Pregnancy Category: UK
Pharmacologic: temporary class
Pharmacologic: temporary class
Treatment of progressive unresectable/metastatic melanoma previously treated with ipilimumab and if BRAF V600 mutation positive, a BRAF inhibitor.
Acts as a human programmed death receptor-1 (PD-1) blocking antibody. Inhibits T-cell proliferation and cytokine production.
Decreased spread of melanoma.
Absorption: IV administration results in complete bioavailability.
Metabolism and Excretion: Unknown.
Half-life: 26.7 days.
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
- immune-mediated pneumonitis (life-threatening)
- cough (most frequent)
- peripheral edema
- immune-mediated colitis
- immune-mediated hepatitis (most frequent)
- immune-mediated nephritis/renal dysfunction
- rash (most frequent)
- immune-mediated hyper/hypothyroidism
Fluid and Electrolyte
- hyperkalemia (most frequent)
Drug-Drug interactionNone noted.
Intravenous (Adults) 3 mg/kg every two weeks, immune-mediated adverse reactions may require dose modification/discontinuation).
Solution for intravenous use: 40 mg/4 mL single-use vial, 100 mg/10 mL single-use vial
- 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 DiagnosesDiarrhea (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
- 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.
- 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.
- ↓ spread of melanoma.