WARNING

Empaveli (pegcetacoplan) is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. While Empaveli can be effective in managing PNH, like any medication, it comes with potential risks. Some of the risks associated with taking Empaveli include:

• Infusion-related reactions: Some people may experience infusion-related reactions such as fever, chills, nausea, headache, or fatigue during or after receiving Empaveli.
• Increased risk of infections: Empaveli may increase the risk of infections, including serious and potentially life-threatening infections. Patients should be monitored for signs and symptoms of infection while taking this medication.
• Risk of meningococcal infections: Patients treated with Empaveli are at increased risk of meningococcal infections, which can be severe or fatal. Vaccination against meningococcal infection is recommended before starting Empaveli treatment.
• Thromboembolic events: Thromboembolic events, including blood clots, have been reported in patients receiving Empaveli. Patients with a history of thromboembolism or other risk factors for thromboembolic events should be closely monitored.
• Hypersensitivity reactions: Some individuals may experience hypersensitivity reactions to Empaveli, which can manifest as rash, itching, hives, swelling, or difficulty breathing. These reactions can be serious and require immediate medical attention.
• Hematologic effects: Empaveli may affect blood cell counts, leading to low levels of white blood cells, red blood cells, or platelets. Regular blood tests are necessary to monitor for these effects.
• Liver function abnormalities: Changes in liver function, including elevated liver enzymes, have been reported in patients receiving Empaveli. Liver function should be monitored regularly during treatment.
• Fetal risk: Empaveli may cause fetal harm if used during pregnancy. Women of childbearing age should use effective contraception during Empaveli treatment and for at least 8 weeks after the last dose.

It’s important for patients considering Empaveli treatment to discuss the potential risks and benefits with their healthcare provider and to closely follow their provider’s guidance for monitoring and managing these risks.

Why is this medication prescribed?

Empaveli (pegcetacoplan) is prescribed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and potentially life-threatening blood disorder characterized by the destruction of red blood cells, leading to anemia, fatigue, and other complications. PNH is caused by the abnormal breakdown of red blood cells due to the lack of certain proteins on the surface of these cells.

Empaveli works by inhibiting the complement system, a part of the immune system involved in the destruction of red blood cells in PNH. By blocking the complement system, Empaveli helps to reduce the destruction of red blood cells and manage the symptoms of PNH.

How should this medicine be used?

Empaveli (pegcetacoplan) is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. Here are the general guidelines for using Empaveli:

• Dosage: The dosage of Empaveli is determined by the healthcare provider based on factors such as the patient’s weight and medical condition.
• Administration: Empaveli is administered by intravenous (IV) infusion. A healthcare professional will typically administer the infusion in a clinic or hospital setting.
• Frequency: Empaveli is usually given once every two weeks. The exact dosing schedule may vary depending on the individual patient’s needs and response to treatment.
• Preparation: The healthcare provider will prepare the Empaveli infusion according to the manufacturer’s instructions. The medication may need to be diluted with a sterile solution before administration.
• Infusion: The infusion of Empaveli is typically administered over a period of time specified by the healthcare provider. The infusion rate may vary depending on factors such as the patient’s tolerance and any potential infusion-related reactions.
• Monitoring: Patients receiving Empaveli may require regular monitoring of their blood cell counts and liver function to ensure the medication is effective and not causing any adverse effects. Healthcare providers will typically schedule follow-up appointments to monitor the patient’s response to treatment.
• Vaccination: Prior to starting Empaveli treatment, patients should be vaccinated against meningococcal infection, unless the risk of immediate treatment outweighs the risk of infection. Additional booster doses may be necessary depending on vaccination history.
• Contraception: Empaveli may cause fetal harm if used during pregnancy. Women of childbearing age should use effective contraception during Empaveli treatment and for at least 8 weeks after the last dose.

It’s essential for patients to follow their healthcare provider’s instructions carefully when using Empaveli and to report any side effects or concerns promptly. Additionally, patients should attend all scheduled appointments for monitoring and follow-up care.

