NIKTIMVO Solution for injection Ref.[115487] Active ingredients: Axatilimab

Source: FDA, National Drug Code (US) Revision Year: 2025

1. Indications and Usage

NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

2. Dosage and Administration

2.1 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.

2.2 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.

Table 1. Recommended NIKTIMVO Dosage Modifications for Adverse Reactions:

Adverse Reaction	Severity*	Dosage Modification
Infusion-related reactions [see Warnings and Precautions (5.1)]	Grade 1 or 2	• Temporarily interrupt the infusion until resolution or decrease infusion rate by 50%. • Initiate symptomatic treatment (e.g., antihistamines and antipyretics). • For subsequent infusions, premedicate and resume the infusion at 50% of the prior infusion rate.
	Grade 3 or 4	Permanently discontinue NIKTIMVO.
Elevation of AST or ALT (on the day of dosing) [see Adverse Reactions (6.1)]	Grade 3 with total bilirubin ≤ Grade 1	Withhold NIKTIMVO until recovery to Grade 2, then resume NIKTIMVO at 0.2 mg/kg (maximum 23 mg) every 2 weeks.
Elevation of AST or ALT (regardless of the time of the reaction) [see Adverse Reactions (6.1)]	ALT or AST ≥ 3 times ULN with total bilirubin ≥2 times ULN and ALP <2 times ULN	Withhold NIKTIMVO and investigate for drug-induced liver injury. If confirmed, permanently discontinue NIKTIMVO.
	Grade 4	Permanently discontinue NIKTIMVO.
Elevation of CPK, amylase, or lipase [see Adverse Reactions (6.1)]	≥ Grade 3	• If diagnostic evaluation results show no evidence of end-organ damage, continue NIKTIMVO without dose reduction. • If diagnostic evaluation results show evidence of end-organ damage, permanently discontinue NIKTIMVO.
	Symptomatic ≥ Grade 3	Permanently discontinue NIKTIMVO.
Other Nonhematologic Adverse Reactions [see Adverse Reactions (6.1)]	Grade 3	Withhold NIKTIMVO until recovery to Grade 2: • If delayed by ≤ 4 weeks from the planned infusion, resume NIKTIMVO at 0.2 mg/kg (maximum 23 mg) every 2 weeks. • If delayed by >4 weeks from the planned infusion, permanently discontinue NIKTIMVO.
	Grade 4	Permanently discontinue NIKTIMVO.

AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; ALP = alkaline phosphatase; CPK = creatine phosphokinase.
^* Graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse
Events (CTCAE) v5.

2.3 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 [see Dosage and Administration (2.1)] 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.

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.

16.2. Storage and Handling

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

Manufactured by: Incyte Corporation, Wilmington, DE 19803, U.S. License No.2228

Licensed from: Syndax Pharmaceuticals, Inc., Waltham, MA 02451

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