Teclistamab

What is Teclistamab?

• Teclistamab (Tecvayli), is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) antibody.
• Teclistamab-cqyv is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology.
• Teclistamab-cqyv consists of an anti-BCMA heavy chain and light chain and an anti-CD3 heavy chain and light chain with two interchain disulfide bonds connecting the two arms.

Immunoglobulin G4-lambda, anti-CD3E + anti-TNFRSF17 bispecific

What are the uses of this medicine?

Teclistamab (Tecvayli) is a prescription medicine to treat adults with multiple myeloma who:

• have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and
• their cancer has come back or did not respond to prior treatment.

How does this medicine work?

• A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human B-cell maturation antigen (BCMA; TNFRSF17), a tumor-associated antigen (TAA) expressed on plasma cells, with potential antineoplastic activity.
• Upon administration, teclistamab binds to both CD3 on T-cells and BCMA expressed on malignant plasma cells.
• This results in the cross-linking of T-cells and tumor cells, and induces a potent cytotoxic T-lymphocyte (CTL) response against BCMA-expressing plasma cells.
• BCMA, a member of the tumor necrosis factor receptor superfamily that is specifically overexpressed on malignant plasma cells, plays a key role in promoting plasma cell survival.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Teclistamab was approved for medical use in the European Union in August 2022, and in the United States in October 2022.
• The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

How should this medicine be used?

Recommended dosage: Initially, it is usually given on days 1, 4, and 7 for the first 3 doses and then once a week thereafter.

• Day 1: 0.06 mg/kg
• Day 4: 0.3 mg/kg
• Day 7: 1.5 mg/kg

Weekly Dosing Schedule:

• 1.5 mg/kg once weekly.

• Patients should be hospitalized for 48 hours after administration of all doses within the Tecvayli step-up dosing schedule.

Administration:

• Tecvayli will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen), your thigh or another area of your body may be injected.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 30 mg/3 mL (10 mg/mL) in a single-dose vial
• 153 mg/1.7 mL (90 mg/mL) in a single-dose vial

This medicine is available in fallowing brand namesː

• Tecvayli

What side effects can this medication cause?

The most common side effects of this medicine include:

• fever
• pain in your joints and muscles, back and chest muscles, and in your arms and legs
• tiredness and weakness
• upper respiratory tract infections and pneumonia
• nausea
• headache
• diarrhea

Less common, but serious side effects may include:

• Neurologic problems
• Liver problems
• Infections
• Decreased white blood cell counts
• Allergic reactions and injection site reactions

What special precautions should I follow?

• Tecvayli can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of all doses within the Tecvayli step-up dosing schedule.
• Tecvayli can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, confusion, dysgraphia, motor dysfunction, neuropathy, or encephalopathy. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of Tecvayli step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.
• Tecvayli is available only through a restricted program under a REMS called the Tecvayli REMS because of the risks of CRS and neurologic toxicity, including ICANS.
• Tecvayli can cause hepatotoxicity, including fatalities. Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
• Tecvayli can cause severe, life-threatening, or fatal infections. Discuss the signs and symptoms of infection.
• Tecvayli can cause neutropenia and febrile neutropenia. Discuss the signs and symptoms associated with neutropenia and febrile neutropenia.
• Tecvayli can cause both systemic administration-related reactions and local injection-site reactions. Advise patients to immediately seek medical attention for any signs and symptoms of systemic administration-related reactions. Advise patients that local injection-site reactions may occur and to report any severe reactions.
• Based on its mechanism of action, Tecvayli may cause fetal harm when administered to a pregnant woman. Advise pregnant women to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with Tecvayli and for 5 months after the last dose.
• Advise women not to breastfeed during treatment with Tecvayli and for 5 months after the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on the mechanism of action, Tecvayli may cause fetal harm when administered to a pregnant woman.
• There are no available data on the use of Tecvayli in pregnant women.

Can this medicine be used in children?

• The safety and efficacy of Tecvayli have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: teclistamab-cqyv
• Inactive ingredients: edetate disodium, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection

Who manufactures and distributes this medicine?

Manufactured by: Janssen Biotech, Inc., Horsham, PA

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Teclistamab
• FDA Teclistamab

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