Tecvayli
Tecvayli (teclistamab or teclistamab-cqyv) is a monoclonal antibody known as bispecific T-cell engager (BiTE). It’s used to treat advanced multiple myeloma when other medications haven’t worked well. Tecvayli (teclistamab) is given as an injection under the skin. When you first start this medication, you'll stay in the hospital to receive the “step-up” doses so your provider can monitor you for serious side effects, like cytokine release syndrome. After that, you'll receive it once a week or once every two weeks, typically in an outpatient clinic.
What is Tecvayli (teclistamab)?
What is Tecvayli (teclistamab) used for?
- Advanced multiple myeloma in adults who've already tried at least four other therapies
How Tecvayli (teclistamab) works
Tecvayli (teclistamab) is a monoclonal antibody. More specifically, it’s called a bispecific T-cell engager, or BiTE therapy. This medication works by binding to 2 targets: it grabs onto both the multiple myeloma cancer cells and immune cells in your body called T-cells. By bringing these cells together, Tecvayli (teclistamab) makes it easier for the T cells to attack the cancer cells. In addition, when Tecvayli (teclistamab) binds to both cells, the multiple myeloma cancer cells can’t grow or spread as well.
Drug facts
Side effects of Tecvayli (teclistamab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Lower blood cell counts (up to 92%)
- Fever (76%)
- Cytokine release syndrome (72%)
- Low protein (albumin) levels in blood (68%)
- Muscle pain (44%)
- Higher liver enzymes in blood (up to 42%)
- Electrolyte changes in blood (up to 38%)
- Skin reaction around injection site (37%)
- Tiredness (33%)
- Respiratory infections (up to 26%)
- Nausea (25%)
- Headache (25%)
- Diarrhea (21%)
Less Common Side Effects
- Bone pain
- Chills
- Constipation
- Vomiting
- Numbness and tingling
- Changes in blood pressure
- Lower appetite
- Movement problems
Tecvayli (teclistamab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome: Fever, trouble breathing, chills, low blood pressure, changes in heart rhythm, headache
- Serious nervous system problems: headache, confusion, difficulty speaking, difficulty writing, seizures
- Serious liver problems: yellow skin, yellow eyes, swelling in the belly
- Serious infection: fever, cough, weakness, tiredness, body aches, chills, painful rash, blisters, stomach pain
The following Tecvayli (teclistamab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet, muscle weakness, headache, change in vision, confusion or trouble speaking, dizziness, loss of balance or coordination, trouble walking, tremors or shaking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Muscle pain
- Nausea
- Pain, redness, or irritation at injection site
Pros and cons of Tecvayli (teclistamab)
Pros
- Recommended treatment option for people with multiple myeloma after 4 prior therapies
- Works in a targeted; less likely to harm healthy cells than traditional chemotherapy
- Given as a brief injection under the skin (once the "step-up" doses are complete), so more convenient than infusions
Cons
- Requires hospital stay during the "step-up" doses
- Injected under the skin; not best option for people who don't like needles
- Can cause a serious side effect called cytokine release syndrome
Pharmacist tips for Tecvayli (teclistamab)
- Tecvayli (teclistamab) is given as a shot underneath your skin, usually in the stomach-area. You’ll likely experience injection-related reactions, such as redness or swelling. If so, you can apply an ice pack to help relieve the symptoms.
- Depending on your Tecvayli (teclistamab) dose, you might need more than one injection for a full dose. If so, your provider will give you the injections in different places to lower the risk of skin irritation.
- People who receive Tecvayli (teclistamab) are more likely to get seriously sick from infections. You can help prevent infections by washing your hands often, avoiding crowds, and washing raw fruits and vegetables thoroughly before eating them.
- Your provider might recommend you take an antiviral medication, such as acyclovir (Zovirax), to prevent shingles infections while you’re taking Tecvayli (teclistamab). Ask your provider what medications you might need to prevent other types of infections.
- If you have a temperature of 100.4 Fahrenheit or higher, get medical help right away. This means you have a fever, which can either be a sign of an infection or an early sign of cytokine release syndrome (CRS) - both potentially serious side effects of Tecvayli (teclistamab).
- Females who are taking Tecvayli (teclistamab) should avoid breastfeeding during treatment and for 5 months after the last dose. We don’t know whether Tecvayli (teclistamab) is found in breast milk and whether it affects breastfed babies, but there’s a possible risk of harm to a baby.
