TM Owner Roche
Mosunetuzumab 1mg/ml Vial
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Indications & Clinical Uses
- This sheet's brand field, 'Mosunetuzumab', is the active-substance name rather than a marketed brand; the approved brand for mosunetuzumab-axgb is Lunsumio, made by Genentech/Roche.
- Lunsumio is a CD20xCD3 bispecific antibody that brings a patient's own T-cells into contact with CD20-positive B-cells so the T-cells destroy them.
- In the US it has accelerated approval for adult patients with relapsed or refractory follicular lymphoma after two or more prior lines of systemic therapy, with continued approval dependent on confirmatory trial results; the EU label approves it for adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.
- It is not approved for children.
- Lunsumio is given only in a hospital or specialist cancer centre by intravenous infusion, using a step-up dosing schedule in the first cycle, and is not interchangeable with other CD20xCD3 bispecific antibodies such as glofitamab or epcoritamab, which have different dosing schedules.
Side Effects
- Lunsumio carries a boxed warning for cytokine release syndrome (CRS), which can be serious or life-threatening and occurs in roughly 2 in 5 patients, most often after the first or second dose; symptoms include fever, low blood pressure, low oxygen levels and chills, and the step-up dosing schedule plus pre-treatment medicines are used specifically to lower this risk.
- Very common reactions include CRS, fatigue, rash, headache, fever, joint or muscle pain, cough and itching.
- Neurological effects, including confusion or tremor and, rarely, more severe immune effector cell-associated neurotoxicity syndrome (ICANS), have also been reported and require close monitoring.
- Serious infections occur in around 1 in 6 patients, and low blood counts (lymphocytes, neutrophils, platelets) are very common and are checked with regular blood tests.
- Patients must get urgent medical help for fever, breathing difficulty, severe dizziness, new confusion or unusual bleeding during or shortly after an infusion.
Precautions & Warnings
- Lunsumio is given only as an intravenous infusion by a healthcare provider experienced in managing CRS and neurological toxicity; hospitalisation is recommended around the first full dose for many patients, and it must never be given as a rapid injection.
- Tocilizumab and emergency equipment should be available at each infusion visit.
- Rare but potentially fatal haemophagocytic lymphohistiocytosis has been reported and treatment should be interrupted if suspected.
- Tumour flare can occur in patients with bulky disease.
- Lunsumio may cause fetal harm, so effective contraception is required during treatment and for 3 months after the last dose, and it should be avoided in pregnancy or breastfeeding unless clearly needed.
- Live or live-attenuated vaccines should be avoided before and during treatment because of the effect on the immune system.
- Blood counts, signs of infection and neurological status are checked regularly, and dosing may be delayed, reduced or stopped based on the severity of CRS or neurotoxicity.
Avoid Interactions
- Because CRS caused by Lunsumio releases cytokines that can temporarily reduce the liver enzyme (CYP450) activity that clears many other medicines, blood levels of narrow-therapeutic-index drugs such as certain anticoagulants, anti-seizure medicines or immunosuppressants may rise, particularly around the first dose and during any CRS episode; the treating team monitors for increased effects or toxicity of these medicines.
- Patients should not receive live vaccines while the immune system is suppressed by treatment.
- Corticosteroids, antihistamines and antipyretics may be used before infusions to reduce CRS risk and should be taken exactly as directed.
- Patients should tell their healthcare provider about every prescription medicine, over-the-counter product and supplement they use, since infusion-day medicine timing is individually planned in hospital and should not be changed without medical advice.
References
Frequently Asked Questions
Lunsumio (mosunetuzumab-axgb) treats adults with follicular lymphoma that has come back or not responded after two or more previous treatments. It directs your own T-cells to attack cancerous B-cells and is given by IV infusion in a hospital or cancer centre, never at home.
Lunsumio is given as an intravenous infusion in hospital, never at home. Cycle 1 uses small step-up doses (1 mg, then 2 mg, then 60 mg) to lower cytokine release syndrome risk, then a standard 60 mg or 30 mg dose is given every 3 weeks.
Lunsumio carries a boxed warning for cytokine release syndrome, which can be serious and causes fever, low blood pressure and low oxygen, mainly after the first doses. Other common effects include fatigue, rash, headache, fever, joint pain and low blood counts, plus possible confusion or tremor.
Avoid live vaccines while receiving Lunsumio, since it affects your immune system. Because cytokine release syndrome can change how your body processes other medicines, tell your care team about every drug and supplement you take. Effective contraception is required during and for 3 months after treatment.
Each infusion is given in hospital with close monitoring for cytokine release syndrome, especially after the first two doses of cycle 1, when you may be admitted overnight. Staff check your blood pressure, oxygen and temperature during and after the infusion and have treatment ready if needed.
No. Lunsumio can harm an unborn baby, so it is not used in pregnancy, and anyone who can become pregnant needs effective contraception during treatment and for 3 months after the last dose. Tell your care team before starting if you are pregnant, planning pregnancy, or breastfeeding.
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