Keytruda (Pembrolizumab) – NSCLC | HongKong DengYue Medicine

Keytruda Application Scope

Keytruda is a humanized monoclonal antibody that blocks PD‑1, enabling the immune system to better target and destroy certain types of cancer cells.

Characteristics

• Ingredients: Pembrolizumab

• Properties: Programmed death receptor‑1 (PD‑1) blocking antibody, supplied as a 25 mg/mL concentrate for intravenous infusion.

• Packaging Specification: Glass vial, 4 mL vial containing 25 mg/mL concentrate (100 mg total). Available in single (4 mL) or double-vial packs.

• Storage: Store refrigerated (2–8 °C); protect from light until use

• Expiry Date: ​As marked on the vial label; do not use after expiration. Inspect before use.

• Executive Standard: Under U.S. FDA NDA 125514; marketed globally per EMA’s European Public Assessment Report (EPAR).

• Approval Number: FDA Approved September 4, 2014 (NDA 125514)

• Date of Revision:

  • U.S. label last updated June 2025 (noted changes in indications)

  • Safety updates in March 2024; dosage/advice updated January–September 2025 sections 1 & 2.

• Manufacturer: Developed and produced by Merck & Co., Inc.

Guidelines for the Use of Keytruda

• Dosage and Administration:

  • Administered via IV infusion, generally 200 mg every 3 weeks, or 400 mg every 6 weeks.

  • Dosing tailored to indication and sometimes patient weight; see full prescribing info.

• Adverse Reactions:

  • Immune-mediated: colitis, pneumonitis, endocrinopathies, hepatitis, nephritis, skin disorders.

  • Alerts caution: these may be severe or life-threatening.

  • Common: fatigue, rash, itching, diarrhea.

• Contraindications:

  • No strict contraindications,

  • However, use may be avoided in patients with active autoimmune conditions or those on high-dose immunosuppressants.

• Precautions:

  • Monitor organ function (lungs, liver, gut, kidneys, hormones); treat immune events promptly with steroids.

  • Women of childbearing potential should avoid pregnancy during treatment and for some time after.

Keytruda Interactions

• Drug Interactions:

  • No direct metabolism via CYP450;

  • However, it may alter other immune-based therapies.

  • Caution when co-administered.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.