TM Owner AstraZeneca
Tremelimumab 300mg/15ml Vial
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Indications & Clinical Uses
- This product is labelled 'Tremelimumab' on the sheet, using the generic (INN) name of the active ingredient rather than a trade name; there is no marketed product called simply 'Tremelimumab' - the approved brand is Imjudo (tremelimumab-actl), made by AstraZeneca, and this entry is sourced from Imjudo's FDA and EMA labelling.
- Imjudo is a CTLA-4-blocking monoclonal antibody supplied as a 300 mg/15 mL (20 mg/mL) concentrate for solution for infusion, matching this sheet's strength; a smaller 25 mg/1.25 mL vial is also available.
- It is never used alone: Imjudo is approved only in combination with durvalumab (Imfinzi) - for adults with unresectable hepatocellular carcinoma (liver cancer), usually as a single 300 mg dose with durvalumab followed by durvalumab alone every 4 weeks, and for metastatic non-small cell lung cancer without EGFR/ALK mutations, where a 75 mg dose is given every 3 weeks with durvalumab and chemotherapy for up to 5 doses.
- It is given only by intravenous infusion over 60 minutes in a hospital or cancer centre.
Side Effects
- Imjudo (tremelimumab) carries no boxed warning.
- In liver cancer, when combined with durvalumab, side effects affecting 20% or more of patients include rash, diarrhoea, tiredness, itching, muscle and bone pain, and stomach pain; underactive thyroid and raised liver enzymes are also very common.
- In lung cancer with chemotherapy, nausea, tiredness, reduced appetite, muscle pain, rash and diarrhoea are most common.
- The most serious risk is immune-mediated reactions, where the activated immune system attacks healthy organs - causing lung inflammation, colitis, hepatitis, thyroid, adrenal or pituitary problems, type 1 diabetes, kidney inflammation, severe skin reactions, pancreatitis or myocarditis - which can be severe, fatal, start at any time, and appear even after stopping treatment.
- Infusion reactions can also occur.
- Report new cough, breathlessness, bloody diarrhoea, yellowing skin, dark urine, chest pain or unusual tiredness immediately.
Precautions & Warnings
- Imjudo (tremelimumab) is given only by healthcare professionals as a 60-minute intravenous infusion through a dedicated line, never as a push or bolus and never mixed with other medicines.
- Before and during treatment you will have blood tests for liver, kidney and thyroid function and blood sugar, and your team will watch closely for immune-mediated reactions, managed by pausing treatment and giving corticosteroids.
- Tell your team about any autoimmune disease, organ or stem cell transplant, or lung or liver problems before starting.
- Imjudo can harm an unborn baby: women who could become pregnant need a pregnancy test and effective contraception during treatment and for at least 3 months after the last dose, and should not breastfeed during this time.
- Carry your patient alert card and show it to any healthcare professional you see.
- Unopened vials are stored by the pharmacy at 2°C to 8°C, protected from light, and must not be frozen or shaken.
Avoid Interactions
- No formal drug-interaction studies have been done with Imjudo (tremelimumab), and as an antibody it is not broken down by liver enzymes, so classic drug or food interactions such as grapefruit are not expected.
- What matters most: corticosteroids or other immunosuppressants taken before starting may reduce how well Imjudo works, so tell your team if you take them - steroids used later to treat side effects are expected and appropriate.
- Other checkpoint inhibitors or immunotherapies can add to immune-mediated toxicity and should only be combined as prescribed.
- Imjudo is designed to be given with durvalumab as separate infusions in a set order - Imjudo first, then durvalumab, then chemotherapy in lung cancer - and must not be mixed in the same bag or line.
- Ask before any vaccination.
- Tell your healthcare provider about every medicine, herbal remedy and supplement you use.
References
Frequently Asked Questions
'Tremelimumab' is the active ingredient's generic name; the approved medicine is Imjudo (tremelimumab-actl), made by AstraZeneca. It's an immunotherapy used with durvalumab (Imfinzi) for adults with unresectable liver cancer and metastatic non-small cell lung cancer. Tremelimumab is never given alone.
Tremelimumab, sold as Imjudo, is given as a 60-minute intravenous drip in a hospital or cancer centre, always with durvalumab. For liver cancer it's usually one 300 mg dose; for lung cancer it's 75 mg every 3 weeks with chemotherapy, up to 5 doses total.
Common Tremelimumab (Imjudo) side effects with durvalumab include rash, diarrhoea, tiredness, itching and muscle pain. It can trigger serious immune reactions affecting the lungs, gut, liver, hormone glands, kidneys or heart, sometimes after treatment ends. Report new cough, breathlessness, yellow skin or severe diarrhoea straight away.
Avoid pregnancy during Tremelimumab (Imjudo) treatment and for at least 3 months after the last dose, and don't breastfeed during that time. Tell your team before starting if you take steroids, other immune-suppressing medicines, or have autoimmune disease. Check with your team before any vaccination.
You'll have blood tests before and during Tremelimumab (Imjudo) treatment to check liver, kidney and thyroid function and blood sugar. These catch immune-related side effects early, treated by pausing therapy and giving steroids. Carry a patient alert card to show any healthcare professional you see.
Yes. Tremelimumab is the generic name of the active ingredient; Imjudo is AstraZeneca's approved brand name (tremelimumab-actl in the US). There is no separate product simply called 'Tremelimumab' - all information here comes from Imjudo's official prescribing information.
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