Talvey

Generic name: talquetamab-tgvs
Dosage form: injection, for subcutaneous use
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Nov 6, 2023.

What is 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.

Talquetamab side effects

Also, see the Important Information section.

Common Talvey side effects may include:

• changes in your sense of taste;

• trouble swallowing, dry mouth;

• diarrhea, weight loss;

• muscle or joint pain;

• feeling very tired;

• problems with your fingernails or toenails;

• dry skin and mucous membranes; or

• fever, nose, sinuses or throat infection.

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:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• pain or burning when you urinate;

• pale skin, easy bruising, unusual bleeding; or

• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Talvey may cause other serious side effects. Call your doctor at once if you have:

• mouth problems or weight loss;

• rash, skin redness, or red bumps;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, pale skin, cold hands, and feet, feeling light-headed or short of breath;

• neurological problems - headache, jerking muscle movements, rigid muscles, feeling restless, numbness and tingling, confusion, problems speaking, muscle spasms, tremors, double vision, changes in handwriting, problems walking, muscle weakness in body or face, hearing loss, burning, throbbing, or stabbing pain; or

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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.

Related/similar drugs

Abecma, Tecvayli, Revlimid, Darzalex, Velcade, Pomalyst, Kyprolis

Important information

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:

• fever (100.4°F or higher)
• dizziness or lightheadedness
• chills
• difficulty breathing
• feeling anxious
• headache
• fast heartbeat

Neurologic problems

Symptoms of neurologic problems with Talvey may include:

• headache
• feeling confused
• being less alert or aware
• feeling disoriented
• trouble speaking or writing
• shaking (tremors)
• numbness and tingling (feeling like “pins and needles”)
• feeling sleepy
• feeling very sleepy with low energy
• slow or difficulty thinking
• seizures
• muscle weakness
• memory loss
• burning, throbbing, or stabbing pain

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”.

Talvey Dosing Information

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 you receive your dose, “Step-up dose 1” is given on day 1 of treatment. “Step-up dose 2” is usually given on day 4 of treatment. The first “treatment dose” is usually given on day 7 of treatment.
• If you receive your dose every 2 weeks, “Step-up dose 1” is given on day 1 of treatment. “Step-up dose 2” is usually given on day 4 of treatment. “Step-up dose 3” is usually given on day 7 of treatment. The first “treatment dose” is usually given on day 10 of treatment.

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.

Before Taking Talvey

Before you receive Talvey, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection

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:

• Your healthcare provider should do a pregnancy test before you start treatment with Talvey.
• You should use effective birth control (contraception) during treatment and for 3 months after your last dose of Talvey.

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.

How will I receive Talvey?

• Talvey will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in the stomach area (abdomen). Talvey may also be injected into your thigh or another area of your body.
• You will need to stay in the hospital for 48 hours after some doses of talquetamab. Talk with your doctor if you have any questions.

• You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.

• Your treatment with Talvey may be temporarily or permanently discontinued if you have certain side effects.

• You will need medical tests before and during treatment with this medicine.

• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Precautions

Do not drive, operate heavy machinery, or do other dangerous activities during and for 48 hours after your Talvey “step-up dose” is completed or at any time during treatment with Talvey, if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

Ingredients

Active ingredient: talquetamab-tgvs
Inactive ingredients: edetate disodium, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, and Water for Injection, USP.

Manufacturer

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer