Talvey
Generic name: Talquetamab-tgvs
Dosage form: injection, for subcutaneous use
Drug class:
Miscellaneous antineoplastics
Usage of Talvey
Talvey (talquetamab-tgvs) is used to treat adults with multiple myeloma, a cancer of the bone marrow. Talvey is a T-cell engager that works by attaching to myeloma cancer cells and the immune system (T cells), which activates the immune system to kill multiple myeloma cells. Talvey is a bispecific GPRC5D-directed CD3 T-cell engager, which means that it targets GPRC5D on myeloma cells and CD3 on the surface of T cells.
Talvey is used when cancer has not responded to treatment (refractory) or has come back after treatment (relapsed). Talvey is FDA-approved to be used by patients who have already received at least 4 different treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody to treat their multiple myeloma, AND their cancer has come back or did not respond to prior treatments.
Talvey received FDA approval on August 9, 2023, for the Janssen Pharmaceutical Companies of Johnson & Johnson.
Talvey side effects
Also, see the Important Information section.
Common Talvey side effects may include:
Serious Talvey side effects
Get emergency medical help if you have signs of an allergic Reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effects fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
Talvey may cause other serious side effects. Call your doctor at once if you have:
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking Talvey
Before you receive Talvey, tell your healthcare provider about all of your medical conditions, including if you:
Females and Pregnancy
Tell your healthcare provider if you are pregnant or plan to become pregnant. Talquetamab-tgvs may harm your unborn baby. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with Talvey.
Females who are able to become pregnant:
Breastfeeding
Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Talvey passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of Talvey.
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How to use Talvey
Talvey is given weekly or every 2 weeks. Your healthcare provider will decide the number of days to wait between your doses of this medicine as well as how many treatments you will receive.
If your dose is delayed for any reason, you may need to repeat the “step-up dosing schedule” to receive Talvey. Before each “step up” dose, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses. Your healthcare provider will monitor you for signs and symptoms of CRS, neurologic problems, as well as other side effects and treat you as needed.
Warnings
Talvey is available only through the Tecvayli and Talvey Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.
You will receive a Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.
Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital. If you have any questions about this medicine, ask your healthcare provider. Your healthcare provider may temporarily stop or completely stop your treatment if you develop CRS, neurologic problems or any other side effects that are severe.
Talvey may cause side effects that are serious, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and neurologic problems.
Call your healthcare provider or get medical help right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment with this medicine:
Cytokine Release Syndrome (CRS)
CRS is common during treatment with this medicine and can also be serious or life-threatening. Signs and symptoms of CRS may include:
Neurologic problems
Symptoms of neurologic problems with Talvey may include:
Due to the risk of CRS and neurologic problems, you should be hospitalized for 48 hours after all doses of Talvey that are part of the “step-up dosing schedule”. The “step-up dosing schedule” is when you receive the first 2 or 3 doses, which are smaller “step-up” doses, and also the first full “treatment dose”.
Disclaimer
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