Registered Kenya · PPB

NIVOLUNIX 40 INJECTION

NIVOLUMAB INN

H2021/CTD8547/18726 NIVOLUMAB INN 40MG GENERIC/BIOSIMILARS INN generic

What it does

Nivolumab is a medication that helps treat certain types of cancer by boosting the body's immune response against cancer cells.

Commonly used for: advanced melanoma (skin cancer), non-small cell lung cancer, kidney cancer (renal cell carcinoma)

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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.
H2021/CTD8547/18726
Registration date
2021-09-01 00:00:00
Expiry date
2026 September 01
Status
Registered
Active ingredient
NIVOLUMAB INN
Dosage form
NIVOLUMAB INN 40MG
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 19:52:48 · updated 2026-08-28 02:30:29

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

About this medicine

Nivolumab is a medication that helps treat certain types of cancer by boosting the body's immune response against cancer cells.

What it treats

  • advanced melanoma (skin cancer)
  • non-small cell lung cancer
  • kidney cancer (renal cell carcinoma)

How it works

It works by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the immune response.

Who it's for

It is used for patients with specific types of cancer who may benefit from immunotherapy.

Cautions

  • • Be cautious if taking other medications that can affect bone marrow function.

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

Clinical monograph: Nivolumab

BNF-referenced

Nivolumab is a human immunoglobulin G4 monoclonal antibody that functions as an immune checkpoint inhibitor. It specifically binds to the programmed death-1 (PD-1) receptor on T-cells, thereby blocking its interaction with PD-L1 and PD-L2 ligands, which are often overexpressed in tumors. This blockade enhances T-cell activation and proliferation, improving the immune response against cancer cells.

Indications

  • Melanoma
  • Renal cell carcinoma
  • Non-small cell lung cancer
  • Malignant pleural mesothelioma
  • Urothelial carcinoma
  • Squamous cell cancer of the head and neck
  • Classical Hodgkin lymphoma
  • Gastrointestinal cancer

Dosage

Children: Safety and efficacy in children have not been established; refer to the BNF for Children for any potential use.

Adults: Dosage varies based on the specific indication; refer to the BNF for detailed dosing recommendations.

Mechanism of action

Nivolumab works by inhibiting the PD-1 pathway, which normally downregulates immune responses. By blocking PD-1, nivolumab prevents tumor cells from evading immune detection, promoting the activation of T-cells to attack and destroy cancer cells.

Pharmacodynamics

The pharmacodynamic effect of nivolumab is characterized by enhanced T-cell activity and increased immune surveillance against tumors. This may lead to an extended duration of response and improved overall survival in patients with certain malignancies. However, this immune activation can also result in immune-related adverse effects due to increased inflammation.

Pharmacokinetics

Nivolumab exhibits linear pharmacokinetics over a wide dose range. It has a volume of distribution of approximately 6.6 L. The half-life of nivolumab ranges from 15 to 28 days, allowing for less frequent dosing schedules. It is primarily eliminated through the reticuloendothelial system and does not undergo extensive metabolism by cytochrome P450 enzymes.

Contra-indications

  • Hypersensitivity to nivolumab or any of its excipients
  • History of severe or life-threatening cutaneous adverse reactions associated with other immunostimulant therapies

Adverse effects

  • Fatigue
  • Diarrhea
  • Nausea
  • Pruritus
  • Rash
  • Anorexia
  • Abdominal pain
  • Myalgia
  • Arthralgia
  • Hypersensitivity reactions
  • Autoimmune conditions exacerbation
  • Severe cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
  • Immune-mediated pneumonitis
  • Immune-mediated colitis
  • Immune-mediated hepatitis
  • Nephritis
  • Endocrinopathies

Interactions

  • Corticosteroids may reduce nivolumab efficacy due to immunosuppressive effects
  • Other immunosuppressive agents may increase the risk of adverse effects

Precautions

  • Caution in patients with a history of severe autoimmune disease
  • Monitoring for signs of severe cutaneous adverse reactions
  • Resuscitation facilities should be available during administration

Pregnancy

There are no adequate data on the use of nivolumab in pregnant women. Nivolumab is not recommended during pregnancy.

Breast-feeding

It is unknown whether nivolumab is excreted in human milk. A decision should be made whether to discontinue breastfeeding or to discontinue the drug.

Storage

Store in a refrigerator (2–8°C) and protect from light. Consult product literature for storage conditions after preparation of the infusion.

Formulations

  • Nivolumab 1 mg/ml concentrate for solution for infusion
BNF 85 (British National Formulary) p.981 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.