Tecvayli side effects: What you should know

Tecvayli can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who received Tecvayli in clinical trials:

• fever
• muscle, joint, back, arm, or leg pain
• injection site reaction
• fatigue
• cytokine release syndrome*

* 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 “Side effect specifics” section below.

Mild side effects can occur with Tecvayli use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Tecvayli’s prescribing information.

Mild side effects that have been reported with Tecvayli include:

• headache
• fever
• chills
• mild infection, such as the common cold or urinary tract infection (UTI)
• muscle, joint, back, arm, or leg pain
• injection site reaction
• fatigue
• diarrhea
• constipation
• nausea and vomiting
• reduced appetite
• edema (swelling due to fluid buildup)
• mild allergic reaction*

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while receiving Tecvayli and want to tell the FDA about it, visit MedWatch.

* An allergic reaction is possible after receiving Tecvayli. For more information about this side effect, see “Side effect specifics” below.

Tecvayli may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Tecvayli’s prescribing information.

If you develop serious side effects while taking Tecvayli, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

• Severe or life threatening infection, such as pneumonia. Symptoms can include:
  • fever and chills
  • cough
  • shortness of breath
• Liver damage. Symptoms can include:
  • upper right abdominal pain
  • dark-colored urine
  • jaundice
• Low counts of red blood cells, white blood cells, or platelets. Symptoms can include:
  • fatigue
  • unusually pale-looking skin, gums, or nail beds
  • bruising or bleeding more easily
• Kidney problems, such as sudden kidney failure. Symptoms can include:
  • dark-colored urine
  • less frequent urination
  • swollen ankles or feet
• Irregular heartbeat. Symptoms can include:
  • sensation of your heart fluttering or skipping beats
  • fast or slow heart rate
  • dizziness or fainting
• Cytokine release syndrome.*
• Neurologic toxicity.*
• Severe allergic reaction.†

* 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 “Side effect specifics” section below.
† An allergic reaction is possible after receiving Tecvayli. For more information, see the “Side effect specifics” section below.

Learn more about some of the side effects that Tecvayli may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Tecvayli.

Cytokine release syndrome

Tecvayli has a boxed warning for cytokine release syndrome (CRS). A boxed warning is the most serious warning from the Food and Drug Administration (FDA). In clinical trials, CRS was a commonly reported side effect.

CRS is sometimes called a “cytokine storm.” It’s a condition that can occur when your immune system releases large amounts of proteins called cytokines. The cytokines cause an inflammatory reaction throughout your body. In turn, this can interfere with bodily processes and affect how well certain organs function.

Symptoms of CRS with Tecvayli are typically mild. However, symptoms can be severe and even life threatening in rare cases. Symptoms of CRS may include:

• fever or chills
• dizziness
• fast heart rate
• headache
• anxiety or restlessness

What you can do

Due to the risk of CRS, Tecvayli is only available through a risk evaluation and mitigation strategy (REMS) program. The FDA requires REMS programs for certain drugs to make sure they are administered safely.

Doctors must be certified by the REMS program in order to administer Tecvayli.

To help prevent CRS, your doctor will increase your Tecvayli dosage gradually over your first three injections. Before each of your first three Tecvayli doses, you’ll also be given medications to help prevent CRS. You’ll likely be given:

• a corticosteroid such as dexamethasone
• an antihistamine such as Benadryl (diphenhydramine)
• a fever reducer such as Tylenol (acetaminophen)

After each of your first three injections, you’ll need to stay in the healthcare facility where you receive your injections for at least 48 hours. This is so your doctor can monitor you for CRS and treat your symptoms if needed.

If you have symptoms of CRS, tell your doctor right away. Your doctor may prescribe medication and other supportive care to treat your symptoms. Depending on the severity of your symptoms, they may also delay your next Tecvayli dose. In some cases, they may stop your Tecvayli treatment.

If you have questions or concerns about the risk of CRS with Tecvayli, talk with your doctor.

Neurologic toxicity

Tecvayli may cause neurological toxicity, which is damage to your nervous system (brain and nerves). In Tecvayli’s clinical trials, neurological toxicity was common. In most cases, it was mild. However, in rare cases, severe and life threatening toxicity has been reported.

Symptoms of neurological toxicity may include:

• headache
• numbness or tingling sensations
• confusion
• difficulty speaking, hearing, or writing
• difficulty with body movements, such as walking

What you can do

Due to the risk of neurological toxicity, Tecvayli is only available through a REMS program. Your doctor must be certified through the REMS program to administer this drug.

To help prevent neurological toxicity, your doctor will increase your Tecvayli dosage gradually over your first three injections.

After each of your first three doses, you’ll need to stay in the healthcare facility where you receive your injections for at least 48 hours. This is so your doctor can monitor you for neurological toxicity and treat your symptoms if necessary.

If you have symptoms of neurological toxicity, tell your doctor right away. Your doctor may prescribe medication and other supportive care to treat your symptoms. Depending on the severity of your symptoms, they may also delay your next Tecvayli dose or stop treatment completely.

Do not drive if you have symptoms of neurological toxicity.

If you have questions or concerns about the risk of neurological toxicity with Tecvayli, talk with your doctor.

Allergic reaction

As with most drugs, Tecvayli can cause an allergic reaction in some people. In the drug’s clinical trials, this side effect was rare.

Symptoms can be mild or serious and can include:

• skin rash
• itching
• flushing
• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Tecvayli. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Below is important information you should consider before taking Tecvayli.

Boxed warnings

This drug has boxed warnings about the risks of cytokine release syndrome and neurologic toxicity. These are serious warnings from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Tecvayli. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Infection. Tecvayli can increase your risk of infection, including some infections that may be severe or life threatening. Before receiving Tecvayli, be sure to tell your doctor if you have an active or reoccurring infection. Your doctor may prescribe medication to treat or help prevent infections during your Tecvayli treatment.

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 and breastfeeding. If you’re pregnant or breastfeeding, Tecvayli is not considered safe for you to take. Talk with your doctor about other treatment options for your condition. If you can become pregnant, your doctor will likely recommend using birth control during Tecvayli treatment and for 5 months after your last dose.

In addition, you should not breastfeed during Tecvayli treatment and for 5 months after your last dose. Talk with your doctor about other healthy ways to feed your child during Tecvayli treatment.

Alcohol consumption. It may not be safe to drink alcohol while receiving Tecvayli treatment. Drinking alcohol may increase your risk of certain side effects, such as nausea, headache, diarrhea, and liver problems. If you have questions about drinking alcohol during treatment, talk with your doctor.

If you’d like to learn more about Tecvayli, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

• More information about Tecvayli. For details about other aspects of Tecvayli, refer to this article.
• Cost. If you’d like to learn about Tecvayli and cost, see this article.
• A look at multiple myeloma. For details about multiple myeloma, see our cancer hub.

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.