Sunitinib Malate (Sutent)

Trade Name : SUTENT

Pfizer Laboratories Div Pfizer Inc

CAPSULE

Strength 12.5 mg/1

Storage and handling for SUTENT

SUNITINIB MALATE Protein Kinase Inhibitors [MoA],Kinase Inhibitor [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sunitinib Malate (Sutent) which is also known as SUTENT and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 12.5 mg/1 per ml. Read more

Sunitinib Malate (Sutent) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Hepatotoxicity has been observed in clinical trials and postmarketing experience. Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended .
WARNING: HEPATOTOXICITY
See full prescribing information for complete boxed warning.
Hepatotoxicity has been observed in clinical trials and postmarketing experience. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended n

No data

SUTENT is a kinase inhibitor indicated for:

the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ()
the treatment of advanced renal cell carcinoma (RCC). ()
the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ()
the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. ()

GIST and Advanced RCC:
Adjuvant RCC:
pNET:
Dose Modification:

No data

Capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg ()

None.

None ()

No data

Hepatotoxicity, including fatal liver failure, has been observed. Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. Interrupt SUTENT for Grade 3 or 4 drug-related hepatic adverse reactions and discontinue if there is no resolution. Do not restart SUTENT if patients experience severe changes in liver function tests or have signs and symptoms of liver failure. ()
Cardiovascular events including myocardial ischemia, myocardial infarction, left ventricular ejection fraction declines to below the lower limit of normal and cardiac failure including death have occurred. Monitor patients for signs and symptoms of congestive heart failure. Discontinue SUTENT for clinical manifestations of congestive heart failure. ()
Prolonged QT intervals and Torsade de Pointes have been observed. Monitor patients at higher risk for developing QT interval prolongation. Consider monitoring of electrocardiograms and electrolytes. ()
Hypertension may occur. Monitor blood pressure and treat as needed. ()
Hemorrhagic events, including tumor-related hemorrhage, and viscus perforation (both with fatal events) have occurred. Perform serial complete blood counts and physical examinations. ()
Cases of Tumor Lysis Syndrome (TLS) (some fatal) have been reported primarily in patients with RCC and GIST with high tumor burden. Monitor these patients closely and treat as clinically indicated. ()
Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported. Discontinue SUTENT in patients developing TMA. ()
Proteinuria, including renal failure or a fatal outcome, has occurred. Monitor urine protein. Interrupt treatment for 24-hour urine protein u22653 grams. Discontinue for repeat episodes of protein u22653 grams despite dose reductions or nephrotic syndrome. ()
Necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) (some fatal) have occurred. Discontinue SUTENT if these events occur. ()
Thyroid dysfunction may occur. Patients with signs and/or symptoms suggestive of hypothyroidism or hyperthyroidism should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice. ()
Hypoglycemia may occur. Check blood glucose levels regularly and assess if antidiabetic drug dose modifications are required. ()
Osteonecrosis of the jaw has been reported. Consider preventive dentistry prior to treatment with SUTENT. If possible, avoid invasive dental procedures, particularly in patients receiving intravenous bisphosphonate therapy. ()
Wound Healing: Impaired wound healing has occurred with SUTENT. Temporary interruption of therapy with SUTENT is recommended in patients undergoing major surgical procedures. ()
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (, , )

The following serious adverse reactions are discussed in greater detail in other sections of the labeling.
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchn

The most common adverse reactions (u226525%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia. ()

No data

CYP3A4 Inhibitors: Consider dose reduction of SUTENT when administered with strong CYP3A4 inhibitors. ()
CYP3A4 Inducers: Consider dose increase of SUTENT when administered with strong CYP3A4 inducers. ()

No data

Lactation: Advise women not to breastfeed. ()

Treatment of overdose with SUTENT should consist of general supportive measures. There is no specific antidote for overdosage with SUTENT. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Cases of accidental overdose have been reported; these cases were associated with adverse reactions consistent with the known safety profile of SUTENT, or without adverse reactions. A case of intentional overdose involving the ingestion of 1500 mg of SUTENT in an attempted suicide was reported without adverse reaction. In nonclinical studies, mortality was observed following as few as 5 daily doses of 500 mg/kg (3000 mg/m) in rats. At this dose, signs of toxicity included impaired muscle coordination, head shakes, hypoactivity, ocular discharge, piloerection, and gastrointestinal distress. Mortality and similar signs of toxicity were observed at lower doses when administered for longer durations.

SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with -[2-(diethylamino)ethyl]-5-[()-(5-fluoro-1,2-dihydro-2-oxo--indol-3-ylidine)methyl]-2,4-dimethyl--pyrrole-3-carboxamide (1:1). The molecular formula is CHFNO u2219 CHO and the molecular weight is 532.6 Daltons.
The chemical structure of sunitinib malate is:
Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2.
SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing sunitinib malate equivalent to 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib together with mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients.
The orange gelatin capsule shells contain titanium dioxide and red iron oxide. The caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. The yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide. The black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide.

No data

The carcinogenic potential of sunitinib has been evaluated in 2 species: rasH2 transgenic mice and Sprague-Dawley rats. There were similar positive findings in both species. In rasH2 transgenic mice, gastroduodenal carcinomas and/or gastric mucosal hyperplasia, as well as an increased incidence of background hemangiosarcomas were observed at doses u226525 mg/kg/day following daily dose administration of sunitinib in studies of 1 or 6 months duration. No proliferative changes were observed in rasH2 transgenic mice at 8 mg/kg/day. Similarly, in a 2-year rat carcinogenicity study, administration of sunitinib in 28-day cycles followed by 7-day dose-free periods resulted in findings of duodenal carcinoma at doses as low as 1 mg/kg/day (approximately 0.9 times the AUC in patients given the RDD of 50 mg/day). At the high dose of 3 mg/kg/day (approximately 8 times the AUC in patients at the RDD of 50 mg/day), the incidence of duodenal tumors was increased and was accompanied by findings of gastric mucous cell hyperplasia and by an increased incidence of pheochromocytoma and hyperplasia of the adrenal gland.
Sunitinib did not cause genetic damage when tested in in vitro assays (bacterial mutation [Ames test], human lymphocyte chromosome aberration) and an in vivo rat bone marrow micronucleus test.
In a female fertility and early embryonic development study, female rats were administered oral sunitinib (0.5, 1.5, 5 mg/kg/day) for 21 days prior to mating and for 7 days after mating. Preimplantation loss was observed in females administered 5 mg/kg/day (approximately 5 times the AUC in patients administered the RDD of 50 mg/day). No adverse effects on fertility were observed at doses u22641.5 mg/kg/day (approximately 1 time the clinical AUC at the RDD of 50 mg/day). In addition, effects on the female reproductive system were identified in a 3-month oral repeat-dose monkey study (2, 6, 12 mg/kg/day). Ovarian changes (decreased follicular development) were noted at 12 mg/kg/day (approximately 5 times the AUC in patients administered the RDD), while uterine changes (endometrial atrophy) were noted at u22652 mg/kg/day (approximately 0.4 times the AUC in patients administered the RDD). With the addition of vaginal atrophy, the uterine and ovarian effects were reproduced at 6 mg/kg/day (approximately 0.8 times the AUC in patients administered the RDD) in a 9-month monkey study (0.3, 1.5, and 6 mg/kg/day administered daily for 28 days followed by a 14 day respite).
In a male fertility study, no reproductive effects were observed in male rats dosed with 1, 3, or 10 mg/kg/day oral sunitinib for 58 days prior to mating with untreated females. Fertility, copulation, conception indices, and sperm evaluation (morphology, concentration, and motility) were unaffected by sunitinib at doses u226410 mg/kg/day approximately u226526 times the AUC in patients administered the RDD).

No data

No data

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
LAB-0317-24.0

No data

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0069-0550-38
Pfizer
Sutentn- (sunitinib malate)
12.5 mg*
Capsules
28 Capsulesn- Rx only

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0069-0770-38
Pfizer
Sutentn- (sunitinib malate)
25 mg*
Capsules
28 Capsulesn- Rx only

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0069-0980-38
Pfizer
Sutentn- (sunitinib malate)
50 mg*
Capsules
28 Capsulesn- Rx only

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0069-0830-38ttttt tttttt
Pfizer
Sutentn- (sunitinib malate)
37.5 mg*
Capsules
28 CapsulesRx only

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Sunitinib Malate (Sutent)

Trade Name : SUTENT

CAPSULE

Storage and handling for SUTENT

Disclaimer

Delivery Process

Product information is meant for

Packaging and Delivery

About GNH

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Sunitinib Malate (Sutent)

Trade Name : SUTENT

CAPSULE

Storage and handling for SUTENT

Disclaimer

Delivery Process

Product information is meant for

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?