Teclistamab

Teclistamab (Tecvayli) is a treatment for relapsed or refractory multiple myeloma used to help slow disease progression, manage symptoms, and improve quality of life. Teclistamab works by binding to both the cancer cells and T-cells from the immune system, which causes cancer cells to die. Teclistamab multiple myeloma treatment is given as an infusion weekly or two weekly as a maintenance dose. Teclistamab brand name is Tecvayli.

Teclistamab's FDA approval indication is for relapsed or refractory multiple myeloma in adults who have received:

• At least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro)
• At least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Multiple myeloma is a blood cancer of a type of white blood cell called plasma cells, which are found in the bone marrow. In multiple myeloma, these plasma cells change, spread rapidly, and replace normal cells in the bone marrow with tumors. On the outside of multiple myeloma cancer cells, there is a large number of proteins called BCMA (short for B-cell maturation antigen). Teclistamab-cqyv can target the MM cancer cells by binding to BCMA proteins.

Teclistamab's mechanism of action (MOA) is by binding to the BMCA antigen on the cancer cell and the CD3 receptor on the T-cell; this activates the immune system and causes the MM cells to die.

The teclistamab class of medicines is bispecific T-cell engager antibodies, and it has two parts: one section binds to proteins called BMCA on the outside of the multiple myeloma cells, and the other section binds to T-cells from the immune system.

Teclistamab is available under a special program called Risk Evaluation and Mitigation Strategy (REMS). Teclistamab REMS goal is to prevent, monitor, and manage the serious risk of cytokine release syndrome (CRS) and neurologic toxicity. This helps to ensure the benefits of teclistamab-cqyvi outweigh its risks.

See “What should I know about the Tecvayli (Teclistamab) REMS program?” for more information.

Follow all the directions on your instruction sheets. Read the Patient Wallet Card about serious side effects and learn what symptoms to watch for. Keep the card with you at all times.

Teclistamab administration

Teclistamab is given by a healthcare provider as an injection under the skin (subcutaneous injection) in the stomach-area, thigh, or another area.

Teclistamab is given initially as Step-up doses.

• This means the first dose is the lowest dose and is called Step-up dose 1. It is given on day 1.
• The second dose is slightly higher and is called Step-up dose 2. It is usually given on day 4.

The next dose is the first treatment dose which is higher than step-up dose 1 and step-up dose 2. The first treatment dose is usually on day 7 and is usually weekly after that.

You will need to stay in the hospital for 48 hours after Step-up dose 1, Step-up dose 2, and your first treatment dose. Talk with your doctor if you have any questions.

You may be given other medications to help prevent serious side effects. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment with this medicine may be temporarily or completely discontinued if you have certain side effects.

You will need medical tests before and during treatment with this medicine.

Teclistamab maintenance dosage

Patients who have achieved and maintained a complete response or better for a minimum of 6 months may be transferred to every two weeks (biweekly )dosing schedule.

Teclistamab-cqyv may cause side effects that are serious, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and Neurologic problems. Call your healthcare provider right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment:

• Cytokine Release Syndrome (CRS). Call your doctor if you have symptoms of a serious side effect, such as fever, chills, trouble breathing, vomiting, or severe tiredness.
• Neurologic problems. Call your doctor if you have symptoms of neurological problems such as headache, jerking muscle movements, numbness and tingling, tremors, double vision, problems walking, or hearing loss.

Due to the risk of CRS and neurologic symptoms, you will need to stay in the hospital for 48 hours after all doses of Tecvayli that are part of the “step-up dosing schedule.” For more information about the “Step-up dosing schedule”.

To make sure teclistamab is safe for you, tell your doctor if you have:

• an infection.

Pregnancy

• You may need to have a negative pregnancy test before starting this treatment.
• May harm an unborn baby. Use effective birth control while using teclistamab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.

Breastfeeding

• Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

Common teclistamab side effects

Common teclistamab side effects may include:

• pain, bruising, swelling, or irritation where the medicine was injected;
• headache;
• nausea, diarrhea;
• tiredness, weakness;
• joint pain, muscle pain in the back, chest, arms, and legs;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• fever, chills, cough with mucus, chest pain, feeling short of breath.

Serious teclistamab side effects

Get emergency medical help if you have signs of an allergic reaction, including hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effects: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Teclistamab-cqyv may cause other serious side effects. Call your doctor at once if you have:

• bruising, swelling, warmth, redness, oozing, or bleeding where an injection was given;
• neurological problems--headache, jerking muscle movements, rigid muscles, feeling restless, numbness and tingling, confusion, problems speaking, muscle spasms, tremors, double vision, changes in handwriting, problems walking, muscle weakness in body or face, hearing loss, burning, throbbing, or stabbing pain;
• signs of infection or low white blood cell counts--cold symptoms such as stuffy nose, sneezing, sore throat, fever, night sweats, swollen glands, cough, wheezing, chest pain, mouth or skin sores, body aches, unusual tiredness; or
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Usual Adult Dose of Teclistamab Multiple Myeloma

General dosing information

• Patients should be hospitalized for 48 hours after administration of all doses within the step-up dosing schedule.
• Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.
• The first treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.
• Administer pretreatment medications 1 to 3 hours before each dose of the step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose to reduce the risk of CRS: corticosteroid (oral or intravenous dexamethasone 16 mg), histamine-1 (H1) receptor antagonist (oral or intravenous diphenhydramine 50 mg or equivalent), and antipyretics (oral or intravenous acetaminophen 650 mg to 1,000 mg or equivalent).

Teclistamab (Tecvayli) is available as:

• 30 mg/3 mL (10 mg/mL) single-dose vial. NDC: 57894-449-01 (10 digit) or 57894-0449-01 (11 digit)
• 153 mg/1.7 mL (90 mg/mL) single-dose vial. NDC: 57894-450-01 (10 digit) or 57894-0450-01 (11 digit)

Teclistamab J-code is J9380 (Tecvayli teclistamab-cqyv, 0.5 mg)J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important accurate and consistent coding for billing and reimbursement purposes.

Your physician will need Tecvayli J-code when filling out forms for your treatment.

ICD-10-CM Diagnosis Codes

Diagnosis codes are used on both inpatient and outpatient claims.ICD-10-CM Diagnosis Codes used for multiple myeloma include:

• C90.00 Multiple myeloma not having achieved remission
• C90.02 Multiple myeloma in relapse

Call your doctor for instructions if you miss an appointment for your injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity for 48 hours after receiving certain doses of this medicine or until neurological symptoms go away. Your reactions could be impaired.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. See the link below to check for interactions with this medicine.

Review the Teclistamab Package Insert (Tecvayli Package Insert) for more detailed information about this medicine. The Teclistamab Prescribing Information (PI) contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you may have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

• Store refrigerated at 2°C to 8°C (36°F to 46°F.
• Tevayli should be stored in the original carton to protect it from light.
• Do not freeze.

Active ingredient: teclistamab-cqyv

Inactive ingredients: edetate disodium, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection

Teclistamab manufacturer Janssen Biotech, Inc., Horsham, PA 19044, USA (Tacvayli Brand)