NIVOLUNIX (Nivolumab) 100 MG INJECTION 1's

Nivolunix (nivolumab) 100mg is a high-potency intravenous immunotherapy agent belonging to the class of PD-1 (Programmed Death-1) immune checkpoint inhibitors. Nivolumab is a fully human IgG4 monoclonal antibody that binds specifically to the PD-1 receptor expressed on T-cells, blocking its interaction with PD-L1 and PD-L2 ligands overexpressed on tumour cells. This blockade restores the natural anti-tumour immune response, allowing cytotoxic T-lymphocytes to recognise and destroy cancer cells.

Nivolunix 100mg is the standard strength vial used for adult dosing in most approved indications and is widely used across oncology centres in Kenya and sub-Saharan Africa.

Approved Indications:

•       Non-small cell lung cancer (NSCLC) — first- and second-line, alone or with ipilimumab

•       Classical Hodgkin lymphoma (cHL) — relapsed/refractory after autologous stem cell transplant

•       Squamous cell carcinoma of the head and neck (SCCHN) — recurrent/metastatic

•       Urothelial carcinoma (bladder cancer) — locally advanced or metastatic, post-platinum

•       Renal cell carcinoma (RCC) — advanced, combined with ipilimumab (first-line) or as monotherapy

•       Hepatocellular carcinoma (HCC) — previously treated with sorafenib

•       Colorectal cancer — MSI-H or MMR-deficient metastatic disease

•       Gastric/gastroesophageal junction adenocarcinoma — HER2-negative, combined with chemotherapy

•       Melanoma — unresectable or metastatic, alone or with ipilimumab

•       Oesophageal squamous cell carcinoma — first-line with fluoropyrimidine + platinum chemotherapy

Preparation

•       Must be prepared and administered by a qualified oncology healthcare professional.

•       Inspect the vial — the solution should be clear to opalescent, colourless to pale yellow. Discard if particulates or discolouration are observed.

•       Withdraw the required dose and dilute into 0.9% sodium chloride or 5% dextrose to achieve a concentration of 1–10mg/mL.

•       Do not shake the vial; mix by gentle inversion.

•       Use within 24 hours if stored at 2°C–8°C after preparation, or within 4 hours at room temperature (up to 25°C).

•       Do not freeze the prepared infusion solution.

Administration

•       Administer as an IV infusion over 30–60 minutes through an in-line sterile, non-pyrogenic, low-protein-binding filter (pore size 0.2–1.2 µm).

•       Do not administer as an IV push or bolus.

•       Do not co-infuse with other drugs through the same IV line.

•       Flush the IV line with saline before and after infusion.

Dosing Guidelines

•       Monotherapy: 240mg every 2 weeks, OR 480mg every 4 weeks

•       Combination with ipilimumab: 3mg/kg every 3 weeks (4 doses), then 240mg every 2 weeks

•       Gastric/NSCLC combination: 360mg every 3 weeks with chemotherapy, or 240mg every 2 weeks

•       Dose adjustments: No dose reductions are made; doses are delayed or permanently discontinued based on immune-mediated toxicity grade.

•       Renal/hepatic impairment: No dose adjustment required for mild-moderate impairment; use with caution in severe impairment.

•       Paediatric: 3mg/kg every 2 weeks for cHL (ages 12–17); not established for most indications under 18

Missed Dose

If a dose is missed, administer as soon as possible and reset the schedule. Do not double-dose.

Common Side Effects

•       Fatigue and asthenia (very common)

•       Nausea, decreased appetite, diarrhoea

•       Rash, pruritus, vitiligo

•       Musculoskeletal pain, arthralgia

•       Cough, dyspnoea (shortness of breath)

•       Peripheral oedema

•       Elevated liver enzymes (ALT, AST)

Serious / Immune-Mediated Side Effects

Seek immediate medical attention if you experience any of the following:

•       Immune-mediated pneumonitis (lung inflammation) — can be fatal

•       Immune-mediated hepatitis — liver failure risk

•       Immune-mediated colitis — severe diarrhoea/perforation

•       Immune-mediated endocrinopathies — hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes

•       Immune-mediated nephritis and renal failure

•       Severe skin reactions — Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)

•       Myocarditis and pericarditis — potentially fatal cardiac events

•       Neurotoxicity — Guillain-Barré syndrome, myasthenia gravis, encephalitis

•       Infusion-related reactions — including anaphylaxis

•       Haematological toxicity — aplastic anaemia, haemolytic anaemia, thrombocytopaenia

Rare Side Effects

•       Uveitis and other ocular inflammatory events

•       Pancreatitis

•       Demyelinating disorders

•       Solid organ graft rejection

•       Complications in allogeneic haematopoietic stem cell transplant recipients

•       Immune-mediated adverse reactions (imARs): Can affect any organ system. Monitor closely; manage with corticosteroids (1–2mg/kg/day prednisolone equivalent) for Grade 2+. Permanently discontinue for Grade 4 or recurrent Grade 3 reactions.

•       Infusion reactions: Monitor patients during and after infusion. Have emergency resuscitation equipment available.

