nivolumab

nivolumab

( nye-vol-ue-mab),

Opdivo

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: temporary class
Pregnancy Category: UK

Indications

Treatment of progressive unresectable/metastatic melanoma previously treated with ipilimumab and if BRAF V600 mutation positive, a BRAF inhibitor.

Action

Acts as a human programmed death receptor-1 (PD-1) blocking antibody. Inhibits T-cell proliferation and cytokine production.

Therapeutic effects

Decreased spread of melanoma.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 26.7 days.

Time/action profile

ROUTEONSETPEAKDURATION
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Contraindications/Precautions

Contraindicated in: Obstetric: Pregnancy (may cause fetal harm); Lactation: Discontinue breastfeeding.
Use Cautiously in: Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Respiratory

  • immune-mediated pneumonitis (life-threatening)
  • cough (most frequent)

Cardiovascular

  • peripheral edema

Gastrointestinal

  • immune-mediated colitis
  • immune-mediated hepatitis (most frequent)

Genitourinary

  • immune-mediated nephritis/renal dysfunction

Dermatologic

  • rash (most frequent)

Endocrinologic

  • immune-mediated hyper/hypothyroidism

Fluid and Electrolyte

  • hyperkalemia (most frequent)

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intravenous (Adults) 3 mg/kg every two weeks, immune-mediated adverse reactions may require dose modification/discontinuation).

Availability

Solution for intravenous use: 40 mg/4 mL single-use vial, 100 mg/10 mL single-use vial

Nursing implications

Nursing assessment

  • Monitor for signs and symptoms of immune-mediated pneumonitis (shortness of breath, chest pain, new or worse cough) periodically during therapy. Treat with corticosteroids 1–2 mg/kg/day prednisone equivalents for ≥Grade 2 pneumonitis followed by corticosteroid taper. Withhold nivolumab and monitor symptoms for moderate (Grade 2) pneumonitis; resume therapy when recovery to Grade 0 to 1. Permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) pneumonitis.
  • Monitor for signs and symptoms of immune-mediated colitis (diarrhea, abdominal pain, mucus or blood in stool, with or without fever). Treat with corticosteroids at doses of 1–2 mg/kg/day of prednisone or equivalents followed by corticosteroid taper for severe (Grade 3) or life-threatening (Grade 4) colitis. Treat with corticosteroids at a dose of 0.5 mg/kg/day of prednisone or equivalent followed by corticosteroid taper for moderate (Grade 2) colitis or > 5 days; if worsening or no improvement despite corticosteroids increase dose to 1–2 mg/kg/day prednisone equivalents. Withhold nivolumab for Grade 2 or 3 colitis; permanently discontinue nivolumab for Grade 4 colitis or for recurrent colitis upon restarting nivolumab.
  • Lab Test Considerations: Monitor for abnormal liver tests prior to and periodically during therapy. Administer corticosteroids at dose of 1–2 mg/kg/day prednisone equivalents for ≥Grade 2 transaminase ↑, with or without ↑ in total bilirubin. Withhold for moderate (Grade 2) and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis.
    • Monitor for ↑ serum creatinine prior to and periodically during therapy. Administer corticosteroids at a dose of 1–2 mg/kg/day prednisone equivalents followed by corticosteroid taper for life-threatening (Grade 4) ↑ serum creatinine and permanently discontinue nivolumab. Withhold nivolumab for severe (Grade 3) or moderate (Grade 2) ↑ serum creatinine and administer corticosteroids at a dose of 0.5–1 mg/kg/day prednisone equivalents followed by corticosteroid taper. If worsening or no improvement occurs, increase dose of corticosteroids to 1–2 mg/kg/day prednisolone equivalents and permanently discontinue nivolumab.
    • Monitor thyroid function prior to and periodically during therapy. Treat hypothyroidism with replacement therapy. Use medical management for hyperthyroidism. Immune-mediated thyroid dysfunction does not require dose modification of nivolumab.

Potential Nursing Diagnoses

Diarrhea (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Intravenous Administration
  • Intermittent Infusion: Diluent: 0.9% NaCl or D5W. Concentration: 1 mg/mL to 10 mg/mL. Mix by gentle inversion; do not shake. Solution is clear to slightly opalescent, colorless to slightly yellow; do not administer solution if discolored or contains particulate matter other than translucent to white proteinaceous particles. Solution is stable at room temperature for up to 4 hr and 24 hr if refrigerated.
  • Rate: Infuse through a sterile, non-pyrogenic, low-protein binding 0.2 micrometer to 1.2 micrometer in-line filter over 60 min. Flush line at end of infusion.
  • Y-Site Incompatibility: Do not administer other drugs through same infusion line.

Patient/Family Teaching

  • Explain purpose of nivolumab to patient.
  • Advise patient to notify health care professional immediately if signs and symptoms of pneumonitis, colitis, hepatitis (jaundice, severe nausea or vomiting, pain on right side of abdomen, lethargy, easy bruising or bleeding), kidney problems (decreased urine output, blood in urine, swollen ankles, loss of appetite), hormone gland problems (rapid heart beat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, deepening of voice, muscle aches, dizziness or fainting, persistent or unusual headache) occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patient of reproductive potential to use highly effective contraception during and for 5 mo after last dose; may cause fetal harm. Avoid breastfeeding during therapy.
  • Emphasize importance of keeping scheduled appointments for blood work or other laboratory tests.

Evaluation/Desired Outcomes

  • ↓ spread of melanoma.
References in periodicals archive ?
This mechanism is also suggested as a predictive factor for responsiveness to the new immuno- oncology drugs that act through PD-1 and PD-L1 such as nivolumab, pembrolizumab and pidilizumab.
In the genitourinary field, this included the use of nivolumab (a programmed death-1 [PD-1] immune checkpoint inhibitor) alone or in combination with ipilimumab (a cytotoxic T-lymphocyte-associated protein 4 [CTLA-4] inhibitor), for the treatment of mRCC.
In an international trial 945 patients with advanced melanoma were treated with ipilimumab and nivolumab.
Thousands of terminally-ill patients could be given a new lease of life with a combination of two types of immunotherapy drugs - nivolumab and ipilimumab.
Nivolumab is one of a new generation of immunotherapy drugs.
The findings were statistically significant and may have treatment implications for the use in recently pregnant women of antibodies against PD-1 cell-surface receptors, a class of biologies that include nivolumab and pembrolizumab, both approved in 2014 for advanced melanoma.
In a small study, the drug nivolumab, from Bristol-Myers Squibb, significantly shrank tumors in 20 of 23 patients, or 87 percent, with Hodgkin lymphoma.
20% interest in Bristol-Myers Squibb's nivolumab, a leading PD-1
Response rates in late-stage metastatic melanoma for the immunotherapy monoclonal antibodies MK-3475 and nivolumab are unprecedented with responses anticipated to be highly durable after cessation of treatment.
This involves using a drug called Yervoy and another called Nivolumab, which fight and suppress the cancer simultaneously, in a revolutionary new way.
The combination of an immunotherapy drug called ipilimumab and the antibody drug nivolumab was reported in the New England Journal of Medicine.