TALVEY: Uses, Dosage & Side Effects
A bispecific T-cell engager antibody targeting GPRC5D for the treatment of relapsed or refractory multiple myeloma in adults who have received at least three prior lines of therapy
TALVEY (talquetamab) is a first-in-class bispecific antibody that redirects the body's T cells to attack multiple myeloma cancer cells by simultaneously binding to GPRC5D on tumor cells and CD3 on T cells. It is approved for adults with relapsed or refractory multiple myeloma who have received at least three prior therapies. This guide covers uses, dosing, side effects, interactions, and important safety information based on current international guidelines.
Quick Facts
Key Takeaways
- TALVEY is a bispecific antibody that bridges T cells and GPRC5D-expressing myeloma cells, enabling immune-mediated tumor killing in heavily pretreated multiple myeloma patients.
- It is administered by subcutaneous injection with a step-up dosing schedule to minimize cytokine release syndrome (CRS), followed by weekly (0.4 mg/kg) or biweekly (0.8 mg/kg) maintenance dosing.
- Common side effects include CRS, skin and nail changes, taste alterations, dry mouth, infections, and low blood cell counts, which require close monitoring by healthcare professionals.
- Patients must be monitored at a healthcare facility for at least 48 hours after each step-up dose due to the risk of serious immune reactions.
- Live vaccines must be avoided from at least 4 weeks before treatment to at least 4 weeks after the last dose, and women of childbearing potential must use effective contraception during and for 3 months after treatment.
What Is TALVEY and What Is It Used For?
TALVEY is a cancer medicine containing the active substance talquetamab. Talquetamab is a bispecific antibody, a type of protein engineered to recognize and bind to two specific targets in the body simultaneously. It has been designed to bind to GPRC5D (G protein-coupled receptor class C group 5 member D), a protein found on multiple myeloma cancer cells, and to CD3 (cluster of differentiation 3), a protein found on T cells. T cells are a type of white blood cell that forms part of the body's natural immune defense system and can destroy cancer cells when properly directed.
When TALVEY binds to both of these targets, it physically bridges the myeloma cancer cells and the T cells, bringing them into close proximity. This contact activates the T cells and enables them to release cytotoxic molecules, including perforin and granzymes, which directly destroy the GPRC5D-expressing myeloma cells. This mechanism of action is often described as "redirected T-cell cytotoxicity" and represents a novel approach to treating multiple myeloma.
GPRC5D is a protein that is highly expressed on the surface of multiple myeloma cells but has limited expression on normal tissues, primarily in the hair follicles and some skin structures. This relative selectivity for tumor cells is what makes GPRC5D an attractive therapeutic target, though the expression on normal tissues does explain some of the characteristic side effects observed with TALVEY treatment, including skin, nail, and taste changes.
TALVEY is approved for the treatment of adults with multiple myeloma, a cancer of the plasma cells in the bone marrow. It is specifically indicated for patients whose disease has relapsed or is refractory (resistant) after having received at least three prior types of treatment that have either stopped working or did not work at all. These prior treatments typically include an immunomodulatory agent (such as lenalidomide), a proteasome inhibitor (such as bortezomib), and an anti-CD38 monoclonal antibody (such as daratumumab). Patients eligible for TALVEY represent a heavily pretreated population with limited remaining therapeutic options.
What Should You Know Before Taking TALVEY?
Contraindications
TALVEY must not be given to patients who are allergic (hypersensitive) to talquetamab or to any of the other ingredients in the formulation, including disodium edetate, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose, and water for injections. If you have previously experienced an allergic reaction to any of these substances, inform your healthcare provider before treatment begins.
Warnings and Precautions
There are several serious side effects that may occur after starting TALVEY treatment. You must immediately inform your doctor or nurse if any of these develop, as they may require urgent medical attention.
Before you receive TALVEY, your doctor will check your blood to assess levels of different blood cells and to test for signs of infection. Any active infections will be treated before starting this medicine. After each dose, your doctor will monitor you for side effects and will regularly check your blood counts, since the number of white blood cells, red blood cells, and platelets can decrease during treatment.
