Avacincaptad pegol

Avacincaptad pegol
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: Muhammad Waleed, M.B.B.S. [2]

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Overview

Avacincaptad pegol is a Avacincaptad pegol is a complement C5 protein inhibitor that is FDA approved for the treatment of IZERVAY is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).. Common adverse reactions include Common adverse reactions (≥5% of patients) include conjunctival hemorrhage, increased intraocular pressure, and endophthalmitis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

IZERVAY is available as an intravitreal injection solution in a strength of 20 mg/mL.The recommended dosage of IZERVAY is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection into the affected eye once every month.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

IZERVAY (avacincaptad pegol) does not have an approved pediatric indication or dosage.

Off-Label Use and Dosage (Pediatric)

Contraindications

IZERVAY is contraindicated in patients with ocular or periocular infections and in patients with active intraocular inflammation.

Warnings

Endophthalmitis and Retinal Detachments: Patients should be monitored for any signs of infection or retinal detachment following intravitreal injection. Increased Intraocular Pressure: Monitor intraocular pressure after the injection. Thromboembolic Events: Although rare, there is a potential risk for arterial thromboembolic events.

Adverse Reactions

Clinical Trials Experience

Common side effects include:

Increased intraocular pressure (9%) Blurred vision (8%) Eye bleeding (9%) Neovascular AMD (7%)​

Serious side effects include:

Eye infection Severe eye pain or redness Light sensitivity Visual disturbances​ .

Postmarketing Experience

There is limited information regarding Avacincaptad pegol Postmarketing Experience in the drug label.

Drug Interactions

No specific drug interaction studies have been performed.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There are no adequate data on IZERVAY use in pregnant women to inform any drug-associated risks.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Avacincaptad pegol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Avacincaptad pegol during labor and delivery.

Nursing Mothers

There are no data on the presence of avacincaptad pegol in human milk, its effects on the breastfed infant, or on milk production.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

No overall differences in safety or effectiveness were observed between elderly patients and younger patients.

Gender

There is no FDA guidance on the use of Avacincaptad pegol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Avacincaptad pegol with respect to specific racial populations.

Renal Impairment

No dosage adjustment is necessary.

Hepatic Impairment

No dosage adjustment is necessary.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Avacincaptad pegol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Avacincaptad pegol in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Avacincaptad pegol Administration in the drug label.

Monitoring

There is limited information regarding Avacincaptad pegol Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Avacincaptad pegol and IV administrations.

Overdosage

There is limited information regarding Avacincaptad pegol 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 Avacincaptad pegol Pharmacology in the drug label.

Mechanism of Action

Avacincaptad pegol is a complement C5 protein inhibitor. By binding to complement component 5 (C5), it prevents the cleavage into C5a and C5b, and subsequently inhibits the formation of the membrane attack complex (C5b-9). This action helps reduce inflammation and cell death in the retina associated with GA.

Structure

There is limited information regarding Avacincaptad pegol Structure in the drug label.

Pharmacodynamics

Inhibition of C5 by avacincaptad pegol leads to decreased inflammation in the retina.

Pharmacokinetics

The systemic exposure of avacincaptad pegol after intravitreal administration is low. The specifics of absorption, distribution, metabolism, and excretion are determined by the local administration and its targeted action within the eye.

Nonclinical Toxicology

There is limited information regarding Avacincaptad pegol Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Avacincaptad pegol Clinical Studies in the drug label.

How Supplied

There is limited information regarding Avacincaptad pegol How Supplied in the drug label.

Storage

There is limited information regarding Avacincaptad pegol Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Risk of Infection: Patients should be informed about the risk of endophthalmitis and advised to seek immediate medical attention if they experience symptoms such as eye pain, redness, sensitivity to light, or changes in vision. Adherence to Treatment Schedule: Patients should understand the importance of adhering to the monthly injection schedule.

Precautions with Alcohol

Alcohol-Avacincaptad pegol interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Avacincaptad pegol Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Avacincaptad pegol 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.