Niktimvo Dosage

Recommended Dosage

For patients weighing at least 40 kg, administer NIKTIMVO 0.3 mg/kg, up to a maximum dose of 35 mg, as an intravenous infusion over 30 minutes every 2 weeks until progression or unacceptable toxicity.

Dosage Modifications for Adverse Reactions

Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of NIKTIMVO therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved.

For recommended NIKTIMVO dosage modifications due to adverse reactions, see Table 1.

Preparation and Administration

Preparation

• Use aseptic technique to prepare NIKTIMVO.
• Visually inspect the vial for particulate matter and discoloration prior to dilution. NIKTIMVO is a slightly opalescent, pale brownish yellow solution. Discard the vial if the solution is cloudy, discolored, or contains visible particles.
• Do not shake the vial.
• Determine the dose and total volume of NIKTIMVO solution needed. Each mL of NIKTIMVO contains 50 mg of axatilimab-csfr.

Dilution

• Withdraw the calculated volume of NIKTIMVO solution from the vial and add it into an intravenous infusion bag made of polyvinyl chloride (PVC), polyolefin, polyolefin with polyamide, or ethylene vinyl acetate (EVA) containing 0.9% Sodium Chloride Injection to achieve a final concentration between the range of 0.24 mg/mL and 0.75 mg/mL.
• Discard vial with any unused portion.
• Mix diluted solution by gentle inversion. Do not shake.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted solution is a clear to slightly opalescent, colorless solution that may contain trace amounts of translucent to white particles. Discard if the solution is cloudy, discolored, or contains extraneous particulate matter other than trace amounts of translucent to white particles.

Storage of diluted NIKTIMVO solution

• Immediately use diluted NIKTIMVO solution. If not used immediately, the diluted solution can be stored:
  
  - At room temperature [up to 25°C (77°F)] for no more than 4 hours from the time of preparation to the end of the infusion.
  
  OR
  
  - Refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours. If refrigerated, allow the diluted solution to come to room temperature prior to administration. The diluted solution must be administered within 4 hours (including infusion time) once it is removed from the refrigerator.

• Do not freeze or shake the diluted solution.

Administration

• Administer diluted NIKTIMVO solution by intravenous infusion over 30 minutes through a dedicated infusion line that includes a sterile, low-protein binding 0.2-micron in-line or add-on polyethersulfone (PES) filter.
• Do not co‑administer other drugs through the same infusion line.
• After administration, flush the infusion line with 0.9% Sodium Chloride Injection.