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Description of product
What is Sutent and how is it used?
Sutent is a prescription medicine used to treat the symptoms of Gastrointestinal Stromal Tumor, Renal Cell Carcinoma, and Pancreatic Neuroendocrine Tumors. Sutent may be used alone or with other medications.
Sutent belongs to a class of drugs called Antineoplastics, Tyrosine Kinase Inhibitor; Antineoplastics, VEGF Inhibitor.
It is not known if Sutent is safe and effective in children.
What are the possible side effects of Sutent?
Sutent may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- fever,
- sore throat,
- burning in your eyes,
- skin pain,
- red or purple skin rash that spreads and causes blistering and peeling,
- loss of appetite,
- stomach pain on the upper right side,
- tiredness,
- itching,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- decreased urination,
- nosebleeds,
- pain, redness, numbness, and peeling skin or your hands or feet,
- easy bruising,
- unusual bleeding,
- purple or red spots under your skin,
- painful skin sores,
- sores in your mouth or on your lips,
- jaw pain or numbness,
- red or swollen gums,
- loose teeth,
- slow healing after dental work,
- confusion,
- thinking problems,
- vision loss,
- seizure,
- swelling,
- rapid weight gain,
- fast or pounding heartbeats,
- fluttering in your chest,
- shortness of breath,
- sudden dizziness,
- lightheadedness,
- severe headache,
- blurred vision,
- pounding in your neck or ears,
- headache,
- hunger,
- sweating,
- fast or slow heart rate,
- feeling jittery,
- changes in your mental state,
- blood in your urine,
- pain and swelling in your stomach,
- bloody or tarry stools,
- coughing up blood,
- vomit that looks like coffee grounds,
- tiredness,
- muscle cramps,
- nausea,
- vomiting,
- diarrhea,
- tingling in your hands and feet or around your mouth,
- severe or worsening tiredness,
- depression,
- agitation, tremors,
- nervousness,
- sweating,
- hair loss,
- weight changes, and
- irregular menstrual periods
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Sutent include:
- indigestion,
- decreased appetite,
- stomach pain,
- nausea,
- vomiting,
- diarrhea,
- weakness,
- tiredness,
- mouth sores or pain,
- altered sense of taste,
- blisters or rash on your hands or feet,
- bruising,
- bleeding, and
- increased blood pressure
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Sutent. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
DESCRIPTION
SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2oxo- 3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 • C4H6O5 and the molecular weight is 532.6 Daltons.
The chemical structure of sunitinib malate is:
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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.
INDICATIONS
Gastrointestinal Stromal Tumor (GIST)
SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Advanced Renal Cell Carcinoma (RCC)
SUTENT is indicated for the treatment of advanced renal cell carcinoma.
Adjuvant Treatment Of Renal Cell Carcinoma (RCC)
SUTENT is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
Advanced Pancreatic Neuroendocrine Tumors (pNET)
SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.
DOSAGE AND ADMINISTRATION
Recommended Dose For GIST And Advanced RCC
The recommended dose of SUTENT for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). SUTENT may be taken with or without food.
Recommended Dose For Adjuvant Treatment Of RCC
The recommended dose of SUTENT for the adjuvant treatment of RCC is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles. SUTENT may be taken with or without food.
Recommended Dose For pNET
The recommended dose of SUTENT for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. SUTENT may be taken with or without food.
Dose Modification For Adverse Reactions
Dose interruption and/or dose modification in 12.5 mg increments or decrements is recommended based on individual safety and tolerability. The maximum dose administered in the pNET study was 50 mg daily. In the adjuvant RCC study, the minimum dose administered was 37.5 mg.
Dose Modification For Co-Administration Of Strong CYP3A4 Inhibitors Or Inducers
Strong CYP3A4 inhibitors such as ketoconazole may increase sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. A dose reduction for SUTENT to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily should be considered if SUTENT must be co-administered with a strong CYP3A4 inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
CYP3A4 inducers such as rifampin may decrease sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. A dose increase for SUTENT to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily should be considered if SUTENT must be co-administered with a CYP3A4 inducer. If dose is increased, the patient should be monitored carefully for toxicity [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dose Modification For End-Stage Renal Disease (ESRD) Patients On Hemodialysis
No starting dose adjustment is required in patients with end-stage renal disease (ESRD) on hemodialysis. However, given the decreased exposure compared to patients with normal renal function, subsequent doses may be increased gradually up to 2-fold based on safety and tolerability [see CLINICAL PHARMACOLOGY].
HOW SUPPLIED
Dosage Forms And Strengths
12.5 mg Capsules
Hard gelatin capsule with orange cap and orange body, printed with white ink “Pfizer” on the cap and “STN 12.5 mg” on the body.
25 mg Capsules
Hard gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” on the cap and “STN 25 mg” on the body.
37.5 mg Capsules
Hard gelatin capsule with yellow cap and yellow body, printed with black ink “Pfizer” on the cap and “STN 37.5 mg” on the body.
50 mg Capsules
Hard gelatin capsule with caramel top and caramel body, printed with white ink “Pfizer” on the cap and “STN 50 mg” on the body.
Storage And Handling
12.5 mg Capsules
Hard gelatin capsule with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body; available in:
Bottles of 28 capsules: NDC 0069-0550-38
25 mg Capsules
Hard gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body; available in:
Bottles of 28 capsules: NDC 0069-0770-38
37.5 mg Capsules
Hard gelatin capsule with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body; available in:
Bottles of 28 capsules: NDC 0069-0830-38
50 mg Capsules
Hard gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body; available in:
Bottles of 28 capsules: NDC 0069-0980-38
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see United States Pharmacopeia (USP) Controlled Room Temperature].