Pregnancy Category: D
Pharmacologic: monoclonal antibodies
Pharmacologic: monoclonal antibodies
Treatment of unresectable or metastatic melanoma with disease progression despite ipilimumab and a BRAF inhibitor (if positive for the BRAF V600 mutation).
Programmed death (PD) receptor-1–blocking antibody (an IgG4 kappa immunglobulin) that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 resuling in inhibition of T-cell proliferation and decreased cytokine production.
Decreased spread of melanoma.
Absorption: IV administration results in complete bioavailability.
Metabolism and Excretion: Unknown.
Half-life: 26 days.
Time/action profile (response)
|IV||within 3 mo||unk||may persist for > 8.8 mos|
Contraindicated in: Obstetric: Pregnancy (may cause fetal harm); Lactation: Discontinue pembrolizumab or discontinue breastfeeding.
Use Cautiously in: Obstetric: Females with reproductive potential; Moderate to severe hepatic impairment; Pediatric: Safe and effective use in children has not been established.
Adverse Reactions/Side Effects
Central nervous system
- dizziness (most frequent)
- fatigue (most frequent)
- headache (most frequent)
- insomnia (most frequent)
- immune-mediated pneumonitis (life-threatening)
- immune-mediated colitis (life-threatening)
- immune-mediated Hepatitis (life-threatening)
- ↓ appetite (most frequent)
- constipation (most frequent)
- diarrhea (most frequent)
- nausea (most frequent)
- immune-mediated nephritis (life-threatening)
- pruritus (most frequent)
- rash (most frequent)
- immune-mediated hypophysitis (life-threatening)
- immune-mediated hyperthyroidism
- immune-mediated hypothyroidism
- arthralgia (most frequent)
- back pain (most frequent)
- extremity pain (most frequent)
- mylagia (most frequent)
- anemia (most frequent)
- sepsis (life-threatening)
- other immune mediated adverse reactions
Drug-Drug interactionNone noted.
Intravenous (Adults) 2 mg/kg every 3 wk.
Lyophilized powder for injection (requires reconstitution): 50 mg/single use vial
- Monitor for signs and symptoms of immune-mediated pneumonitis (shortness of breath, chest pain, new or worse cough) periodically during therapy. Evaluate with x-ray. Treat with corticosteroids for ≥Grade 2 pneumonitis. Withhold pembrolizumab 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 colitis (diarrhea, abdominal pain, mucus or blood in stool, with or without fever). Treat with corticosteroids for ≥Grade 2 colitis. Withhold pembrolizumab and monitor symptoms for moderate (Grade 2) or severe (Grade 3) colitis; resume therapy when recovery to Grade 0 to 1. Permanently discontinue for life-threatening (Grade 4) colitis.
- Assess for signs and symptoms of immune-mediated hepatitis (yellowing of skin or whites of eyes, unusual darkening of urine, unusual tiredness, pain in right upper stomach) before each dose. Treat with corticosteroids for ≥Grade 2. Withhold or discontinue pembrolizumab depending on severity of liver enzyme elevations. Resume therapy when recovery to Grade 0 to 1.
- Monitor for clinical signs and symptoms of hypophysitis (persistent or unusual headache, extreme weakness, dizziness or fainting, vision changes) during therapy. Treat with corticosteroids for ≥Grade 2 hypophysitis. Withhold pembrolizumab and monitor symptoms for moderate (Grade 2) hypophysitis; withhold or discontinue for severe (Grade 3), and resume therapy when recovery to Grade 0 to 1. Permanently discontinue for life-threatening (Grade 4) hypophysitis.
- Lab Test Considerations: Monitor for changes in renal function. Treat with corticosteroids for ≥Grade 2 nephritis. Withhold pembrolizumab and monitor symptoms for moderate (Grade 2) nephritis; resume therapy when recovery to Grade 0 to 1. Permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) nephritis.
- Monitor for changes in thyroid function at start of and periodically during therapy, and as indicated based on clinical evaluation. Administer corticosteroids for ≥Grade 3 hyperthyroidism, withhold pembrolizumab for severe (Grade 3) hyperthyroidism and resume therapy when recovery to Grade 0 to 1. Permanently discontinue for life-threatening (Grade 4) hyperthyroidism. Manage hypothyroidism with thyroid replacement without interruption of therapy or corticosteroids.
Potential Nursing DiagnosesDiarrhea (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
- Intermittent Infusion: Reconstitute by injecting 2.3 mL of Sterile Water for Injection along vial walls; swirl slowly, do not shake. Allow up to 5 min for bubbles to clear. 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. Diluent: 0.9% NaCl. Mix using gently inversion. Concentration: 1 mg/mL to 10 mg/mL.
- Rate: Infuse through a sterile, non-pyrogenic, low-protein binding 0.2 micron to 0.5 micron in-line or add-on filter over 30 min.
- Y-Site Incompatibility: Do not administer other drugs through same infusion line.
- Explain purpose of pembrolizumab to patient.
- Advise patient to notify health care professional immediately if signs and symptoms of pneumonitis, colitis, hepatitis, kidney problems (change in amount or color of urine), 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 4 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.