Axatilimab-csfr
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Axatilimab-csfr is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody that is FDA approved for the treatment of 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.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Administer only as an intravenous infusion over 30 minutes.
- 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.
DOSAGE FORMS AND STRENGTHS
Injection: 9 mg/0.18 mL solution in a single-dose vial. Injection: 22 mg/0.44 mL solution in a single-dose vial. Injection: 50 mg/mL solution in a single-dose vial.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Axatilimab-csfr in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Axatilimab-csfr in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Axatilimab-csfr FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Axatilimab-csfr in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Axatilimab-csfr in pediatric patients.
Contraindications
There is limited information regarding Axatilimab-csfr Contraindications in the drug label.
Warnings
There is limited information regarding Axatilimab-csfr Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Axatilimab-csfr Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Axatilimab-csfr Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Axatilimab-csfr Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Axatilimab-csfr in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Axatilimab-csfr in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Axatilimab-csfr during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Axatilimab-csfr in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Axatilimab-csfr in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Axatilimab-csfr in geriatric settings.
Gender
There is no FDA guidance on the use of Axatilimab-csfr with respect to specific gender populations.
Race
There is no FDA guidance on the use of Axatilimab-csfr with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Axatilimab-csfr in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Axatilimab-csfr in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Axatilimab-csfr in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Axatilimab-csfr in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Axatilimab-csfr Administration in the drug label.
Monitoring
There is limited information regarding Axatilimab-csfr Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Axatilimab-csfr and IV administrations.
Overdosage
There is limited information regarding Axatilimab-csfr overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Axatilimab-csfr Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Axatilimab-csfr Mechanism of Action in the drug label.
Structure
There is limited information regarding Axatilimab-csfr Structure in the drug label.
Pharmacodynamics
There is limited information regarding Axatilimab-csfr Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Axatilimab-csfr Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Axatilimab-csfr Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Axatilimab-csfr Clinical Studies in the drug label.
How Supplied
There is limited information regarding Axatilimab-csfr How Supplied in the drug label.
Storage
There is limited information regarding Axatilimab-csfr Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Axatilimab-csfr Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Axatilimab-csfr interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Axatilimab-csfr Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Axatilimab-csfr Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.