Axatilimab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Colony Stimulating Factor-1 Receptor Blocker
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration NIKTIMVO 9 mg and 22 mg are available in different concentrations: 9 mg/0.18 mL 9 mg/0.9 mL 22 mg/0.44 mL 22 mg/2.2 mL (10 mg/mL) Prior to preparation, check the vial labels to confirm which concentration is being used to avoid dosing errors, including underdosage and overdosage [see Dosage Forms and Strengths] .
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] and total volume of NIKTIMVO solution needed.
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.
| AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; ALP = alkaline phosphatase; CPK = creatine phosphokinase. | ||
| Adverse Reaction | SeverityGraded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5. | 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. | |
Drug interactions
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- Axatilimab
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Axatilimab is a humanized monoclonal antibody to the colony stimulating factor-1 receptor that is used to treat patients with chronic graft-versus-host disease who have active disease despite having received at least two previous systemic therapies. Axatilimab therapy is often accompanied by transient serum enzyme elevations, but it has not been linked to instances of clinically apparent liver injury with jaundice.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, NIKTIMVO may cause fetal harm when administered to pregnant women [see Clinical Pharmacology ( 12.1 )] . There are no available data on the use of NIKTIMVO in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with axatilimab-csfr. Targeted mutation of CSF-1R or CSF-1 in rodent models results in prenatal and perinatal death, deficits in growth, and pleiotropic impact on multiple organ systems, including skeletal and reproductive.
Regulation by CSF-1R on non-mononuclear phagocytic cells and macrophages plays a role in the innate immune protection of the fetus and in pregnancy maintenance and embryo-fetal development. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, NIKTIMVO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Breastfeeding (LactMed)
No information is available on the use of axatilimab during breastfeeding. Because axatilimab is a large protein molecule with a molecular weight of about 150,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. The manufacturer recommends that breastfeeding be discontinued during therapy and for 30 days after the last dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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