Sunitinib Malate

SUNITINIB MALATE- sunitinib malate capsule
Mylan Pharmaceuticals Inc.

WARNING: HEPATOTOXICITY

Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules as recommended [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

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 indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

2 DOSAGE AND ADMINISTRATION

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 dosage of sunitinib malate capsules for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food.

2.4 Dosage Modifications for Adverse Reactions

To manage adverse reactions, the recommended dosage modifications are provided in Table 1. Table 2 provides the recommended dosage reductions of sunitinib malate capsules for adverse reactions.

Table 1. Recommended Dosage Reductions of Sunitinib Malate Capsules for Adverse Reactions

Indications

GIST

RCC

pNET

Advanced RCC

Adjuvant RCC

First dose reduction

37.5 mg once daily

37.5 mg once daily

37.5 mg once daily

25 mg once daily

Second dose reduction

25 mg once

daily

25 mg once

daily

NA

NA

Table 2. Recommended Dosage Modifications for Sunitinib Malate Capsules for Adverse Reactions

Adverse Reaction

Severity

Dosage Modifications for Sunitinib Malate Capsules

Hepatotoxicity [see Warnings and Precautions (5.1)]

Grade 3

Withhold until resolution to Grade 0 to 1 or baseline.
Resume at a reduced dose.
For recurring Grade 3 permanently discontinue.

Grade 4

Permanently discontinue.

Cardiovascular events [see Warnings and Precautions (5.2)]

Asymptomatic cardiomyopathy (left ventricular ejection fraction greater than 20% but less than 50% below baseline or below the lower limit of normal if baseline was not obtained)

Withhold until resolution to Grade 0 to 1 or baseline.
Resume at reduced dose.

Clinically manifested congestive heart failure (CHF)

Permanently discontinue.

Hypertension [see Warnings and Precautions (5.4)]

Grade 3

Withhold until resolution to Grade 0 to 1 or baseline.
Resume at a reduced dose.

Grade 4

Permanently discontinue.

Hemorrhagic events [see Warnings and Precautions (5.5)]

Grade 3 or 4

Withhold until resolution to Grade 0 to 1 or baseline.
Either resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction.

Thrombotic microangiopathy [see Warnings and Precautions (5.7)]

Any Grade

Permanently discontinue.

Proteinuria or Nephrotic syndrome [see Warnings and Precautions (5.8)]

3 or more grams proteinuria in 24 hours in the absence of nephrotic syndrome

Withhold until resolution to Grade 0 to 1 or baseline.
Resume at a reduced dose.

Nephrotic syndrome or recurrent proteinuria of 3 or more grams per 24 hours despite dose reductions

Permanently discontinue.

Dermatological toxicities Erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), Necrotizing fasciitis [see Warnings and Precautions (5.9)]

Any Grade

Permanently discontinue.

Reversible posterior leukoencephalopathy syndrome [see Warnings and Precautions (5.10)]

Any Grade

Permanently discontinue.

Osteonecrosis of the jaw [see Warnings and Precautions (5.13)]

Any Grade

The safety of resumption of sunitinib malate capsules after osteonecrosis has not been established.
Either resume at a reduced dose or discontinue depending on the severity and persistence of the adverse reaction.

Impaired wound healing [see Warnings and Precautions (5.14)]

Any Grade

The safety of resumption of sunitinib malate capsules after resolution of wound healing has not been established.
Either resume at a reduced dose or discontinue depending on the severity and persistence of the adverse reaction.

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