Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Tecvayli

Descriptions


Teclistamab-cqyv injection is used to treat relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) multiple myeloma in patients who have received at least 4 previous treatment. These previous treatments include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This medicine is available only under a restricted distribution program called Tecvayli® and Talvey® REMS (Risk Evaluation and Mitigation Strategy) Program.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of teclistamab-cqyv injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of teclistamab-cqyv injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Serious infections—Use with caution. May make this condition worse.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given as a shot under your skin, usually in the stomach or thigh. Your doctor will ask you to stay for 48 hours after receiving this medicine.

It is very important that you understand the requirements of the Tecvayli® and Talvey® REMS program, and become familiar with the Tecvayli® and Talvey® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

You will receive this medicine on a "step-up dosing schedule" and then you will receive the first "treatment dose":

  • Step-up dose 1: Given on Day 1 of treatment.
  • Step-up dose 2: Given between 2 to 4 days of treatment after step-up dose 1, or up to 7 days after step-up dose 1.
  • Treatment dose: Given between 2 to 4 days after step-up dose 2, or up to 7 days after step-up dose 2.

You may receive an antiviral medicine to prevent shingles.

You may also receive other medicines (eg, allergy medicine, fever medicine, steroid) 1 to 3 hours before receiving this medicine to help prevent unwanted reactions to the injection.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 5 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.

Ask your doctor for a patient wallet card. This card will list the symptoms of cytokine release syndrome and nervous system problems. Carry the card with you at all times during treatment. You will need to show the card to any doctor who treats you.

Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause serious liver problems. Check with your doctor right away if you have clay colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have fast heartbeat, fever, itching, swelling of the face, throat, or tongue, or trouble breathing after receiving this medicine.

This medicine may cause dizziness, confusion, or tremors. Do not drive or do anything else that could be dangerous during and for 48 hours after receiving this medicine until you know how this medicine affects you.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Absence of or decrease in body movement
  2. agitation
  3. back pain
  4. being forgetful
  5. bladder pain
  6. bleeding gums
  7. bloating or swelling of the face, arms, hands, lower legs, or feet
  8. bloody eye
  9. bloody nose
  10. bloody or cloudy urine
  11. blurred vision
  12. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  13. body aches or pain
  14. chest pain, discomfort, or tightness
  15. chills
  16. collection of blood under the skin
  17. coma
  18. confusion
  19. confusion as to time, place, or person
  20. cough
  21. coughing up blood
  22. decreased urine output
  23. deep, dark purple bruise
  24. depression
  25. difficult, burning, or painful urination
  26. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  27. drowsiness
  28. dryness or soreness of the throat
  29. ear congestion
  30. fever
  31. frequent urge to urinate
  32. hallucinations
  33. headache
  34. hoarseness
  35. holding false beliefs that cannot be changed by fact
  36. hostility
  37. increased menstrual flow or vaginal bleeding
  38. irritability
  39. itching, pain, redness, or swelling
  40. loss of voice
  41. lower back or side pain
  42. mood or mental changes
  43. muscle aches, stiffness, spasm, tightness, or twitching
  44. nausea and vomiting
  45. nerve pain
  46. nervousness
  47. nosebleeds
  48. pain in the lower back, bottom, hips, or upper leg
  49. pain or tenderness around the eyes and cheekbones
  50. paralysis
  51. pounding in the ears
  52. pounding or rapid pulse
  53. problems with speech or speaking
  54. prolonged bleeding from cuts
  55. rapid or irregular heartbeat
  56. red or dark brown urine
  57. red or black, tarry stools
  58. seizures
  59. shakiness in the legs, arms, hands, feet
  60. slow or fast heartbeat
  61. sneezing
  62. sore throat
  63. stiff neck
  64. stuffy or runny nose
  65. stupor
  66. sweating
  67. swelling of the face, ankles, or hands
  68. tender, swollen glands in the neck
  69. tingling of the hands or feet
  70. trembling and shaking of the hands
  71. trouble breathing
  72. trouble in swallowing
  73. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  74. unusual excitement, nervousness, or restlessness
  75. unusual weight gain or loss
  76. voice changes
  77. weight gain

Incidence not known

  1. Burning, throbbing, or stabbing pain
  2. clay colored stools
  3. decreased appetite
  4. double vision
  5. jerking movements
  6. loss of appetite
  7. pale skin
  8. stomach pain or tenderness
  9. trouble speaking
  10. ulcers, sores, or white spots in the mouth
  11. unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  2. constipation
  3. diarrhea
  4. difficulty in moving
  5. joint pain
  6. lack or loss of strength
  7. muscle or bone pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/teclistamab-cqyv-subcutaneous-route/precautions/drg-20545969