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Same active ingredient — pay up to 25% less
These brands contain the same active ingredient (Gilteritinib Fumarate). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Gilteritinib Fumarate is used to treat adults whose acute myeloid leukemia (AML) has come back (relapsed) or has not responded to earlier treatment (refractory), when the leukemia carries a FMS-like tyrosine kinase 3 (FLT3) mutation. The mutation must be confirmed by an FDA-approved test.
Pharmacology
Gilteritinib is a small molecule that blocks several receptor tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3). In cells that were made to express FLT3, it reduced FLT3 receptor signaling and cell proliferation. This held for FLT3-ITD and for the tyrosine kinase domain mutations (TKD) FLT3-D835Y and FLT3-ITD-D835Y. Gilteritinib also induced apoptosis in leukemic cells expressing FLT3-ITD.
Pharmacodynamics: In patients with relapsed or refractory AML who were given Gilteritinib 120 mg, FLT3 phosphorylation was inhibited by more than 90%. The effect came quickly (within 24 hours after the first dose) and it was sustained. This was measured with an ex vivo plasma inhibitory activity (PIA) assay.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Patient Selection
Choose patients for AML treatment with Gilteritinib based on a FLT3 mutation found in the blood or bone marrow. Information on FDA-approved tests for detecting a FLT3 mutation in AML is available.
Recommended Dosage
The recommended starting dose of Gilteritinib is 120 mg by mouth once daily, with or without food. Response may be delayed, so if there is no disease progression or unacceptable toxicity, treatment for a minimum of 6 months is recommended to allow time for a clinical response. Don't break or crush the tablets. Give them at about the same time each day. If a dose is missed or not taken at the usual time, give it as soon as possible on the same day, at least 12 hours before the next scheduled dose. Then return to the normal schedule the following day. Do not give 2 doses within 12 hours.
Dose Modification
Check blood counts and blood chemistries, including creatine phosphokinase, before starting Gilteritinib. Repeat them at least once weekly for the first month, once every other week for the second month, and once monthly for the rest of the therapy. Do an electrocardiogram (ECG) before starting treatment, on days 8 and 15 of cycle 1, and before the start of the next two cycles.
Side Effects
The following adverse drug reactions with Gilteritinib Fumarate are described elsewhere in the labeling: fever, dizziness or lightheadedness, cough, rapid weight gain, trouble breathing, swelling of your arms or legs, rash, and decreased urination.
Cautions & Contraindications
Warnings & Precautions
Differentiation Syndrome Of 319 patients treated with Gilteritinib Fumarate in the clinical trials, 3% had differentiation syndrome. It is linked with rapid growth and differentiation of myeloid cells, and it can be life-threatening or fatal if it isn't treated. Symptoms in patients on Gilteritinib Fumarate included fever, dyspnea, pleural effusion, pericardial effusion, pulmonary edema, hypotension, rapid weight gain, peripheral edema, rash and renal dysfunction. Some cases also had acute febrile neutrophilic dermatosis at the same time. The syndrome appeared as early as 2 days and up to 75 days after starting Gilteritinib Fumarate, and it was seen with or without leukocytosis. Of the 11 patients who had it, 9 (82%) recovered after treatment or after the dose of Gilteritinib Fumarate was interrupted. If differentiation syndrome is suspected, start dexamethasone 10 mg IV every 12 hours (or an equivalent dose of another oral or IV corticosteroid) and hemodynamic monitoring until the patient improves. Taper the corticosteroids once symptoms resolve, and give them for a minimum of 3 days. Symptoms may return if corticosteroid treatment is stopped too early. If severe signs and/or symptoms persist for more than 48 hours after corticosteroids are started, interrupt Gilteritinib Fumarate until the signs and symptoms are no longer severe. Posterior Reversible Encephalopathy Syndrome Of 319 patients treated with Gilteritinib Fumarate in the clinical trials, 1% had posterior reversible encephalopathy syndrome (PRES), with symptoms including seizure and altered mental status. The symptoms resolved after Gilteritinib Fumarate was stopped. A diagnosis of PRES needs confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Stop Gilteritinib Fumarate in patients who develop PRES. Prolonged QT Interval Gilteritinib Fumarate has been associated with prolonged cardiac ventricular repolarization (QT interval). Of the 317 patients who had a post-baseline QTc measurement while on Gilteritinib Fumarate in the clinical trial, 1% had a QTc interval greater than 500 msec and 7% had an increase from baseline QTc greater than 60 msec. Do an electrocardiogram (ECG) before starting treatment with Giltela, on days 8 and 15 of cycle 1, and before the start of the next two cycles. Interrupt Gilteritinib Fumarate and reduce the dose in patients who have a QTcF >500 msec. Hypokalemia or hypomagnesemia may raise the risk of QT prolongation, so correct them before and during Gilteritinib Fumarate treatment. Pancreatitis Of 319 patients treated with Gilteritinib Fumarate in the clinical trials, 4% had pancreatitis. Evaluate patients who develop signs and symptoms of pancreatitis. Interrupt Gilteritinib Fumarate and reduce the dose in patients who develop pancreatitis. Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, Gilteritinib Fumarate can cause embryo-fetal harm when given to a pregnant woman. In animal reproduction studies, giving Gilteritinib Fumarate to pregnant rats during organogenesis caused embryo-fetal lethality, suppressed fetal growth and teratogenicity at maternal exposures (AUC24) of approximately 0.4 times the AUC24 in patients receiving the recommended dose. Females of reproductive potential should be advised to use effective contraception during treatment with Gilteritinib Fumarate and for at least 6 months after the last dose. Males with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 4 months after the last dose. Pregnant women, patients who become pregnant while receiving Gilteritinib Fumarate, and male patients with pregnant female partners should be told about the potential risk to the fetus.
