TM Owner Janssen
Talvey 40mg Injection
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Indications & Clinical Uses
- Talvey 40mg/mL is a vial of talquetamab-tgvs, a bispecific antibody made by Janssen that binds both GPRC5D on myeloma cells and CD3 on T-cells, directing the immune system to attack the cancer.
- It is approved under accelerated approval for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
- Continued approval may depend on further trial confirmation of clinical benefit.
- Talvey is given by subcutaneous injection with a step-up dosing schedule at the start of treatment, and because of its serious risks it is administered only by a healthcare provider, with hospitalisation required around the first step-up doses; it is not a medicine patients inject at home.
Side Effects
- Talvey carries a BOXED WARNING for cytokine release syndrome (CRS), including life-threatening or fatal reactions, which is why hospitalisation for 48 hours after each step-up dose is required, and for neurologic toxicity including ICANS, which can also be serious or life-threatening.
- Very common side effects, each affecting more than 1 in 5 patients, include fever, CRS, taste changes or loss of taste, nail changes, muscle and joint pain, skin changes, rash, fatigue, weight loss, dry mouth, and difficulty swallowing.
- Low blood counts (neutropenia, affecting about a third of patients at severe grade) and serious infections also occur.
- Report fever, confusion, slurred speech, tremor, difficulty swallowing or breathing, or severe mouth soreness to your care team immediately.
Precautions & Warnings
- Because of the boxed warning for CRS and neurologic toxicity/ICANS, Talvey is available only through the Tecvayli and Talvey REMS restricted-distribution programme, which requires the treating hospital or clinic to be specially certified.
- Patients are monitored closely for at least 48 hours after each step-up dose and instructed to seek urgent care for any fever, confusion or neurological symptoms even after leaving hospital.
- Oral toxicity (dry mouth, taste loss, mouth sores) affects most patients and is monitored, along with liver enzymes and complete blood counts throughout treatment.
- Talvey is contraindicated in pregnancy and can cause fetal harm, so effective contraception is required during treatment and for a period after the last dose; breastfeeding is not recommended.
- Talvey is for subcutaneous injection only.
Avoid Interactions
- Because Talvey can trigger CRS with release of inflammatory cytokines such as IL-6, it should not be combined with other agents that increase infection or cytokine-release risk without careful specialist assessment, and live or live-attenuated vaccines should be avoided during treatment because of the underlying immune effects and disease state.
- Medicines that suppress the immune system, or that also affect blood counts, may add to the risk of serious infection or cytopenia seen with Talvey and require closer monitoring.
- As this is a hospital-administered treatment, your care team will already review your full medicine list, but you should tell them about every prescription medicine, over-the-counter product, supplement and any other cancer treatment you have received or are receiving.
References
Frequently Asked Questions
Talvey (talquetamab) treats relapsed or refractory multiple myeloma in adults who have already tried at least four other therapies, including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody. It works by directing the immune system's T-cells to attack myeloma cells.
Talvey is given as a subcutaneous injection by a healthcare provider, starting with smaller step-up doses before the full treatment dose. You are hospitalised for about 48 hours after each step-up dose so your care team can watch for reactions, then continue treatment on an outpatient schedule.
Talvey's boxed warning covers cytokine release syndrome (CRS), which can be life-threatening or fatal, and neurologic toxicity including ICANS. Because of this, Talvey is only available through the restricted TALVEY REMS program, and you are hospitalised after each step-up dose for close monitoring.
Very common effects include fever, CRS, taste changes, nail and skin changes, joint pain, fatigue, weight loss and dry mouth. Tell your care team immediately about fever, confusion, tremor, slurred speech or trouble swallowing, since these can signal CRS or the neurologic toxicity named in the boxed warning.
Each step-up dose is given in hospital, where you stay for about 48 hours for monitoring of temperature, blood pressure and neurological symptoms because of the CRS and ICANS risk. Blood counts and liver enzymes are also checked regularly throughout treatment, even once you move to outpatient dosing.
No. Talvey can cause fetal harm, so effective contraception is required during treatment and for a period after your last dose - discuss the exact duration with your care team. Breastfeeding is not recommended while receiving Talvey because of the potential risk to the infant.
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