Tecvayli is a brand-name prescription drug. It’s FDA-approved to treat multiple myeloma in adults in certain situations. Multiple myeloma is a cancer that affects a specific type of white blood cell.

For this use, the cancer must be refractory or relapsed after treatment with at least four other therapies in the past. (“Refractory” means the cancer did not respond to other treatments. “Relapsed” means the cancer has come back after other treatments.)

For more information, see the “Tecvayli use for multiple myeloma” section below.

Drug details

The active drug in Tecvayli is teclistamab-cqyv. 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 approved in the future.

Tecvayli belongs to a class of drugs called monoclonal antibodies. It comes as a solution inside of a single-use vial. The drug is available in two strengths: 30 milligrams (mg) and 153 mg per vial.

Tecvayli is given as a subcutaneous injection. Because of the risk of serious side effects, Tecvayli is only given by a healthcare professional in a specialized facility. For more information, see the “How Tecvayli is administered” section below.

FDA approval

The Food and Drug Administration (FDA) approved Tecvayli in 2022. It’s important to note that the drug received accelerated approval from the FDA.

Accelerated approval means the FDA made Tecvayli available to the public before all of the drug’s clinical trials were completed. This type of approval is sometimes given to medications used for conditions that do not have many treatment options. This includes multiple myeloma, which Tecvayli is used to treat.

The FDA will decide whether to give Tecvayli full approval after all its clinical trials have been completed.

Effectiveness

For information about the effectiveness of Tecvayli, see the “Tecvayli use for multiple myeloma” section below.

Tecvayli contains the active ingredient teclistamab-cqyv. 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 approved in the future.

Tecvayli is a biologic drug that’s available only as a brand-name drug. It’s not currently available in generic or biosimilar form.

A biologic drug is made from parts of living cells, whereas traditional drugs are made using chemicals. A generic drug is an exact copy of the active drug in a brand-name medication. A generic is just as safe and effective as the brand-name drug. Generics tend to cost less than brand-name drugs.

It’s not possible to make exact copies of biologic drugs. So instead of generics, biologics have biosimilars. They’re considered to be as effective and safe as the brand-name drug. As with generics, biosimilars are often less expensive than brand-name medications.

As with all medications, the cost of Tecvayli can vary. The actual price you’ll pay depends on your insurance plan and your location. It also depends on the cost of your visit to a healthcare professional to receive your Tecvayli doses.

Before approving coverage for Tecvayli, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Tecvayli, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Tecvayli, or if you need help understanding your insurance coverage, help is available.

A program called Janssen Compass is available for Tecvayli. 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.

Biosimilar form

Tecvayli is a biologic drug, meaning it’s made from parts of living cells. Tecvayli is not currently available in a biosimilar form.

Traditional drugs are made from chemicals and can have generics. These are exact copies of the active drug in the brand-name medication. However, it’s not possible to make exact copies of biologic drugs. So instead of generics, biologics have biosimilars. They’re considered to be as effective and safe as the brand-name drug.

As with generics, biosimilars are often less expensive than brand-name medications.

The Tecvayli dosage your doctor prescribes will depend on certain factors. These include your body weight and the side effects you may have.

Typically, your doctor will start by prescribing a low dosage of Tecvayli. Then they’ll increase it over time to reach the treatment dosage that’s recommended for your condition.

The following information describes dosages that are commonly used 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

Tecvayli comes as a solution inside of a single-use vial. It’s available in two strengths: 30 milligrams (mg) and 153 mg per vial.

Tecvayli is given as a subcutaneous injection. Because of the risk of serious side effects, Tecvayli is only given by a healthcare professional in a specialized facility. For more information, see the “How Tecvayli is administered” section below.

Dosage for multiple myeloma

Tecvayli is approved to treat multiple myeloma in certain adults. To learn when Tecvayli is prescribed, see the “Tecvayli use for multiple myeloma” section below.

For multiple myeloma, you’ll typically receive two starting doses of Tecvayli before receiving the first treatment dose.

For the first starting dosage, you’ll receive 0.06 mg per kilogram (mg/kg)* of your body weight on day one. For the second starting dosage, you’ll receive 0.3 mg/kg of your body weight on day four.

For the first treatment dosage, you’ll receive 1.5 mg/kg of your body weight on day seven. Then you’ll continue receiving treatment dosages once a week after that.

As an example, a 185-pound (lb) person weighs about 84 kg. Their Tecvayli starting dosage on day one would be about 5 mg. Their second starting dosage on day four would be about 25 mg. Then, their treatment dosage would be about 126 mg once per week, starting on day seven.

Your healthcare professional may adjust your dosage schedule if you have certain side effects. They’ll tell you when you’ll receive each Tecvayli injection. They’ll also tell you how many dosages are needed to treat your condition.

