PD-1 Inhibitor Pregnancy: There are no data in pregnant women and animal studies have shown embryofoetal toxicity; nivolumab is an IgG4 and can cross the placenta. Not recommended during pregnancy or in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk; effective contraception should be used for at least 5 months after the last dose. It is unknown whether nivolumab is secreted in human milk — decide whether to discontinue breast-feeding or therapy (§4.6).

Nivolumab (Head and Neck SCC)

Brand names: Opdivo

Nivolumab is an intravenous immune-checkpoint inhibitor used in recurrent or metastatic squamous cell carcinoma of the head and neck that has progressed on or after platinum-based chemotherapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 240 mg

Route: Intravenous infusion over 30 minutes

Frequency: Every 2 weeks

Squamous cell cancer of the head and neck (nivolumab monotherapy), adults: 240 mg every 2 weeks over 30 minutes (§4.2, Table 1). Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. The SPC's general monotherapy dose is either 240 mg every 2 weeks or 480 mg every 4 weeks depending on indication and population; for head and neck SCC only the 240 mg every 2 weeks schedule is listed (the 480 mg every 4 weeks option is listed for melanoma, RCC, adjuvant MIUC and adjuvant oesophageal/GOJ cancer). Weight-banded adolescent dosing (12 years and older weighing less than 50 kg: 3 mg/kg every 2 weeks over 30 minutes or 6 mg/kg every 4 weeks over 60 minutes) is stated in the SPC only for melanoma, renal cell carcinoma and adjuvant MIUC — NOT for head and neck SCC. Combination regimens with ipilimumab in the same SPC apply to other tumour types and must not be transposed to head and neck SCC. The fetched §4.2 extract is truncated before the treatment-modification guidance — dose withholding/discontinuation rules for immune-related adverse reactions must be verified against the full SPC. Source product: OPDIVO 10 mg/mL concentrate for solution for infusion.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients (§4.3)

Side effects

Fatigue (44%) (§4.8, pooled monotherapy dataset n=4646)
Musculoskeletal pain (28%), arthralgia (17%) (§4.8)
Diarrhoea (26%), nausea (22%), constipation (16%), abdominal pain (15%), vomiting (12%) (§4.8)
Rash (24%), pruritus (19%) (§4.8)
Cough (22%), dyspnoea (16%), upper respiratory tract infection (15%) (§4.8)
Immune-related adverse reactions affecting multiple organ systems (e.g. hypothyroidism, hyperthyroidism, thyroiditis; pneumonitis; hypersensitivity/infusion-related reactions), which may occur at any time during or after therapy — patients should be monitored for at least 5 months after the last dose (§4.4/§4.8)

Clinical monograph

How it works

Nivolumab is a monoclonal antibody against the programmed death-1 (PD-1) receptor on T cells; by blocking PD-1 engagement with its ligands it restores T-cell-mediated antitumour immune responses.

Prescribing in practice

Immune-related adverse events can affect almost any organ — including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and skin reactions — and may be severe, delayed or life-threatening, requiring prompt recognition and corticosteroid or immunosuppressive management.
Infusion-related reactions can occur, and treatment should be initiated and supervised by oncologists experienced in immunotherapy.
Endocrine effects such as thyroid dysfunction, hypophysitis and adrenal insufficiency may present insidiously and need replacement therapy rather than drug discontinuation alone.

Monitoring

Monitor liver and thyroid function, glucose, renal function and clinical status before each cycle, with a low threshold to investigate new respiratory, gastrointestinal, endocrine or dermatological symptoms as immune-related toxicity.

Counselling the patient

Report any new or worsening symptoms promptly — breathlessness, persistent diarrhoea, jaundice, severe tiredness or rash — as the immune system can attack normal organs.
Carry your immunotherapy alert card and show it to any healthcare professional you see.
Side effects can appear weeks or months after treatment, so keep reporting them even after a dose.

Evidence & guidelines

Nivolumab is licensed in platinum-refractory recurrent/metastatic head and neck SCC on the basis of a randomised trial showing improved overall survival versus standard chemotherapy, and is positioned by NICE within those criteria.

Reference: CheckMate 141 (Ferris et al. NEJM 2016); NICE TA490; MHRA SPC Opdivo; ESMO HNSCC Guidelines (2021); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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