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.

keytruda

Characteristics

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.

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.

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.