Talvey is a brand-name drug that’s prescribed for multiple myeloma when other treatments haven’t worked. Talvey contains the active drug talquetamab-tgvs. It comes as a subcutaneous injection.
Talvey is prescribed to treat multiple myeloma (a type of cancer that affects certain blood cells) in adults. It’s prescribed for people who have already received four or more different drug regimens to treat this condition, including specific types of drugs, but the cancer either didn’t respond or came back.
Drug details
You’ll find key information about Talvey below.
- Drug class: bispecific antibodies (a type of immunotherapy)
- Drug form: subcutaneous injection given by a healthcare professional
- Generic available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2023
- Accelerated approval?
yes
Talvey is available only as a brand-name medication. It contains the active drug talquetamab-tgvs.* This active drug isn’t currently available in generic form.
A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.
*The reason “-tgvs” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.
The Talvey dosage your doctor prescribes will depend on several factors. These include:
- your body weight
- how your body responds to the drug
The following information describes dosages that are commonly prescribed or recommended. However, be sure to follow the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Talvey comes as a solution in a vial. The drug is available in two strengths: 2 milligrams per milliliter (mg/mL) and 40 mg/mL.
Talvey is given as a subcutaneous injection. It’s typically injected under the skin of your abdomen. Your doctor may need to administer multiple injections to give you your full dose.
The drug can only be given by a healthcare professional who has received special training to manage certain serious side effects* that are possible during Talvey treatment. You may need to stay in the hospital for at least 48 hours after receiving a dose of Talvey.
* Talvey has a boxed warning for certain side effects. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Talvey precautions” section below.
Dosage for multiple myeloma
For the first few doses of Talvey, your doctor will determine your dosage by following a “step-up” dosing schedule. Step-up dosing is a schedule by which the doctor slowly increases the dosage over time to reach the target dose. This reduces the risk of serious side effects, including cytokine release syndrome.
Your doctor will calculate your exact dose based on your body weight in kilograms (kg). For reference, 1 kg is about 2.2 pounds (lb).
After you complete the initial step-up schedule, Talvey may be given once every 1 or 2 weeks.
Below is an example of a weekly dosing schedule for Talvey for an adult who weighs 70 kg (about 154 lb):
| Day or week | Dosage | Dose example for 70-kg adult |
| day 1 | step-up dose: 0.01 milligrams per kilogram (mg/kg) | 0.7 mg |
| day 4 | step-up dose: 0.06 mg/kg | 4.2 mg |
| day 7 | first treatment dose: 0.4 mg/kg | 28 mg |
| once weekly | subsequent treatment doses: 0.4 mg/kg once weekly | 28 mg |
Below is an example of a biweekly (every 2 weeks) dosing schedule for Talvey for an adult who weighs 70 kg (about 154 lb):
| Day or week | Dosage | Dose example for 70-kg adult |
| day 1 | step-up dose: 0.01 mg/kg | 0.7 mg |
| day 4 | step-up dose: 0.06 mg/kg | 4.2 mg |
| day 7 | step-up dose: 0.4 mg/kg | 28 mg |
| day 10 | first treatment dose: 0.8 mg/kg | 56 mg |
| once every 2 weeks | subsequent treatment doses: 0.8 mg/kg once every 2 weeks | 56 mg |
Your doctor may give you a different dosage or delay your next dose depending on several factors. These may include whether you develop certain side effects from Talvey, the specific symptoms and severity of these side effects, and how long it takes your body to recover from them.
To help prevent or reduce certain side effects from Talvey, your doctor will give you pretreatment medications. These are typically given 1–3 hours before Talvey and include:
- a corticosteroid such as dexamethasone (Hemady)
- an antihistamine such as diphenhydramine (Benadryl)
- a fever reducer such as acetaminophen (Tylenol)
About receiving Talvey
Below you’ll find information about key dosage issues.
- If you miss a dose. If you miss your appointment for your dose of Talvey, call your doctor’s office right away. They’ll reschedule your appointment and adjust your dosing schedule if necessary.
