Tecvayli

Tecvayli (teclistamab) is a bispecific monoclonal antibody used to treat adults with relapsed and refractory multiple myeloma. Tecvayli helps slow the progression of multiple myeloma, manage symptoms, and improve quality of life.

As a bispecific antibody, Tecvayli binds simultaneously to the B‑cell maturation antigen (BCMA) on myeloma cells and the CD3 receptor on T‑cells, a type of white blood cell that is part of the immune system. Tecvayli brings the cells close together and activates T-cells to attack and kill the cancer cells.

Tecvayli is given as a subcutaneous (under-the-skin) injection by your healthcare provider. It is typically administered once a week or every two weeks as a maintenance dose.

Tecvayli FDA approval is as a treatment 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.

Tecvayli (teclistamab) first received FDA approval on October 25, 2022, under the accelerated approval designation, based on positive results from MajesTEC-1 (NCT04557098, NCT03145181), a Phase 1/2 single-arm study.

This has since been supported by landmark Phase 3 MajesTEC-3 data. After three years of follow-up, Tecvayli plus daratumumab hyaluronidase-fihj (Darzalex Faspro) demonstrated an 83% reduction in the risk of disease progression or death versus standard regimens (HR 0.17; P<0.0001), with significant improvements across all key endpoints, including:

• 3-year PFS rate: 83% vs. 30% (control)
• 3-year OS rate: 83.3% vs. 65% (control)
• Overall response rate: 89% vs. 75.3% (control)
• Complete response rate (≥CR): 81.8% vs. 32.1% (control)
• MRD-negativity: 58.4% vs. 17.1% (control).

Tecvayli's mechanism of action is a bispecific T-cell engager (BiTE) antibody that targets both BCMA on multiple myeloma cells and CD3 on T-cells (immune cells). By simultaneously binding to these two antigens, Tecvayli helps T-cells to recognize and kill BCMA-expressing myeloma cells, leading to cytotoxic activity against the tumor.

In a phase 1/2 single-arm study with heavily pretreated patients at a median follow-up of 14.1 months, using a once-weekly subcutaneous dose of teclistamab:

• 63% achieved a response
• 39.4% experienced a complete response or better
• 11.3 months median progression-free survival (PFS)
• 18.4 months median duration of response

Multiple myeloma is a type of blood cancer that affects plasma cells, a type of white blood cell found in the bone marrow. In multiple myeloma, abnormal plasma cells spread rapidly and replace normal cells in the bone marrow.

The multiple myeloma cells have large amounts of a protein on their surface called BCMA (B-cell maturation antigen). Tecvayli works by targeting these cells, binding to the BCMA proteins, and helping the T cells in the immune system recognize and attack the cancer cells.

Tecvayli is available under a special program called Risk Evaluation and Mitigation Strategy (REMS). The Tecvayli and Talvey REMS program's 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 this medicine outweigh its risks. See “What should I know about the Tecvayli 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.

Tecvayli is given by a HCP (healthcare professional) as an injection under the skin (subcutaneous injection) in the stomach area, thigh, or another area.

Tecvayli carries a Boxed Warning for Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), which can be fatal. A Boxed Warning is the FDA’s most stringent safety warning.

Call your HCP 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.
• Immune effector cell-associated neurotoxicity syndrome (ICANS). 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 your first and second step-up doses, and stay close to a healthcare facility and be monitored for 48 hours after your first treatment dose. For more information about the “Step-up dosing schedule”.

To make sure this medicine is safe for you, tell your doctor if you currently 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 Tecvayli side effects

Common Tecvayli 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 Tecvayli 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 effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Tecvayli 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 the 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.

Initial Tecvayli dosage

Tecvayli 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 and Step-up dose 2, and stay close to a healthcare facility and be monitored for 48 hours after 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.

Maintenance Tecvayli 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.

Table Adult Tecvayli Dose for Multiple Myeloma

General dosing information

• Patients should be hospitalized for 48 hours after the first and second step-up doses, and should stay close to a healthcare facility and be monitored for 48 hours after the first treatment dose.
• 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).

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)

Tecvayli J-code is J9380 (teclistamab-cqyv, 0.5 mg)J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies.

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.

Do not drive or operate heavy or dangerous machinery during and for 48 hours after your step-up dosing schedule is completed, or at any time during treatment if you develop new neurological symptoms such as dizziness, confusion, tremors, or sleepiness, until the symptoms go away.

Tell your HCP (healthcare professional) 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.

HCPs and patients often use the Tecvayli Package Insert (PI) for more detailed information about this medicine. The Tecvayli Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). 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.

The Package Insert is sometimes called Tecvayli Prescribing Information (PI) or FDA label.

• Store refrigerated at 2°C to 8°C (36°F to 46°F.
• This medicine 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

Tecvayli manufacturer Janssen Biotech, Inc., Horsham, PA 19044, USA