TM Owner Janssen
Tecvayli 153mg/1.7ml Injection
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Indications & Clinical Uses
- Tecvayli (teclistamab-cqyv) 153 mg/1.7 mL is a bispecific T-cell engaging antibody that binds BCMA on myeloma cells and CD3 on T-cells, directing the immune system to attack multiple myeloma.
- It is FDA-approved for adults with relapsed or refractory multiple myeloma, either in combination with daratumumab (and hyaluronidase) after at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, or alone after at least four prior lines including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
- Tecvayli is given as a subcutaneous injection, starting with a two-step step-up dosing schedule under close hospital observation, followed by ongoing maintenance doses that may sometimes continue in an outpatient setting once tolerated.
- Manufactured by Janssen Biotech, Tecvayli is available only through the TECVAYLI and TALVEY REMS program at certified healthcare facilities.
Side Effects
- Tecvayli carries a boxed warning for cytokine release syndrome (CRS), which can be life-threatening or fatal, and for neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS); both require the step-up dosing schedule and hospital monitoring to reduce risk.
- Very common effects (20% or more) include CRS itself, low antibody levels (hypogammaglobulinemia), upper respiratory infections, cough, diarrhea, muscle or joint pain, injection-site reactions, fatigue, fever, headache, nausea and low blood counts (lymphopenia, neutropenia, low platelets).
- Report fever, chills, low blood pressure, confusion, difficulty speaking, tremor, unsteadiness or trouble breathing to your care team immediately, as these can signal CRS or neurologic toxicity requiring urgent treatment.
- Serious infections are also more likely because Tecvayli lowers normal antibody levels.
Precautions & Warnings
- Tecvayli is only available through the TECVAYLI and TALVEY REMS program: prescribers, pharmacies and healthcare facilities must be certified, and you are hospitalized for 48 hours after each of the first two step-up doses to monitor for CRS and neurologic toxicity, with tocilizumab kept available for CRS treatment.
- Blood counts, antibody levels and signs of infection are monitored regularly, and vaccination against herpes zoster and other infections is generally recommended before starting.
- Live vaccines should be avoided during treatment.
- Effective contraception is required during treatment and for 5 months after the last dose because of possible harm to a developing fetus; Tecvayli should not be used in pregnancy or while breastfeeding.
- Tecvayli is given only by subcutaneous injection by a healthcare professional and must never be given intravenously or self-injected without specific training and clearance.
Avoid Interactions
- Tell your healthcare provider about all medicines and supplements you take, including any recent or planned vaccinations.
- Because Tecvayli triggers cytokine release, it can temporarily change levels of certain liver enzymes that process other drugs (CYP450 substrates), so medicines with a narrow safety margin, such as warfarin, may need closer monitoring or dose adjustment during and shortly after treatment, especially if CRS occurs.
- Live vaccines should not be given during Tecvayli treatment because of ongoing immune suppression; non-live vaccines, including for herpes zoster, are usually recommended beforehand.
- Other medicines that suppress the immune system may add to infection risk from Tecvayli's effect on antibody levels.
- Tecvayli must not be mixed with other medicines in the same syringe.
References
Frequently Asked Questions
Tecvayli (teclistamab) treats adults with relapsed or refractory multiple myeloma, either combined with daratumumab after one prior treatment line, or alone after at least four prior lines including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody. It directs your immune T-cells to attack myeloma cells.
Tecvayli is given by subcutaneous injection, starting with two small step-up doses given in hospital, each followed by 48 hours of monitoring. After the step-up phase, maintenance doses continue on a set schedule, sometimes in an outpatient clinic once you have tolerated treatment well.
Tecvayli carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity (ICANS), both of which can be life-threatening. Common effects include fever, low antibody levels, infections, cough, diarrhea, fatigue and low blood counts. Report fever, confusion, tremor, trouble speaking or breathing to your care team at once.
Avoid live vaccines during Tecvayli treatment, since it suppresses normal immune function; non-live vaccines, including herpes zoster, are usually given beforehand. Effective contraception is needed during treatment and for 5 months after the last dose, and Tecvayli is not used in pregnancy or while breastfeeding.
You are hospitalized for 48 hours after each of the first two step-up doses because Tecvayli's boxed warning covers cytokine release syndrome and neurologic toxicity, which most often appear early in treatment. Tocilizumab is kept available to treat CRS if it develops during this monitored period.
No. Tecvayli is dispensed only through the TECVAYLI and TALVEY REMS program, so only specially certified prescribers, pharmacies and healthcare facilities can order and administer it. This restriction exists because of the risk of serious cytokine release syndrome and neurologic toxicity described in its boxed warning.
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