Anti-CTLA-4 monoclonal antibody Pregnancy: Based on findings from animal studies and its mechanism of action, tremelimumab can cause fetal harm when administered to a pregnant woman; there are no available data on use in pregnant women. In animal studies CTLA-4 blockade is associated with increased risk of immune-mediated rejection of the developing fetus and fetal death, and human IgG2 is known to cross the placental barrier. Advise pregnant women and females of reproductive potential of the potential risk to a fetus and of the need for effective contraception.

Tremelimumab (Specialist drug)

Brand names: Imjudo

Tremelimumab is a monoclonal antibody immune checkpoint inhibitor used under specialist supervision, typically combined with other agents, for cancers including hepatocellular carcinoma and non-small-cell lung cancer.

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: Unresectable hepatocellular carcinoma (uHCC), patients weighing 30 kg and more: 300 mg as a single dose, in combination with durvalumab 1,500 mg, on Day 1 of Cycle 1

Route: Intravenous infusion over 60 minutes after dilution (give tremelimumab before durvalumab on the same day)

Frequency: uHCC: a single dose at Cycle 1 Day 1, after which durvalumab 1,500 mg is continued as a single agent every 4 weeks until disease progression or unacceptable toxicity

uHCC, patients weighing less than 30 kg: a single dose of 4 mg/kg followed by durvalumab 20 mg/kg on Day 1 of Cycle 1, then durvalumab 20 mg/kg as a single agent every 4 weeks. Metastatic NSCLC (in combination with durvalumab and platinum-based chemotherapy), patients weighing 30 kg and more: 75 mg every 3 weeks with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, then durvalumab 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, plus a fifth dose of tremelimumab 75 mg in combination with durvalumab dose 6 at week 16. Metastatic NSCLC, patients weighing less than 30 kg: 1 mg/kg every 3 weeks with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles, then durvalumab 20 mg/kg every 4 weeks with histology-based pemetrexed every 4 weeks, plus a fifth dose of 1 mg/kg with durvalumab dose 6 at week 16. Weigh patients prior to each infusion and calculate the dose from body weight and tumour histology. If fewer than 4 cycles of platinum-based chemotherapy are given, the remaining tremelimumab cycles (up to a total of 5) should be given after the chemotherapy phase in combination with durvalumab every 4 weeks. Dose modification: no dose reduction is recommended — in general withhold for severe (Grade 3) immune-mediated adverse reactions and permanently discontinue for life-threatening (Grade 4) reactions, recurrent Grade 3 reactions requiring systemic immunosuppression, or inability to reduce corticosteroids to 10 mg prednisone or equivalent per day within 12 weeks. Refer to the durvalumab prescribing information for its dosing. Paediatric population: safety and effectiveness have not been established in paediatric patients (in an open-label study of 41 patients aged 1 to under 17 years given tremelimumab with durvalumab, no new safety signals were observed; exposure in patients under 35 kg was lower than in adults given the same weight-based dose). No UK SPC posology was available in the fetched bundle — this draft is from US labelling (IMJUDO) and must be verified against the UK SPC.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None (the US label states 'None')

Side effects

Severe and fatal immune-mediated adverse reactions, which can occur in any organ system — including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic reactions and pancreatitis
Infusion-related reactions — interrupt, slow the rate of infusion, or permanently discontinue based on severity
Most common adverse reactions (20% or more) in uHCC: rash, diarrhoea, fatigue, pruritus, musculoskeletal pain and abdominal pain
Most common adverse reactions (20% or more) in metastatic NSCLC: nausea, fatigue, musculoskeletal pain, decreased appetite, rash and diarrhoea
Most common laboratory abnormalities (40% or more) in uHCC: increased AST, increased ALT, decreased haemoglobin, decreased sodium, increased bilirubin, increased alkaline phosphatase and decreased lymphocytes

Clinical monograph

How it works

It blocks CTLA-4 on T cells, removing an inhibitory checkpoint and enhancing T-cell-mediated antitumour immune responses.

Prescribing in practice

Immune-mediated adverse reactions can affect any organ (including colitis, hepatitis, pneumonitis and endocrinopathies) and may require corticosteroids and treatment interruption.
It is a specialist immunotherapy usually given in combination regimens, for example with durvalumab.
Pre-existing autoimmune disease warrants careful assessment before use per the SPC.

Monitoring

Monitor liver and thyroid function, blood glucose and for any new immune-related symptoms before and during treatment.

Counselling the patient

Report new diarrhoea, breathlessness, severe tiredness or any unexplained symptoms promptly, even after treatment ends.
Carry an alert card and tell other clinicians you are receiving immunotherapy.
Effective contraception is advised during and after treatment.

Evidence & guidelines

Use in combination immunotherapy is supported by trials such as HIMALAYA and POSEIDON and relevant NICE appraisals.

Reference: NICE TA887; SmPC; 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.

Calculators

Pathways