CTLA-4 Inhibitor Pregnancy: Ipilimumab can cause fetal harm when administered to a pregnant woman; there is insufficient human data in pregnancy. In animal studies it produced higher incidences of abortion, stillbirth, premature delivery and infant mortality. Ipilimumab is an IgG1 and has the potential to cross the placenta; effects are likely to be greater during the second and third trimesters. Advise pregnant women of the potential risk to a fetus.

Ipilimumab (RCC — in Combination)

Brand names: Yervoy

Ipilimumab is a CTLA-4 immune checkpoint inhibitor monoclonal antibody, used in combination with nivolumab for advanced renal cell carcinoma.

Adult dose

Dose: 1 mg/kg

Route: Intravenous infusion over 30 minutes after dilution, given immediately following nivolumab 3 mg/kg on the same day

Frequency: Every 3 weeks for a maximum of 4 doses; after completing 4 doses of the combination, nivolumab is administered as a single agent until disease progression or unacceptable toxicity

Max: Maximum of 4 doses in combination with nivolumab for advanced renal cell carcinoma

INDICATION: the regimen above is the US label's advanced renal cell carcinoma regimen (YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses). Refer to the nivolumab prescribing information for its dosing after the combination is completed. OTHER LABELLED REGIMENS (not the RCC regimen): unresectable or metastatic melanoma — 3 mg/kg every 3 weeks for a maximum of 4 doses as a single agent, or 3 mg/kg every 3 weeks with nivolumab 1 mg/kg for a maximum of 4 doses; adjuvant melanoma — 3 mg/kg every 3 weeks for 4 doses followed by 3 mg/kg every 12 weeks for up to 4 additional doses; MSI-H or dMMR colorectal cancer — 1 mg/kg every 3 weeks with nivolumab 240 mg (adults and paediatric patients weighing 40 kg or more) or with nivolumab 3 mg/kg (paediatric patients weighing less than 40 kg), maximum of 4 doses; hepatocellular carcinoma — 3 mg/kg over 30 minutes immediately following nivolumab 1 mg/kg over 30 minutes, every 3 weeks for up to 4 doses; metastatic NSCLC — 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks (with or without 2 cycles of platinum-doublet chemotherapy); malignant pleural mesothelioma — 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks; oesophageal squamous cell carcinoma — 1 mg/kg every 6 weeks with nivolumab 3 mg/kg every 2 weeks or 360 mg every 3 weeks. PAEDIATRIC: safety and effectiveness are established only in patients aged 12 years and older, and only for melanoma and MSI-H/dMMR colorectal cancer indications — NOT for renal cell carcinoma; the 1 mg/kg with nivolumab 3 mg/kg regimen for paediatric patients weighing under 40 kg belongs to the colorectal cancer indication and must not be transferred to RCC. DOSE MODIFICATION: in general withhold for severe (Grade 3) and permanently discontinue for life-threatening (Grade 4) immune-mediated adverse reactions; see the full prescribing information for detailed modifications. SOURCE NOTE: no UK SPC (eMC) was fetched in this bundle — this draft is distilled from the US YERVOY prescribing information (E.R. Squibb & Sons, label date 2026-06-12) and must be verified against the UK SPC. The §2.2 dosage table, §5 warnings and §6 adverse reactions are truncated at the source-fetch limit, and no drug-interactions section was retrieved.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None — the US label section 4 Contraindications reads 'None'

Side effects

Fatigue
Diarrhoea
Rash and pruritus
Nausea
Headache
With nivolumab (incidence 20% or more) additionally: musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnoea, upper respiratory tract infection, arthralgia, hypothyroidism, constipation, decreased weight and dizziness. Severe and fatal immune-mediated adverse reactions (any organ system) and infusion-related reactions are the labelled serious risks

Clinical monograph

How it works

It blocks CTLA-4 on T cells, removing an inhibitory signal and augmenting T-cell activation and proliferation against tumour cells.

Prescribing in practice

It causes immune-related adverse events that can affect any organ system (including colitis, hepatitis, pneumonitis, endocrinopathies and skin reactions) and may be severe or life-threatening, requiring prompt corticosteroid or immunosuppressive management per protocol.
Immune toxicities are more frequent and severe with combination ipilimumab plus nivolumab than with single-agent checkpoint inhibition.
Endocrinopathies such as hypophysitis and thyroid dysfunction may present non-specifically and can be irreversible; assess against the SPC and local immunotherapy pathways.

Monitoring

Monitor liver function, thyroid and other endocrine function, blood glucose and clinical symptoms before each cycle and review for emergent immune-related toxicity throughout treatment.

Counselling the patient

Report new or worsening symptoms promptly, including diarrhoea, breathlessness, rash, severe fatigue or unusual thirst.
Carry an alert card noting you are receiving immunotherapy.
Side effects can appear weeks or months after treatment, so keep reporting new symptoms.

Evidence & guidelines

The CheckMate 214 trial established ipilimumab plus nivolumab for intermediate/poor-risk advanced renal cell carcinoma, and it is recommended by NICE.

Reference: CheckMate 214 (Motzer et al. NEJM 2018); 7-year OS data (Motzer et al. NEJM 2022); NICE TA581; MHRA SPC Yervoy; EAU RCC Guidelines 2024; 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