|
| |
Sunitinib malate capsules
SUTENT®
|
|
FDA Approval: |
January 2006 |
|
Indication: |
Gastrointestinal stromal tumour (GIST) in patients with disease
progression on imatinib or intolerance to imatinib Advanced renal
cell carcinoma (RCC) |
|
Pharmacology: |
Multiple receptor tyrosine kinases inhibitor |
|
Usual Dose: |
50 mg orally once a day for 4 weeks on, followed by 2 weeks off |
|
Contraindications: |
Hypersensitivity to ingredients |
|
Warnings: |
May cause left ventricular dysfunction; monitor LVEF at baseline and
during treatment Monitor patients for CHF and discontinue if
clinical signs of CHF occur
Reduce dose or interrupt treatment if LVEF falls to 20 to 50%
below baseline
May cause bleeding (most commonly epistaxis), including severe
and life-threatening tumor-related pulmonary and GI hemorrhage
Monitor patients for hypertension and treat as clinically
appropriate
Interrupt sunitinib treatment until severe hypertension can be
controlled
Monitor patients for adrenal insufficiency during periods of
stress (surgery, trauma, severe infection)
Has caused yellow skin discoloration in ⅓ of
patients, hair/skin depigmentation, hand-foot syndrome
Obtain CBC, platelet count, and serum chemistry at the start of
each treatment cycle
Safety and efficacy not established in pediatric patients
Women should avoid pregnancy during treatment
Breastfeeding is not recommended during treatment |
|
Pregnancy Category: |
D |
|
Side Effects: |
Diarrhea, hypertension, hemorrhage/bleeding, mucositis, skin
abnormalities, taste alteration Fatigue, fever, peripheral edema
Nausea, stomatitis, vomiting, constipation, abdominal pain,
flatulence, glossodynia
Rash, skin discoloration, hand-foot syndrome, alopecia, dry skin,
hair color change
Headache, arthralgia, myalgia, back pain, limb pain
Dyspnea, cough
Anorexia, asthenia, dehydration
Neutropenia, anemia, lymphopenia, thrombocytopenia, leukopenia |
|
Drug Interactions: |
Strong CYP450 3A4 inhibitors (eg, itraconazole, ketoconazole,
clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir,
ritonavir, saquinavir, terlithromycin, voriconazole) Grapefruit
CYP450 3A4 inducers (eg, carbamazepine, dexamethasone,
phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St
John's wort) |
|
Every effort has been made to ensure that the
information provided by Cerner Multum, Inc. (“Multum”) is accurate, up-to-date,
and complete, but no guarantee is made to that effect. In addition, the drug
information contained herein may be time sensitive. Multum information has been
compiled for use by healthcare practitioners and end-users in the United States.
Cerner Multum does not warrant that uses outside of the United States are
appropriate.
Multum’s drug information does not endorse drugs, diagnose patients or recommend
therapy. Multum’s drug information is an informational resource designed to
assist licensed healthcare practitioners in caring for their patients and/or to
serve end-users viewing this service as a supplement to, and not a substitute
for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Healthcare practitioners should use their professional judgment in using the
information provided. The absence of a warning for a given drug or drug
combination in no way should be construed to indicate that the drug or drug
combination is safe, effective or appropriate for any given patient.
Multum does not assume any responsibility for any aspect of healthcare
administered with the aid of information Multum provides.
The information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions, or
adverse effects. If you have questions about the drugs you are taking, check
with your doctor, nurse or pharmacist.
Copyright 2006-2007 Cerner Multum, Inc.
|
