Pegcetacoplan (Subcutaneous)

Generic name: pegcetacoplan [ peg-set-a-KOE-plan ]
Brand name: Empaveli
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com. Last updated on Aug 7, 2024.

Subcutaneous route(Solution)

Warning: Serious Infections Caused by Encapsulated Bacteria

Meningococcal infections may occur in patients treated with pegcetacoplan and may become rapidly life-threatening or fatal if not recognized and treated early. Use of pegcetacoplan may predispose individuals 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.Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients with altered immunocompetence associated with complement deficiencies.

Vaccinate patients against encapsulated bacteria as recommended at least 2 weeks prior to administering the first dose of pegcetacoplan unless the risks of delaying therapy with pegcetacoplan outweigh the risk of developing a serious infection.

Vaccination reduces, but does not eliminate, the risk of serious infections. Monitor patients for early signs of infections and evaluate immediately if infection is suspected.

Pegcetacoplan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the EMPAVELI REMS, prescribers must enroll in the program. Enrollment in the EMPAVELI REMS program and additional information are available by telephone: 1-888-343-7073 or at www.empavelirems.com .

Uses for pegcetacoplan

Pegcetacoplan injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH.

This medicine is available only under a restricted distribution program called Empaveli™ REMS (Risk Evaluation and Mitigation Strategy) Program.

Before using pegcetacoplan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pegcetacoplan injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegcetacoplan injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper use of pegcetacoplan

A nurse or other trained health professional may give you this medicine. It is given through a needle placed under your skin, usually in the stomach, thighs, hips or upper arm. It must be given slowly, so the needle will have to stay in place using an infusion pump for at least 30 minutes (for 2 infusion sites) or at least 60 minutes (for 1 infusion site).

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

It is very important that you understand the requirements of the Empaveli™ REMS program, and become familiar with the Empaveli™ medication guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide and patient instructions if you do not have one.

If you use this medicine at home, you will be shown the body areas where the infusion can be given. Use a different body area each time you give yourself an injection. Keep track of where you give each injection to make sure you rotate body areas. This will help prevent skin problems. Do not inject into areas where the skin is tender, red, bruised, or hard or in areas with tattoos, scars, or stretch marks.

Allow this medicine to warm to room temperature for 30 minutes before using it. Do not warm it in any other way.

Check the liquid in the vial. It should be clear and colorless to slightly yellow solution. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.

Tell your doctor if you are changing treatment from eculizumab or ravulizumab 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™.
Switching from ravulizumab to Empaveli™: You should start receiving Empaveli™ 4 weeks after your last dose of ravulizumab.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injectable dosage form (solution):
- For paroxysmal nocturnal hemoglobinuria (PNH):
  - Adults—1080 milligrams (mg) injected under the skin 2 times a week.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

If you miss a dose of this medicine, use it as soon as possible. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

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

Precautions while using pegcetacoplan

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine could harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this treatment. Use an effective form of birth control during treatment with this medicine and for 40 days after the last dose to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

Pegcetacoplan may increase your chance of having serious infections, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae. Avoid people who are sick or have infections. Tell your doctor right away if you develop headaches, nausea, vomiting, fever, a stiff neck or back, a rash, confusion, muscle aches, or if your eyes have become sensitive to light. Make sure you have received a vaccine to prevent encapsulated bacterial infections at least 2 weeks before you receive this medicine. You may also be given antibiotic medicines for 2 weeks to prevent infections if you are to use this medicine right away. If you have already received the vaccine in the past, your doctor will decide if you need another dose.

Ask your doctor for a patient safety card. This card will list the symptoms of encapsulated bacterial infections and what to do if you have them. 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.

This medicine may cause infusion-related reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, chest pain, trouble breathing, itching or rash, lightheadedness, fainting, or swelling of the face, tongue, or throat after receiving this medicine.

When this medicine 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 this medicine. Be sure to keep all appointments.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Side Effects of pegcetacoplan

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
bleeding gums
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the urine or stools
bloody vomit
blurred vision
body aches or pain
change in the color, amount, or odor of the vaginal discharge
chest pain, discomfort, or tightness
chills
confusion
cough or hoarseness
cough producing mucus
decreased urine
diarrhea
difficulty in breathing
dizziness
dry mouth
ear congestion
fainting
fever
flu-like symptoms
general feeling of discomfort or illness
headache
increased thirst
irregular heartbeat
lightheadedness
loss of appetite
loss of voice
mood changes
muscle aches, pain, or cramps
nausea
numbness or tingling in the hands, feet, or lips
pinpoint red spots on the skin
pounding in the ears
rapid, shallow breathing
rapid weight gain
seizures
slow or fast heartbeat
sneezing
sore throat
severe stomach pain
sleepiness
stuffy or runny nose
thickening of bronchial secretions
tingling of the hands or feet
trouble breathing
tooth or gum pain
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common