EMPAVELI 1080 mg/20 mL (Pegcetacoplan) Injection

EMPAVELI (pegcetacoplan) 1080 mg/20 mL injection is a prescription complement inhibitor used in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in adults and children aged 12 years and older. For C3G and primary IC-MPGN, EMPAVELI is indicated to reduce proteinuria and loss of kidney function.

EMPAVELI contains pegcetacoplan, a targeted complement C3 inhibitor. By binding to complement protein C3 and its activation fragment C3b, pegcetacoplan regulates complement activation and helps control downstream complement activity.

Empaveli 1080 Mg/20 ML

Generic Name: Pegcetacoplan Injection

Manufacturer: Apellis Pharmaceuticals

EMPAVELI 1080 mg/20 mL – Key Information

• Brand: EMPAVELI
• Active ingredient: Pegcetacoplan
• Strength: 1080 mg/20 mL
• Concentration: 54 mg/mL
• Dosage form: Injection
• Route: Subcutaneous injection
• Drug class: Complement inhibitor
• Manufacturer: Apellis Pharmaceuticals
• Prescription medicine: Yes

The EMPAVELI 1080 mg/20 mL vial is a single-dose presentation containing 54 mg/mL pegcetacoplan.

What Is EMPAVELI (Pegcetacoplan) Used For?

EMPAVELI is a prescription medicine indicated for:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

EMPAVELI is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

C3 Glomerulopathy (C3G) and Primary IC-MPGN

EMPAVELI is also indicated for adults and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) to reduce proteinuria and loss of kidney function.

How Does EMPAVELI Work?

EMPAVELI contains pegcetacoplan, which targets the complement system by binding to C3 and C3b. This inhibits complement activation and the generation of downstream complement effectors.

Because complement activation plays an important role in PNH and certain complement-mediated kidney diseases, controlling this pathway can help address disease activity.

Dosage and Administration

The recommended dosage for adults with PNH is 1,080 mg administered subcutaneously twice weekly.

For adults with C3G or primary IC-MPGN, the recommended dosage is also 1,080 mg subcutaneously twice weekly. Pediatric dosing for patients 12 years and older is based on body weight and should follow the prescribing information provided by the treating healthcare professional.

EMPAVELI may be administered using a commercially available infusion pump or the EMPAVELI Injector, according to the prescribed instructions.

Do not change the dose or frequency of EMPAVELI without medical advice.

Important Safety Information

EMPAVELI carries a boxed warning for serious and potentially life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.

Patients should receive appropriate vaccination against encapsulated bacteria before starting treatment when possible, according to current medical recommendations. Patients receiving EMPAVELI remain at increased risk of serious infections and should be monitored for signs and symptoms of infection.

EMPAVELI can also cause infusion-related or allergic reactions. Seek immediate medical attention for symptoms such as difficulty breathing, wheezing, swelling of the face, tongue or throat, chest pain, dizziness, fainting, rapid heartbeat, vomiting, or severe skin reactions.

Common Side Effects

In adults with PNH, commonly reported adverse reactions include:

• Injection-site reactions
• Infections
• Diarrhea
• Abdominal pain
• Respiratory tract infections
• Pain in the extremities
• Low potassium levels
• Fatigue
• Viral infections
• Cough
• Joint pain
• Dizziness
• Headache
• Rash

In adults and children 12 years and older treated for C3G or primary IC-MPGN, commonly reported adverse reactions include injection-site reactions, fever, nasopharyngitis, influenza, cough, and nausea.

Why Is EMPAVELI Prescribed?

EMPAVELI provides targeted inhibition of the complement C3 pathway and is an established treatment option for adults with PNH and for patients aged 12 years and older with C3G or primary IC-MPGN under the applicable prescribing information.

Treatment should be initiated and monitored by a qualified healthcare professional familiar with complement-mediated disorders.

Buy EMPAVELI (Pegcetacoplan) Online

If you are looking for EMPAVELI 1080 mg/20 mL (pegcetacoplan) injection, verify the product strength, prescription requirements, storage conditions, and authenticity before purchase.

EMPAVELI is a prescription medicine and should only be used under the supervision of a qualified healthcare professional. Availability and dispensing requirements may vary by country.

Important: This product information is provided for educational purposes and is not a substitute for medical advice, diagnosis, or the official prescribing information. Always follow your healthcare professional’s instructions and the approved product labeling.

 

FAQ’s

What is EMPAVELI?

EMPAVELI is a prescription medicine containing pegcetacoplan, a complement C3 inhibitor used to treat adults with PNH and adults and children aged 12 years and older with C3G or primary IC-MPGN.

How is EMPAVELI administered?

EMPAVELI is administered by subcutaneous injection. The prescribed dose and administration method should be followed exactly as directed by the healthcare professional.

What strength is EMPAVELI available in?

EMPAVELI injection is available as 1,080 mg/20 mL (54 mg/mL) in a single-dose vial.

How often is EMPAVELI given?

The recommended adult dosage for PNH and for C3G or primary IC-MPGN is generally 1,080 mg twice weekly. Pediatric dosing for C3G or primary IC-MPGN is weight-based.

Is EMPAVELI a prescription medicine?

Yes. EMPAVELI is a prescription medicine and should be used under appropriate medical supervision.

What are the major risks of EMPAVELI?

The most important risk is serious infection caused by encapsulated bacteria. EMPAVELI can also cause infusion-related reactions and other adverse effects. Consult the full prescribing information and your healthcare professional before treatment.