Teclistamab
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Boxed warning
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI.
Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ] .
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI.
Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )
Handling and access
REMS
RequiredStated in the label quoted on this page.
- Restricted distribution (ETASU)
- Prescriber certification or enrollment
- Pharmacy certification
- Healthcare setting certification
- Required testing or monitoring
- Medication Guide
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Important Dosage and Administration Information TECVAYLI is for subcutaneous injection only. Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Tables 1 and 2 [see Dosage and Administration ] .
Administer TECVAYLI subcutaneously according to the step-up dosing schedule in Tables 1 and 2 to reduce the incidence and severity of cytokine release syndrome (CRS). Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2.
Instruct patients to remain within proximity of a healthcare facility and monitor them daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule [see Dosage and Administration and Warnings and Precautions (5.1 , 5.2) ] . Refer to Tables 8, 9, 10, and 11 to determine the dosage based on predetermined weight ranges [see Dosage and Administration ] .
Preparation and Administration TECVAYLI is for subcutaneous use by a healthcare provider only. TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and ICANS [see Warnings and Precautions (5.1 , 5.2) ] . TECVAYLI is a clear to slightly opalescent, colorless to light yellow solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is discolored, or cloudy, or if foreign particles are present. TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.
Do not combine TECVAYLI vials of different concentrations to achieve treatment dose. Use aseptic technique to prepare and administer TECVAYLI. Preparation of TECVAYLI Refer to the following reference tables for the preparation of TECVAYLI. Refer to Tables 8, 9, 10 and 11 below to determine the dosage based on predetermined weight ranges.
Use Table 8 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 1 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial. [See table below.] (0.06 mg/kg) Injection Volumes and Number of Vials Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial Patient Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial=3 mL) 35 to 39.9 2.2 0.22 1 40 to 44.9 2.5 0.25 1 45 to 49.9 2.8 0.28 1 50 to 59.9 3.3 0.33 1 60 to 69.9 3.9 0.39 1 70 to 79.9 4.5 0.45 1 80 to 89.9 5.1 0.51 1 90 to 99.9 5.7 0.57 1 100 to 109.9 6.3 0.63 1 110 to 119.9 6.9 0.69 1 120 to 129.9 7.5 0.75 1 130 to 139.9 8.1 0.81 1 140 to 149.9 8.7 0.87 1 150 to 160 9.3 0.93 1 Use Table 9 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 2 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial. [See table below.] (0.3 mg/kg) Injection Volumes and Number of Vials Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial Patient Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial=3 mL) 35 to 39.9 11 1.1 1 40 to 44.9 13 1.3 1 45 to 49.9 14 1.4 1 50 to 59.9 16 1.6 1 60 to 69.9 19 1.9 1 70 to 79.9 22 2.2 1 80 to 89.9 25 2.5 1 90 to 99.9 28 2.8 1 100 to 109.9 31 3.1 2 110 to 119.9 34 3.4 2 120 to 129.9 37 3.7 2 130 to 139.9 40 4 2 140 to 149.9 43 4.3 2 150 to 160 47 4.7 2 Use Table 10 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the 1.5 mg/kg dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial. [See table below.] 1 40 to 44.9 64 0.71 1 45 to 49.9 71 0.79 1 50 to 59.9 83 0.92 1 60 to 69.9 99 1.1 1 70 to 79.9 108 1.2 1 80 to 89.9 126 1.4 1 90 to 99.9 144 1.6 1 100 to 109.9 153 1.7 1 110 to 119.9 171 1.9 2 120 to 129.9 189 2.1 2 130 to 139.9 198 2.2 2 140 to 149.9 216 2.4 2 150 to 160 234 2.6 2 Use Table 11 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the 3 mg/kg dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial. [See table below.] 0 to 44.9 126 1.4 1 45 to 49.9 144 1.6 1 50 to 59.9 162 1.8 2 60 to 69.9 198 2.2 2 70 to 79.9 225 2.5 2 80 to 89.9 252 2.8 2 90 to 99.9 288 3.2 2 100 to 109.9 315 3.5 3 110 to 119.9 342 3.8 3 120 to 129.9 378 4.2 3 130 to 139.9 405 4.5 3 140 to 149.9 432 4.8 3 150 to 160 468 5.2 4 Remove the appropriate strength TECVAYLI vial(s) from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)].
Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm TECVAYLI in any other way. Gently swirl the vial for approximately 10 seconds to mix. Do not shake. Withdraw the required injection volume of TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle.
Each injection volume should not exceed 2 mL. Divide doses that require greater than 2 mL equally into multiple syringes. Use TECVAYLI with stainless steel injection needles and polypropylene or polycarbonate syringe material. Replace the transfer needle with an appropriately sized needle for injection. Administration of TECVAYLI Inject the required volume of TECVAYLI into the subcutaneous tissue of the abdomen (preferred injection site).
