Axatilimab-csfr

Axatilimab-csfr
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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.