Nexavar

Nexavar Manufacturers

• Bayer Healthcare Pharmaceuticals Inc.
  

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  Nexavar | Bayer Healthcare Pharmaceuticals Inc.

  

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  2.1 Recommended Dose for Hepatocellular Carcinoma, Renal Cell Carcinoma, and Differentiated Thyroid Carcinoma

  The recommended daily dose of NEXAVAR is 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal). Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

  2.2 Dose Modifications for Suspected Adverse Drug Reactions

  Temporary interruption of NEXAVAR is recommended in patients undergoing major surgical procedures [see Warnings and Precautions (5.7)].

  Temporary interruption or permanent discontinuation of NEXAVAR may be required for the following:

  • Cardiac ischemia or infarction [see Warnings and Precautions (5.1)] • Hemorrhage requiring medical intervention [see Warnings and Precautions (5.2)] • Severe or persistent hypertension despite adequate anti-hypertensive therapy [see Warnings and Precautions (5.3)] • Gastrointestinal perforation [see Warnings and Precautions (5.5)] • QTc prolongation [see Warnings and Precautions (5.9)] • Severe drug-induced liver injury [see Warnings and Precautions (5.10)] Dose modifications for Hepatocellular Carcinoma and Renal Cell Carcinoma

  When dose reduction is necessary, the NEXAVAR dose may be reduced to 400 mg once daily. If additional dose reduction is required, NEXAVAR may be reduced to a single 400 mg dose every other day [see Warnings and Precautions (5)].

  Suggested dose modifications for dermatologic toxicities are outlined in Table 1.

  Table 1: Suggested Dose Modifications for Dermatologic Toxicities in Patients with Hepatocellular or Renal Cell Carcinoma

  Dermatologic Toxicity Grade

  Occurrence

  Suggested Dose Modification

  Grade 1: Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema or discomfort of the hands or feet which does not disrupt the patient’s normal activities

  Any occurrence

  Continue treatment with NEXAVAR and consider topical therapy for symptomatic relief

  Grade 2: Painful erythema and swelling of the hands or feet and/or discomfort affecting the patient’s normal activities

  1st occurrence

  Continue treatment with NEXAVAR and consider topical therapy for symptomatic relief

  If no improvement within 7 days, see below

  No improvement within 7 days or 2nd or 3rd occurrence

  Interrupt NEXAVAR treatment until toxicity resolves to Grade 0–1

  When resuming treatment, decrease NEXAVAR dose by one dose level (400 mg daily or 400 mg every other day)

  4th occurrence

  Discontinue NEXAVAR treatment

  Grade 3: Moist desquamation, ulceration, blistering or severe pain of the hands or feet, or severe discomfort that causes the patient to be unable to work or perform activities of daily living

  1st or 2nd occurrence

  Interrupt NEXAVAR treatment until toxicity resolves to Grade 0–1

  When resuming treatment, decrease NEXAVAR dose by one dose level (400 mg daily or 400 mg every other day)

  3rd occurrence

  Discontinue NEXAVAR treatment

  Dose modifications for Differentiated Thyroid Carcinoma Table 2: Recommended Doses for Patients with Differentiated Thyroid Carcinoma Requiring Dose Reduction

  Dose Reduction

  NEXAVAR Dose

  First Dose Reduction

  600 mg daily dose

  400 mg and 200 mg 12 hours apart (2 tablets and 1 tablet 12 hours apart – either dose can come first)

  Second Dose Reduction

  400 mg daily dose

  200 mg twice daily (1 tablet twice daily)

  Third Dose Reduction

  200 mg daily dose

  200 mg once daily (1 tablet once daily)

  When dose reduction is necessary for dermatologic toxicities, reduce the NEXAVAR dose as indicated in Table 3 below.

  Table 3: Recommended Dose Modifications for Dermatologic Toxicities for Patients with Differentiated Thyroid Carcinoma

  Dermatologic Toxicity Grade

  Occurrence

  NEXAVAR Dose Modification

  Grade 1: Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema or discomfort of the hands or feet which does not disrupt the patient’s normal activities

  Any occurrence

  Continue treatment with NEXAVAR

  Grade 2: Painful erythema and swelling of the hands or feet and/or discomfort affecting the patient’s normal activities

  1st occurrence

  Decrease NEXAVAR dose to 600 mg daily

  If no improvement within 7 days, see below

  No improvement within 7 days at reduced dose
  or
  2nd occurrence

  Interrupt NEXAVAR until resolved or improved to grade 1

  If NEXAVAR is resumed, decrease dose (see Table 2)

  3rd occurrence

  Interrupt NEXAVAR until resolved or improved to grade 1

  If NEXAVAR is resumed, decrease dose (see Table 2)

  4th occurrence

  Discontinue NEXAVAR permanently

  Grade 3:

  Moist desquamation, ulceration, blistering, or severe pain of the hands or feet, resulting in inability to work or perform activities of daily living

  1st occurrence

  Interrupt NEXAVAR until resolved or improved to grade 1

  If NEXAVAR is resumed, decrease dose by one dose level (see Table 2)

  2nd occurrence

  Interrupt NEXAVAR until resolved or improved to grade 1

  When NEXAVAR is resumed, decrease dose by 2 dose levels (see Table 2)

  3rd occurrence

  Discontinue NEXAVAR permanently

  Following improvement of Grade 2 or 3 dermatologic toxicity to Grade 0–1 after at least 28 days of treatment on a reduced dose of NEXAVAR, the dose of NEXAVAR may be increased one dose level from the reduced dose. Approximately 50% of patients requiring a dose reduction for dermatologic toxicity are expected to meet these criteria for resumption of the higher dose and roughly 50% of patients resuming the previous dose are expected to tolerate the higher dose (that is, maintain the higher dose level without recurrent Grade 2 or higher dermatologic toxicity)

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