Sutent Capsules (Hard Gelatin)
Sunitinib
12.5mg
Pfizer Europe MA EEIG
| Pack size | 30's Plastic Bottle |
|---|---|
| Dispensing mode | POM |
| Source | BELGIUM |
| Agent | Gulf Drug LLC |
| Retail Price | 7942.50 AED |
Available as:
Indications
Sutent Capsules (Hard Gelatin) 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).
Adverse 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
Mechanism of Action
Multikinase inhibitor (including VEGF & PDGF receptor tyrosine kinases) some of which are implicated in tumor growth, angiogenesis, and metastasis.
Note
Sutent 12.5mg Capsules (Hard Gelatin) manufactured by Pfizer Europe MA EEIG. Its generic name is Sunitinib. Sutent is availble in United Arab Emirates.
Farmaco UAE drug index information on Sutent Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.