Alternatively, TECVAYLI may be injected into the subcutaneous tissue at other sites (e.g., thigh). If multiple injections are needed, administer injections at least 2 cm apart. Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact. Storage and Disposal If the prepared dosing syringe(s) of TECVAYLI is not used immediately, store syringe(s) at 2 °C to 8 °C (36 °F to 46 °F) or at ambient temperature 15 °C to 30 °C (59 °F to 86 °F) for a maximum of 20 hours.
Discard syringe(s) after 20 hours, if not used. Dispose of any unused product or waste material in accordance with local requirements.
| Patient Body Weight (kg) | Total Dose (mg) | Volume of Injection (mL) | Number of Vials (1 vial=3 mL) |
|---|---|---|---|
| 35 to 39.9 | 2.2 | 0.22 | 1 |
| 40 to 44.9 | 2.5 | 0.25 | 1 |
| 45 to 49.9 | 2.8 | 0.28 | 1 |
| 50 to 59.9 | 3.3 | 0.33 | 1 |
| 60 to 69.9 | 3.9 | 0.39 | 1 |
| 70 to 79.9 | 4.5 | 0.45 | 1 |
| 80 to 89.9 | 5.1 | 0.51 | 1 |
| 90 to 99.9 | 5.7 | 0.57 | 1 |
| 100 to 109.9 | 6.3 | 0.63 | 1 |
| 110 to 119.9 | 6.9 | 0.69 | 1 |
| 120 to 129.9 | 7.5 | 0.75 | 1 |
| 130 to 139.9 | 8.1 | 0.81 | 1 |
| 140 to 149.9 | 8.7 | 0.87 | 1 |
| 150 to 160 | 9.3 | 0.93 | 1 |
| Patient Body Weight (kg) | Total Dose (mg) | Volume of Injection (mL) | Number of Vials (1 vial=3 mL) |
|---|---|---|---|
| 35 to 39.9 | 11 | 1.1 | 1 |
| 40 to 44.9 | 13 | 1.3 | 1 |
| 45 to 49.9 | 14 | 1.4 | 1 |
| 50 to 59.9 | 16 | 1.6 | 1 |
| 60 to 69.9 | 19 | 1.9 | 1 |
| 70 to 79.9 | 22 | 2.2 | 1 |
| 80 to 89.9 | 25 | 2.5 | 1 |
| 90 to 99.9 | 28 | 2.8 | 1 |
| 100 to 109.9 | 31 | 3.1 | 2 |
| 110 to 119.9 | 34 | 3.4 | 2 |
| 120 to 129.9 | 37 | 3.7 | 2 |
| 130 to 139.9 | 40 | 4 | 2 |
| 140 to 149.9 | 43 | 4.3 | 2 |
| 150 to 160 | 47 | 4.7 | 2 |
| Patient Body Weight (kg) | Total Dose (mg) | Volume of Injection (mL) | Number of Vials (1 vial=1.7 mL) |
|---|---|---|---|
| 35 to 39.9 | 56 | 0.62 | 1 |
| 40 to 44.9 | 64 | 0.71 | 1 |
| 45 to 49.9 | 71 | 0.79 | 1 |
| 50 to 59.9 | 83 | 0.92 | 1 |
| 60 to 69.9 | 99 | 1.1 | 1 |
| 70 to 79.9 | 108 | 1.2 | 1 |
| 80 to 89.9 | 126 | 1.4 | 1 |
| 90 to 99.9 | 144 | 1.6 | 1 |
| 100 to 109.9 | 153 | 1.7 | 1 |
| 110 to 119.9 | 171 | 1.9 | 2 |
| 120 to 129.9 | 189 | 2.1 | 2 |
| 130 to 139.9 | 198 | 2.2 | 2 |
| 140 to 149.9 | 216 | 2.4 | 2 |
| 150 to 160 | 234 | 2.6 | 2 |
Drug interactions
Check teclistamab against a medication listLabel text (2 paragraphs)
7 DRUG INTERACTIONS TECVAYLI causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of certain cytochrome P450 (CYP) enzymes, resulting in increased exposure of CYP substrates, which may increase the risk of adverse reactions of the CYP substrates. The highest risk of drug-drug interaction is expected to occur after initiation of TECVAYLI step-up dosing schedule up to 7 days after the first treatment dose and during and after CRS [see Warnings and Precautions (5.1) ] . Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions.
Consider decreasing the dosage of the concomitant CYP substrate as needed. Certain CYP Substrates : Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate, as needed ( 7 ).
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible cause of clinically apparent liver injury.
Teclistamab is a bispecific human monoclonal antibody to the B cell maturation antigen (BCMA) and CD3, which targets the antibody to T cells (T cell engager) and is used in the treatment of refractory or relapsing multiple myeloma. Teclistamab has major side effects including cytokine release syndrome as well as immune related conditions, including liver injury, which can be serious and even fatal.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on the mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TECVAYLI in pregnant patients to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus.
Advise women of the potential risk to the fetus. TECVAYLI is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with TECVAYLI should be considered. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Breastfeeding (LactMed)
No information is available on the clinical use of teclistamab during breastfeeding. Because teclistamab is a large protein molecule with a molecular weight of 146,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. The manufacturer recommends that breastfeeding be withheld during therapy and for 5 months after the last dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.