* For reference, 1 kg is about 2.2 lb.

What if I miss a dose?

If you miss an appointment to receive your Tecvayli injection, reschedule it as soon as possible.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or putting a note where you’ll see it, such as on your bathroom mirror or bedside table. You could also download a reminder app on your phone.

Will I need to receive this drug long term?

Tecvayli may be prescribed as a long-term treatment. The length of time you’ll receive the drug depends on the side effects you have and whether your condition is improving.

If you and your doctor determine that Tecvayli is safe and effective for you, you’ll likely receive it long term.

Tecvayli can cause mild or serious side effects. The following lists contain some of the key side effects that may occur during treatment with Tecvayli. These lists do not include all possible side effects.

For more information about the possible side effects of Tecvayli, 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 Tecvayli, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Tecvayli. To learn about other mild side effects, talk with your doctor or pharmacist, or view Tecvayli’s prescribing information.

Mild side effects of Tecvayli can include:

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 Tecvayli, see “Allergic reaction” below.

Serious side effects

Serious side effects from Tecvayli can occur. 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:

  • Liver problems, such as liver failure. Symptoms can include:
    • loss of appetite
    • nausea and vomiting
    • dark urine
  • Kidney problems, such as acute kidney injury. Symptoms can include:
    • confusion
    • swelling in your legs, ankles, or feet
    • urinating a lesser amount than is typical for you
  • Severe infection, such as pneumonia. Symptoms vary depending on the type of infection. However, they can include:
    • fever or chills
    • cough
  • High blood pressure, which may not cause symptoms unless it’s severe. Symptoms of severely high blood pressure can include:
    • sweating
    • headache
  • Low level of hemoglobin (a protein found in red blood cells). Symptoms can include:
    • pale-looking skin
    • dizziness
    • shortness of breath
    • cold hands or feet
  • Low level of platelets (a type of red blood cell). Symptoms can include:
    • bruising more easily than is typical for you
    • bleeding, such as nosebleeds or bloody gums
  • Low levels of specific white blood cells. This condition can occur with or without fever, and it may not cause any other symptoms. However, it can be detected with certain blood tests.
  • Risk of cytokine release syndrome.*
  • Risk of neurologic toxicity.*
  • Severe allergic reaction.†

* Tecvayli has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Tecvayli precautions” section below.
† For details about allergic reaction and Tecvayli, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after receiving Tecvayli. This side effect was rare in clinical trials of the drug.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare. However, it is 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 Tecvayli, 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.

Tecvayli is given as a subcutaneous injection by a healthcare professional. They’ll typically inject the drug under the skin of your abdomen or thigh.

Because of the risk of serious side effects, Tecvayli is only given in a specialized facility. These facilities have been certified by the Tecvayli risk evaluation and mitigation strategy (REMS) program. The REMS program helps make sure that your healthcare professional understands the instructions for administering Tecvayli. It also helps make sure that they know how to recognize and treat serious side effects that can occur with the drug.

You’ll likely stay in the specialized facility where you receive Tecvayli injections for at least 48 hours after your first two doses. This allows your healthcare professional to monitor you closely for serious side effects. Your healthcare professional can advise you on whether you’ll stay in the facility after receiving other doses of the drug.

When it’s administered

You’ll likely receive two starting doses of Tecvayli before receiving the first treatment dose. The starting dosages are typically given on day one and day four. The first treatment dosage is typically given on day seven. Then Tecvayli is injected once a week after that.

To help make sure that you don’t miss an injection appointment, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

The Food and Drug Administration (FDA) approves prescription drugs such as Tecvayli to treat certain conditions.

Tecvayli is approved to treat multiple myeloma in adults in certain situations.

For this use, the multiple myeloma must be refractory or relapsed. “Refractory” means the cancer did not respond to other treatments. “Relapsed” means the cancer has come back after other treatments.

In addition, the multiple myeloma must have been treated with at least four other therapies in the past. These therapies must include a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody. Below are some examples of these therapies:

  • Proteasome inhibitors. Examples include carfilzomib (Kyprolis) and bortezomib (Velcade).
  • Anti-CD38 monoclonal antibodies. Examples include isatuximab (Sarclisa) and daratumumab (Darzalex).
  • Immunomodulators. Examples include pomalidomide (Pomalyst) and lenalidomide (Revlimid).

Multiple myeloma explained

Multiple myeloma is a cancer that affects plasma cells (a type of white blood cell). Plasma cells are found in the bone marrow, which is the spongy tissue inside of bones. These cells help your immune system fight infection.

With multiple myeloma, your body makes a large number of abnormal plasma cells. These abnormal cells are unable to fight infection. They may also continue to multiply and form tumors.

Multiple myeloma may not cause any symptoms. However, possible symptoms can include:

You can learn more about multiple myeloma by visiting our cancer hub.