More tips about Tecvayli (teclistamab) “step-up” doses
- When you’re starting Tecvayli (teclistamab) for the first time, you’ll need to stay in the hospital during and for 2 days after the “step-up” doses to monitor you for serious side effects. Make sure to bring things you need to make your stay as comfortable as possible, such as loose-fitting clothes. Ask your provider for ideas if you’re not sure what you might need.
- Let your provider know right away if you experience symptoms of cytokine release syndrome (CRS), such as fever, chills, or headache. While your provider will monitor you for 2 days after the Tecvayli (teclistamab) “step-up” doses, CRS symptoms can still show up after this time, when you’re already home.
- You’re at highest risk for nervous system related problems during the Tecvayli (teclistamab) “step-up” doses, such as tiredness, movement problems, and confusion. You're recommended to avoid driving or do anything that needs a lot of focus for 2 days after you finish “step-up” doses. It’s best if you can arrange for a family member or caregiver to give you a ride home after your treatment.
- If you need to pause Tecvayli (teclistamab) for more than 4 weeks, such as to manage a side effect, your provider will ask you to repeat the step-up dose process when you restart taking the medication. This includes staying in the hospital for monitoring after each step-up dose.
Common questions about Tecvayli (teclistamab)
No, Tecvayli (teclistamab) isn't considered a chemotherapy medication. Chemotherapy typically works by attacking cells that are growing quickly, and Tecvayli (teclistamab) works differently. It’s considered a targeted therapy that specifically targets multiple myeloma cancer cells and T-cells (a type of immune cells). In doing so, Tecvayli (teclistamab) helps activate the immune system to attack the cancer cells.
A Risk Evaluation and Mitigation Strategy (REMS) program is a special program created by the FDA. It’s used for medications that need special monitoring because they might cause serious side effects. These requirements help keep people taking the medication as safe as possible. Tecvayli (teclistamab) has a REMS program because it can cause serious problems with your nervous system and a reaction called cytokine release syndrome. For Tecvayli (teclistamab) specifically, providers must complete training about these possible side effects to make sure they can safely monitor you.
Cytokine release syndrome (CRS) is a type of immune reaction your body might have after you take Tecvayli (teclistamab). CRS is a common side effect of Tecvayli (teclistamab) and can be serious. In mild cases of CRS, symptoms include tiredness, body aches, and low-grade fever. But, this reaction can also be severe and cause high fever, dangerously low blood pressure, a serious blood clotting disorder, and organ damage. CRS is most likely to happen during the first three doses of Tecvayli (teclistamab), so you'll be monitored in the hospital during this time.
Yes, Tecvayli (teclistamab) can cause problems in the nervous system. Most of the time, the symptoms are mild and can include headache, numbness in the fingers, or movement problems. But rarely, people receiving Tecvayli (teclistamab) have experienced a serious side effect called immune effector-cell associated neurotoxicity syndrome (ICANS) that causes symptoms such as difficulty speaking, difficulty writing (dysgraphia), and confusion. If you experience any of these symptoms, seek medical attention right away because your provider might need to pause your treatment.
Typically, you'll need to stay in the hospital when you first start Tecvayli (teclistamab), during the “step-up” doses. This is because you're most likely to experience serious immune-related and nervous system-related side effects during this time. Staying in the hospital allows your care team to catch symptoms of these side effects early and treat them quickly. If you don’t have any serious side effects during your "step-up" treatment, you can probably receive future injections in an outpatient setting.
Some people taking Tecvayli (teclistamab) experience nausea, but it’s usually mild. Your provider might recommend an oral medication to help manage nausea, such as ondansetron (Zofran) or prochlorperazine (Compazine). Contact your provider if you’re experiencing nausea that’s severe or won’t go away.
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Risks and warnings for Tecvayli (teclistamab)
Tecvayli (teclistamab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome
Cytokine release syndrome (CRS) is a common and potentially life-threatening side effect of Tecvayli (teclistamab). CRS happens when small immune proteins called cytokines overreact to Tecvayli (teclistamab) treatment. Most people experience CRS within the first three injections, when their provider is raising the dose. Symptoms of CRS can appear up to 6 days after an injection and can include tiredness, headache, body aches, and low-grade fever. In more serious cases, CRS can lead to organ damage.
To prevent CRS, your provider will give you pre-treatment medications, like corticosteroids and antihistamines, before your first three doses of Tecvayli (teclistamab). To be safe, they’ll also ask you to stay in the hospital for two days after your first three doses to monitor you for symptoms and provide treatment if needed.
