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
|
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)
Recommended Vaccination and Prophylaxis
- Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current ACIP recommendations at least 2 weeks prior to initiation of EMPAVELI therapy.
- If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis, according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible.
- Healthcare professionals who prescribe EMPAVELI must enroll in the REMS for EMPAVELI
Recommended Dosage Regimen
- The recommended dose of EMPAVELI is 1,080 mg administered subcutaneously twice weekly. EMPAVELI can be administered via a commercially available infusion pump with a reservoir of at least 20 mL or with EMPAVELI Injector.
Dosage for patients switching to EMPAVELI from C5 inhibitors
To reduce the risk of hemolysis with abrupt treatment discontinuation:
- For patients switching from eculizumab, initiate EMPAVELI while continuing eculizumab at its current dose. After 4 weeks, discontinue eculizumab before continuing on monotherapy with EMPAVELI.
- For patients switching from ravulizumab, initiate EMPAVELI no more than 4 weeks after the last dose of ravulizumab.
Dose Adjustment
- For lactate dehydrogenase (LDH) levels greater than 2 × the upper limit of normal (ULN), adjust the dosing regimen to 1,080 mg every three days.
- In the event of a dose increase, monitor LDH twice weekly for at least 4 weeks.
Missed Dose
- Administer EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose.
Administration
EMPAVELI is for subcutaneous administration using:
- an infusion pump OR
- EMPAVELI Injector, a single-use, disposable on body injector
- EMPAVELI is intended for use under the guidance of a healthcare professional. Train patients and/or caregivers on how to prepare and administer EMPAVELI prior to use. After proper training a patient may self-administer, or the patient's caregiver may administer EMPAVELI, if a healthcare provider determines that it is appropriate.
- Follow the steps below and use aseptic technique to prepare and administer EMPAVELI, either by an infusion pump or EMPAVELI Injector:
- Prior to use‚ allow EMPAVELI to reach room temperature for approximately 30 minutes. Keep the vial in the carton until ready for use to protect from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EMPAVELI is a clear, colorless to slightly yellowish solution. Do not use if the liquid looks cloudy, contains particles, or is dark yellow.
- Discard any unused portion of EMPAVELI.
Preparation with Infusion Pump
- Refer to the EMPAVELI Instructions for Use and the infusion pump manufacturer's instructions for full preparation and administration information.
- Use a needleless transfer device (such as a vial adapter) or a transfer needle to fill the syringe.
- Rotate infusion sites (i.e., abdomen, thighs, hips, upper arms) from one infusion to the next. Do not infuse where the skin is tender, bruised, red, or hard. Avoid infusing into tattoos, scars, or stretch marks.
- If multi-infusion sets are needed, ensure the infusion sites are at least 3 inches apart.
- The typical infusion time is approximately 30 minutes (if using two infusion sites) or approximately 60 minutes (if using one infusion site).
Preparation with EMPAVELI Injector
- Refer to the EMPAVELI Injector Instructions for Use, which comes with the device.
- Use a needleless transfer device (such as a vial adapter).
- EMPAVELI Injector is for abdominal subcutaneous use only. Rotate the site of each subcutaneous administration. Do not inject where the skin is tender, bruised, red, or hard. Avoid injecting into tattoos, scars, or stretch marks.
- Injection time is approximately 30 to 60 minutes.
- Injection: 1,080 mg/20 mL (54 mg/mL) clear, colorless to slightly yellowish 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 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.