Niktimvo
(Axatilimab-Csfr)Check Drug InteractionsCheck known drug interactions.
Check Drug InteractionsDosage & Administration
See Full Prescribing Information for 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.
| 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 ] | Grade 1 or 2 | |
| Grade 3 or 4 | Permanently discontinue NIKTIMVO. | |
| Elevation of AST or ALT (on the day of dosing) [see Adverse Reactions ] | 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 ] | 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 ] | ≥ Grade 3 | |
| Symptomatic ≥ Grade 3 | Permanently discontinue NIKTIMVO. | |
| Other Nonhematologic Adverse Reactions [see Adverse Reactions ] | Grade 3 | Withhold NIKTIMVO until recovery to Grade 2: |
| Grade 4 | Permanently discontinue NIKTIMVO. | |
Preparation
Dilution
Storage of diluted NIKTIMVO solution
Administration
PrescriberAI is currently offline. Try again later.
By using PrescriberAI, you agree to the AI Terms of Use.
This AI tool offers medical information for informational purposes only and is not a substitute for professional medical judgment or advice.
Physicians and healthcare professionals should exercise their expertise and discretion when interpreting and applying the provided information to specific clinical situations.
Niktimvo Prescribing Information
Dosage and Administration (Preparation
Dilution
Storage of diluted NIKTIMVO solution
Administration
| 1/2025 |
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.
- Administer only as an intravenous infusion over 30 minutes. ()
2.3 Preparation and AdministrationPreparation- 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. 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.
- The recommended dosage of NIKTIMVO is 0.3 mg/kg (maximum 35 mg) every 2 weeks in adult and pediatric patients weighing 40 kg and above. ()
2.1 Recommended DosageFor 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.
See Full Prescribing Information for 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.
| 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 ] | Grade 1 or 2 |
|
| Grade 3 or 4 | Permanently discontinue NIKTIMVO. | |
| Elevation of AST or ALT (on the day of dosing) [see Adverse Reactions ] | 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 ] | 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 ] | ≥ Grade 3 |
|
| Symptomatic ≥ Grade 3 | Permanently discontinue NIKTIMVO. | |
| Other Nonhematologic Adverse Reactions [see Adverse Reactions ] | Grade 3 | Withhold NIKTIMVO until recovery to Grade 2:
|
| Grade 4 | Permanently discontinue NIKTIMVO. | |
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. 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.
NIKTIMVO injection is a slightly opalescent, pale brownish yellow solution available as:
- 9 mg/0.18 mL in a single-dose vial.
- 22 mg/0.44 mL in a single-dose vial.
- 50 mg/mL in a single-dose vial.
Lactation: Advise not to breastfeed. (
Risk Summary
There are no data on the presence of axatilimab-csfr in human milk or the effects on the breastfed child or milk production. Maternal IgG is known to be present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of NIKTIMVO.
None.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available