Pegcetacoplan
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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Black Box Warning
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SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
See full prescribing information for complete Boxed Warning.
Condition Name: (EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B [see Warnings and Precautions (5.1)]. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS ) |
Overview
Pegcetacoplan is a complement inhibitor that is FDA approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).. There is a Black Box Warning for this drug as shown here. Common adverse reactions include injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Pegcetacoplan FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pegcetacoplan in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pegcetacoplan in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Pegcetacoplan 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 Pegcetacoplan in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pegcetacoplan in pediatric patients.
Contraindications
There is limited information regarding Pegcetacoplan Contraindications in the drug label.
Warnings
|
SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
See full prescribing information for complete Boxed Warning.
Condition Name: (EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B [see Warnings and Precautions (5.1)]. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS ) |
There is limited information regarding Pegcetacoplan Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Pegcetacoplan Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Pegcetacoplan Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Pegcetacoplan Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Pegcetacoplan in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pegcetacoplan in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pegcetacoplan during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pegcetacoplan in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Pegcetacoplan in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Pegcetacoplan in geriatric settings.
Gender
There is no FDA guidance on the use of Pegcetacoplan with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pegcetacoplan with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pegcetacoplan in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pegcetacoplan in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pegcetacoplan in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pegcetacoplan in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Pegcetacoplan Administration in the drug label.
Monitoring
There is limited information regarding Pegcetacoplan Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Pegcetacoplan and IV administrations.
Overdosage
There is limited information regarding Pegcetacoplan 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 Pegcetacoplan Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Pegcetacoplan Mechanism of Action in the drug label.
Structure
There is limited information regarding Pegcetacoplan Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pegcetacoplan Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Pegcetacoplan Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Pegcetacoplan Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Pegcetacoplan Clinical Studies in the drug label.
How Supplied
There is limited information regarding Pegcetacoplan How Supplied in the drug label.
Storage
There is limited information regarding Pegcetacoplan 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 Pegcetacoplan Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Pegcetacoplan 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 Pegcetacoplan Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Pegcetacoplan 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.