- Length of treatment. Talvey is meant to be a long-term treatment. If you and your doctor determine that Talvey is safe and effective for you, you’ll likely receive it long term.
Talvey can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while receiving Talvey. These lists do not include all possible side effects.
For more information about the possible side effects of Talvey, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Talvey, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Talvey. To learn about other mild side effects, talk with your doctor or pharmacist or view Talvey’s prescribing information.
Mild side effects of Talvey can include:
- mild infection, such as the common cold
- nail problems, such as changes in nail color or texture
- low blood pressure
- dry mouth and skin
- diarrhea
- headache
- fatigue
- mild allergic reaction*
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
* For more information about allergic reaction and Talvey, see “Allergic reaction” below.
Serious side effects
Serious side effects from Talvey are common. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Severe mouth problems, which may lead to significant weight loss. Symptoms can include:
- painful swallowing
- changes in your sense of taste
- dry mouth
- Serious infection. Symptoms can include:
- chills
- fatigue
- feeling generally unwell
- Liver problems. Symptoms can include:
- jaundice
- urine that’s darker than is typical
- pain in your upper-right abdomen
- loss of appetite
- Severe skin problems, such as rash or irritation.
- Blood disorders, such as low white blood cells or low red blood cells.
- Risk of cytokine release syndrome.*
- Risk of serious neurologic damage.*
- Severe allergic reaction.†
* Talvey has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Talvey precautions” section below.
† For details about allergic reaction and Talvey, see “Allergic reaction” below.
ALLERGIC REACTIONAs with most drugs, some people can have an allergic reaction after receiving Talvey. This side effect wasn’t reported in clinical trials of this drug but can still occur.
Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- trouble breathing
Call your doctor right away if you have an allergic reaction to Talvey, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
The Food and Drug Administration (FDA) approves prescription drugs such as Talvey to treat certain conditions. Talvey may also be prescribed off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.
Talvey for multiple myeloma
Talvey is prescribed to treat multiple myeloma (a type of cancer that affects certain blood cells) in adults.* It’s prescribed for people who have already received four or more different drug regimens to treat this condition, including specific types of drugs, but the cancer either didn’t respond or came back.
Specifically, doctors may prescribe Talvey after the following types of drugs have already been tried:
- a proteasome inhibitor such as bortezomib (Velcade)
- an immunomodulator such as lenalidomide (Revlimid)
- an anti-CD38 monoclonal antibody such as isatuximab (Sarclisa)
Talvey and children
It isn’t known whether Talvey is safe or effective for children with multiple myeloma. The drug has only been approved* for use in adults.
* For this use, Talvey received
Talvey can interact with several other medications. The drug isn’t known to interact with supplements or foods.
Before starting Talvey, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
Interactions with medications
Medications that can interact with Talvay include certain drugs that are affected by enzymes called cytochrome P450. There are many drugs that are affected by cytochrome P450. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Alcohol interaction
Alcohol is not known to interact with Talvey. However, Talvey may cause liver problems. Consuming alcohol often or in large amounts can also cause liver problems. So drinking alcohol while receiving Talvey may further increase the risk or severity of liver problems.
If you have questions about how much alcohol is safe to drink while receiving Talvey, talk with your doctor or pharmacist.
As with all medications, the cost of Talvey can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Financial and insurance assistance. If you need financial support to pay for Talvey, or if you need help understanding your insurance coverage, help is available.
A program called Janssen Compass is available for Talvey. For more information and to find out whether you’re eligible for support, call 844-628-1234 or visit the program website.
To learn more about saving money on prescriptions, check out this article.
Generic version. Talvey is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.
Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Talvey, talk with your doctor. They can tell you about other medications that may work well for you.
Teclistamab-cqyv* (Tecvayli) is a similar drug to Talvey.
*The reason “-cqyv” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.
If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.
Talvey and pregnancy
Talvey should not be received during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this medication. Your doctor may suggest birth control options to use during treatment with Talvey.