Vaccines and TALVEY
Tell your doctor or nurse before receiving TALVEY if you have recently had a vaccination or are scheduled to receive one. Your immune system may not respond as well to vaccines while you are taking this medicine. You should not receive live vaccines, a particular type of vaccine, from at least 4 weeks before starting TALVEY treatment until at least 4 weeks after your last dose. Inactivated vaccines may still be administered but their effectiveness may be reduced.
Pregnancy and Breastfeeding
TALVEY may potentially be transferred from the mother to the developing fetus. The effects of talquetamab on fetal development are unknown, and a risk to newborns and infants cannot be excluded. If you are pregnant, think you may be pregnant, or are planning to become pregnant, seek advice from your doctor or nurse before receiving this medicine.
If you become pregnant during treatment, you must immediately inform your doctor or nurse. Women of childbearing potential must use effective contraception during treatment and for 3 months after the last dose of TALVEY. Your doctor will check for pregnancy before starting treatment.
If your partner becomes pregnant while you are receiving TALVEY, you must also immediately inform your doctor. If TALVEY has been administered during pregnancy, live vaccinations for the newborn should be postponed until the baby is at least 4 weeks old.
It is not known whether talquetamab passes into breast milk. There may be a risk to breastfed newborns and infants. Discuss the risks and benefits with your doctor before starting treatment. If you and your doctor decide to discontinue treatment, you should not breastfeed for 3 months after the last dose.
Children and Adolescents
TALVEY should not be used in children and adolescents under 18 years of age because the medicine has not been studied in this age group and it is not known how it would affect them.
Driving and Using Machines
Some people may feel tired, dizzy, or confused when taking TALVEY. You should not drive, use tools, or operate machinery from the time you receive your first dose until at least 48 hours after your first treatment dose, or as directed by your doctor. If you experience neurological symptoms at any time during treatment, avoid driving and operating machinery until symptoms resolve.
How Does TALVEY Interact with Other Drugs?
Tell your doctor or nurse about all medicines you are currently taking, have recently taken, or might take. This includes non-prescription medicines and herbal remedies. While talquetamab is not extensively metabolized by cytochrome P450 enzymes, the release of cytokines during CRS episodes can potentially affect the metabolism of drugs that are CYP450 substrates. This is a class effect observed with T-cell engaging therapies and is most relevant during the initial step-up dosing period.
| Interacting Drug/Class | Severity | Effect | Recommendation |
|---|---|---|---|
| Live vaccines | Major | Immune suppression may lead to uncontrolled infection from live vaccine strains | Avoid from 4 weeks before to 4 weeks after last dose |
| CYP450 substrates with narrow therapeutic index (e.g., warfarin, cyclosporine) | Moderate | CRS-induced cytokines may alter CYP450 enzyme activity, changing drug levels | Monitor levels closely during step-up dosing; adjust doses as needed |
| Inactivated vaccines | Minor | Reduced immune response to vaccination | May be given but effectiveness may be reduced; discuss timing with doctor |
| Other immunosuppressive agents | Moderate | Additive immunosuppression increasing infection risk | Monitor for infections; consider prophylactic antimicrobials |
Because TALVEY affects T-cell function and can cause significant immunosuppression (particularly through lymphopenia and hypogammaglobulinemia), the concurrent use of other immunosuppressive therapies should be carefully considered. Patients receiving TALVEY are at increased risk of infections, and the addition of further immunosuppressive agents may compound this risk. Pre-medications given before step-up doses, including corticosteroids, antihistamines, and acetaminophen, are considered part of the standard treatment protocol and are not classified as problematic interactions.
What Is the Correct Dosage of TALVEY?
TALVEY will be given to you under the supervision of a doctor experienced in treating patients with multiple myeloma. Your doctor will determine the appropriate dose based on your body weight. TALVEY is administered as a subcutaneous injection (under the skin), typically in the abdomen (preferred site) or thigh.
