Sunitinib Malate 37.5 mg/1
Sunitinib Malate · CAPSULE · Novadoz Pharmaceuticals LLC
Sunitinib Malate is a capsule containing sunitinib malate at 37.5 mg/1, taken oral. Manufactured by Novadoz Pharmaceuticals LLC.
Key Facts
- Brand Name
- Sunitinib Malate
- Generic Name
- Sunitinib Malate
- NDC Code (Product)
72205-118- Manufacturer
- Novadoz Pharmaceuticals LLC
- Strength
- 37.5 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214824
- Marketing Start
- 02/14/2025
Recall History
Teva Pharmaceuticals USA Inc
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
AvKARE
Labeling: Label Mix-Up
AvKARE
Labeling: Label Mix-Up
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sunitinib malate is a kinase inhibitor indicated for: treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. ( 1.4) 1.1 Gastrointestinal Stromal Tumor Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. 1.2 Advanced Renal Cell Carcinoma Sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC). 1.3 Adjuvant Treatment of Renal Cell Carcinoma Sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. 1.4 Advanced Pancreatic Neuroendocrine Tumors Sunitinib malate capsules are…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION GIST and Advanced RCC : The recommended dosage is 50 mg orally once daily for the first 4 weeks of each 6-week cycle (Schedule 4/2). ( 2.1 ) Adjuvant Treatment of RCC : The recommended dosage is 50 mg orally once daily for the first 4 weeks of a 6-week cycle (Schedule 4/2) for a maximum of 9 cycles. ( 2.2 ) pNET : The recommended dosage is 37.5 mg orally once daily. ( 2.3 ) 2.1 Recommended Dosage for GIST and Advanced RCC The recommended dosage of sunitinib malate capsules for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food. 2.2 Recommended Dosage for Adjuvant Treatment of RCC The recommended dosage of sunitinib malate capsules 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. Sunitinib malate capsules may be taken with or without food. 2.3 Recommended Dosage for pNET The recommended dosa…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS CYP3A4 Inhibitors : Consider dose reduction of sunitinib malate when administered with strong CYP3A4 inhibitors. ( 7.1 ) CYP3A4 Inducers : Consider dose increase of sunitinib malate when administered with strong CYP3A4 inducers. ( 7.1 ) 7.1 Effect of Other Drugs on Sunitinib Malate Strong CYP3A4 Inhibitors Co-administration with strong CYP3A4 inhibitors may increase sunitinib plasma concentrations [see Clinical Pharmacology ( 12.3 )] . Select an alternate concomitant medication with no or minimal enzyme inhibition potential. Consider a dose reduction for sunitinib malate when it is co‑administered with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.5 )] . Strong CYP3A4 Inducers Co-administration with strong CYP3A4 inducers may decrease sunitinib plasma concentrations [see Clinical Pharmacology ( 12.3 )] . Select an alternate concomitant medication with no or minimal enzyme induction potential. Consider a dose increase for sunitinib malate when it must be co‑administered with CYP3A4 inducers [see Dosage and Administration ( 2.5 )] . 7.2 Drugs that Prolong QT Interval Sunitinib malate is associated with QTc interval prolongation [see Warnings and Prec…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. Hepatotoxicity [see Warnings and Precautions ( 5.1 )] Cardiovascular Events [see Warnings and Precautions ( 5.2 )] QT Interval Prolongation and Torsade de Pointes [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Hemorrhagic Events [see Warnings and Precautions ( 5.5 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.6 )] Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] Proteinuria [see Warnings and Precautions ( 5.8 )] Dermatologic Toxicities [see Warnings and Precautions ( 5.9 )] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions ( 5.10 )] Thyroid Dysfunction [see Warnings and Precautions ( 5.11 )] Hypoglycemia [see Warnings and Precautions ( 5.12 )] Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.13 )] Impaired Wound Healing [see Warnings and Precautions ( 5.14 )] The most common adverse reactions (≥25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding …
Frequently Asked Questions
What is Sunitinib Malate used for?
Sunitinib Malate contains Sunitinib Malate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Sunitinib Malate a controlled substance?
Sunitinib Malate is not classified as a controlled substance by the DEA.
What is the generic name for Sunitinib Malate?
The generic name for Sunitinib Malate is Sunitinib Malate. There are 6 other brand versions of Sunitinib Malate.
What is the NDC code for Sunitinib Malate 37.5 mg/1?
The NDC (National Drug Code) for Sunitinib Malate 37.5 mg/1 is 72205-118, listed by Novadoz Pharmaceuticals LLC.