Contraindications
Patients who are hypersensitive to Gilteritinib or to any of the excipients in the product must not take it. Anaphylactic reactions have been seen in clinical trials.
Pregnancy & Breastfeeding
Pregnancy
Gilteritinib can cause fetal harm when it is given to a pregnant woman. This comes from animal studies and from how the medicine works. There are no data on Gilteritinib use in pregnant women, so a drug-associated risk of adverse developmental outcomes can't be worked out. In animal reproduction studies, pregnant rats given the medicine during organogenesis had embryo-fetal lethality, suppressed fetal growth and teratogenicity. This happened at maternal exposures (AUC24) of about 0.4 times the AUC24 in patients receiving the recommended dose. Pregnant women should be told about the potential risk to the fetus. Adverse outcomes in pregnancy occur regardless of the mother's health or whether she uses medicines. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk in clinically recognised pregnancies is 2%-4% for major birth defects and 15%-20% for miscarriage.
Lactation
There are no data on whether Gilteritinib and/or its metabolites pass into human milk, what effect they have on a breastfed child, or what effect they have on milk production. When radiolabeled Gilteritinib was given to lactating rats, the radioactivity in the milk was higher than in the mother's plasma at 4 and 24 hours after the dose. In animal studies, Gilteritinib and/or its metabolite(s) reached the tissues of infant rats through the milk. Because a breastfed child could have serious adverse reactions, a lactating woman should be advised not to breastfeed during treatment and for at least 2 months after the last dose.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Safety and effectiveness of Gilteritinib Fumarate in children have not been established.
Geriatric Use: Clinical studies included 319 patients on Gilteritinib Fumarate. Of these, 43% were age 65 years or older, and 13% were 75 years or older. Doctors saw no overall differences in effectiveness or safety between the patients aged 65 years or older and the younger patients.
Storage
Keep Gilteritinib Fumarate below 30°C, in a cool and dry place. Protect it from light, and keep it out of the reach of children.
Drug Interactions
Common questions about Gilternib 40 mg
What is Gilternib 40 mg Tablet?
Gilternib 40 mg Tablet is a medicine that contains Gilteritinib Fumarate. It is made by Everest Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Gilternib used for?
Gilteritinib Fumarate is used to treat adults whose acute myeloid leukemia (AML) has come back (relapsed) or has not responded to earlier treatment (refractory), when the leukemia carries a FMS-like tyrosine kinase 3 (FLT3) mutation. The mutation must be confirmed by an FDA-approved test.
What are the side effects of Gilternib?
The following adverse drug reactions with Gilteritinib Fumarate are described elsewhere in the labeling: fever, dizziness or lightheadedness, cough, rapid weight gain, trouble breathing, swelling of your arms or legs, rash, and decreased urination.
Can I take Gilternib during pregnancy or while breastfeeding?
Pregnancy Gilteritinib can cause fetal harm when it is given to a pregnant woman. This comes from animal studies and from how the medicine works. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Gilternib?
Keep Gilteritinib Fumarate below 30°C, in a cool and dry place. Protect it from light, and keep it out of the reach of children.
Can I take other medicines with Gilternib?
Some medicines can interact with Gilteritinib Fumarate, for example: Sertraline, Escitalopram, Fluoxetine. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Giltela by Jenphar Bangladesh Ltd. has the same ingredient and strength for ৳500.00 per unit, compared with ৳670.00 for Gilternib. Ask your doctor or pharmacist before switching.
Do I need a prescription for Gilternib?
Gilternib is a prescription (Rx) medicine. Take it as your doctor advises.