Drug Interaction:
Rifampicin, phenobarbital, phenytoin, carbamazepine , St Johns Wort,
or other potent CYP3A4 Inducers.
antifungal, ritonavir,macrolides, grapefruit juice, or other potent CYP3A4 inhibitors,
anticoagulants, antiarrhythmics, i.v. biphosphonates
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 56
Name of the Drug- Sunitinib maleate capsules
12.5mg/25mg/50mg
Pharmacological Classification- For G.I Stromal tumor
Advanced renal cell cancer
Date of Approval- 10-04-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Sunitinib maleate Capsules 10-04-2007
12.5mg/25mg/50mg
For G.I. Stromal tumor, Advanced Renal Cell Carcinoma
Metastatic renal cell carcinoma( RCC)
Adverse Reaction:
Haemorrhage, blood dyscrasisias, dysgeusia, orophyngeal dryness/discomfort,
pleural effusion, dyspnoea, headache, hypertension, GI upset,
oseophagitis, stomatitis, anorexia, skin disorders, fatigue,
asthenia, dizziness, insomnia, paresthesia, hypoaesthesia, hyperaesthesia
peripheral neuropathy, alopecia, hand foot-syndrome, fever, chills,
dehydration, depression, lacrimation,
flushing, hot flushes, cough, chelitis,
muscle spasm, arthalgia, myalgia, renal failure, hypothyroidism,
chromaturia, odema, wt. loss, pain, hair and nail discoloration,
decreased haemoglobin, platelet count anfd ejection factor,
raised liver enzyme, creatinine, amylase, creatine kinase and uric acid
reports of thromboembolism, heart failure, cardiomyopathy, myocardial disorders,
GI perforation, seizures, tumor lysis, syndrome
Contra-Indications:
Severe hepatic impairment
lactation, pregnancy
ensure adequate contrception in women of child bearing potential
Special Precautions-
Pulmonary tumors, hypertension, risk of fatal pulmonary haemorhage,
Perform FBC before each treatment cycle
Monitor patients with cardiovascular risk factors for signs of CHF
Discontinue if ejection function < 50% and > 20% below baseline
History of risk factors for QT prolongation.
Pre-existing cardiac disease, bradycardia, or electrolyte disturbances
Check thyroid function at base line every 3 months
Monitor for symptoms of pancreatitis or hepatic failure, discontinue if present
Perform baseline urine analysis and minitor for development or worsening of protienuria
Discontinue if nephrotic syndrome occurs
Monitor LFT discontinue if hepatic failure occurs
Risk of ostenonecrosis of jaw usually associated with concomittant or previous
i.v. bisphosphanate use
Perform dental examination and appropiate dental treatment prior to therapy
Avoid invasive dental procedures during therapy
risk of impaired wound healing, discontinue in major surgery
Dosages/ Overdosage Etc:
Indication-
Metastatic renal cell carcinoma( RCC)
Dosage-
GIST ( gastro intestinal stromal tumor )and RCC -
50mg daily for 4 weeks followed by a 2 week rest period
Adjust if necesary according to tolerance in 12.5mg steps
range 25 -75 mg daily for GIST and RCC
Below 18 years not recommended
Pregnancy and lactation:
Use contraindicated during pregnancy and lactation
Ensure adequate contrception in women of child bearing potential