Teclistamab-cqyv (Tecvayli®)
Pronounce: tek-LIS-tuh-mab
Classification: Bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager
About Teclistamab-cqyv (Tecvayli®)
This medication is a bispecific BCMA-directed CD3 T-cell engager used to treat some forms of multiple myeloma (MM). This medication activates your T-cells (part of your immune system) by connecting the CD3 antigen (found on T-cells) with BCMA, which is found on the surface of MM cells. The redirected T-cells kill MM cells.
This medication is given as a subcutaneous (SubQ, under the skin) injection. The dosage of this medication depends on your body size. You will receive the “step-up dosing schedule” for three doses in the hospital. Next, you will receive your weekly treatment dose in an outpatient facility 7 days after finishing the step-up dosing schedule.
You will be given “pre-medications” before each step-up dose of this medication. These may include a steroid, a histamine-1 (H1) receptor antagonist (such as diphenhydramine/Benadryl), and an antipyretic (such as acetaminophen/Tylenol). Some patients will need these pre-medications with every dose depending on adverse reactions.
You will need to stay in the hospital for at least 2 days once you have finished the step-up schedule (first 3 doses) of the injection so that your care team can monitor your reaction.
TECVAYLI REMS Program
This medication is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI REMS. This program is in place due to the risks of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS). Prescribers and pharmacies/healthcare settings must be certified with the program by enrolling and completing training. Prescribers must counsel patients on CRS and neurotoxicity and complete and provide patients with a Patient Wallet Card to carry with them at all times.
Possible Side Effects
These are some of the most common or most serious side effects of this medication. Talk with your provider about the side effects you are having and how they can be managed.
Cytokine Release Syndrome (CRS)
Cytokine release syndrome (CRS) is an inflammatory reaction that affects your whole body. This medication can cause a quick and sudden release of cytokines (proteins) from your immune cells into your blood. Your body may become overwhelmed by this release of cytokines.
Symptoms of CRS include
- Fever.
- Fatigue.
- Nausea or vomiting.
- Feeling dizzy or lightheaded.
- Headache.
- Trouble breathing or swallowing.
- Swelling of your face.
- Chest pain or racing heartbeat.
- Coughing or wheezing.
This can be a very serious side effect. Let your provider know right away so that treatment can be started if needed.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
This medication can cause serious nervous system changes, called Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Symptoms can range from mild confusion to serious effects like seizures and swelling of the brain (called cerebral edema). Other symptoms may be:
- Shaking (tremors).
- Being unable to understand speech or unable to speak as you normally do (called aphasia).
- Change in consciousness.
- Seizures.
ICANS often happens within 1 week of receiving this medication. Call your provider if you or a caregiver notice any of these nervous system changes.
Infection and Low White Blood Cell Count (Leukopenia or Neutropenia)
This medication can cause serious infections, with or without a decrease in white blood cell counts.
White blood cells (WBC) help your body fight infection. While you are having cancer treatment, your WBC count can drop, putting you at a higher risk of an infection. Tell your provider right away if you have a fever (a temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips for preventing infection:
- Hand washing, both yours and your visitors, is the best way to prevent the spread of infection.
- Avoid large crowds and people who are sick (those who have a cold, fever, or cough, or if someone you live with has these symptoms).
- When working outside, wear clothes that protect you, like long pants and gloves.
- Do not handle pet waste.
- Keep all cuts and scratches clean.
- Shower or bathe daily.
- Brush your teeth at least twice a day.
- Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
- Ask your providers before scheduling dental appointments or procedures.
Ask your providers before you or someone you live with has any vaccines.
Low Platelet Count (Thrombocytopenia)
Platelets are blood cells that help your blood clot. Thrombocytopenia is when your platelet count is lower than normal, and you are at a higher risk of bleeding. Tell your providers if you have any bruising or bleeding, including nose bleeds, bleeding gums, or blood in your urine or stool. If your count gets too low, you may receive platelets from a donor.
- Do not use a razor (an electric razor is fine).
- Do not do activities that can cause injury or bleeding.
