pembrolizumab

(redirected from Keytruda)

pembrolizumab

(pem-broe-li-zoo-mab),

Keytruda

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: monoclonal antibodies
Pregnancy Category: D

Indications

Treatment of unresectable or metastatic melanoma with disease progression despite ipilimumab and a BRAF inhibitor (if positive for the BRAF V600 mutation).

Action

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.

Therapeutic effects

Decreased spread of melanoma.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 26 days.

Time/action profile (response)

ROUTEONSETPEAKDURATION
IVwithin 3 mounkmay persist for > 8.8 mos

Contraindications/Precautions

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)

Respiratory

  • immune-mediated pneumonitis (life-threatening)

Gastrointestinal

  • immune-mediated colitis (life-threatening)
  • immune-mediated Hepatitis (life-threatening)
  • ↓ appetite (most frequent)
  • constipation (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)

Genitourinary

  • immune-mediated nephritis (life-threatening)

Dermatologic

  • pruritus (most frequent)
  • rash (most frequent)
  • vitiligo

Endocrinologic

  • immune-mediated hypophysitis (life-threatening)
  • immune-mediated hyperthyroidism
  • immune-mediated hypothyroidism

Musculoskeletal

  • arthralgia (most frequent)
  • back pain (most frequent)
  • extremity pain (most frequent)
  • mylagia (most frequent)

Hematologic

  • anemia (most frequent)

Miscellaneous

  • sepsis (life-threatening)
  • other immune mediated adverse reactions

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intravenous (Adults) 2 mg/kg every 3 wk.

Availability

Lyophilized powder for injection (requires reconstitution): 50 mg/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. 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 Diagnoses

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

Implementation

  • Intravenous Administration
  • 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.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • ↓ spread of melanoma.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
Merck's anti-PD-1 therapy Keytruda has been approved in combination with Inlyta, a tyrosine kinase inhibitor, by the European Commission for the first-line treatment of patients with advanced renal cell carcinoma, or RCC.
Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] [greater than or equal to]10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
The assay is now approved as an aid in identifying patients with ESCC for treatment with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada).
ENPNewswire-August 1, 2019--FDA Approves New Monotherapy Indication for Merck's KEYTRUDA
M2 PHARMA-July 31, 2019-FDA Approves New Monotherapy Indication for Merck's Keytruda
M2 EQUITYBITES-October 24, 2018-Merck's Keytruda improves overall survival in phase three Keynote-048 trial
NORDIC BUSINESS REPORT-October 5, 2018-Medivir reports positive interim data on birinapant in combination with Keytruda from phase 1 data of study
Global Banking News-October 5, 2018-Medivir reports positive interim data on birinapant in combination with Keytruda from phase 1 data of study
Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate) in combination with MSD's anti-PD-1 therapy KEYTRUDA (generic name: pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma.
Medivir AB began enrollment in the company's Phase I/II study of birinapant in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab), which is marketed by Merck.
Merck & Co scored a double hit on Sunday with new clinical data showing its Keytruda immunotherapy offered big benefits in previously untreated lung cancer patients, either when given on its own or with chemotherapy.