Talvey and birth control
It’s not known whether Talvey is safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re receiving Talvey.
Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.
For females receiving Talvey
Females who are able to become pregnant should use birth control during treatment and for 3 months after their last dose of Talvey.
For males receiving Talvey
Talvey’s manufacturer hasn’t provided any specific guidance related to contraception for males receiving the drug.
Talvey and breastfeeding
Talvey should not be received while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication. Your doctor may recommend other ways to feed your child during Talvey treatment and for 3 months after your last dose.
Here are answers to some frequently asked questions about Talvey.
How does Talvey work?
Talvey is a bispecific antibody drug. “Bispecific” means that the drug can bind to two different targets at the same time. Talvey treats multiple myeloma by attaching to the following types of receptors (proteins) in the body:
- G protein-coupled receptor class C group 5 member D (GPRC5D), which is a receptor on the surface of multiple myeloma cells as well as various types of healthy cells
- CD3, which is a receptor on the surface of T cells (T cells are part of the immune system and help fight cancer)
By attaching to GPRC5D and CD3 at the same time, Talvey acts as a bridge connecting multiple myeloma cells and T cells. When the drug attaches to the T cell, it activates the T cell to attack the connected cancer cell.
If you have additional questions about Talvey’s mechanism of action (how the drug works), talk with your doctor or pharmacist.
Will Talvey cure multiple myeloma?
Talvey hasn’t been shown to cure multiple myeloma. However, in a clinical trial, some people experienced a complete response. This means that the number of multiple myeloma cells became too low to be detected by medical tests.
Keep in mind that individual results can differ from what was seen in the clinical trial.
Talvey works by helping your immune system attack cancer cells. It’s a type of immunotherapy. Talk with your doctor for more information about what to expect with Talvey treatment.
Can Talvey cause long-term side effects?
It isn’t known whether Talvey causes long-term side effects. It’s a new drug, and clinical trials are still researching its safety and effectiveness.
If you develop bothersome or severe side effects during Talvey treatment, tell your doctor. They’ll help you determine whether the treatment should be paused or stopped. They’ll also recommend ways to manage the drug’s side effects.
Talk with your doctor if you have questions about how long side effects may last with this medication.
This drug comes with several precautions.
FDA warnings
This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
Risk of cytokine release syndrome. Talvey may cause cytokine release syndrome (CRS), which can be serious or even life threatening. CRS was a common side effect in the drug’s clinical trial.
Symptoms of CRS may include:
- fever or chills
- feeling dizzy or anxious
- shortness of breath
- fast heart rate
To lower this risk, doctors typically prescribe a low starting dose of Talvey and slowly increase it over time. They’ll likely also give you medications before each dose of Talvey to help prevent CRS. To monitor for CRS and other side effects, you may need to stay in the hospital for 48 hours after you receive Talvey.
If CRS occurs, your doctor will likely have you stop treatment with Talvey. After you recover from CRS, your doctor will determine whether it’s safe for you to consider restarting the drug.
Risk of serious neurologic damage. Talvey may cause problems with the nervous system. This can lead to a condition called immune effector cell-associated neurotoxicity syndrome (ICANS), which can be serious or even life threatening. Neurologic damage, including ICANS, was a common side effect in Talvey’s clinical trial.
Symptoms of serious neurologic damage may include:
To lower this risk, doctors typically prescribe a low starting dose of Talvey and slowly increase it over time. To monitor for ICANS and other side effects, you may need to stay in the hospital for 48 hours after you receive Talvey.
If signs or symptoms of neurologic damage develop during Talvey treatment, your doctor will likely have you stop treatment with it. After you recover, your doctor will determine whether it’s safe for you to consider restarting the drug.
Other precautions
Before receiving Talvey, discuss your health history with your doctor. Talvey may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- active infection
- past allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
Note: For more information about the potential negative effects of Talvey, see the “Talvey side effects” section above.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.