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Talquetamab

Also known as: Talvey

Route: Subcutaneous

1 interaction on record⛔ Black Box Warning

Talquetamab has 1 known drug interaction based on U.S. FDA drug labeling data. 1 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Cyp Substrates. Patients taking Talquetamab should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 1
Major: 1

Major (1)

Talquetamab + Cyp Substrates— Talquetamab causes cytokine release that may suppress CYP enzyme activity, resulting in increased exposure of CYP substr…

Talquetamab + Cyp Substrates⚠️Major

Talquetamab causes cytokine release that may suppress CYP enzyme activity, resulting in increased exposure of CYP substrates. Risk is highest during step-up dosing (up to 14 days after first dose) and during/after cytokine release syndrome.

⛔ FDA Black Box 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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ) , Warnings and Precautions (5.1) ] . Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life threatening or fatal reactions, can occur with TALVEY. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue TALVEY based on severity [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity. ( 2.2 , 2.5 , 5.1 ) Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur in patients receiving TALVEY. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold or permanently discontinue TALVEY based on severity. ( 2.5 , 5.2 ) TALVEY is availa

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Based on the mechanism of action, TALVEY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TALVEY in pregnant women to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with talquetamab-tgvs. Talquetamab-tgvs causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, TALVEY has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. 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.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.