Registered Kenya · PPB

IMFINZI 50MG/ML INJECTION

DURVALUMAB

H2026/CTD13143/28244 50 MG/ML NEW/INNOVATOR antineoplastic and immunomodulating agents INN generic

What it does

Durvalumab is a medication used to help the body's immune system fight certain types of cancer.

Commonly used for: bladder cancer, non-small cell lung cancer

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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.
H2026/CTD13143/28244
Registration date
-
Expiry date
2031 March 25
Status
Registered
Active ingredient
DURVALUMAB
Dosage form
50 MG/ML
Strength
-
Pack size
VIAL: 10R COLORLESS, TYPE I GLASS, USP/PH. EUR. STOPPER: 20 MM TEFLON-COATED, GRAY, SILICONIZED, CHLOROBUTYL RUBBER, USP/PH. EUR. SEAL: 20 MM, ALUMINIUM, FLIP-OFF, LACQUERED. 120 MG/VIAL: DARK GRAY 500 MG/VIAL: WHITE
Therapeutic class
NEW/INNOVATOR
ATC class (WHO)
L01FF - PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
RxNorm RxCUI
1919503
Manufacturer / MAH
Astrazeneca
Applicant / LTR
ASTRAZENECA UK LIMITED
Country of origin
FOREIGN
Manufacturer location
10th & 11th Floor Neville Tower 2nd Floor Hardy Towers, Ramanujan IT City, Tharamani, Chennai, Tamil Nadu 600113, India

Source: Pharmacy and Poisons Board · fetched 2026-06-28 18:58:11 · updated 2026-09-25 02:04:01

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

About this medicine

Durvalumab is a medication used to help the body's immune system fight certain types of cancer.

What it treats

  • bladder cancer
  • non-small cell lung cancer

How it works

Durvalumab works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to better fight the cancer.

Who it's for

This medicine is for adults with specific types of cancer that may respond to immune therapy.

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

Clinical monograph: Durvalumab

BNF-referenced

Durvalumab is a human monoclonal antibody that selectively binds to the programmed cell death ligand-1 (PD-L1), thereby inhibiting its interaction with programmed cell death protein-1 (PD-1) and CD80. This blockade enhances the immune response against tumor cells, leading to anti-tumor activity. It is used primarily in oncology to treat certain types of cancers, including non-small cell lung cancer and urothelial carcinoma.

Indications

  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Other PD-L1 expressing malignancies

Dosage

Children: null

Adults: 500 mg every 3 weeks for 4 doses, then 1 g every 6 weeks from week 13 onwards, with adjustments based on side effects and infusion-related reactions.

Mechanism of action

Durvalumab binds to PD-L1, preventing its interaction with PD-1 and CD80 receptors. This action enhances T-cell activation and proliferation, promoting a stronger immune-mediated response against tumor cells.

Pharmacodynamics

The binding of Durvalumab to PD-L1 interrupts the inhibitory signals that normally dampen T-cell responses. This mechanism leads to increased T-cell activity against tumor cells, which can result in tumor regression. Clinical studies have shown improved overall survival rates in patients with PD-L1 expressing tumors treated with Durvalumab.

Pharmacokinetics

Durvalumab exhibits a biphasic pharmacokinetic profile, with a distribution half-life of approximately 12-20 days and an elimination half-life of around 18 days. It is administered via intravenous infusion, and its pharmacokinetics may be influenced by factors such as patient-specific characteristics and co-administered therapies. Durvalumab is primarily eliminated through a combination of target-mediated drug disposition and non-specific clearance.

Adverse effects

  • Adrenal insufficiency
  • Anaemia
  • Arthralgia
  • Autoimmune haemolytic anaemia
  • Chills
  • Durvalumab-related infusion reaction
  • Diarrhoea
  • Enterocolitis
  • Haemorrhagic fever
  • Gastrointestinal disorders
  • Hyperthyroidism
  • Hypertransaminasaemia
  • Hypothyroidism
  • Myalgia
  • Nausea
  • Pancreatitis

Precautions

  • History of severe or life-threatening cutaneous adverse reactions associated with other immunostimulant antineoplastic drugs
  • Patients who receive an allogeneic haematopoietic stem cell transplant before or after durvalumab treatment may be at an increased risk of transplant-related complications and should be closely monitored
  • Increased risk of rejection in solid organ transplant recipients

Pregnancy

Avoid-limited information available.

Breast-feeding

Avoid during treatment and for at least 4 months after last treatment-no information available.

Storage

Store in a refrigerator (2–8°C) and protect from light-consult product literature for storage conditions after dilution.

Formulations

  • Solution for infusion, 500 mg/10 mL concentrate
BNF 85 (British National Formulary) p.974 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.