Description and Brand Names

Drug information provided by: Merative, Micromedex®

Descriptions


Talquetamab-tgvs 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 treatments. 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 talquetamab-tgvs 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 talquetamab-tgvs 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 infection—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.

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 weekly or biweekly (every 2 weeks) "step-up dosing schedule". Weekly dosing schedule: You will receive this medicine on Days 1 and 4, followed by the first treatment dose on Day 7. After you receive your first treatment dose, this medicine is usually given once a week. Biweekly dosing schedule: You will receive this medicine on Days 1, 4, and 7, followed by the first treatment dose on Day 10. After you receive your first treatment dose, this medicine is usually given every 2 weeks. Your doctor will ask you to stay for 48 hours after receiving the step-up doses.

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 3 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.

This medicine may cause mouth problems and weight loss. Check with your doctor right away if you have change or loss of taste, difficulty swallowing, dry mouth, or swelling or inflammation of the mouth.

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 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 skin reactions (eg, rash, maculopapular rash, erythema, and erythematous rash). Check with your doctor right away if you have flushing, redness of the skin, rash with flat lesions or small raised lesions on the skin, or unusually warm skin.

This medicine may cause dizziness, confusion, sleepiness, 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. Agitation
  2. back pain
  3. being forgetful
  4. blurred vision
  5. body aches or pain
  6. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  7. chest pain
  8. chills
  9. coma
  10. confusion
  11. confusion as to time, place, or person
  12. cough or hoarseness
  13. diarrhea
  14. dizziness
  15. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  16. drowsiness
  17. ear congestion
  18. fainting
  19. fast, pounding, or irregular heartbeat or pulse
  20. fever or chills
  21. hallucinations
  22. headache
  23. holding false beliefs that cannot be changed by fact
  24. increased sensitivity to pain
  25. increased sensitivity to touch
  26. irritability
  27. itching of the vagina or genitals
  28. lightheadedness
  29. loss of memory
  30. loss of smell
  31. loss of voice
  32. lower back or side pain
  33. mood or mental changes
  34. muscle or bone pain
  35. muscle spasms
  36. nausea
  37. nerve pain
  38. painful or difficulty urination
  39. problems with memory
  40. rapid or irregular heartbeat
  41. rash with flat lesions or small raised lesions on the skin
  42. seizures
  43. shakiness in the legs, arms, hands, or feet
  44. sneezing
  45. sore throat
  46. stiff muscles
  47. stiff neck
  48. stuffy or runny nose
  49. sweating
  50. swelling
  51. thick, white vaginal discharge with mild or no odor
  52. tingling in the hands and feet
  53. trembling and shaking of the hands or feet
  54. trouble breathing
  55. unsteadiness or awkwardness
  56. unusual excitement, nervousness, or restlessness
  57. unusual tiredness or weakness
  58. vomiting
  59. weakness in arms, hands, legs, or feet
  60. weight loss
  61. white patches in the mouth or throat or on the tongue
  62. white patches with diaper rash

Less common

  1. Black, tarry stools
  2. pale skin
  3. ulcers, sores, or white spots in the mouth
  4. unusual bleeding or bruising

Incidence not known

  1. Bleeding gums
  2. burning, throbbing, or stabbing pain
  3. dark urine
  4. double vision
  5. hearing loss
  6. jerking movements
  7. pinpoint red spots on the skin
  8. rigid muscles
  9. stomach pain, severe
  10. trouble speaking
  11. yellow eyes or skin

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. Change or loss of taste
  2. constipation
  3. decreased appetite
  4. difficulty swallowing
  5. dry mouth
  6. loss of sense of taste
  7. reduced or lessening or loss of sense of taste
  8. swelling or inflammation of the mouth

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: May 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/talquetamab-tgvs-subcutaneous-route/description/drg-20555986