KIMMTRAK- tebentafusp injection, solution, concentrate
Immunocore Commercial LLC
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)].
KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
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)]. Information on FDA-approved tests is available at http://www.fda.gov/companiondiagnostics.
The recommended dosage of KIMMTRAK administered intravenously is:
- 20 mcg on Day 1
- 30 mcg on Day 8
- 68 mcg on Day 15
- 68 mcg once every week thereafter
Treat patients until unacceptable toxicity or disease progression occur.
Administer the first three infusions of KIMMTRAK in an appropriate healthcare setting by intravenous infusion over 15-20 minutes. Monitor patients during the infusion and for at least 16 hours after the infusion is complete.
If the patient does not experience Grade 2 or worse hypotension (requiring medical intervention) during or after the third infusion, administer subsequent doses in an appropriate ambulatory care setting, and monitor patients for a minimum of 30 minutes following each of these infusions [see Warnings and Precautions (5.1)].
No dosage reduction for KIMMTRAK is recommended. Dosage modifications for KIMMTRAK for adverse reactions are summarized in Table 1.
|a Based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (NCI CTCAEv4.03).|
|Adverse Reaction||Severity||KIMMTRAK Dosage Modifications|
|Cytokine Release Syndrome (CRS) [see Warnings and Precautions (5.1)]||Moderate defined as temperature ≥ 38°C with
|Severe defined as temperature ≥ 38°C with || |
|Life threatening defined as temperature ≥ 38°C with || |
|Skin Reactions [see Warnings and Precautions (5.2)]||Grade 2 or 3a|| |
|Grade 4a|| |
|Elevated Liver Enzymes [see Warnings and Precautions (5.3)]||Grade 3 or 4a|| |
|Other Adverse Reactions [see Adverse Reactions (6.1)]||Grade 3a|| |
|Grade 4a|| |
- A 2-step dilution process is required for preparation of the final KIMMTRAK dose for infusion.
- Use aseptic technique for dilution and preparation of intravenous infusion solutions.
- Visually inspect parenteral drug products and infusion bags for particulate matter and discoloration prior to administration, whenever solution and container permit.
Step 1: Preparation of the Infusion Bag
To prevent adsorption of tebentafusp-tebn to the infusion bag and other components of the drug delivery system, prepare an Albumin (Human) in 0.9% Sodium Chloride Injection, USP solution as follows:
- Using a 1 mL syringe with graduations of 2 decimal places and a sterile needle, withdraw the calculated volume of Albumin (Human) into the syringe (see Table 2 below) and add to the 100 mL 0.9% Sodium Chloride Injection, USP bag constructed of polyolefins (PO) [such as polyethylene (PE) and polypropylene (PP)] or polyvinyl chloride (PVC) to make a final Albumin (Human) concentration of 250 mcg/mL.
*Albumin (Human); use concentration as per local availability. Examples include but are not restricted to the following strengths: 5%, 20%, or 25%. 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
- Gently homogenize the prepared solution by completing the following steps:
- Invert the infusion bag so that the bag is upside down with the entry port positioned on top. Then tap the side of the port tubing to ensure that any residual solution is released into the bulk solution.
- Mix the prepared solution by gently rotating the bag lengthwise 360 degrees from the inverted position at least 5 times. Do not shake the infusion bag.
- Repeat (i) and (ii) an additional three times.
Step 2- Preparation of KIMMTRAK Solution for Infusion
- Do not shake the KIMMTRAK vial.
- Using a 1 mL syringe with graduations of 2 decimal places and a sterile needle, withdraw the required volume of KIMMTRAK 100 mcg/ 0.5 mL as per the dose required (shown in Table 3 below) and add to the prepared 100 mL infusion bag containing 0.9% Sodium Chloride Injection, USP plus Albumin (Human).
- Discard the single-dose vial containing the unused portion of KIMMTRAK in accordance with local requirements. Do not prepare more than one dose from the vial.
Day of treatment Dose (mcg) of KIMMTRAK Volume (mL) of KIMMTRAK Day 1 20 0.1 Day 8 30 0.15 Day 15 and weekly thereafter 68 0.34
- Mix the infusion bag by following the same procedure outlined in Step 1b.
- Immediately administer the diluted solution via intravenous infusion over 15-20 minutes through a dedicated intravenous line. A sterile, non-pyrogenic, low protein binding 0.2 micron in-line filter infusion set should be used. Administer the entire contents of the KIMMTRAK infusion bag.
- Administer the prepared infusion bag within 4 hours from the time of preparation including the duration of infusion. During the 4-hour window, the KIMMTRAK infusion bag should remain at room temperature.
- If not used immediately, store the KIMMTRAK infusion bag in a refrigerator at 2°C to 8°C (36°F to 46°F) and infuse within 24 hours from the time of preparation, which includes the storage time in the refrigerator, the time allowed for equilibration of the infusion bag to room temperature, and the duration of the infusion.
- Once removed from the refrigerator, do not refrigerate KIMMTRAK infusion bag again. Do not freeze. Discard unused KIMMTRAK solution beyond the recommended storage time.
- Do not mix KIMMTRAK with other drugs or administer other drugs through the same intravenous line.
- Upon completion of KIMMTRAK infusion, flush the infusion line with adequate volume of sterile 0.9% Sodium Chloride Injection, USP to ensure that the entire contents of the infusion bag are administered.
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