Registered Kenya · PPB

ANTI D 300 MCG

TRINBELIMAB

H2025/CTD10930/23547 300 MCG / ML GENERIC/BIOSIMILARS

What it does

Trinbelimab is a medication that helps the immune system fight certain diseases.

Commonly used for: autoimmune diseases, inflammatory conditions

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2025/CTD10930/23547
Registration date
-
Expiry date
2030 October 27
Status
Registered
Active ingredient
TRINBELIMAB
Dosage form
300 MCG / ML
Strength
-
Pack size
CLEAR COLORLESS, USP TYPE – 1, TUBULAR GLASS VIAL OF 2 ML CAPACITY. THE VIALS ARE BUNGED WITH 13 MM CHLOROBUTYL RUBBER BUNG AND SEALED WITH 13 MM ALUMINUM FLIP OFF SEALS (TRANSPARENT GREEN)
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Nairobi Enterprises
Country of origin
FOREIGN
Manufacturer location
JWW2+25R, Old Mombasa Rd, Nairobi. Shiv business park, Opposite SGR Nairobi terminus-old Mombasa road , Warehouse NO-15, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:26:23 · updated 2026-09-25 02:11:51

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Trinbelimab is a medication that helps the immune system fight certain diseases.

What it treats

  • autoimmune diseases
  • inflammatory conditions

How it works

It works by targeting specific parts of the immune system to reduce inflammation and prevent the body from attacking itself.

Who it's for

This medication is for adults with specific autoimmune disorders.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: trinbelimab

Trinbelimab is a monoclonal antibody that selectively targets the programmed cell death protein 1 (PD-1) receptor. It is designed to enhance the immune response against cancer cells by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This mechanism allows T cells to remain active and attack tumor cells more effectively. Trinbelimab is currently under investigation for its efficacy in various malignancies, including melanoma, non-small cell lung cancer, and other solid tumors.

Indications

  • Melanoma
  • Non-small cell lung cancer
  • Other solid tumors

Dosage

Children: Refer to established guidelines for specific dosing information, as pediatric dosing may differ significantly from adult dosing.

Adults: Refer to established guidelines for specific dosing information, which may vary based on the indication and clinical scenario.

Mechanism of action

Trinbelimab binds to the PD-1 receptor on T cells, preventing its interaction with PD-L1 and PD-L2 ligands. This blockade inhibits the downregulation of T cell activation and proliferation, thereby enhancing the anti-tumor immune response. The PD-1 pathway is a critical regulator of immune tolerance and plays a significant role in tumor evasion from immune surveillance.

Pharmacodynamics

The pharmacodynamic effects of trinbelimab include increased T cell activation, proliferation, and cytokine production. This leads to a more robust anti-tumor response and the potential for tumor regression. The degree of response can vary based on the tumor microenvironment, including the presence of PD-L1 expressing tumor cells.

Pharmacokinetics

Trinbelimab exhibits typical pharmacokinetic properties of monoclonal antibodies, including a long half-life, which allows for less frequent dosing. It is administered via intravenous infusion, and its clearance can be influenced by factors such as patient weight, renal function, and the presence of anti-drug antibodies. The drug distribution is extensive, with a volume of distribution reflecting that of the plasma and interstitial fluid.

Adverse effects

  • Injection site reactions
  • Headache
  • Fatigue
  • Nausea
  • Diarrhea
  • Rash
  • Increased risk of infections

Precautions

  • Monitor for signs of immune-mediated adverse reactions
  • Use with caution in patients with a history of autoimmune disease
  • Consider the risk of infections in patients receiving immunotherapy

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is unknown whether trinbelimab is excreted in human milk. Caution should be exercised when administering to a nursing woman.

Storage

Store in a refrigerator at 2 to 8 degrees Celsius, do not freeze. Protect from light.

Formulations

  • Injection solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.