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Talvey
Talquetamab‑tgvs
$975.00
3mg · 1 vial
BrandBranded medicine· By Janssen
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3mg
40mg
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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity
Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life threatening or fatal reactions, can occur with TALVEY. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue TALVEY based on severity
Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS)
Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur in patients receiving TALVEY. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold or permanently discontinue TALVEY based on severity.
About Talvey
Overview
Talvey (talquetamab-tgvs) is a prescription antibody medicine given as an injection under the skin. It treats adults with multiple myeloma that has returned or has not responded to treatment after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. It works by binding to CD3 on immune T cells and GPRC5D on myeloma cells, helping T cells target the myeloma cells. Its FDA accelerated approval is based on response rates and how long responses lasted; continued approval may depend on confirmatory trials verifying clinical benefit.
What it treats
- Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This use has accelerated FDA approval based on response rate and how long responses lasted; continued approval may depend on confirmation of clinical benefit in further trials.
Safety information
Side effects
Common side effects include fever, cytokine release syndrome (CRS), changes in taste, nail changes, muscle and joint pain, skin problems or rash, tiredness, weight loss, dry mouth, dry skin, difficulty swallowing, upper respiratory tract infections, diarrhea, low blood pressure and headache. Serious side effects that warrant contacting a doctor include CRS, effects on the nervous system including immune effector cell-associated neurotoxicity syndrome (ICANS), mouth problems and weight loss, infections, low blood cell counts, skin reactions and liver damage. Infections can be life-threatening or fatal. Contact your doctor if you develop signs of infection, a worsening rash, mouth problems, difficulty swallowing or weight loss. Severe decreases in lymphocytes, neutrophils, white blood cells and hemoglobin can occur. Blood counts and liver blood tests need monitoring during treatment. Your prescriber may pause or permanently stop treatment depending on the severity of side effects. Talvey may harm an unborn baby. People who can become pregnant should use effective contraception.
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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity
Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life threatening or fatal reactions, can occur with TALVEY. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue TALVEY based on severity
Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS)
Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur in patients receiving TALVEY. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold or permanently discontinue TALVEY based on severity.
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.
Before taking this medicine
The FDA label lists no contraindications for Talvey. Talvey requires monitoring for mouth-related side effects, weight loss, infections, low blood cell counts, skin reactions including worsening rash, and liver injury. Infections can be serious, life-threatening or fatal. Blood counts, liver enzymes and bilirubin should be checked as directed by the treating clinician. Some side effects may require treatment to be paused or permanently stopped, depending on severity. Talvey may harm an unborn baby. Women who could become pregnant should use effective contraception. Do not breastfeed during treatment.
Interactions
Talvey may increase blood levels of certain medicines broken down by liver enzymes called CYP enzymes. For some medicines, even small increases can cause serious side effects. Tell your doctor about all medicines you take; they may need to monitor drug levels or signs of toxicity. This interaction is more likely when Talvey treatment begins, through 14 days after the first treatment dose, and during and after cytokine release syndrome (CRS).
Using Talvey
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 TALVEY (TALQUETAMAB) INJECTION [JANSSEN BIOTECH, INC.] (DailyMed, retrieved 19 September 2026).
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