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Tecvayli
Teclistamab‑cqyv
$1560.00
10mg/ml · 1 vial
BrandBranded medicine· By Janssen
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10mg/ml
153mg
FDA boxed warningCytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity.
Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS.
TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).
About Tecvayli
Overview
Tecvayli (teclistamab-cqyv) is a prescription antibody medicine given by injection under the skin to adults with multiple myeloma that has returned or has not responded to treatment. It is used with daratumumab and hyaluronidase-fihj after at least one prior line of treatment that included a proteasome inhibitor and an immunomodulatory medicine. It can also be used alone after at least four prior lines of treatment that included a proteasome inhibitor, an immunomodulatory medicine and an anti-CD38 antibody. It works by binding to T-cells and a protein called BCMA on myeloma cells, helping activate T-cells to destroy myeloma cells.
What it treats
Tecvayli is used to treat adults with multiple myeloma that has returned or has not responded to treatment: - In combination with daratumumab and hyaluronidase-fihj after at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. - On its own after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Safety information
Side effects
Common side effects of Tecvayli used alone include fever, cytokine release syndrome, muscle or bone pain, injection-site reactions, tiredness, upper respiratory tract infections, nausea, headache, pneumonia and diarrhea. When used with daratumumab and hyaluronidase-fihj, common side effects also include low antibody levels, cough, COVID-19, gastroenteritis and weight loss. Serious side effects that warrant prompt contact with your doctor include cytokine release syndrome, nervous system toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS), liver damage, infections and allergic or other administration-related reactions. Liver damage and infections can be life-threatening or fatal. Pneumonia is among the commonly reported infections. Severe blood-test abnormalities can include low levels of white blood cells, including lymphocytes and neutrophils, as well as low hemoglobin and platelets. Your doctor will monitor blood counts and liver tests and may pause or permanently stop treatment depending on the severity of side effects. Tecvayli may harm an unborn baby. If you could become pregnant, use effective contraception and contact your doctor if you become pregnant during treatment.
FDA boxed warning
Cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity.
Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS.
TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Interactions
Tecvayli can trigger the release of cytokines, which may slow how certain liver enzymes break down other medicines. This can raise levels of those medicines and increase the risk of side effects. The interaction risk is highest when Tecvayli treatment begins, through 7 days after the first treatment dose, and during and after cytokine release syndrome (CRS). Tell your doctor about all medicines you take. For medicines where even a small rise in blood levels could cause serious side effects, your doctor may monitor blood levels or signs of toxicity and adjust the other medicine if needed.
Using Tecvayli
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label TECVAYLI (TECLISTAMAB-CQYV) INJECTION [JANSSEN BIOTECH, INC.] (DailyMed, retrieved 19 September 2026).
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