•       Embryo-foetal toxicity: Advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose.

•       Breastfeeding: Discontinue breastfeeding during treatment and for 5 months after the last dose.

•       Elderly patients: No dose adjustment required; however, monitor for immune-mediated toxicities more vigilantly.

•       Thyroid function: Check TSH at baseline and periodically during treatment — thyroid disorders may develop insidiously.

•       Blood glucose: Screen for hyperglycaemia as immune-mediated type 1 diabetes can occur.

•       Corticosteroid use: High-dose systemic corticosteroids used to manage imARs may reduce the anti-tumour efficacy of nivolumab. Taper as quickly as clinically feasible.

•       Systemic corticosteroids: Used therapeutically to manage imARs; prophylactic use may reduce efficacy — avoid routine pre-medication unless managing infusion reactions.

•       Other immunosuppressants (azathioprine, mycophenolate, cyclosporin): Increased risk of imARs when combined; monitor closely.

•       Ipilimumab (CTLA-4 inhibitor): Approved combination but substantially increases risk of high-grade imARs. Requires close monitoring.

•       Chemotherapy agents (paclitaxel, platinum compounds, fluorouracil): Co-administration is approved in certain regimens; enhanced toxicity monitoring required.

•       Live vaccines: Avoid live attenuated vaccines during and for several months after nivolumab therapy — risk of severe or disseminated infection.

•       Antidiabetic agents: Monitor blood glucose as immune-mediated diabetes may alter requirements for insulin or oral hypoglycaemics.

•       No significant CYP450-based drug-drug interactions — nivolumab is metabolised via proteolytic pathways, not cytochrome P450 enzymes.

•       Store at 2°C–8°C (refrigerated) — do not freeze.

•       Keep the vial in the outer carton to protect from light.

•       Do not shake the vial.

•       Once diluted for infusion: use within 4 hours at room temperature (≤25°C) or within 24 hours refrigerated (2°C–8°C).

•       Discard any unused portion — this product contains no preservatives.

•       Keep out of reach and sight of children.

•       Do not use beyond the expiry date printed on the label.

Nivolunix (nivolumab) 100mg injection is classified as a Prescription Only Medicine (POM) in Kenya under the Pharmacy and Poisons Act (Cap 244). It may only be prescribed by a licensed medical practitioner — ideally a specialist oncologist — and dispensed by a registered pharmacist.

In Kenya, nivolumab is primarily available through National Cancer Institute of Kenya (NCI-K) affiliated hospitals, Kenyatta National Hospital (KNH), Aga Khan University Hospital (AKUH), and select private oncology centres. Import and supply are regulated by the Pharmacy and Poisons Board (PPB).

Patients may access nivolumab through the NHIF Managed Care programmes for select oncology indications, though coverage varies. Private insurance pre-authorisation is typically required.

Nivolunix 100mg is a high-cost, high-risk oncology biologic. Pharmacists should verify the complete chemotherapy/immunotherapy order against the patient's approved protocol before dispensing. Confirm allergy status, hepatic/renal function results, and baseline autoimmune screening. Ensure cold-chain integrity during transport and advise the patient or caregiver on refrigerated storage at home if applicable. Counsel patients to carry their immunotherapy ID card at all times. Document and report any adverse events through the PPB pharmacovigilance system.

Q1: What is Nivolunix used for?

A: Nivolunix (nivolumab) is an immunotherapy drug used to treat several types of cancer, including lung cancer, melanoma, kidney cancer, bladder cancer, liver cancer, and certain lymphomas. It works by helping your immune system fight cancer cells.

Q2: How is Nivolunix given?

A: Nivolunix is administered as an intravenous (IV) infusion by a healthcare professional in a hospital or clinic setting. It is never given as an injection into muscle or under the skin. The infusion typically takes 30–60 minutes.

Q3: How often will I receive Nivolunix?

A: The typical schedule for monotherapy is every 2 weeks (240mg) or every 4 weeks (480mg). When combined with other agents, the schedule may differ. Your oncologist will determine the right schedule for you.

Q4: Can Nivolunix cure my cancer?

A: Nivolumab can achieve durable remissions in some patients, and a subset experience long-term disease control. However, response rates vary depending on the cancer type, biomarkers (such as PD-L1 expression and TMB), and individual patient factors. Your oncologist will discuss realistic expectations with you.

Q5: What should I do if I experience side effects?

A: Contact your oncology team immediately if you experience new symptoms such as difficulty breathing, chest pain, severe diarrhoea, skin rash, or any sudden worsening. Immune-mediated side effects can be serious but are usually manageable if caught early.

Q6: Can I take other medications while on Nivolunix?

A: Always inform your doctor and pharmacist about every medication, supplement, or herbal product you take. Certain immunosuppressants and live vaccines should be avoided. Most routine medications are safe, but your care team needs to review them.

Q7: Is Nivolunix safe during pregnancy?

A: No. Nivolumab can harm an unborn baby. Both male and female patients must use effective contraception during treatment and for 5 months after the last dose. If you are pregnant or planning to become pregnant, discuss this with your doctor immediately.