Registered Kenya · PPB

PEMBROXIM INJECTION

PEMBROLIZUMAB INN

H2021/CTD8470/18741 100MG GENERIC/BIOSIMILARS INN generic

What it does

Pembrolizumab is a medicine that helps the body's immune system fight cancer.

Commonly used for: certain types of cancer, malignant melanoma (skin cancer), non-small cell lung cancer

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Registration & product details

Registration no.
H2021/CTD8470/18741
Registration date
2021-08-27 00:00:00
Expiry date
-
Status
Registered
Active ingredient
PEMBROLIZUMAB INN
Dosage form
100MG
Strength
-
Pack size
ONE CLEAR GLASS VIAL IN A CARTON BOX
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Generics Africa
Applicant / LTR
BEACON MEDICARE LTD
Country of origin
FOREIGN
Manufacturer location
Generics Africa Limited, RAFIKI BUSINESS PARK, OFF THIKA SUPER HIGHWAY, RING ROAD, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:52:35 · updated 2026-08-03 03:01:44

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

About this medicine

Pembrolizumab is a medicine that helps the body's immune system fight cancer.

What it treats

  • certain types of cancer
  • malignant melanoma (skin cancer)
  • non-small cell lung cancer

How it works

It works by blocking a specific protein on immune cells, which helps the immune system to attack cancer cells more effectively.

Who it's for

This medicine is for adults and children with certain cancers that can be treated with immunotherapy.

Cautions

  • • Be careful if you are taking other medicines that can affect blood cell production.

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

Clinical monograph: Pembrolizumab

BNF-referenced

Pembrolizumab is a monoclonal antibody that functions as an immune checkpoint inhibitor. It specifically binds to the programmed death-1 (PD-1) receptor on T cells, thereby enhancing the immune response against tumor cells. This mechanism allows the immune system to recognize and attack cancer cells more effectively, making pembrolizumab a critical treatment option for various malignancies.

Indications

  • Melanoma
  • Non-small cell lung cancer
  • Urothelial carcinoma
  • Classical Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Renal cell carcinoma
  • Colorectal cancer
  • Oesophageal carcinoma
  • Breast cancer
  • Endometrial carcinoma
  • Cervical cancer
  • Gastric cancer
  • Small intestine cancer
  • Biliary cancer

Dosage

Children: For paediatric dosing

Adults: The dosage of pembrolizumab is typically 200 mg administered every 3 weeks or 400 mg every 6 weeks, depending on the specific indication and clinical context. Refer to the BNF for specific dosing recommendations based on the patient's condition and response.

Mechanism of action

Pembrolizumab binds to the programmed death-1 (PD-1) receptor on T cells, inhibiting its interaction with PD-L1 and PD-L2, which are ligands that normally downregulate immune responses. By blocking this pathway, pembrolizumab enhances the activation and proliferation of T cells, promoting a more robust immune response against tumor cells.

Pharmacodynamics

The pharmacodynamics of pembrolizumab are primarily related to its role in the modulation of T cell activity. By inhibiting PD-1, pembrolizumab increases T cell activation, which can lead to improved anti-tumor activity. Clinical outcomes include enhanced immune-mediated tumor destruction and improved survival rates in patients with certain types of cancer.

Pharmacokinetics

Pembrolizumab has a half-life of approximately 26 days, allowing for convenient dosing schedules. The drug is administered via intravenous infusion, and its pharmacokinetics can be affected by various factors, including the patient's body weight. It is primarily eliminated through the reticuloendothelial system, and its clearance is linear across the therapeutic dose range.

Contra-indications

  • History of interstitial pulmonary disease
  • Severe dry eye
  • History of keratitis
  • History of ulcerative keratitis

Adverse effects

  • Immune-mediated adverse reactions
  • Skin reactions
  • Pneumonitis
  • Colitis
  • Hepatitis
  • Endocrinopathies
  • Nephritis
  • Infusion-related reactions

Interactions

  • Corticosteroids may reduce the effectiveness of pembrolizumab
  • Other immunosuppressive agents may interfere with its therapeutic effect

Precautions

  • Monitor for immune-related adverse effects
  • Patients with a history of keratitis should be observed closely
  • Evaluate for underlying pulmonary disease prior to treatment

Pregnancy

Avoid use during pregnancy due to potential toxicity in animal studies.

Breast-feeding

Manufacturer advises to avoid breastfeeding during and for 2 months after treatment.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.

Formulations

  • Pembrolizumab 50 mg/ml solution for infusion
  • Pembrolizumab 100 mg/4 ml concentrate for solution for infusion
BNF 85 (British National Formulary) p.984 PubChem / pathway

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.