Kimmtrak

Generic Name: tebentafusp-tebn

Dosage Form: injection

Medically reviewed, A Ras MD. Updated on March 24, 2022.

What is Kimmtrak?

Kimmtrak is a prescription medication for adults who are HLA-A*02:01 positive with uveal cancer that can’t be treated surgically or has developed.

Your doctor will check for the presence of the gene HLA-A*02:01 to determine if Kimmtrak is appropriate for you. It isn’t known whether this medication can be used safely and effectively for children.

Tebentafusp-tebn is a CD3 T cell engager with a bispecific gp100 peptide-HLA-directed T cell receptor. Tebentafusp-tebn has a molecular weight of about 77 kDa. Tebentafusp-tebn is made in E. coli bacteria using recombinant DNA technology.

KIMMTRAK (tebentafusp-tebn) injection comes as a sterile, preservative-free, clear, colorless, or slightly yellowish solution for intravenous infusion in a single-dose vial.

Tebentafusp-tebn (100 mcg), citric acid monohydrate (0.95 mg), disodium hydrogen phosphate (2.91 mg), mannitol (5 mg), polysorbate 20 (0.1 mg), trehalose (25 mg), and water for injection with a pH of 6.5 are all contained in each single-dose vial.

Mechanism of Action

Tebentafusp-tebn is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumor cells.

In vitro, tebentafusp-tebn bound to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumor cells.

Important information

Kimmtrak can trigger severe side effects that could be life-threatening. It generally occurs during the very first 3 injections. These adverse effects include:

Your healthcare provider will test for these issues in the course of treatment. Your healthcare provider could temporarily suspend or stop treatment if you experience serious adverse effects.

Warnings and Precautions

Prior to receiving Kimmtrak

Before you get Kimmtrak inform your healthcare provider of the medical conditions you suffer from for example, if you are:

For females who have the potential to get pregnant:

What other medications could have an effect on Kimmtrak?

Inform your doctor about the medicines you are taking such as prescription and over-the-counter medications such as vitamins, herbal supplements.

How do I get my Kimmtrak?

Dosage and administration

kimmtrak

Selection of Patients

Patients should be selected for treatment of metastatic or unresectable uveal melanoma by using KIMMTRAK using an HLA-A*02-02:01 genotyping test that is positive, A FDA-approved test for identification of HLA-A*02 genotypes isn’t currently available.

 Dosage Recommendation

The dose of KIMMTRAK that is recommended to be administered via intravenously is:

  • 20 mg on Day 1.
  • 30 mg on Day 8
  • The 68 mg mcg level on Day 15
  • One dose of 68 mg once a week after that

Treat patients until toxic levels or progression of disease occurs.

Infuse the first three times of KIMMTRAK in a safe medical setting using intravenous infusions lasting between 15 and 20 minutes. Be sure to monitor patients throughout the infusion as well as until at the least 16 hours following the infusion has been completed.

If the patient doesn’t have Grade 2 or greater hypotension (requiring medical intervention) following or immediately following the third infusion, give additional doses in a suitable medical setting. Also, keep track of patients for at least 30 minutes after each infusion.

Dosage Modifications to prevent adverse Reactions

Dosage reduction for KIMMTRAK is not recommended. is suggested. Dosage adjustments for KIMMTRAK in case of adverse reactions are listed in Table 1.

