PD-1 Inhibitor Pregnancy: Contraindicated — PD-1 inhibition may disrupt fetal-maternal tolerance; effective contraception during and for 5 months after treatment

Nivolumab (Head and Neck SCC)

Brand names: Opdivo

Adult dose

Dose: 240 mg IV every 2 weeks or 480 mg IV every 4 weeks

Route: Intravenous infusion over 30 minutes

Frequency: Every 2 weeks or every 4 weeks

Max: 480 mg per dose (4-weekly)

R/R HNSCC after platinum-based chemotherapy; no PD-L1 biomarker requirement unlike pembrolizumab in this setting

Paediatric dose

Dose: Not established for HNSCC N/A/kg

Route: N/A

Frequency: N/A

Max: N/A

Not licensed for HNSCC in paediatrics

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment for mild-moderate impairment

Paediatric weight-based calculator

Patient weight (kg)

Not licensed for HNSCC in paediatrics

Clinical pearls

CheckMate 141 (Ferris et al. NEJM 2016): nivolumab significantly improved OS vs investigator's choice (cetuximab, methotrexate, or docetaxel) in platinum-refractory R/M HNSCC (7.5 vs 5.1 months; HR 0.70) — first immunotherapy approval in HNSCC; NICE TA490
No PD-L1 requirement: unlike pembrolizumab which requires CPS testing for first-line selection, nivolumab's CheckMate 141 showed benefit regardless of PD-L1 expression — simplifies patient selection in second-line setting
Treatment duration: continue until progression or unacceptable toxicity; maximum 2 years in some guidelines (if achieving sustained response); restart after irAE resolution if grade 1-2; permanently discontinue if grade 3-4 pneumonitis, colitis, or hepatitis
irAE management shared class knowledge: same principles as pembrolizumab — high-dose steroids (prednisolone 1-2 mg/kg/day) for grade ≥2 irAEs; immunosuppressants (infliximab, mycophenolate) for steroid-refractory irAEs
Sequential immunotherapy: if pembrolizumab used first-line, nivolumab efficacy in second-line is uncertain (cross-resistance possible); clinical trial preferred in this scenario

Contraindications

Active severe autoimmune disease
Known hypersensitivity

Side effects

Immune-mediated adverse events (colitis, pneumonitis, hepatitis, endocrinopathies)
Fatigue
Nausea
Rash
Pruritus

Interactions

Systemic corticosteroids — chronic use may reduce efficacy
Live vaccines — avoid

Monitoring

TFTs, LFTs, creatinine (each cycle)
FBC
Respiratory symptoms (pneumonitis)
GI symptoms (colitis)
Skin assessment

Reference: BNFc; BNF 90; CheckMate 141 (Ferris et al. NEJM 2016); NICE TA490; MHRA SPC Opdivo; ESMO HNSCC Guidelines (2021). Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Pathways