Empaveli (pegcetacoplan)
Complement Inhibitors Subcutaneous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Pegcetacoplan is a complement inhibitor.
Pegcetacoplan is a pegylated complement inhibitor that targets complement C3. In binding to complement protein C3 (and its activation fragment C3b), pegcetacoplan regulates the cleavage of C3 and the generation of downstream effectors of complement activation. In paroxysmal nocturnal hemoglobinuria (PNH), pegcetacoplan acts proximally in the complement cascade that controls both C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis.
By targeting C3, pegcetacoplan works higher in the complement system than the complement C5 inhibitors, eculizumab and ravulizumab, which are also used in the management of PNH. In C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis, pegcetacoplan binds C3 and C3b resulting in inhibition of C3 activation, reducing C3 glomerular fragment deposition, and decreasing C5 convertase activity and subsequent assembly of C5b-9.
In patients with PNH, steady-state serum concentrations were achieved approximately 4-6 weeks following the first dose of pegcetacoplan. In patients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis, steady-state serum concentrations were achieved approximately 4-8 weeks following twice weekly pegcetacoplan infusion. Drug exposure increased proportionally over a dose range from 45-1440 mg (0.04-1.33 times the approved recommended dose) in patients with PNH.
After a single dose of pegcetacoplan, the median time to peak plasma drug concentration is 108-144 hours (4.5-6 days). Pegcetacoplan is expected to be metabolized into small peptides and amino acids by catabolic pathways. The median effective elimination half-life of pegcetacoplan is 8.6 days in patients with PNH, 10.2 days in patients with C3 glomerulopathy, and 10.8 days in patients with primary immune-complex membranoproliferative glomerulonephritis.
USES: Pegcetacoplan is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells.
This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce the need for blood transfusions. This medication is also used to treat certain kidney problems (such as complement 3 glomerulopathy - C3G, primary immune-complex membranoproliferative glomerulonephritis - IC-MPGN). Pegcetacoplan helps to lower levels of protein in the urine.
Generic name: pegcetacoplan
Pronunciation: (peg-SET-a-KOE-plan)
Drug class: Complement Inhibitors
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Empaveli
Indications
The following indications are listed for Empaveli:
- Complement Component 3 Glomerulopathy
- Paroxysmal Nocturnal Hemoglobinuria
- Primary Immune-Complex Membranoproliferative Glomerulonephritis
Dosing
For LDH levels >2 times the upper limit of normal, adjust the pegcetacoplan dosage regimen to 1080 mg every 3 days. Monitor LDH twice weekly for at least 4 weeks after a dosage increase.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Empaveli 1,080 Mg/20 Ml Vial | Maintenance | Inject 20 milliliters (1,080 mg) via infusion pump by subcutaneous route twice weekly. |
No dosing information is available for this tab.
Drug interactions
No drug-drug interactions with pegcetacoplan noted by the manufacturer.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Hypersensitivity to pegcetacoplan or any component in the formulation.
*For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.
- Lactation
- Infection
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects (incidence >=10%) of pegcetacoplan in clinical studies for PNH were injection-site reactions, infections (including respiratory tract infections and viral infections), cough, abdominal pain, diarrhea, pain in the extremities, hypokalemia, fatigue, arthralgia, dizziness, headache, and rash.
The most common adverse effects (incidence >=10%) of pegcetacoplan in clinical studies for C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis were infusion site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.
More Frequent
- Conjunctival hemorrhage
- Hypokalemia
- Infection
- Neovascular age-related macular degeneration
Less Frequent
- Biliary tract infection
- Gastrointestinal vascular ischemia
- Hypersensitivity pneumonitis
- Hypertension
- Ocular hypertension
- Posterior capsule opacification
- Punctate keratitis
- Retinal hemorrhage
- Vitreous detachment
Rare or Very Rare
- Anaphylaxis
- Facial edema
- Hypersensitivity drug reaction
- Meningococcemia
- Retinal vascular occlusion
- Retinal vasculitis
More Frequent
- Acute abdominal pain
- Cough
- Diarrhea
- Dizziness
- Fatigue
- Injection site sequelae
- Ocular discomfort
- Skin rash
- Upper respiratory infection
- Viral infection
- Vitreous floater
Less Frequent
- Abdominal distension
- Arthralgia
- Back pain
- Chest pain
- Drowsy
- Ecchymosis
- Endophthalmitis
- Epistaxis
- Erythema
- Fever
- Headache disorder
- Myalgia
- Pain in extremities
- Pain in oropharynx
- Peripheral edema
- Sepsis
- Symptoms of anxiety
- Thrombocytopenic disorder
Rare or Very Rare
- Urticaria
Precautions
No enhanced messaging available.
The safety and efficacy of pegcetacoplan have been established in pediatric patients >=12 years of age for the treatment of C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis. Clinical data supporting use for this indication are from a trial that enrolled 55 pediatric patients >=12 years of age.
The safety and efficacy of pegcetacoplan have not been established in pediatric patients with PNH.
Data on pegcetacoplan use during pregnancy are insufficient to inform a drug-associated risk of major birth 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).
ICD codes
| Code | Type | Description |
|---|---|---|
| Complement component 3 glomerulopathy | ||
| N04.6 | ICD10CM | Nephrotic syndrome with dense deposit disease |
| N04.A | ICD10CM | Nephrotic syndrome with c3 glomerulonephritis |
| Paroxysmal nocturnal hemoglobinuria | ||
| D59.5 | ICD10CM | Paroxysmal nocturnal hemoglobinuria [marchiafava-micheli] |
| Primary immune-complex membranoproliferative glomerulonephritis | ||
| N06.5 | ICD10CM | Isolated proteinuria with diffuse mesangiocapillary glomerulonephritis |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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