Weekly Dosing Schedule (0.4 mg/kg)
Step-Up Phase
- Step-up Dose 1: 0.01 mg/kg on Day 1
- Step-up Dose 2: 0.06 mg/kg given 2-4 days after Dose 1
- First Treatment Dose: 0.4 mg/kg given 2-4 days after Dose 2
Maintenance Phase
After the third dose, the treatment dose of 0.4 mg/kg is given once weekly. Treatment continues for as long as the patient is benefiting from TALVEY.
Biweekly Dosing Schedule (0.8 mg/kg)
Step-Up Phase
- Step-up Dose 1: 0.01 mg/kg on Day 1
- Step-up Dose 2: 0.06 mg/kg given 2-4 days after Dose 1
- Step-up Dose 3: 0.4 mg/kg given 2-4 days after Dose 2
- First Treatment Dose: 0.8 mg/kg given 2-4 days after Dose 3
Maintenance Phase
After the fourth dose, the treatment dose of 0.8 mg/kg is given once every two weeks. Treatment continues for as long as the patient is benefiting from TALVEY.
| Dose | Weekly Schedule | Biweekly Schedule | Monitoring |
|---|---|---|---|
| Step-up 1 | 0.01 mg/kg | 0.01 mg/kg | 48-hour observation |
| Step-up 2 | 0.06 mg/kg | 0.06 mg/kg | 48-hour observation |
| Step-up 3 | 0.4 mg/kg (treatment dose) | 0.4 mg/kg | 48-hour observation |
| Step-up 4 | N/A | 0.8 mg/kg (treatment dose) | 48-hour observation |
| Maintenance | 0.4 mg/kg weekly | 0.8 mg/kg every 2 weeks | Regular blood tests |
Pre-Medications
Before receiving the step-up doses (the first three doses for the weekly schedule, or the first four doses for the biweekly schedule), you will receive pre-medications to help reduce the risk of side effects. These typically include:
- Antihistamines to reduce the risk of allergic reactions
- Corticosteroids (such as dexamethasone) to reduce inflammation
- Antipyretics (such as acetaminophen/paracetamol) to reduce fever
You may also receive these medications with later doses depending on your symptoms and medical history.
Missed Dose
It is very important that you attend all appointments for your treatment to work properly. If you miss a scheduled appointment, contact your healthcare team as soon as possible to reschedule. Your doctor will determine the appropriate timing for your next dose based on how long since your last injection.
Overdose
TALVEY is administered by a doctor or nurse in a clinical setting, which makes accidental overdose unlikely. If an overdose does occur, your healthcare team will monitor you for signs and symptoms of side effects and provide appropriate supportive treatment. There is no specific antidote for talquetamab overdose.
What Are the Side Effects of TALVEY?
Like all medicines, TALVEY can cause side effects, although not everybody gets them. Some side effects can be serious and potentially life-threatening, so it is essential to seek immediate medical attention if you experience the serious symptoms described below.