Table 1. Modifications to Dose to adverse reactions
Adverse Reaction Severity KIMMTRAK Dosage Modifications
Cytokine Release Syndrome (CRS) Moderate defined as temperature ≥ 38°C with

  • Hypotension that responds to fluids (does not require vasopressors) or
  • Hypoxia requiring low flow nasal canula (≤ 6 L/min) or blow-by oxygen
  • If hypotension and hypoxia do not improve within 3 hours or CRS worsens, escalate care and manage according to next higher level of severity
  • For moderate CRS that is persistent (lasting 2-3 hours) or recurrent, administer corticosteroid premedication (e.g. dexamethasone 4 mg or equivalent) at least 30 minutes prior to next dose
Severe defined as temperature ≥ 38°C with

  • Hemodynamic instability requiring a vasopressor (with or without vasopressin) or
  • Worsening hypoxia or respiratory distress requiring high flow nasal canula (> 6 L/min oxygen) or face mask
  • Withhold KIMMTRAK until CRS and sequelae have resolved
  • Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent)
  • Resume KIMMTRAK at same dose level (i.e., do not escalate if severe CRS occurred during initial dose escalation; resume escalation once dosage is tolerated)
  • For severe CRS, administer corticosteroid premedication (e.g. dexamethasone 4 mg or equivalent) at least 30 minutes prior to next dose
Life threatening defined as temperature ≥ 38°C with

  • Hemodynamic instability requiring multiple vasopressors (excluding vasopressin)
  • Worsening hypoxia or respiratory distress despite oxygen administration requiring positive pressure
  • Permanently discontinue KIMMTRAK
  • Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent)
Skin Reactions Grade 2 or 3a
  • Withhold KIMMTRAK until ≤ Grade 1 or baseline
  • Resume KIMMTRAK at same dose level (i.e., do not escalate if Grade 3 skin reactions occurred during initial dose escalation; resume escalation once dosage is tolerated)
  • For persistent reactions not responding to oral steroids, consider intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent)
Grade 4a
  • Permanently discontinue KIMMTRAK
  • Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent)
Elevated Liver Enzymes Grade 3 or 4a
  • Withhold KIMMTRAK until ≤ Grade 1 or baseline.
  • Resume KIMMTRAK at same dose level if the elevated liver enzymes occur in the setting of Grade 3 CRS; resume escalation if next administration is tolerated.
  • If the elevated liver enzymes occur outside the setting of Grade 3 CRS
    • resume escalation if the current dose is less than 68 mcg,
    • or resume at same dose level if dose escalation has completed
  • Administer intravenous corticosteroids if no improvement within 24 hours
Other Adverse Reactions Grade 3a
  • Withhold KIMMTRAK until ≤ Grade 1 or baseline
  • Resume KIMMTRAK at same dose level (i.e., do not escalate if other Grade 3 adverse reaction occurred during initial dose escalation; resume escalation once dosage is tolerated)
Grade 4a
  • Permanently discontinue KIMMTRAK

 

Preparedness and administration

Preparation

  • Two steps of dilution are necessary for the preparation of your final KIMMTRAK dose to be used for infusion.
  • Utilize an aseptic method for dilution and the preparation of solutions for infusion intravenously.
  • Examine parenteral drugs or infusion containers for particles of material and coloration prior to administration, if the containers and solutions allow.

Step 1 Making the Infusion Bag

To stop the adsorption process of KIMMTRAK to the infusion bag as well as others of the delivery device make the Albumin (Human) in a 0.9 percent Sodium Chloride Injection USP solution following:

  • With a 1mL syringe featuring graduation intervals that are 2 decimal places, and a needle that is sterile, take the measured volume of albumin (Human) in the Syringe (see TABLE 2 Below) and add it to the 100 milliliters below) and add to the 100 0.9 below) and then add to the 100 mL 0.9 Sodium Chloride Injection USP bag that is made up from polyolefins (PO) (such as below) and add to the polyethylene (PE) as well as polypropylene (PP)(see below) (or polyvinyl chloride (PVC) to create an Albumin (Human) amount of around 250 mg/mL. Table 2 Illustrations of albumin (Human) concentration and volumes

