Company: Takeda Products Ireland Ltd.
Legal category: Prescription. Hospital. Sport permitted.
Active ingredient: Brentuximab vedotin 50mg.
Description: Powder for concentrate for solution for infusion.
Presentation: 50mg per vial, price available on request.
Indications: Treatment of adults with relapsed or refractory CD30+ Hodgkin lymphoma following 1) autologous stem cell transplant (ASCT), or 2) at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Treatment of adults with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Pharmacology: Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers an anti-neoplastic agent selectively to CD30-expressing tumour cells resulting in apoptotic death. Binding of ADC to CD30 on the cell surface initiates internalisation of the ADC-CD30 complex, which then traffics to the lysosomal compartment. Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.
Dosage: Adult: Administer 1.8mg/kg as an intravenous infusion over 30 minutes every 3 weeks. If patient’s weight is more than 100kg, dose calculation should use 100kg. If stable disease or better is achieved, patients should receive minimum 8 cycles and up to a maximum of 16 cycles. Premedicate with paracetamol, antihistamine and a corticosteroid if prior infusion-related reactions have occurred. Adjust dose if neutropenia or peripheral neuropathy occurs; see SPC. Elderly: Over 65 years, safety and efficacy not established. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy, lactation.
Special precautions: Monitor patient before (including complete blood counts) and after infusion. Continue treatment until disease progression or unacceptable toxicity. Progressive multifocal leukoencephalopathy (PML) reported after multiple prior chemotherapy treatments; monitor closely for symptoms suggestive of PML (e.g. cognitive, neurological, or behavioural symptoms). Monitor carefully for serious infections (e.g. pneumonia, staphylococcal bacteraemia, herpes zoster) and opportunistic infections (Pneumocystis jiroveci pneumonia, oral candidiasis). Discontinue immediately and permanently if anaphylactic reactions occur. Interrupt if infusion-related reactions occur; restart at slower rate after symptom resolution. Reported: Peripheral neuropathy (may require delay and dose reduction or discontinuation), Steven-Johnson syndrome (discontinue), hyperglycaemia (monitor serum glucose closely), tumour lysis syndrome, febrile neutropenia. Renal/hepatic impairment (limited experience). Grade 3 or 4 anaemia, thrombocytopenia, and prolonged Grade 3 or 4 neutropenia may occur. Women of childbearing potential should use two methods of effective contraception during and until 30 days after treatment. Men should have sperm samples frozen and stored before treatment, and should not father a child during and for up to 6 months following treatment. Driving/using machines. Contains sodium.
Drug interactions: Contra: Bleomycin. Caution: Strong CYP3A4 and P-glycoprotein inhibitors (e.g. ketoconazole). Rifampicin.
Adverse drug reactions: Infections (including upper RTI, herpes zoster, pneumonia), neutropenia, anaemia, thrombocytopenia, hyperglycaemia, peripheral sensory neuropathy, peripheral motor neuropathy, dizziness, demyelinating polyneuropathy, cough, dyspnoea, GI upset, alopecia, pruritus, rash, myalgia, arthralgia, back pain, fatigue, pyrexia, infusion-related reactions, chills.
Full prescribing information and references available from Takeda Products Ireland Ltd. Telephone (01) 6420021 or 1800 937 970.