- Talk to your provider before taking any non-steroidal, anti-inflammatory medications (NSAIDs) like Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib), and others. These can raise the risk of bleeding.
- Use a soft-bristle toothbrush to brush your teeth. Ask your provider about flossing or using toothpicks.
Liver Toxicity
This medication can cause liver toxicity, or liver problems, which your provider may monitor for with blood tests called liver function tests. Symptoms may be:
- Yellowing of your skin or eyes.
- Dark or brown urine.
- Pain in your abdomen (belly).
Tell your provider if you have any of these symptoms.
Low Red Blood Cell Count (Amemia)
Anemia is when your red blood cell count is lower than normal. Red blood cells carry oxygen to the tissues in your body. When your red cell count is low, you may feel tired or weak. Tell your providers if you have shortness of breath, trouble breathing, or pain in your chest. If your count gets too low, you may receive a blood transfusion.
Muscle or Joint Pain/Aches
Your provider can recommend medications and other strategies to help relieve pain.
Electrolyte Abnormalities
This medication can affect your electrolytes (potassium, magnesium, sodium, calcium, etc.). Your electrolyte levels will be checked with blood tests. If your levels get too low, you may be given electrolytes by IV (intravenously through your vein) or by mouth. Talk to your provider before taking any supplements.
Injection Site Reactions
You may have pain, redness, or swelling at the site of the injection. There is also a chance of allergic reaction with this medication. During the injection and afterward, if you have a hard time breathing or swallowing, facial swelling, have chest pain, "racing" heart, cough or wheezing, develop flushing, hives or rash, nausea or vomiting, lightheadedness, headache, fever, chills, or shakes, let your nurse or care team know right away. Additional medications may be given to help you feel better.
Fatigue
Fatigue can cause exhaustion, feeling worn out and that your body is "heavy" and hard to move, or being unable to focus. It is common when you have cancer, and it is not the same as feeling tired. You may need to adjust your schedule to manage fatigue. Plan times to rest during the day and save your energy for more important activities. Exercise can help lessen fatigue. Talk to your providers about ways to deal with this side effect.
Kidney Problems
This medication can cause kidney problems, like an increased creatinine level. Your provider may monitor for kidney problems with blood tests. Symptoms may be:
- Less urine output than normal.
- Blood in the urine.
- Swelling in the ankles.
- Loss of appetite.
Tell your provider if you have any of these symptoms.
Nausea and/or Vomiting
Talk to your providers if you have nausea and/or vomiting. They can prescribe medications to help you. Making changes to your diet can also help. Avoid things that make your symptoms worse, like heavy or greasy/fatty foods and spicy or acidic foods, like tomatoes, lemons, and oranges. Try saltines or ginger ale to help your symptoms.
Call your providers if you cannot keep fluids down for more than 12 hours or if you feel lightheaded or dizzy.
Diarrhea
Diarrhea is when you pass three or more stools in a day. Your providers can suggest medications to relieve diarrhea. Do not take any medications to manage your diarrhea without talking to your provider first, as your stool may need to be tested. To manage it, try eating foods that are low in fiber and bland, like white rice and boiled or baked chicken. Try not to eat raw fruits, vegetables, whole grain breads, cereals, and seeds. Soluble fiber is a type of fiber found in some foods that helps absorb (soak up) fluid. Foods high in soluble fiber are applesauce, bananas (ripe), canned fruit, oranges, boiled potatoes, white rice, foods made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Stay hydrated by drinking 8 to 10 glasses of non-alcoholic, non-caffeinated fluid each day.
Reproductive Concerns
There is a higher risk of health problems for your baby if you are pregnant, become pregnant, or get someone pregnant while on this medication. To lower the risk of birth defects, you should use birth control (contraception) to avoid pregnancy. Talk with your provider about what kind of birth control is safest for you and your partner.
If you can become pregnant, you will need to use effective birth control during treatment and for 5 months after the last dose of this medication, even if your menstrual cycle has stopped or changed.
You should not breastfeed during treatment and for 5 months after the last dose of this medication.