EMPAVELI (pegcetacoplan)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Infection

There are 0 moderate contraindications.

There are 19 severe adverse reactions.

More Frequent	Less Frequent
Conjunctival hemorrhage Hypokalemia Infection Neovascular age-related macular degeneration	Biliary tract infection Gastrointestinal vascular ischemia Hypersensitivity pneumonitis Hypertension Ocular hypertension Posterior capsule opacification Punctate keratitis Retinal hemorrhage Vitreous detachment

Rare/Very Rare
Anaphylaxis Facial edema Hypersensitivity drug reaction Meningococcemia Retinal vascular occlusion Retinal vasculitis

There are 21 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Cough Diarrhea Dizziness Fatigue Injection site sequelae Ocular discomfort Skin rash Upper respiratory infection Viral infection Vitreous floater	Arthralgia Back pain Chest pain Drowsy Ecchymosis Endophthalmitis Epistaxis Headache disorder Pain in extremities

Rare/Very Rare
Urticaria

Data on pegcetacoplan use during pregnancy are insufficient to inform a drug-associated risk of majorbirth defects, miscarriage, or adverse maternal or fetal outcomes. However, untreated PNH in pregnancy is associated with adverse maternal outcomes (e.g., worsening cytopenia, thrombosis, infections, bleeding, miscarriage, increased maternal mortality) and adverse fetal outcomes (e.g., fetal death, premature delivery). Evaluate pregnancy status prior to pegcetacoplan therapy in females of reproductive potential.

Consider use of pegcetacoplan during pregnancy following an assessment of risks and benefits. In pregnant cynomolgus monkeys, subcutaneous pegcetacoplan administration (at 2.9 times the human exposure based on AUC) from gestation through parturition resulted in a significant increase in abortions and stillbirths compared to controls.

It is unknown whether pegcetacoplan distributes into human milk or affects milk production. The potential for drug absorption and harm to the infant are also unknown. Pegcetacoplan was detected in milk of lactating monkeys. Because many drugs are secreted into human milk and there is potential for serious adverse reactions in the breast-fed infant, breast-feeding is not recommended during pegcetacoplan treatment and for 40 days after the last dose.

The manufacturer makes no specific dosage recommendations for geriatric patients. Clinical studies of pegcetacoplan did not include sufficient numbers of geriatric patients (>=65 years of age) to determine whether they respond differently from younger patients. Differences in responses between geriatric and younger patients were not identified in other reported clinical experience. There were no clinically important differences in pegcetacoplan pharmacokinetics based on age (19-81 years old).