Talvey

Talvey (talquetamab-tgvs) injection is an immunotherapy used to treat relapsed or refractory multiple myeloma in adult patients who have already received several prior lines of therapy. Talvey activates the immune system to help fight cancer.

Talvey drug class is a bispecific T-cell engager (BiTE).

Talvey is administered once a week or every 2 weeks as an injection under the skin (subcutaneous injection).

Talvey is FDA-approved to treat adults with:

• Relapsed or refractory multiple myeloma
• Have already received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Talvey FDA approval was granted on August 9, 2023, to Janssen Pharmaceutical Companies of Johnson & Johnson.

Talvey is a bispecific antibody that attaches to myeloma cancer cells and to T cells from the immune system, activating the T cells to attack and kill the cancer cells.

Talvey's mechanism of action is as a bispecific T-cell engager (BiTE) that bridges cancer cells and T cells:

• One arm binds GPRC5D, a protein on the surface of myeloma cells
• The other binds CD3, a protein found on immune cells called T-cells.
• This interaction activates T cells to attack and kill myeloma cells.

Talvey has a boxed warning for Cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.

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”.

Other warnings:

• Oral Toxicity and Weight Loss: Monitor for mouth problems and weight loss. Withhold or permanently discontinue treatment depending on severity.

• Infections: Can cause serious that maybe life-threatening, or lead to death. Monitor for signs and symptoms of infection before and during treatment, any sighns of infection should be treated appropriately. Treatment may be withhold or permanently discontinued based on severity.
• Decreased blood cell counts: Your blood counts will be monitored before and during treatment.
• Skin problems: Skin problems are common during treatment with TALVEY and can also be serious. Tell your healthcare provider if you get skin problems such as skin rash, raised red bumps, or redness of the skin
• Liver problems: Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold or consider permanent discontinuation based on severity.
• Embryo-Fetal Toxicity: This medicine may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

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.

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 effect fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, or 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 the 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. Also, see the Important Information section. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Talvey is given as a subcutaneous injection, with dosing schedules that can be either weekly or biweekly (every two weeks). The treatment begins with a step-up phase to reduce potential side effects:

Step-Up Phase: Patients receive incremental doses to allow the body to adjust to the medication.

Treatment Phase: Following the step-up phase, the maintenance dose is administered either weekly or twice weekly.

General administration information

• 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 reactions. 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.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect talquetamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

HCPs and patients often use the Talvey Package Insert for more detailed information about this medicine. The Prescribing Information is more comprehensive, with greater detail on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the Prescribing Information or the FDA label

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