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 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 *are increased AST,
- infection (pathogen unspecified),
- increased ALT,
- decreased phosphate,
- decreased hemoglobin,
- viral infection,
- increased GGT,
- musculoskeletal pain,
- increased lipase,
- fatigue,
- increased amylase,
- increased calcium,
- increased CPK,
- increased ALP,
- nausea,
- headache,
- diarrhea,
- cough..
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)
- Treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in pediatric patients weighing at least 40 kg.
The recommended dosage of NIKTIMVO is 0.3 mg/kg (maximum 35 mg) every 2 weeks in pediatric patients weighing 40 kg and above
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
None.
Warnings
Infusion-Related Reactions
- NIKTIMVO can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received NIKTIMVO in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3%.
- Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to NIKTIMVO.
- Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue NIKTIMVO based on severity of the reaction.
Embryo-Fetal Toxicity
- Based on its mechanism of action, NIKTIMVO may cause fetal harm when administered to a pregnant woman.
- Advise pregnant women of the potential risk to the fetus.
- Advise females of reproductive potential to use effective contraception during treatment with NIKTIMVO and for 30 days after the last dose.
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.