pegcetacoplan patient assistance

How do I get access to pegcetacoplan?

Pegcetacoplan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the pegcetacoplan REMS, prescribers must enroll in the program.

What is pegcetacoplan used to treat?

Pegcetacoplan is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults. Pegcetacoplan is available only under a special program.

What is the REMS for pegcetacoplan?

Pegcetacoplan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the pegcetacoplan REMS, prescribers must enroll in the program. FDA approved a REMS for pegcetacoplan to ensure that the benefits outweigh the risk.

Is pegcetacoplan a complement inhibitor?

Pegcetacoplan is a complement inhibitor. Pegcetacoplan is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Pegcetacoplan is available in the following dosage form (s) and strength (s): Injection: 1080 mg/20 mL (54 mg/mL) in a single-dose vial.

How is pegcetacoplan given?

What is pegcetacoplan?

How long after pegcetacoplan can you stop eculizumab?

How long after pegcetacoplan can you get pregnant?

What happens if you stop pegcetacoplan?

Where to store pegcetacoplan?

Can you share a medicine with a child?

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What is the cost of EMPAVELI?

The cost for Empaveli subcutaneous solution (1080 mg/20 mL) is around $37,107 for a supply of 160 milliliters, depending on the pharmacy you visit.

How do I get EMPAVELI?

In order to be eligible for the Apellis Patient Assistance Program, you must:Be diagnosed with paroxysmal nocturnal hemoglobinuria (PNH) in accordance with the approved EMPAVELI indication.Be enrolled in ApellisAssist.Have no insurance or be underinsured.Have a prescription for EMPAVELI.More items...

What is EMPAVELI used for?

EMPAVELI is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH). What is the most important information I should know about EMPAVELI? EMPAVELI is a medicine that can affect your immune system and can lower the ability of your immune system to fight infections.

Is EMPAVELI FDA approved?

FDA has approved Empaveli (pegcetacoplan) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. Empaveli is the first PNH treatment that binds to compliment protein C3.

What company makes EMPAVELI?

Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) EMPAVELI, the first targeted C3 therapy, is approved for use in adults with PNH who are: Treatment naïve.

What is Iptacopan?

An orally available, small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, iptacopan binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb).

Is Pegcetacoplan FDA approved?

Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy. Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies.

What type of drug is EMPAVELI?

Empaveli contains the active drug pegcetacoplan, which belongs to a class of medications called complement inhibitors. Empaveli works by stopping your immune system from destroying your red blood cells. Empaveli comes as a liquid solution in a single-dose vial. The drug is given as a subcutaneous infusion.

How often is Ultomiris given?

Loading dose of ULTOMIRIS should be administered 2 weeks after the last eculizumab infusion. Maintenance doses are administered once every 4 or 8 weeks (depending on body weight), starting 2 weeks after the loading dose.

Is Danicopan FDA approved?

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for danicopan (ACH-4471) for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria (PNH) who are sub-optimal responders to a C5 inhibitor alone.

How long do you live with PNH?

Most people lived 10 to 22 years after their diagnosis. But today, people with PHN receive innovative treatment that protects their blood cells and reduces their risk of serious illness. People with PHN can expect to live as long as someone who doesn't have the disease.

Is Empaveli a monoclonal antibody?

Official answer. Empaveli and Soliris are both monoclonal antibodies (also called biologics) but Empaveli is more effective than Soliris at treating paroxysmal nocturnal hemoglobinuria (PNH).

Why did apls stock drop?

Apellis' (APLS) missed earnings and sales estimates in the second quarter of 2022. Consequently, the stock declines.

What is paroxysmal nocturnal hemoglobinuria?

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease of the blood. The disease is characterized by destruction of red blood cells, blood clots, and impaired bone marrow function. PNH is closely related to aplastic anemia.

What is intravitreal Pegcetacoplan?

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for pegcetacoplan for the treatment of geographic atrophy (GA). Pegcetacoplan is an intravitreal targeted C3 therapy that works by regulating excessive activation of the complement cascade.

How does Empaveli compare to Soliris?

Empaveli and Soliris are both monoclonal antibodies (also called biologics) but Empaveli is more effective than Soliris at treating paroxysmal noct...

How does Empaveli work?

Empaveli has effects on the complement system, which is a part of the immune system that enhances (or complements) the ability of antibodies and ph...

How is Empaveli administered?

Empaveli is given subcutaneously (this means under the skin) using an infusion pump, into a clear area of skin on your stomach (avoid around the be...

APL-2 (pegcetacoplan) May Soon Become the First Treatment for ...

Apellis Pharmaceuticals has announced long term results from their Phase 3 DERBY and OAKS clinical studies, testing the efficacy and safety of APL-2 (now called intravitreal pegcetacoplan), as a treatment for geographic atrophy (GA).GA is also known as advanced dry age-related macular degeneration. In an analysis conducted at month 18 of the clinical studies, treatment with both monthly and ...

Pegcetacoplan - Wikipedia

Pegcetacoplan, sold under the brand name Empaveli among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH).. The most common side effects include injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, viral infection, and fatigue. Paroxysmal nocturnal hemoglobinuria is characterized by red blood cell destruction, anemia (red ...

Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy ... - PubMed

Purpose: Geographic atrophy (GA), a late stage of age-related macular degeneration (AMD), is a major cause of blindness. Even while central visual acuity remains relatively well preserved, GA often causes considerable compromise of visual function and quality of life.

American Society of Hematology - Release More Inhibitions ...

Hillmen P, Szer J, Weitz I, . Pegcetacoplan versus eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2021;384(11):1028–1037. PubMed.

FDA approves new treatment for adults with serious rare blood disease

FDA has approved Empaveli (pegcetacoplan) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. Empaveli is the first PNH treatment that ...

Abstract - American Society of Hematology

Jun-Ho Jang, Jonathan Weyne, Umesh Chaudhari, Olivier Harari, Jutta Miller, Bradley Dain, Karoline A Meagher, Merideth L Rodgers, Lorah Perlee, Lori Morton, David M Weinreich, George D. Yancopoulos, Morag Griffin; Pozelimab, a Human Monoclonal Antibody Against Complement Factor C5, Provided Inhibition of Intravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria.

Uses for Pegcetacoplan

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

Pegcetacoplan Dosage and Administration

Pegcetacoplan is available in the following dosage form (s) and strength (s):

Drug Interactions

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Actions

Pegcetacoplan binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation.

Advice to Patients

Advise patients of the risk of serious infection. Inform patients that they are required to receive vaccinations against encapsulated bacteria at least 2 weeks prior to receiving the first dose of pegcetacoplan if they have not been previously vaccinated.

Additional Information

AHFS first Release ™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

What is the purpose of Pegcetacoplan?

Pegcetacoplan helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH.

How long does it take for a doctor to monitor you after stopping Pegcetacoplan?

When pegcetacoplan is stopped you could have red blood cell destruction or breakdown (hemolysis). Your doctor will need to monitor you closely for at least 8 weeks after you stop using pegcetacoplan. Be sure to keep all appointments.

How long after ravulizumab can you switch to empaveli?

Switching from ravulizumab to Empaveli™: You should start receiving Empaveli™ 4 weeks after your last dose of ravulizumab.

How long does it take to switch from eculizumab to empaveli?

Switching from eculizumab to Empaveli™: At first, you should start receiving Empaveli™ while you continue your treatment with eculizumab. Then after 4 weeks , you should stop receiving eculizumab before you continue your treatment with Empaveli™.

How long do you have to carry a patient safety card?

Carry the card with you at all times during treatment and for 2 months after your last dose. You will need to show the card to any doctor who treats you.

How to keep medicine in carton?

Keep the medicine in its original carton, away from direct light, until you are ready to use it. Throw away any unused medicine.

Can you inject Pegcetacoplan at home?

You or your caregiver may be trained to prepare and inject pegcetacoplan at home. Be sure that you understand how to use the medicine and the infusion pump.

How is pegcetacoplan given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Who can provide more information about Pegcetacoplan?

Your pharmacist can provide more information about pegcetacoplan.

What is the most important information I should know about pegcetacoplan?

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or your eyes are more sensitive to light.

What is pegcetacoplan?

Pegcetacoplan is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults.

What are the possible side effects of pegcetacoplan?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

How long after pegcetacoplan can you stop eculizumab?

If you've been using another drug called eculizumab (Soliris), keep using it for 4 weeks after your first dose of pegcetacoplan and then stop the eculizumab.

How long after pegcetacoplan can you get pregnant?

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use birth control while using pegcetacoplan and for at least 40 days after your last dose. Tell your doctor if you become pregnant.

How much does Empaveli cost?

The cost for Empaveli subcutaneous solution (1080 mg/20 mL) is around $36,790 for a supply of 160 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans. Empaveli is available as a brand name drug only, a generic version is not yet available.

How much does a free drug card save?

The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.

What is empaveli used for?

Empaveli (pegcetacoplan) is a member of the selective immunosuppressants drug class and is commonly used for Paroxysmal Nocturnal Hemoglobinuria.

What is Empaveli Apellis Bridge?

Empaveli Apellis Bridge Program: Eligible commercially insured patients may receive assistance with their prescriptions if experiencing a delay or change in insurance ; for additional information contact the program 866-692-7527.

How is pegcetacoplan given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

What is pegcetacoplan?

Pegcetacoplan is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults.

How long after pegcetacoplan can you stop eculizumab?

If you've been using another drug called eculizumab ( Soliris ), keep using it for 4 weeks after your first dose of pegcetacoplan and then stop the eculizumab.

How long after pegcetacoplan can you get pregnant?

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use birth control while using pegcetacoplan and for at least 40 days after your last dose. Tell your doctor if you become pregnant.

What happens if you stop pegcetacoplan?

If you stop using pegcetacoplan, tell your doctor if you have any new or worsening symptoms, such as: tiredness, confusion, stomach pain, trouble breathing or swallowing, blood in your urine, (in men) trouble having an erection, chest pain, pain in one leg, or numbness or weakness on one side of the body.

Where to store pegcetacoplan?

Store vials in the refrigerator, in the original carton to protect from light. Do not use expired pegcetacoplan.

Can you share a medicine with a child?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Uses For Pegcetacoplan

Pegcetacoplan Dosage and Administration

Cautions For Pegcetacoplan

Drug Interactions

Actions

Advice to Patients

Additional Information

Preparations

Frequently Asked Questions