Effectiveness for multiple myeloma

Tecvayli has been found effective for treating multiple myeloma. The drug is included as a treatment option in the National Comprehensive Cancer Network (NCCN) guidelines for multiple myeloma.

To find out how the drug performed in clinical trials, see Tecvayli’s prescribing information.

Tecvayli and children

Tecvayli is not approved for use in children. It’s not known whether the drug is safe or effective for children.

To help reduce your risk of cytokine release syndrome* from Tecvayli, your doctor may prescribe other medications along with it. These medications may be given 1 to 3 hours before your first two Tecvayli injections.

Below are a few medications your doctor may have you take before Tecvayli:

Your doctor can advise you on whether you should take any medications before receiving other doses of Tecvayli.

* Tecvayli has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Tecvayli precautions” section below.

Tecvayli isn’t known to interact with alcohol.

If you drink alcohol, talk with your doctor about an amount that’s safe for you to consume during Tecvayli treatment.

Tecvayli can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Tecvayli precautions” section below.

Tecvayli and other medications

Tecvayli may interact with other medications, herbs, supplements, or foods. However, the manufacturer of Tecvayli didn’t investigate interactions in clinical trials of the drug.

This doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Tecvayli.

Before starting Tecvayli treatment, 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 take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Tecvayli is approved to treat multiple myeloma in certain adults.

Multiple myeloma is a cancer that affects plasma cells (a type of white blood cell). With multiple myeloma, your body makes a large number of abnormal plasma cells. These abnormal cells are unable to fight infection. They may also continue to multiply and form tumors.

To learn more about multiple myeloma and when Tecvayli is used, see the “Tecvayli use for multiple myeloma” section above.

Tecvayli is a type of medication called a monoclonal antibody. It works by attaching to two proteins. One protein is found on T cells.* The other protein is found on multiple myeloma cells. By attaching to both proteins, Tecvayli helps bring T cells to the multiple myeloma cells. This helps your immune system attack the multiple myeloma cells.

* T cells are a type of white blood cell. They help your immune system fight cancer.

How long does it take to work?

Tecvayli starts working right away to treat your cancer. It may take several doses of Tecvayli before the amount of cancer in your body decreases. Your doctor will perform tests to make sure the drug is working to treat your condition.

It may not be safe to receive Tecvayli during pregnancy.

Because of the way the drug works in the body, Tecvayli may cause harm to a fetus. There have not been any clinical trials looking at the effects of the drug on human pregnancy.

If you can become pregnant, your doctor will likely order a pregnancy test before you start Tecvayli treatment. This is to make sure that you are not pregnant before receiving the drug.

If you’re pregnant or planning a pregnancy, talk with your doctor. They can recommend treatment options other than Tecvayli.

If you become pregnant while receiving Tecvayli, tell your doctor right away. They’ll likely have you stop the drug and may suggest other treatments for your condition.

Tecvayli may not be 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 Tecvayli.

For more information about Tecvayli treatment during pregnancy, see the “Tecvayli and pregnancy” section above.

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 Tecvayli

If you’re female and can become pregnant, you should use an effective form of birth control during Tecvayli treatment. You should continue using birth control for at least 5 months after your last dose of the drug.

For males receiving Tecvayli

The manufacturer of Tecvayli hasn’t given birth control recommendations for males receiving the drug.

If you’re male and sexually active with someone who is able to become pregnant, talk with your doctor. They can assess your birth control needs while you’re receiving Tecvayli.

It’s not known for certain whether Tecvayli causes side effects in a child who is breastfed. There haven’t been clinical trials to determine whether the drug passes into breast milk.

To be safe, your doctor will likely recommend that you do not breastfeed during Tecvayli treatment. They’ll also typically advise you to not breastfeed for at least 5 months after your last dose.

If you’re breastfeeding or planning to do so, talk with your doctor. They can recommend ways to feed your child during and after receiving Tecvayli.

Here are answers to some frequently asked questions about Tecvayli.

Do I need to avoid anything after I’ve received Tecvayli?

Yes, it’s important that you avoid certain activities until you know how Tecvayli will affect you.

For at least 48 hours after the first two doses of Tecvayli, you should not perform activities that require you to be alert. This includes operating heavy machinery and driving. It’s important to avoid these activities because Tecvayli may cause neurologic toxicity (damage to the nervous system).* This side effect can affect your memory and coordination.

If you have neurologic toxicity as a side effect of Tecvayli, you should avoid these activities until your symptoms resolve.

Keep in mind that you will stay in the specialized facility where you receive Tecvayli injections for at least 48 hours after receiving the first two doses. This allows your healthcare professional to watch you closely for serious side effects, including neurologic toxicity.

