nivolumab

(redirected from Opdivo)

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
IVunknownunknownunknown

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 ?
M2 PHARMA-March 8, 2018-Bristol-Myers Squibb's Opdivo receives US FDA approval for four-week dosing schedule
M2 EQUITYBITES-March 8, 2018-Bristol-Myers Squibb's Opdivo receives US FDA approval for four-week dosing schedule
Opdivo also was approved for a shorter 30-minute infusion across all approved indications.
Bristol-Myers Squibb Company, announced new data from a cohort of the phase 2 CheckMate -142 trial evaluating Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC).
TARIS Biomedical LLC, and Bristol-Myers Squibb have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS' investigational product, TAR-200 (GemRIS), in combination with Bristol-Myers Squibb's programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab).
has gained FDA approval for Opdivo (nivolumab) injection for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Bristol-Myers Squibb (BMS) and Daiichi Sankyo have entered a collaborative clinical trial to evaluate the combination of BMS' immunotherapy Opdivo (nivolumab) and Daiichi Sankyo's investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and urothelial (bladder) cancers.
have announced that they have entered into a collaboration agreement to jointly develop the combination therapy of Eisai's multi-kinase inhibitor, Lenvima (lenvatinib mesylate) and Ono's human anti-human PD-1 (programmed cell death-1) monoclonal antibody, Opdivo (nivolumab) for the treatment of hepatocellular carcinoma (HCC) .
Last year, criticism focused once again on an excessively high-priced anti-cancer drug - Opdivo (generic name "nivolumab"), launched by Ono Pharmaceutical in September 2014.
After 5 years, 34% of patients receiving Opdivo were alive compared to 16% of melanoma patients receiving conventional treatment methods.
Drugmaker Bristol-Myers Squibb had tried a catch-all approach with its Opdivo drug but it failed to help previously untreated patients when given on its own in a trial that included people with low levels of a protein called PD-L1.
How do KOLs view Roche's anti- PD-L1 monoclonal antibody, atezolizumab, compared with BMS' Opdivo (nivolumab) and Merck & Co.