Very Common
May affect more than 1 in 10 people
- Cytokine release syndrome (CRS) – fever, low blood pressure, chills, breathing difficulty
- Immune effector cell-associated neurotoxicity syndrome (ICANS) – confusion, disorientation, drowsiness
- Nail problems (nail dystrophy, discoloration, ridging)
- Musculoskeletal pain (muscle and bone pain)
- Anemia (low red blood cell count)
- Fatigue and tiredness
- Chills
- Weight loss
- Dry skin and mucous membranes (xerosis)
- Lymphopenia (low lymphocyte count)
- Motor dysfunction (movement difficulties)
- Dizziness
- Sensory neuropathy (tingling, numbness, pain)
- Encephalopathy (brain function changes)
- Diarrhea
- Nausea
- Constipation
- Abdominal pain
- Vomiting
- Upper respiratory tract infections
- Itching (pruritus)
- Decreased appetite
- Pain
- Leukopenia (low white blood cell count)
- Hypokalemia (low potassium levels)
- Hypophosphatemia (low phosphate levels)
- Hypomagnesemia (low magnesium levels)
- Hypogammaglobulinemia (low antibody levels)
- Edema (swelling due to fluid retention)
- Injection site reactions
- Elevated liver enzyme levels
- COVID-19 infection
- Coagulation changes (decreased fibrinogen, prolonged INR and PTT)
- Bacterial infections
- Oral pain
- Fungal infections
- Fever (pyrexia)
- Headache
- Shortness of breath (dyspnea)
- Cough
- Taste changes (dysgeusia), dry mouth, difficulty swallowing (dysphagia), mouth inflammation (stomatitis)
- Skin problems including rash
- Neutropenia (low neutrophil count)
- Thrombocytopenia (low platelet count)
Common
May affect up to 1 in 10 people
- Hair loss (alopecia)
- Bleeding events (which may be serious)
- Pneumonia (lung infection)
- Viral infections
- Sepsis (blood poisoning)
- Febrile neutropenia (low neutrophils with fever)
- Hand-foot syndrome (palmar-plantar erythrodysesthesia)
Uncommon
May affect up to 1 in 100 people
- Inability to coordinate muscle movements (ataxia)
The side effect profile of TALVEY reflects its dual mechanism of action. The activation of T cells can lead to immune-mediated effects such as CRS and ICANS, while the targeting of GPRC5D on normal tissues accounts for the dermatological, oral, and taste-related side effects. These on-target, off-tumor effects are generally manageable and tend to stabilize during continued treatment, though they can significantly impact quality of life for some patients.
Your healthcare team will regularly monitor your blood counts, liver function, and electrolyte levels throughout treatment. Low blood cell counts (neutropenia, lymphopenia, anemia, and thrombocytopenia) are very common and may increase the risk of infections and bleeding. Immunoglobulin replacement therapy may be considered for patients with severe hypogammaglobulinemia and recurrent infections.
How Should You Store TALVEY?
TALVEY is stored at the hospital or clinic by your healthcare team. The following storage information ensures the medicine remains safe and effective:
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F)
- Do not freeze the solution
- Keep in the original packaging to protect from light
- Before use, allow the vial to reach room temperature (15°C to 30°C) for at least 15 minutes. Do not warm by any other method
- Once at room temperature, gently swirl the vial for about 10 seconds. Do not shake
- Inspect the solution before use – it should be colorless to light yellow. Do not use if the solution is cloudy, discolored, or contains visible particles
Do not use TALVEY after the expiry date stated on the carton and vial label after "EXP." The expiry date refers to the last day of the stated month. Any unused medicine should be disposed of in accordance with local environmental requirements.
What Does TALVEY Contain?
The active substance in TALVEY is talquetamab, a bispecific humanized IgG4-PAA antibody. TALVEY is available in two different concentrations to accommodate the step-up dosing schedule and maintenance therapy:
| Formulation | Concentration | Vial Content | Primary Use |
|---|---|---|---|
| TALVEY 2 mg/mL | 2 mg/mL | 3 mg in 1.5 mL | Step-up doses (0.01 and 0.06 mg/kg) |
| TALVEY 40 mg/mL | 40 mg/mL | 40 mg in 1 mL | Treatment doses (0.4 and 0.8 mg/kg) |
The other (inactive) ingredients are:
- Disodium edetate (EDTA dihydrate)
- Glacial acetic acid (E260)
- Polysorbate 20 (E432) – 0.4 mg/mL; polysorbates may cause allergic reactions in some people
- Sodium acetate trihydrate
- Sucrose
- Water for injections
TALVEY contains less than 1 mmol (23 mg) sodium per dose, meaning it is essentially sodium-free.
TALVEY is a colorless to light yellow solution for injection supplied in a carton containing 1 glass vial. The two concentrations should not be mixed or combined to achieve the required dose. Each injection volume must not exceed 2.0 mL; doses requiring more than 2.0 mL should be divided equally into multiple syringes. The medicine is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe materials.
