Tebentafusp
Generic Name: tebentafusp
Brand Names:
Kimmtrak
11 DESCRIPTION Tebentafusp-tebn is a bispecific gp100 peptide-HLA-directed T cell receptor CD3 T cell engager. Tebentafusp-tebn has an approximate molecular weight of 77 kDa. Tebentafusp-tebn is produced by recombinant DNA technology in Escherichia coli cells. KIMMTRAK (tebentafusp-tebn) injection is supplied in a single-dose vial as a sterile, preservative-free, clear, colorless or slightly yellowish solution for intravenous administration by infusion.
Overview
11 DESCRIPTION Tebentafusp-tebn is a bispecific gp100 peptide-HLA-directed T cell receptor CD3 T cell engager. Tebentafusp-tebn has an approximate molecular weight of 77 kDa. Tebentafusp-tebn is produced by recombinant DNA technology in Escherichia coli cells. KIMMTRAK (tebentafusp-tebn) injection is supplied in a single-dose vial as a sterile, preservative-free, clear, colorless or slightly yellowish solution for intravenous administration by infusion.
Uses
1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
Dosage
2 DOSAGE AND ADMINISTRATION Recommended dosage: 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week thereafter ( 2.2 ). Dilute and administer by intravenous infusion over 15-20 minutes ( 2.2 , 2.4 ). See Full Prescribing Information for instructions on preparation and administration of the diluted solution for intravenous infusion ( 2.2 , 2.4 ). Dosage interruption or permanent discontinuation may be required based on individual safety and tolerability ( 2.3 ). 2.1 Patient Selection Select patients for treatment of unresectable or metastatic uveal melanoma with KIMMTRAK based on a positive HLA-A*02:01 genotyping test of a whole blood sample [see Clinical Studies (14) ] .
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Cytokine Release Syndrome [ see Boxed Warning , Warnings and Precautions (5.1) ] Skin Reactions [ see Warnings and Precautions (5.2) ] Elevated Liver Enzymes [ see Warnings and Precautions (5.3) ] The most common adverse reactions (occurring in ≥ 30%) are cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting ( 6.1 ). The most common laboratory abnormalities (occurring in ≥50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased aspartate aminotransferase, increased alanine aminotransferase, decreased hemoglobin, and decreased phosphate ( 6.1 ).
Warnings
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. 5 WARNINGS AND PRECAUTIONS Skin reactions : Rash, pruritus, and cutaneous edema occurred in patients treated with KIMMTRAK. If skin reactions occur, treat based on persistence and severity of symptoms ( 2.3 , 5.2 ). Elevated liver enzymes : Elevations in liver enzymes occurred in patients treated with KIMMTRAK. Monitor ALT, AST, and total bilirubin ( 2.3 , 5.3 ). Embryo-Fetal toxicity : May cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception ( 5.4 , 8.1 , 8.3 ). 5.1 Cytokine Release Syndrome Cytokine release syndrome (CRS), which may be life threatening, occurred in patients receiving KIMMTRAK. 4 CONTRAINDICATIONS None. None ( 4 ).
Pregnancy
8.1 Pregnancy Risk Summary Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with KIMMTRAK in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK. Molecules of similar molecular weight can cross the placenta resulting in fetal exposure. Advise women of the potential risk to the fetus. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Each KIMMTRAK (tebentafusp-tebn) injection carton (NDC 80446-401-01) contains: One single-dose vial containing 100 mcg of tebentafusp-tebn in 0.5 mL of sterile, preservative-free, clear, colorless or slightly yellowish solution. The vial stopper is not made with natural rubber latex.
Frequently Asked Questions
What is Tebentafusp used for?▼
1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
What are the side effects of Tebentafusp?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Cytokine Release Syndrome [ see Boxed Warning , Warnings and Precautions (5.1) ] Skin Reactions [ see Warnings and Precautions (5.2) ] Elevated Liver Enzymes [ see Warnings and Precautions (5.3) ] The most common adverse reactions (occurring in ≥ 30%) are cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting ( 6.1 ). The most common laboratory abnormalities (occurring in ≥50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased aspartate aminotransferase, increased alanine aminotransferase, decreased hemoglobin, and decreased phosphate ( 6.1 ).
Can I take Tebentafusp during pregnancy?▼
8.1 Pregnancy Risk Summary Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with KIMMTRAK in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK. Molecules of similar molecular weight can cross the placenta resulting in fetal exposure. Advise women of the potential risk to the fetus. In the U.S.
What are the important warnings for Tebentafusp?▼
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. 5 WARNINGS AND PRECAUTIONS Skin reactions : Rash, pruritus, and cutaneous edema occurred in patients treated with KIMMTRAK. If skin reactions occur, treat based on persistence and severity of symptoms ( 2.3 , 5.2 ). Elevated liver enzymes : Elevations in liver enzymes occurred in patients treated with KIMMTRAK. Monitor ALT, AST, and total bilirubin ( 2.3 , 5.3 ). Embryo-Fetal toxicity : May cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception ( 5.4 , 8.1 , 8.3 ). 5.1 Cytokine Release Syndrome Cytokine release syndrome (CRS), which may be life threatening, occurred in patients receiving KIMMTRAK. 4 CONTRAINDICATIONS None. None ( 4 ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.