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Selected Safety Information (SSI)

KEYTRUDA® (pembrolizumab) injection, for intravenous use
KEYTRUDA® is a programmed death receptor-1 (PD-1)-blocking antibody indicated:1

MELANOMA

  • For the treatment of patients with unresectable or metastatic melanoma.
  • For the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

NON-SMALL CELL LUNG CANCER (NSCLC)

  • In combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
  • In combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
  • As a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by a validated test, with no EGFR or ALK genomic tumor aberrations, and is:
    • Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
    • Metastatic.
  • As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L 1 (TPS ≥1%) as determined by a validated test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA®.
  • For the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
  • As a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II. or IIIA NSCLC.

Malignant Pleural Mesothelioma (MPM)

  • in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.

HEAD AND NECK SQUAMOUS CELL CANCER (HNSCC)

  • In combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
  • As a single agent for the first-tine treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
  • As a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

CLASSICAL HODGKIN LYMPHOMA (CHL)

  • For the treatment of adult patients with relapsed or refractory cHL.
  • For the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

UROTHELIAL CARCINOMA

  • In combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
  • As a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
  • Are not eligible for any platinum-containing chemotherapy, or
  • Have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.

MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT CANCER

  • For the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT COLORECTAL CANCER (CRC)

  • For the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by a validated test.

GASTRIC CANCER

  • In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by a validated test.1
  • In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

ESOPHAGEAL CANCER

  • KEYTRUDA®, ln combination with platinum- and fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation.

CERVICAL CANCER

  • In combination with chemoradiotherapy, for the treatment of patients with FIGO 2014 Stags III-IVA cervical cancer.
  • In combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD- L1 (CPS ≥1) as determined by a validated test.

HEPATOCELLULAR CARCINOMA (HCC)

  • For the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

BILIARY TRACT CANCER (BTC)

  • In combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

Merkel Cell Carcinoma (MCC)

  • for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

RENAL CELL CARCINOMA (RCC)

  • In combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
  • In combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
  • For the adjuvant treatment of patients with RCC at Intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

ENDOMETRIAL CARCINOMA

  • In combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
  • In combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by validated test or not MSI-H, who have disease progression following prior systemic therapy in any selling and are not candidates for curative surgery or radiation.

TRIPLE-NEGATIVE BREAST CANCER (TNBC)

  • For the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
  • In combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L 1 (CPS ≥10) as determined by a validated test.

ADULT CLASSICAL HODGKIN LYMPHOMA:
ADDITIONAL DOSING REGIMEN OF 400 MG EVERY 6 WEEKS:

  • For use at an additional recommended dosage of 400 mg every 6 weeks for Classical Hodgkin Lymphoma.2

1This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

2This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.

DOSAGE AND ADMINISTRATION

  • Melanoma: 200 mg every 3 weeks or 400 mg every 6 weeks; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
  • NSCLC: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • MPM: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • HNSCC: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • cHL: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
  • Urothelial Carcinoma: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • MSl·H or dMMR Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
  • MSl·H or dMMR CRC: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • Gastric Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • Esophageal Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • Cervical Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • HCC: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • BTC: 200 mg every 3 weeks or 400 mg every 6 weeks.
  • MCC: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
  • RCC: 200 mg every 3 weeks or 400 mg every 6 weeks as a single agent in the adjuvant setting, or in the advanced setting with either:
    • axitinib 5 mg orally twice daily or
    • lenvatinib 20 mg orally once daily.
  • Endometrial Carcinoma: 200 mg every 3 weeks or 400 mg every 6 weeks.
    • in combination with carboplatin and paclitaxel regardless of MMR or MS! status, or
    • in combination with lenvatinib 20 mg orally once daily for pMMR or not MSI-H tumors.
  • TNBC: 200 rng every 3 weeks or 400 mg every 6 weeks.
  • Administer KEYTRUDA as an intravenous infusion over 30 minutes after dilution.
  • See Full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions.

DOSAGE FORMS AND STRENGTHS

Injection: 100 mg/4 mL (25 mg/mL) solution in a single-dose vial

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Immune-Mediated Adverse Reactions

  • Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection.
  • Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
  • Withhold or permanently discontinue based on severity and type of reaction. Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue KEYTRUDA® based on the severity of reaction.
  • Complications of allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
  • Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
  • Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception.

ADVERSE REACTIONS

Most common adverse reactions (reported in ≥20% of patients) were:

  • KEYTRUDA® as a single agent: fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, nausea, and hypothyroidism.
  • KEYTRUDA® In combination with chemotherapy or chemoradiotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, Insomnia, palmar-plantarerythrodysesthesia, urinary tract infection, and hypothyroidism.
  • KEYTRUDA® in combination with chemotherapy and bevacizumab: peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, and decreased appetite.
  • KEYTRUDA® In combination with axitinib: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantarerythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.
  • KEYTRUDA® in combination with lenvatinib: hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight loss, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysesthesia, dysphonia, rash, hepatotoxicity, and acute kidney injury.
  • KEYTRUDA® in combination with enfortumab vedotin: rash, peripheral neuropathy, fatigue, pruritus, diarrhea, alopecia, weight loss, decreased appetite, dry eye, nausea, constipation, dysgeusia, and urinary tract infection.

USE IN SPECIFIC POPULATIONS

  • Lactation:

Advise women not to breastfeed during treatment with KEYTRUDA® and for 4 months after the final dose.

  • Pregnancy:

Pembrolizumab has the potential to be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus.

  • Fertility:

Fertility studies have not been conducted with pembrolizumab.

  • Egyptian Drug Authority KEYTRUDA® leaflet approval date 27/11/2024
  • Always read the full prescribing information.
  • Healthcare professionals are asked to report any suspected adverse reactions to Egyptian Pharmacovigilance Centre e-mail: pv.followup@edaegypt.gov.eg or Egyptian Drug Authority (EDA) website: https://www.edaegypt.gov.eg or (EPVC) [hotline 15301].