TM Owner Celltrion
Truxima 100mg/10ml Injection
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Indications & Clinical Uses
- Truxima (rituximab-abbs) is a monoclonal antibody biosimilar used to treat several conditions in adults.
- It is approved for non-Hodgkin's lymphoma (NHL) of various types, chronic lymphocytic leukemia (CLL) combined with chemotherapy, and rheumatoid arthritis that has not responded to TNF antagonist therapy.
- Truxima is also used for granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and moderate to severe pemphigus vulgaris.
- All indications require intravenous infusion by trained healthcare professionals in a clinical or hospital setting.
Side Effects
- Infusion-related reactions are very common, occurring during or shortly after the first infusion, with symptoms including fever, chills, hypotension, bronchospasm, and chest discomfort.
- Blood cell reductions (lymphopenia, neutropenia) and increased infections (bacterial, viral, fungal) are frequent.
- Upper respiratory tract infections and urinary tract infections commonly occur.
- Nausea and fatigue are reported by many patients.
- Serious mucocutaneous reactions including Stevens-Johnson syndrome are rare but potentially fatal.
- Seek immediate medical attention for severe reactions, persistent fever, or unusual bleeding or bruising.
Precautions & Warnings
- BOXED WARNING—Fatal infusion reactions can occur, particularly with the first infusion.
- Approximately 80% of fatal reactions occur during initial treatment.
- Must be administered intravenously only by trained healthcare professionals with resuscitation equipment available.
- Screen for hepatitis B infection before starting; reactivation can cause fulminant hepatitis and liver failure.
- Avoid live virus vaccines during and for 12 months after treatment.
- May cause fetal harm; women of childbearing age should use contraception.
- Monitor blood counts regularly.
- Patients with severe active infections should not receive Truxima.
- Risk of progressive multifocal leukoencephalopathy (PML), a fatal brain infection.
Avoid Interactions
- DO NOT give live virus vaccines (including measles, mumps, rubella, varicella, and live influenza vaccines) during treatment or for 12 months after due to risk of vaccine-strain infection.
- Inactivated vaccines may be less effective; consult your doctor about vaccination timing.
- Other immunosuppressive medications increase infection risk.
- Cisplatin and other chemotherapy agents increase toxicity when combined.
- Tell your healthcare provider about all medications, supplements, and recent infections before starting Truxima.
- No direct drug interactions with common outpatient medications, but immune function is significantly compromised during treatment.
References
Frequently Asked Questions
Truxima (rituximab biosimilar) treats certain blood cancers and autoimmune diseases in adults. It is used for non-Hodgkin's lymphoma, chronic lymphocytic leukemia with chemotherapy, rheumatoid arthritis unresponsive to TNF drugs, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris. All treatments require intravenous infusion in a hospital or clinic setting.
Truxima is given by intravenous infusion only, never by injection or mouth. A healthcare professional administers it in a hospital or outpatient clinic with resuscitation equipment present. The first infusion often takes several hours. Subsequent infusions may take less time if the first was well-tolerated.
Infusion reactions (fever, chills, low blood pressure, difficulty breathing) are very common, especially during the first infusion and can be fatal in rare cases. Blood cell counts drop significantly, increasing infection risk. Severe skin reactions, liver reactivation (if hepatitis B positive), and fatal brain infection (PML) are rare but serious. Report any signs immediately.
Avoid live vaccines (measles, mumps, rubella, chickenpox) during treatment and for 12 months after, as they can cause severe infection. Tell your doctor about hepatitis B, active infections, or pregnancy. Other immunosuppressive drugs increase infection risk. Use reliable contraception if able to become pregnant.
The infusion takes place in a clinic with monitoring equipment and trained staff. Vital signs are checked regularly. The first infusion typically takes several hours; later ones may be shorter if tolerated well. You will be observed for at least one hour after treatment to watch for delayed reactions.
Truxima is a biosimilar (rituximab-abbs), meaning it is highly similar to the original rituximab (Rituxan) but made in a different way. It is approved as interchangeable with the reference product, so it can be used in the same situations. Efficacy and safety are equivalent to the original product.
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