The marketing authorization holder for TALVEY is Janssen-Cilag International NV, Beerse, Belgium. It is manufactured by Janssen Biologics B.V. in Leiden, Netherlands, and Janssen Pharmaceutica NV in Beerse, Belgium.
Frequently Asked Questions About TALVEY
TALVEY (talquetamab) is a bispecific antibody used to treat adults with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. It works by redirecting T cells to destroy GPRC5D-expressing myeloma cells.
TALVEY is given as a subcutaneous (under the skin) injection, typically in the abdomen or thigh, by a healthcare professional in a clinical setting. Treatment begins with step-up doses given 2-4 days apart to reduce the risk of cytokine release syndrome, followed by maintenance doses either weekly (0.4 mg/kg) or every two weeks (0.8 mg/kg).
Cytokine release syndrome (CRS) is a serious immune reaction caused by the activation of T cells. Symptoms include fever, low blood pressure, chills, breathing difficulty, and rapid heartbeat. To reduce this risk, TALVEY uses a gradual step-up dosing schedule, and patients receive pre-medications including antihistamines, corticosteroids, and acetaminophen. Patients are monitored for at least 48 hours after each step-up dose. Most CRS events are mild to moderate and manageable with supportive care.
TALVEY targets the GPRC5D protein, which is highly expressed on myeloma cells but is also found on normal tissues including hair follicles, skin structures, and taste buds. When TALVEY directs T cells to attack cells expressing GPRC5D, it can affect these normal tissues as well, leading to skin rash, nail changes, taste loss, and dry mouth. These are considered on-target, off-tumor effects and are generally manageable with supportive care.
Live vaccines should not be given from at least 4 weeks before starting TALVEY treatment until at least 4 weeks after the last dose, as the weakened immune system could lead to uncontrolled infection. Inactivated vaccines may be given during treatment but may be less effective. Discuss your full vaccination schedule with your oncologist before starting TALVEY.
TALVEY should not be used during pregnancy. The effects on fetal development are unknown, and a risk to newborns cannot be excluded. Women of childbearing potential must use effective contraception during treatment and for 3 months after the last dose. If pregnancy occurs during treatment, patients should inform their healthcare provider immediately. Newborns exposed in utero should have live vaccinations delayed until at least 4 weeks of age.
TALVEY offers two dosing schedules: 0.4 mg/kg given once weekly or 0.8 mg/kg given once every two weeks. Both schedules begin with the same step-up dose sequence (0.01 mg/kg, then 0.06 mg/kg), but the biweekly schedule includes an additional step-up dose of 0.4 mg/kg before the 0.8 mg/kg treatment dose. The choice between weekly and biweekly dosing should be made in consultation with your doctor based on your individual clinical situation and preferences.
References
- European Medicines Agency (EMA). TALVEY (talquetamab) – Summary of Product Characteristics. Last updated 2025. Available at: EMA EPAR – TALVEY.
- U.S. Food and Drug Administration (FDA). TALVEY (talquetamab-tgvs) Prescribing Information. Approved August 2023, last revised 2024. Janssen Biotech, Inc.
- Chari A, Minnema MC, Berdeja JG, et al. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma. N Engl J Med. 2022;387(24):2232-2244.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 3.2025.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Multiple Myeloma. Updated 2024.
- World Health Organization (WHO). Model List of Essential Medicines. 23rd List, 2023.
- Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):495-505. (Comparative bispecific antibody trial for context.)
- Bahlis NJ, Tomasson MH, Mohty M, et al. MonumenTAL-1: Updated Analysis of Talquetamab in Patients with Relapsed/Refractory Multiple Myeloma. Blood. 2023;142(Suppl 1).
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Sources
EMA SmPC, FDA Prescribing Information, NCCN & ESMO Guidelines, peer-reviewed clinical trials
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This article was last medically reviewed on . It is based on the latest available evidence from international guidelines and peer-reviewed research. Content is updated regularly as new data become available.