Table2: Examples of Albumin (Human) Concentration and Volumes

Albumin (Human) concentration* Albumin (Human) volume for addition to a 100 mL 0.9% Sodium Chloride Injection, USP Infusion Bag to prepare a concentration of 250 mcg/mL Albumin (Human) in 0.9% Sodium Chloride Injection, USP
5% (50 g/L) 0.5 mL
20% (200 g/L) 0.13 mL
25% (250 g/L) 0.1 mL
  • The solution is homogenized by following the steps:
    1. The infusion bag should be turned upside down in such a way that it is upside down, with the entry port on the top. Then, tap the sides of the tubing for the port to ensure that any remaining solution is dispersed through the bulk solution.
    2. Mix the solution in a bowl by gently turning the bag’s length 360 degrees away from the inverted position at least five times. Don’t shake the bag infusion.
    3. Repeat (i) and (ii) 3 more times.

Step 2-Preparation of KIMMTRAK Solution for Infusion

  • Don’t shake your KIMMTRAK vial.
  • Utilizing a syringe of 1 mL with graduations of two decimal places and using a needle that is sterile, take the amount of KIMMTRAK 100 mcg or 0.5 milliliters as per the dosage needed (shown in TABLE 3 below) and then add it to the prepared 100 mL injection bag that contains 0.9 percent Sodium Chloride Injection (USP) as well as albumin (Human).
  • Take out the single-dose vial that contains the unopened portion of KIMMTRAK according to the local guidelines. Do not take multiple doses in the vial. Table 3: KIMMTRAK Volumes Required for addition to the Infusion Bag

Table3: KIMMTRAK Volumes Required for Addition to the Infusion Bag

Day of treatment Dose (mcg) of KIMMTRAK Volume (mL) of KIMTRAK
Day 1 20 0.1
Day 8 30 0.15
Day 15 and every week following 68 0.34
  • Infusion bags should be mixed following the same steps as in step 1b.

Administration

  • The solution should be administered immediately by intravenous infusion for a period of 15-20 minutes using a designated intravenous line. A non-pyrogenic, sterile, high protein-binding 0.2 micron in-line filter set is recommended. Infuse the entire contents of KIMTRAK infusion bag.
  • The infusion bag that you have prepared should be administered within four hours from when you prepare it, and the time of infusion. In the time frame of 4 hours infusion time, your KIMMTRAK infusion bag is to be left at ambient temperature.
  • If not immediately used then store your KIMMTRAK bags in the refrigerator at 2degC-8degC (36degF up to 46degF) and then infuse it within 24 hours of when you prepare it including the storage time at the refrigeration unit, the amount of time that is needed to bring the bag infusion to room temperature, as well as the time that the infusion will last.
  • After you have removed the bag from the refrigerator, don’t refrigerate KIMMTRAK infusion bag for another time. Don’t freeze. Throw away any unused KIMMTRAK solution after the storage period recommended.
  • Don’t mix KIMMTRAK with other medicines or administer other drugs via an intravenous vein.
  • After the completion of KIMMTRAK infusion after the infusion has been completed, flush the line with a sufficient amount of pure 0.9 percent Sodium Chloride Injection USP to ensure that all the contents of the bag are given.

 

Kimmtrak side effects

Kimmtrak could have serious adverse negative side effects, such as:

The most frequent side effects are:

There are many possible adverse negative effects. Contact your physician to get medical advice on possible side effects. You can report adverse reactions to the FDA via 1-800-FDA1088..

General information regarding the safe and efficient use of Kimmtrak.

Some medicines are used for reasons other than those mentioned in a Patient Information Leaflet. If you’d like more information, speak to your healthcare professional. You could ask your healthcare professional for additional information specifically written for healthcare professionals.

How supplied

Each KIMMTRAK (tebentafusp-tebn) injection carton (NDC 80446-401-01) contains:

The vial stopper is not made with natural rubber latex.

Storage and Handling

Label

KIMMTRAK

  • 80446-401-01 – 100 mcg/0.5 mL Vial Label

KIMMTRAK

Additional details

Always consult your doctor to make sure the information presented on this site is appropriate to your particular situation.

 

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