Your healthcare professional can advise you on whether you’ll stay in the facility after receiving treatment doses of the drug. They can also recommend whether you should avoid any activities after your treatment doses.

* Tecvayli has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Tecvayli precautions” section below.

Will Tecvayli cure multiple myeloma?

No, Tecvayli will not cure multiple myeloma. There’s currently no cure for this type of cancer. However, clinical trials have shown that Tecvayli is effective to help treat the symptoms of multiple myeloma.

If you have additional questions about what to expect with Tecvayli treatment, talk with your doctor.

Is Tecvayli a type of chemotherapy?

No, Tecvayli is not a type of chemotherapy.

Both Tecvayli and chemotherapy drugs are used to treat multiple myeloma. However, each drug works differently to treat this condition.

Tecvayli is a type of drug called a monoclonal antibody. It works by attaching to certain proteins found on cancer cells of a specific type of white blood cell. (For more information, see the “How Tecvayli works” section above.)

Chemotherapy drugs work by killing rapidly growing cells. Cancer cells tend to grow faster than healthy cells. However, chemotherapy drugs can still affect healthy cells. This may lead to many of the side effects from chemotherapy. (To learn more about chemotherapy side effects, see this article.)

For more information about chemotherapy and Tecvayli, talk with your doctor.

This drug comes with several precautions. These are known as drug-condition interactions.

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. Tecvayli may cause cytokine release syndrome (CRS). This condition occurs when the immune system quickly triggers the release of certain proteins into your blood. Having too many of these proteins can make your immune system overactive.

Mild CRS was common in clinical trials of Tecvayli. Symptoms of mild CRS can include headache, fever, diarrhea, nausea, and vomiting.

Severe CRS was rare in clinical trials. However, it can be life threatening for some people. Symptoms of severe CRS may include:

Due to this risk, Tecvayli is only given by a healthcare professional in a specialized facility. These facilities have been certified by the Tecvayli risk evaluation and mitigation strategy (REMS) program. The FDA requires REMS programs for certain medications to help make sure they’re used safely.

For at least 48 hours after your first two Tecvayli doses, you’ll need to stay at the specialized facility where you receive the injection. This allows your doctor to monitor you for serious side effects, such as CRS.

To help reduce your risk of CRS from Tecvayli, your doctor may prescribe other medications along with it. To learn more, see the “Tecvayli use with other drugs” section above.

Tell your doctor right away if you have any symptoms of CRS after receiving Tecvayli injections. They’ll likely stop your Tecvayli treatment and give you treatments for CRS right away.

Risk of neurologic toxicity. Tecvayli may cause neurologic toxicity. This means the drug may cause damage to the nervous system, which includes the brain and nerve cells.

Neurologic toxicity was a common side effect in clinical trials of Tecvayli. In severe cases, this condition can be life threatening.

Neurologic toxicity may cause certain symptoms or lead to other conditions, including:

  • headache
  • confusion
  • muscle spasms
  • numbness or tingling in your arms and legs
  • problems with writing, such as having trouble holding a writing utensil or trouble writing in a straight line
  • encephalopathy (brain damage)

Due to this risk, Tecvayli is only given by a healthcare professional in a specialized facility that’s been certified by the Tecvayli REMS program. The FDA requires REMS programs for certain medications to help make sure they’re used safely.

Neurologic toxicity can affect your memory and coordination. As a precaution, you should not perform activities that require you to be alert for at least 48 hours after the first two doses of Tecvayli. If you have neurologic toxicity as a side effect of Tecvayli, you should avoid these activities until your symptoms resolve.

Keep in mind that you’ll likely stay in the specialized facility where you receive Tecvayli injections for at least 48 hours after receiving the first two doses. This allows your healthcare professional to monitor you closely for serious side effects, including neurologic toxicity.

Tell your doctor if you have any symptoms of neurologic toxicity after receiving Tecvayli injections. They’ll likely stop your Tecvayli injections and treat this condition right away.

Other precautions

Before starting treatment with Tecvayli, talk with your doctor about your health history. Tecvayli may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Active infection. Before starting treatment with Tecvayli, tell your doctor if you have an infection. Tecvayli may cause infections, and could worsen any infection you already have. Your doctor may not start Tecvayli treatment until your infection is managed.
  • Allergic reaction. If you’ve had an allergic reaction to Tecvayli or any of its ingredients, your doctor will likely not prescribe Tecvayli. Ask your doctor what other medications may be better options for you.
  • Pregnancy. It may not be safe to receive Tecvayli while pregnant. For more information, see the “Tecvayli and pregnancy” section above.
  • Breastfeeding. It may not be safe to breastfeed during Tecvayli treatment or for at least 5 months after your last dose. For more information, see the “Tecvayli and breastfeeding” section above.

Note: For more information about the potential negative effects of Tecvayli, see the “Tecvayli 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.