Anifrolumab-fnia
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
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Overview
Anifrolumab-fnia is a type I interferon receptor antagonist that is FDA approved for the treatment of moderate-to severe systemic lupus erythematousus along with standard therapy. Common adverse reactions include bronchitis, nasopharyngitis, herpes zoster, upper respiratory tract infections, infusion related reactions, and cough.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- 300 mg is the recommended dosage of Anifrolumab-fnia.
- Recommended dosage should be given every 4 weeks as an intravenous infusion that takes 30 minutes.
- Administer recommended dosage as soon as possible if a dosage of Anifrolumab-fnia is missed.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Anifrolumab-fnia in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Anifrolumab-fnia in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Anifrolumab-fnia 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 Anifrolumab-fnia in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Anifrolumab-fnia in pediatric patients.
Contraindications
- Patients that have a history of anaphylaxis when taking Anifrolumab-fnia are contradicted.
Warnings
Serious Infections
- Some patients have reported serious and fatal infections when treated with Anifrolumab-fnia.
- Clinical studies show that patients treated with Anifrolumab-fnia were more likely to experience a fatal infection in comparison to patients treated with a placebo.
- Clinical studies show similar reports of experiencing serious infections when comparing the Anifrolumab-fnia to the placebo group.
- Clinical studies showed that risk of herpes zoster and respiratory infections are increased in patients taking Anifrolumab-fnia.
- Advise patients about the risks and benefits of Anifrolumab-fnia treatment.
- Anifrolumab-fnia treatment should be avoided in patients with any clinically significant active infection until infection is resolved.
- Anifrolumab-fnia treatment may be interrupted if a patients is experiencing is not responding to standard anti-infective therapy or develops an infection.
Hypersensitivity Reactions Including Anaphylaxis
- Patients have experienced serious hypersensitivity reactions, infusion-related reactions, and angioedema when treated Anifrolumab-fnia.
- Advise patients that their healthcare provider who can manage hypersensitivity reactions should administer Anifrolumab-fnia treatment.
- Advise patients to seek immediate therapy if they experience hypersensitivity reactions or serious infusion-related reactions when taking Anifrolumab-fnia.
Malignancy
- Immunosuppressants use can increase risk of malignancies.
- Development of potential malignancies during Anifrolumab-fnia treatment is still unknown.
- Advise patients about the risks and benefits of Anifrolumab-fnia treatment if malignancies develop.
Immunization
- Advise patients who have had a live or live-attenuated vaccines should avoid concurrent use with Anifrolumab-fnia.
- Advise patients prior to Anifrolumab-fnia treatment should update immunizations record.
Not Recommended for Concomitant Use with Other Biologic Therapies
- Advise patients to avoid a combination of biologic therapies and Anifrolumab-fnia treatment.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Anifrolumab-fnia Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Anifrolumab-fnia Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Anifrolumab-fnia Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Anifrolumab-fnia in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Anifrolumab-fnia in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Anifrolumab-fnia during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Anifrolumab-fnia in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Anifrolumab-fnia in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Anifrolumab-fnia in geriatric settings.
Gender
There is no FDA guidance on the use of Anifrolumab-fnia with respect to specific gender populations.
Race
There is no FDA guidance on the use of Anifrolumab-fnia with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Anifrolumab-fnia in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Anifrolumab-fnia in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Anifrolumab-fnia in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Anifrolumab-fnia in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Anifrolumab-fnia Administration in the drug label.
Monitoring
There is limited information regarding Anifrolumab-fnia Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Anifrolumab-fnia and IV administrations.
Overdosage
There is limited information regarding Anifrolumab-fnia 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 Anifrolumab-fnia Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Anifrolumab-fnia Mechanism of Action in the drug label.
Structure
There is limited information regarding Anifrolumab-fnia Structure in the drug label.
Pharmacodynamics
There is limited information regarding Anifrolumab-fnia Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Anifrolumab-fnia Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Anifrolumab-fnia Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Anifrolumab-fnia Clinical Studies in the drug label.
How Supplied
There is limited information regarding Anifrolumab-fnia How Supplied in the drug label.
Storage
There is limited information regarding Anifrolumab-fnia 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 Anifrolumab-fnia Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Anifrolumab-fnia 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 Anifrolumab-fnia Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Anifrolumab-fnia 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.