Kimmtrak

About Kimmtrak (Tebentafusp-tebn)

• Tebentafusp, marketed under the brand name Kimmtrak, is a novel bispecific gp100 peptide-HLA-directed CD3 T cell engager.
• Tebentafusp injection is administered through intravenous infusion, Tebentafusp received approval for medical use in the United States on January 25, 2022, with the distinction of being considered a first-in-class medication by the US Food and Drug Administration (FDA).
• Tebentafusp is indicated for the treatment of unresectable or metastatic uveal melanoma in adult patients who are HLA-A 02:01-positive. 
• Tebentafusp, a bispecific fusion protein targets gp100, a melanoma-associated antigen, utilizing a high-affinity T-cell receptor (TCR) binding domain coupled with an anti-CD3 T-cell engaging domain. 
• This unique mechanism redirects T cells, harnessing their potency to eliminate tumor cells expressing gp100. 
• The FDA’s recognition of Tebentafusp as a first-in-class medication underscores its status as an innovative and unparalleled therapeutic option for HLA-A02:01-positive uveal melanoma patients.
• Uveal melanoma, categorized as a rare form of cancer, manifests within the eye’s tissues. Termed intraocular or ocular melanoma, this specific cancer type is exceptionally uncommon, with an incidence rate of only five individuals per million.

Strength: 

The medication is provided in the form of a single-dose vial containing Kimmtrak 100 mcg/0.5 mL solution for intravenous injection.

Recommended Dosage:

The preparation of Kimmtrak for infusion involves a two-step dilution process, emphasizing aseptic techniques. Prior to administration, a visual inspection of parenteral products and infusion bags is recommended. In the first step, an Albumin (Human) in 0.9% Sodium Chloride Injection,  solution is prepared to prevent adsorption of tebentafusp-tebn. The infusion bag is gently homogenized to ensure a uniform solution. 

In the second step, Kimmtrak 100 mcg/0.5 mL is added to the prepared infusion bag containing 0.9% Sodium Chloride Injection, USP plus Albumin (Human). The Kimmtrak vial is not shaken, and any unused portion is discarded in accordance with local requirements. This meticulous process guarantees the proper dilution and preparation of Kimmtrak, a first-in-class bispecific gp100 peptide-HLA-directed CD3 T cell engager, approved for the treatment of unresectable or metastatic uveal melanoma in HLA-A*02:01-positive adult patients.

• The recommended dosage for Kimmtrak involves a series of intravenous infusions: 20 mcg on Day 1, 30 mcg on Day 8, 68 mcg on Day 15, followed by a weekly administration of 68 mcg thereafter. 
• The infusion should be diluted and administered intravenously over 15-20 minutes. 
• Individual safety and tolerability will be monitored, and dosage interruption or permanent discontinuation may be necessary based on the patient’s specific circumstances.

Important:

Administer the diluted Kimmtrak solution promptly through a dedicated intravenous line, using a sterile, non-pyrogenic, low protein binding 0.2-micron in-line filter infusion set. Ensure the entire contents of the infusion bag are delivered over 15-20 minutes. Administer within 4 hours of preparation at room temperature or, if not used immediately, store in a refrigerator at 2°C to 8°C and infuse within 24 hours. 

Do not refrigerate the bag again after removal from the refrigerator, and discard any unused solution beyond the recommended storage time. Avoid mixing Kimmtrak with other drugs or using the same intravenous line for different drugs. Flush the infusion line with sterile 0.9% Sodium Chloride Injection, USP after Kimmtrak infusion to ensure complete administration of the infusion bag’s contents.

Warnings & Precautions

• Patients receiving Kimmtrak may experience Cytokine Release Syndrome (CRS), which has the potential to be serious or life-threatening. 
• It is recommended to monitor patients for at least 16 hours following the first three infusions and subsequently as clinically indicated. 
• Skin reactions, such as rash, pruritus, and cutaneous edema, have been observed, and if they occur, treatment should be based on the persistence and severity of symptoms. 
• Additionally, Kimmtrak treatment has been associated with elevated liver enzymes, and monitoring of ALT, AST, and total bilirubin is advised to assess liver function. 
• Vigilant monitoring and appropriate interventions are crucial in managing these potential adverse effects.
• Inform your doctor about all current medications to prevent potential drug interactions. This ensures your healthcare provider can effectively manage your overall medication regimen, adjust dosages if needed, and minimize the risk of adverse effects or compromised therapeutic outcomes.

Common Kimmtrak Side Effects:

• Cytokine release syndrome (CRS)
• Back pain
• Burning/crawling/itching/numbness/tingling
• Constipation
• Difficulty moving
• Joint pain/swelling
• Skin lightening
• Hair loss/thinning
• Muscle aches/cramps/pain/stiffness
• Night sweats
• Arm/leg pain
• Runny nose
• Shivering
• Sore throat
• Trouble sleeping
• Rash
• Pyrexia (fever)
• Pruritus (itching)
• Fatigue
• Nausea & vomiting
• Chills
• Abdominal pain
• Edema (swelling)
• Hypotension (low blood pressure)
• Dry skin
• Headache
• Dizziness
• Urinary tract infection
• Difficulty breathing
• Seizures

Use in Specific Population

• Due to its mechanism of action, Kimmtrak has the potential to cause fetal harm if administered to pregnant women. 
• There is no available data on the presence of tebentafusp-tebn in human milk, its impact on breastfeeding infants, or its effects on milk production.
• Considering the potential excretion of tebentafusp-tebn in human milk and the risk of serious adverse reactions in breastfeeding infants, patients are advised not to breastfeed during Kimmtrak treatment and for at least one week after the last dose.
• For females and males of reproductive potential, pregnancy testing is recommended for females before initiating Kimmtrak treatment. 
• Females of reproductive potential should employ effective contraception during treatment and for one week following the final dose, as Kimmtrak may pose a risk of fetal harm. 
• The safety and efficacy of Kimmtrak have not been established in pediatric patients, and while no significant differences were observed in patients aged 65 and older compared to younger adults, further studies are needed to determine its appropriateness for the pediatric population.

Storage and Handling

• Keep Kimmtrak stored in its original carton and refrigerated at 2°C to 8°C (36°F to 46°F). 
• Do not freeze the medicine. 
• Protect Kimmtrak from direct light exposure. 
• Keep the medicine away from pets and children.