjects receiving only one dose of gilteritinib. Gilteritinib exposure was increased approximately 1.5-fold in patients with relapsed or refractory AML when coadministered with strong CYP3A, P-gp, and/or BCRP inhibitors.

• Gilteritinib is not an inhibitor or inducer of CYP3A4 or an inhibitor of MATE1 in vivo. The pharmacokinetics of midazolam (a sensitive CYP3A4 substrate) were not significantly affected (Cmax and AUC increased approximately 10%) following once daily administration of gilteritinib (300 mg) for 15 days in patients with relapsed AML. development or treatment resistance due to FLT3 mutation. Additionally, the pharmacokinetics of cehalexin (a sensitive MATE1 substrate) were not significantly affected (Cmax and AUC decreased by less than 10%) following once daily administration of gilteritinib (200 mg) for 15 days in patients with relapsed or refractory AML due to FLT3 mutations. 

• Based on in vitro data, gilteritinib may reduce the effects of drugs that target the 5HT2B receptor or nonspecific sigma receptors (e.g., escitalopram, fluoxetine, sertraline). Avoid concurrent use of these medicinal products with Xospata unless use is considered essential for patient care.

Dealing with missed doses

• If you forget a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time. Do not take double the prescribed dose.

Treatment in case of overdose

• If you overdose, contact your doctor or go to the nearest medical facility for examination and support.

Preserve

• In a dry, airy place, away from direct light.

• Keep out of reach of CHILDREN.

Packing 

• Box of 1 bottle of 90 tablets.

Producer

• Everest Pharma Ltd.