If you develop CRS, your provider will pause Tecvayli (teclistamab). Depending on how severe your symptoms are, sometimes you can restart Tecvayli (teclistamab) when you get better. But, other times, your provider will ask you to stop [EDITOR|DRUG_DISPLAY_NAME]] altogether.
Serious brain and nervous system problems
Some people taking Tecvayli (teclistamab) developed nervous system problems. These problems can be mild, such as headache or numbness in the fingers. In rare, but more serious cases, people have developed a condition called immune effector-cell associated neurotoxicity syndrome (ICANS) with symptoms such as difficulty speaking, difficulty writing, and confusion. Typically, symptoms of ICANS show up during the first few doses of Tecvayli (teclistamab), up to 8 days after the dose.
If you experience any of these symptoms, seek medical attention right away. Typically, you’ll need to pause taking Tecvayli (teclistamab) while your provider looks into it. Depending on how serious the side effect is, you might be able to restart Tecvayli (teclistamab). Or, you might have to stop taking it altogether.
Because these side effects can affect your thinking and movement, you’re recommend to avoid driving or doing activities that need a lot of focus and attention for at least 2 days after your step-up doses of Tecvayli (teclistamab), or anytime you start to experience symptoms.
REMS program
Because Tecvayli (teclistamab) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems including immune effector-cell associated neurotoxicity syndrome (ICANS), it is only available through a special program called a Risk Evaluation and Mitigation Strategy (REMS). This program requires your provider and pharmacy to complete special training to prescribe and dispense Tecvayli (teclistamab). Your provider must know how to diagnose and treat these serious side effects, and must discuss these side effects with you before you start taking Tecvayli (teclistamab).
Serious liver problems
Sometimes, people taking Tecvayli (teclistamab) developed liver problems. These can be mild, such as higher levels of liver enzymes in the blood. Or, they can be serious and lead to liver failure. Your provider will monitor your liver through lab tests, because usually you won’t notice any symptoms or feel differently. But, if you do have yellowish skin, yellow eyes, or sudden stomach pain, contact your provider right away.
Serious infections and lower white blood cell levels
People who take Tecvayli (teclistamab) often have low blood cell counts, particularly low white blood cells (neutropenia). This can raise your risk for developing serious infections. Your provider will regularly monitor your blood cell counts while you’re taking Tecvayli (teclistamab), and they might prescribe other medications such as antibiotics or antivirals to protect you from serious infections.
You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. Contact your provider right away if you have any signs or symptoms of infection such as fever, body aches, chills, cough, or low blood pressure.
Serious allergic reactions
Some people receiving Tecvayli (teclistamab) injections have experienced hypersensitivity reactions. These can be around the injection site (local reaction), or spread throughout your body.
Local reactions usually happen within a few minutes of the injection and usual symptoms include mild redness and swelling. Whole-body reactions are rare, but might include symptoms such as fever or swollen tongue. If you have these symptoms or don’t feel well after your injection, let your nurse or provider know right away. Depending on how serious your reaction is, your provider might ask you to stop Tecvayli (teclistamab).
Harm to unborn baby
Based on the way Tecvayli (teclistamab) works, it might harm an unborn baby or raise the risk for miscarriage (pregnancy loss) when taken during pregnancy. Because of these risks, if you’re a female who can get pregnant, you should use birth control while taking Tecvayli (teclistamab) and for 5 months after the last dose.
Your provider might require a negative pregnancy test before you start treatment. Let your provider know right away if you become pregnant while taking Tecvayli (teclistamab).
Tecvayli (teclistamab) dosage
Typical dosage for Tecvayli (teclistamab)
Your provider will determine your dose of Tecvayli (teclistamab) based on your body weight. This medication is injected under the skin by a healthcare provider, typically in a hospital or clinic setting.
- Starting dose (“step-up” dosing): During your first week of treatment, your provider will raise your dose over the course of a week.
- Day 1 dose: 0.06 mg/kg injected once.
- Day 4 dose: 0.3 mg/kg injected once.
- Day 7 dose: 1.5 mg/kg injected once.
- Maintenance dose: Starting a week after the last dose, your provider will give you 1.5 mg/kg injected under the skin once a week.
- If the medication is working well for you for at least 6 months, your provider might give you 1.5 mg/kg injected under the skin once every two weeks.
What are alternatives to Tecvayli (teclistamab)?
Tecvayli (teclistamab) images
