pegcetacoplan
Empaveli
Pharmaceutical company: Apellis Pharmaceuticals
Pharmacologic classification:Complement inhibitor
Therapeutic classification:Immunomodulator
AVAILABLE FORMS
Tablets: 1,080 mg/20 mL (54 mg/mL) single-dose vial
INDICATIONS AND DOSAGES
Paroxysmal nocturnal hemoglobinuria (PNH)
Adults: 1,080 mg subcut infusion twice weekly via infusion pump.
Adjust-a-dose: For LDH greater than twice the upper limit of normal, infuse 1,080 mg subcut every three days and monitor LDH twice weekly for at least 4 weeks. To reduce the risk of hemolysis with abrupt treatment discontinuation when switching from eculizumab, initiate pegcetacoplan while continuing eculizumab at its current dose; after 4 weeks, discontinue eculizumab and continue pegcetacoplan. When switching from ravulizumab, initiate pegcetacoplan no more than 4 weeks after the last dose of ravulizumab.
CONTRAINDICATIONS AND CAUTIONS
- Black Box Warning: Meningococcal infections may occur in patients treated with pegcetacoplan and may become rapidly life-threatening or fatal if not recognized and treated early. Use predisposes patients to serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae type B.
- Black Box Warning: Contraindicated in patients not currently vaccinated against encapsulated bacteria (including S. pneumoniae, N. meningitidis types A, C, W, Y, and B, and H. influenzae type B) unless the risk of delaying treatment outweighs the risk of developing such a bacterial infection.
- Alert:Contraindicated in patients with serious infection caused by encapsulated bacteria, including S. pneumoniae, N. meningitidis, and H. influenzae.
- Black Box Warning: Pegcetacoplan is available only through a REMS program. Prescribers must enroll in the program by phone (888-343-7073) or at www.empavelirems.com.
- Contraindicated in patients with hypersensitivity to pegcetacoplan or excipients.
- Hypersensitivity reactions (facial swelling, rash, urticaria) may occur. If a severe hypersensitivity reaction (including anaphylaxis) occurs, immediately discontinue infusion, treat per standard of care, and monitor until signs and symptoms resolve.
- Safety and effectiveness in children have not been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- This drug may cause embryo-fetal harm. There are risks to the mother and fetus associated with untreated PNH in pregnancy. Consider use during pregnancy only if benefits outweigh risk.
- It is unknown whether this drug is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, discontinue breastfeeding during treatment and for 40 days after the last dose.
- Pregnancy testing is recommended for females of reproductive potential prior to treatment.
- Female patients of reproductive potential should use effective contraception during treatment and for 40 days after the last dose.
INTERACTIONS
None reported.
ADVERSE REACTIONS
CNS: fatigue, headache.
CV: chest pain, hypertension.
GI: abdominal pain, diarrhea, intestinal ischemia, biliary sepsis.
Musculoskeletal: back pain.
Respiratory: respiratory tract infection, hypersensitivity pneumonitis.
Skin: injection site reaction.
Other: infection, viral infection.
Reactions in bold italics are life-threatening.
Released: August 2021
Nursing Drug Handbook
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