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Nivolumab

Medical and Pharmacy Editor:

Brand Name: Cortone

Generic Name: Nivolumab

Drug Class: Corticosteroids

What Is Nivolumab and How Does It Work?

Nivolumab is a prescription drug indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab.

Nivolumab is also indicated for the treatment of patients with advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck and urothelial carcinoma.

Nivolumab is available under the following different brand names: Opdivo.

Dosage of Nivolumab:

Intravenous solution

  • 40 mg/4 ml (10 mg/ml)
  • 100 mg/10 ml (10 mg/ml)
  • Further dilution required before administration

Dosing Considerations – Should be Given as Follows:

Safety and efficacy has not been established for pediatric use. Adult dosages only:

Melanoma

  • Single agent
  • Indicated as a single agent for BRAF V600 wildtype or BRAF V600 mutation-positive unresectable or metastatic melanoma
  • 240 mg intravenous every 2 weeks infused over 1 hour
  • Continue until disease progression or unacceptable toxicity
  • Combination with ipilimumab
  • Indicated in combination with ipilimumab for treatment of patients with BRAF unresectable or metastatic melanoma
  • 1 mg/kg intravenous infused over 1 hour, followed by ipilimumab (3 mg/kg intravenous infused over 90 min) administer on the same day every 3 weeks for 4 doses
  • Subsequent doses of nivolumab as a single agent are 240 mg intravenous every 2 weeks infused over 1 hour until disease progression or unacceptable toxicity

Non-Small Cell Lung Cancer

  • Indicated for metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy
  • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab
  • 240 mg intravenous every 2 weeks infused over 1 hour
  • Continue until disease progression or unacceptable toxicity

Renal Cell Carcinoma

  • Indicated for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy
  • 240 mg intravenous every 2 weeks infused over 1 hour
  • Continue until disease progression or unacceptable toxicity

Hodgkin Lymphoma

  • Indicated for classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin
  • 3 mg/kg intravenous infused over 1 hour every 2 weeks until disease progression or unacceptable toxicity

Head and Neck Cancer

  • Indicated for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy
  • 3 mg/kg intravenously every 2 weeks infused over 1 hour
  • Continue until disease progression or unacceptable toxicity

Urothelial Carcinoma

  • Indicated for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • 240 mg intravenously every 2 weeks infused over 1 hour
  • Continue until disease progression or unacceptable toxicity

Dosage Modifications

  • Infusion reactions: interrupt or slow infusion rate with mild or moderate reactions; discontinue if severe or life-threatening infusion reactions occur
  • Hypothyroidism or hyperthyroidism: no recommended dose modifications
  • Renal impairment: no dosage modifications required
  • Mild hepatic impairment: no dosage modifications required
  • Moderate or severe hepatic impairment: not studied
  • Note: When administered in combination with ipilimumab, if nivolumab is withheld, ipilimumab should also be withheld

Withhold for any of the following

  • Grade 2 pneumonitis
  • Grade 2 diarrhea or colitis
  • Grade 3 diarrhea or colitis (single-agent nivolumab)
  • Grade 2 or 3 hypophysitis
  • Grade 2 adrenal insufficiency
  • Grade 3 hyperglycemia
  • Encephalitis, new-onset moderate or severe neurologic signs or symptoms
  • Grade 3 rash or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
  • AST or ALT over 3-5 times upper limit of normal (ULN) or total bilirubin over 1.5-3 times ULN
  • Serum creatinine over 1.5-6 times ULN or over 1.5 times baseline
  • Any other severe or grade 3 treatment-related adverse reaction
  • May resume treatment for patients whose adverse reactions recover to grade 0-1

Permanently discontinue for any of the following:

  • Any life-threatening or grade 4 adverse reactions
  • Grade 3 or 4 pneumonitis
  • Grade 3 diarrhea or colitis (nivolumab in combination with ipilimumab)
  • Grade 4 diarrhea or colitis
  • Grade 4 hypophysitis
  • Grade 3 or 4 adrenal insufficiency
  • Grade 4 hyperglycemia
  • Immune-mediated encephalitis
  • Grade 4 rash or confirmed SJS or TEN
  • AST or ALT over 5 times upper limit of normal (ULN) or total bilirubin over 3 times ULN
  • Serum creatinine over 6 times ULN
  • Any severe or grade 3 treatment-related adverse reaction that recurs
  • Inability to reduce corticosteroid dose to up to 10 mg/day of prednisone or equivalent within 12 weeks
  • Persistent grade 2 or 3 treatment-related adverse reactions that do not recover to grade 0-1 within 12 weeks after the last dose

Dosing Considerations

Melanoma

  • Indications for melanoma (as a single agent for BRAF V600 mutation-positive or in combination with ipilimumab) were approved under an accelerated approval based on tumor response rate and durability of response; continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials
  • Information on FDA-approved tests for detection of PD-L1 expression in non small-cell lung cancer (NSCLC) is available at: http://www.fda.gov/CompanionDiagnostics
  • Classical Hodgkin lymphoma (cHL)
  • Indication for cHL approved under accelerated approval based on overall response rate
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Urothelial carcinoma

  • Indication for urothelial carcinoma was approved under accelerated approval based on tumor response rate and duration of response
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Pediatric:

  • 2.5 mg-10 mg/kg/day orally or 20-300 mg/m2/day orally divided every 6-8 hours

Physiologic Replacement

Adult:

  • 0.5-0.75 mg/kg/day orally divided every 8 hours or 25-35 mg/day
  • 0.25-0.35 mg/kg intramuscularly each day

Pediatric:

  • 0.5-0.75 mg/kg/day orally or 20-25 mg/sq.meter/day orally divided every 8 hours
Medically Reviewed by a Doctor on 6/12/2017



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