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Drug overview for KIMMTRAK (tebentafusp-tebn):
Generic name: tebentafusp-tebn (te-BEN-ta-fusp)
Drug class: Antineoplastic - Immunotherapy, T-cell Engager
Therapeutic class: Antineoplastics
Tebentafusp-tebn, a bispecific gp100 peptide-HLA-directed CD3 T cell engager, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: tebentafusp-tebn (te-BEN-ta-fusp)
Drug class: Antineoplastic - Immunotherapy, T-cell Engager
Therapeutic class: Antineoplastics
Tebentafusp-tebn, a bispecific gp100 peptide-HLA-directed CD3 T cell engager, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for KIMMTRAK (tebentafusp-tebn) have been approved by the FDA:
Indications:
Uveal melanoma in HLA-A *02:01 positive patient
Professional Synonyms:
Melanoma of uvea in HLA-A *02:01 positive patient
Indications:
Uveal melanoma in HLA-A *02:01 positive patient
Professional Synonyms:
Melanoma of uvea in HLA-A *02:01 positive patient
The following dosing information is available for KIMMTRAK (tebentafusp-tebn):
No dosage reductions are recommended for tebentafusp-tebn. Interruption of therapy and/or discontinuation of tebentafusp may be necessary based on the severity of the adverse effect.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| KIMMTRAK 100 MCG/0.5 ML VIAL | Maintenance | Adults infuse 68 mcg over 15-20 minute(s) by intravenous route once weekly |
No generic dosing information available.
The following drug interaction information is available for KIMMTRAK (tebentafusp-tebn):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for KIMMTRAK (tebentafusp-tebn):
Drug contraindication overview.
*None.
*None.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for KIMMTRAK (tebentafusp-tebn):
Adverse reaction overview.
The most common adverse reactions (occurring in >=30%) are CRS, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting. The most common laboratory abnormalities (occurring in >=50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
The most common adverse reactions (occurring in >=30%) are CRS, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting. The most common laboratory abnormalities (occurring in >=50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cytokine release syndrome Hypotension |
Anemia Elevated serum lipase Hypertension Hypoalbuminemia Hypocalcemia Hypomagnesemia Hypophosphatemia Increased alanine transaminase Increased aspartate transaminase Lymphopenia Neutropenic disorder Thrombocytopenic disorder |
| Rare/Very Rare |
|---|
| None. |
There are 32 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Chills Dry skin Edema Fatigue Fever Headache disorder Nausea Pruritus of skin Skin rash Vomiting |
Alopecia Anorexia Arthralgia Back pain Constipation Diarrhea Dizziness Dyschromia Dyspnea Flu-like symptoms Flushing Hair discoloration Hyperglycemia Muscle spasm Myalgia Night sweats Pain in extremities Pain in oropharynx Paresthesia Skin hypopigmentation Tachycardia |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for KIMMTRAK (tebentafusp-tebn):
Safety and efficacy of tebentafusp-tebn have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Tebentafusp-tebn may cause fetal harm based on its mechanism of action. There are no tebentafusp data in pregnant women and no animal reproductive and developmental toxicity studies have been conducted to date. Molecules of similar weight can cross the placenta, exposing the fetus. Advise women of the potential risk to the fetus.
It is not known whether tebentafusp-tebn distributes into milk in humans or animals or whether the drug has any effects on breastfed infants or on milk production. Because of the potential for serious adverse reactions to tebentafusp in breastfed infants, women should be advised to discontinue breastfeeding during tebentafusp therapy and for 1 week after the last dose.
No dosage adjustment is necessary. No overall differences in safety or efficacy were observed between patients >=65 years of age compared with younger adults. In the principle efficacy study, nearly half of the patients treated with tebentafusp-tebn were >=65 years of age and 9% were >=75 years of age.
The following prioritized warning is available for KIMMTRAK (tebentafusp-tebn):
WARNING: Tebentafusp may cause a certain serious (sometimes fatal) side effect known as cytokine release syndrome-CRS. You will be given this medication in a hospital or clinic so your doctor can watch for serious side effects and quickly provide treatment if needed. You will be monitored for at least 16 hours after the first 3 treatments.
You will be monitored for at least 30 minutes after later treatments. Tell your doctor right away if you develop symptoms such as fever, chills, headache, nausea, vomiting, stomach/abdominal pain, trouble breathing, skin rash, tiredness, or low blood pressure. If you have side effects, your doctor may temporarily stop or slow down your treatment with this medication. Your doctor may also prescribe other medications before you receive tebentafusp to decrease the risk of side effects.
WARNING: Tebentafusp may cause a certain serious (sometimes fatal) side effect known as cytokine release syndrome-CRS. You will be given this medication in a hospital or clinic so your doctor can watch for serious side effects and quickly provide treatment if needed. You will be monitored for at least 16 hours after the first 3 treatments.
You will be monitored for at least 30 minutes after later treatments. Tell your doctor right away if you develop symptoms such as fever, chills, headache, nausea, vomiting, stomach/abdominal pain, trouble breathing, skin rash, tiredness, or low blood pressure. If you have side effects, your doctor may temporarily stop or slow down your treatment with this medication. Your doctor may also prescribe other medications before you receive tebentafusp to decrease the risk of side effects.
The following icd codes are available for KIMMTRAK (tebentafusp-tebn)'s list of indications:
| Uveal melanoma in HLa-A *02:01 positive patient | |
| C69.3 | Malignant neoplasm of choroid |
| C69.30 | Malignant neoplasm of unspecified choroid |
| C69.31 | Malignant neoplasm of right choroid |
| C69.32 | Malignant neoplasm of left choroid |
| C69.4 | Malignant neoplasm of ciliary body |
| C69.40 | Malignant neoplasm of unspecified ciliary body |
| C69.41 | Malignant neoplasm of right ciliary body |
| C69.42 | Malignant neoplasm of left ciliary body |
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