teclistamab
Tecvayli · ATC code L01FX24
Also known as: Teklistamab
- Key facts
- Active substance
- teclistamab
- ATC code
- L01FX24
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- TECVAYLI 10 mg/mL solution for injection / TECVAYLI 90 mg/mL solution for injection
- Marketing authorisation holder
- 1377
- Information as of
- 2026-10-28
Key facts
Teclistamab (Tecvayli) is a bispecific BCMA × CD3 antibody that redirects T cells against myeloma cells and is used in relapsed or refractory multiple myeloma.
What it is used for
- In combination with daratumumab for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.
- As monotherapy for adults with relapsed and refractory multiple myeloma after at least three prior therapies (immunomodulatory agent, proteasome inhibitor, anti-CD38 antibody) with progression on the last therapy.
Dosing
- Subcutaneous, based on actual body weight; always start with step-up doses (0.06 mg/kg, then 0.3 mg/kg) with pre-treatment (corticosteroid, antihistamine, antipyretic) before each step-up dose.
- Monotherapy: then 1.5 mg/kg weekly; after a complete response or better for at least 6 months, 1.5 mg/kg every two weeks may be considered.
- With daratumumab: step-up on Days 2 and 4, first treatment dose 1.5 mg/kg on Day 8, weekly in Weeks 3 to 8, then 3 mg/kg every two weeks (Weeks 9 to 24) and every four weeks from Week 25.
- After each step-up dose, stay near a healthcare facility and be monitored daily for 48 hours; do not start during active infection.
- No dose adjustment in the elderly or mild to moderate renal impairment; for restarting after dose delays see the full text.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Cytokine release syndrome (CRS), including life-threatening or fatal reactions (fever, hypoxia, hypotension, tachycardia); step-up dosing and pre-treatment reduce the risk.
- Neurologic toxicity including ICANS; withhold or discontinue by grade.
- Serious and fatal infections and hypogammaglobulinaemia; do not start during active infection.
- Neutropenia including febrile neutropenia; monitor blood counts.
Side effects
- Most frequent: hypogammaglobulinaemia, neutropenia, CRS, upper respiratory tract infection, musculoskeletal pain, diarrhoea, anaemia, cough, fatigue, injection site reaction, thrombocytopenia, pneumonia, COVID-19.
- Serious reactions in 65%, including pneumonia (22%), COVID-19 (14%), CRS (11%), sepsis (6%) and febrile neutropenia (3.1%).
Interactions
- Initial cytokine release may suppress CYP450 enzymes; monitor narrow-therapeutic-index CYP450 substrates (e.g. ciclosporin) up to 7 days after the first treatment dose and during CRS.
Pregnancy and breastfeeding
- Verify pregnancy status before starting; women use effective contraception during treatment and for five months after the final dose.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Tecvayli1377 · EMEA/H/C/005865
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Tecvayli
- Liechtenstein
- Tecvayli
- Norway
- Tecvayli
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Tecvayli – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.