Resinib Capsule

Sunitinib
50 mg
Jenphar Bangladesh Ltd.
Pack size 14's Pack
Unite Price 950.00 BDT

Indications

Resinib Capsule is used for: Leukemia, Renal cell carcinoma, Gastrointestinal stromal tumor, Meningioma

Adult Dose

Hepatic Impairment Mild to moderate impairment: Dose adjustment not necessary for initial dose; monitor subsequent doses Severe impairment: Not studied

Child Dose

Safety and efficacy not established

Renal Dose

Renal Impairment No dose adjustment necessary

Administration

May be taken with or without food.

Contra Indications

Hypersensitivity, Renal impairment

Precautions

CHF, HTN, history of QT interval prolongation, patients taking antiarrhythmics or w/ preexisting cardiac disease, bradycardia or electrolyte disturbances, hemorrhagic events, hypothyroidism. Perform CBC & physical exam. May affect ability to drive or operate machinery. Pregnancy.

Pregnancy-Lactation

Pregnancy No available data established in pregnant women to inform a drug-associated risk In animal developmental and reproductive toxicology studies, oral administration of sunitinib to pregnant rats and rabbits throughout organogenesis resulted in teratogenicity (embryolethality, craniofacial and skeletal malformations) at 5.5 and 0.3 times the AUC in patients administered the recommended daily doses (RDD), respectively Advise pregnant women or females of reproductive potential of the potential hazard to a fetus Females of reproductive potential should have a pregnancy test before initiating treatment Advise females of reproductive potential to use effective contraception during treatment and for at least 4 weeks after the last dose Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 7 weeks after the last dose Based on findings in animals, male and female fertility may be compromised by treatment Lactation Unknown if excreted in human milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother Parent drug and/or its metabolites were excreted in the milk of lactating rats; radioactivity was present in the plasma of suckling offspring 24-48 hr after lactating rats received a single oral dose of radioactive bosutinib Because of the potential for serious adverse reactions in breastfed infants from sunitinib, advise a lactating woman not to breastfeed during treatment with sunitinib and for at least 4 weeks after the last dose

Interactions

Increased plasma conc w/ strong CYP3A4 inhibitors (eg ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice). Decreased plasma conc w/ strong CYP3A4 inducers [eg rifampin, dexamethasone, phenytoin, carbamazepine, phenobarb, St. John's wort (Hypericum perforatum)]. Anticoagulants eg warfarin, acenocoumarol (periodically monitor platelets, prothrombin time/INR & physical exam).

Side Effects

Side effects of Sunitinib : >10% Dyspepsia (MRCC 46%), Altered taste (MRCC 43%; GIST 21%), Fatigue (GIST 42%; MRCC 74%), Diarrhea (GIST 40%; MRCC 55%), Rash (MRCC 38%; GIST 14%), Vomiting (MRCC 37%; GIST 24%), Constipation (MRCC 34%; GIST 20%), Skin discoloration (MRCC 33%; GIST 30%), Abdominal pain (GIST 33%; MRCC 20%), Nausea (GIST 31%; MRCC 54%), Anorexia (MRCC 31%; GIST 33%), Mucositis/stomatitis (GIST 29%; MRCC 53%), Dyspnea (MRCC 28%; GIST 10%), HTN (MRCC 28%; GIST 15%), Arthralgia (MRCC 28%; GIST 12%), Bleeding (MRCC 26%; GIST 18%), Headache (MRCC 25%; GIST 13%), Asthenia (GIST 22%), Lymphopenia (MRCC 21%), Fever (GIST 18%; MRCC 15%), Limb pain (MRCC 18%), Back pain (MRCC 17%; GIST 11%), Myalgia (MRCC 17%; GIST 14%), Cough (MRCC 17%; GIST 8%), Dry skin (17%), Hair color changes (17%), Neutropenia (MRCC 13%; GIST 11%), Alopecia (MRCC 12%), Hand-foot syndrome (MRCC 12%; GIST 14%), Dehydration (MRCC 11%) 1-10% Venous thrombotic events, Hemorrhoids, Pancreatitis, Flu-like syndrome <1% Hepatotoxicity, Acute renal failure, Adrenal dysfunction

Mode of Action

Multikinase inhibitor (including VEGF & PDGF receptor tyrosine kinases) some of which are implicated in tumor growth, angiogenesis, and metastasis.

Note

Resinib 50 mg Capsule generic name is Sunitinib. Resinib 50 mg Capsule is manufactured by Jenphar Bangladesh Ltd.Resinib is availble in all over Bangladesh. Mes BD drug index information on Resinib Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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