Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Breastfeeding
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.
Drug Interactions
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.
Other Interactions
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bacterial infections (eg, pneumonia, meningitis, and flu-like infection), encapsulated—Should not be given to patients with these conditions.
- Infection or
- Weakened immune system—Use with caution. This medicine may decrease your body’s ability to fight infection.
Proper Use
A nurse or other trained health professional may give you this medicine. It is given as a shot in the stomach, or through an IV catheter placed under your skin, usually in the stomach, thigh, hip or upper arm. It must be given slowly, so the IV 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 about:
- How to prepare the injection.
- The proper use of the infusion pump and injector.
- How to give the injection.
- How long the injection can be stored at home.
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 as you continue your treatment with Empaveli®.
- Switching from ravulizumab to Empaveli®: You should start receiving Empaveli® no more than 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.
- For paroxysmal nocturnal hemoglobinuria (PNH):
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
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 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 healthcare providers that you are taking this medicine. The results of some tests may be affected by this medicine.
Side Effects
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
- Arm or leg pain
- bloody nose
- diarrhea
- difficulty in moving
- heartburn
- joint pain
- lack or loss of strength
- large, flat, blue or purplish patches in the skin
- pain in the lower back, bottom, hips, or upper legs
- unusual drowsiness, dullness, or feeling of sluggishness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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