Other uses for this medicine

Empaveli (pegcetacoplan) is primarily used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), and its use is mainly restricted to this indication. However, as with many medications, there may be off-label or investigational uses for Empaveli. Off-label use refers to the use of a medication for a purpose other than what it has been officially approved for by regulatory agencies.

What special precautions should I follow?

Special precautions to follow when using Empaveli include:

• Medical history: Before starting Empaveli treatment, inform your healthcare provider about your complete medical history, including any allergies, current medications, past infections, liver problems, or history of blood clots.
• Vaccination: Ensure you are up-to-date with vaccinations, particularly meningococcal vaccines, as Empaveli treatment may increase the risk of meningococcal infections.
• Pregnancy and breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Empaveli with your healthcare provider. Empaveli may cause fetal harm, and its safety during breastfeeding is not established.
• Monitoring: Regular monitoring of blood cell counts and liver function may be necessary during Empaveli treatment to assess its effectiveness and detect any adverse effects.
• Infusion-related reactions: Be aware of the signs and symptoms of infusion-related reactions, such as fever, chills, nausea, headache, or fatigue. Inform your healthcare provider immediately if you experience any of these symptoms during or after Empaveli infusion.
• Infections: Empaveli may increase the risk of infections, including serious and potentially life-threatening infections. Contact your healthcare provider if you develop signs or symptoms of an infection, such as fever, sore throat, or unusual tiredness.
• Hypersensitivity reactions: Some individuals may experience hypersensitivity reactions to Empaveli, such as rash, itching, hives, swelling, or difficulty breathing. Seek immediate medical attention if you experience any of these symptoms.
• Thromboembolic events: Be cautious of the signs and symptoms of thromboembolic events, such as chest pain, shortness of breath, leg swelling, or sudden numbness or weakness. Inform your healthcare provider promptly if you experience any of these symptoms.

Always follow your healthcare provider’s instructions and recommendations regarding Empaveli treatment, and report any concerns or adverse reactions promptly.

What special dietary instructions should I follow?

Regarding special dietary instructions for Empaveli, there are no specific dietary restrictions associated with its use. However, it’s essential to maintain a healthy and balanced diet to support overall health and well-being during treatment.

What should I do if I forget a dose?

If you forget a dose of Empaveli, contact your healthcare provider as soon as possible to discuss the missed dose and receive guidance on how to proceed. It’s essential to adhere to the prescribed dosing schedule to ensure the effectiveness of treatment. Avoid doubling up on doses unless instructed by your healthcare provider.

What side effects can this medication cause?

Empaveli (pegcetacoplan) can cause side effects, although not everyone experiences them. Common side effects may include:

• Headache: Some individuals may experience headaches as a side effect of Empaveli treatment.
• Fatigue: Fatigue or feeling tired may occur in some patients receiving Empaveli.
• Nausea: Nausea or feelings of stomach discomfort may occur as a side effect.
• Diarrhea: Some patients may experience diarrhea while taking Empaveli.
• Infusion-related reactions: During or shortly after receiving Empaveli infusion, some individuals may experience infusion-related reactions such as fever, chills, nausea, headache, or fatigue.
• Infections: Empaveli may increase the risk of infections, including serious and potentially life-threatening infections. Patients should be monitored for signs and symptoms of infection during treatment.
• Hypersensitivity reactions: Some individuals may experience hypersensitivity reactions to Empaveli, which can manifest as rash, itching, hives, swelling, or difficulty breathing. These reactions can be serious and require immediate medical attention.
• Thromboembolic events: Thromboembolic events, including blood clots, have been reported in patients receiving Empaveli. Patients with a history of thromboembolism or other risk factors for thromboembolic events should be closely monitored.
• Liver function abnormalities: Changes in liver function, including elevated liver enzymes, have been reported in patients receiving Empaveli. Regular liver function tests may be necessary during treatment.
• Injection site reactions: Some individuals may experience reactions at the site of Empaveli injection, such as redness, swelling, or pain.

It’s important to report any side effects or concerns to your healthcare provider promptly. They can provide guidance on managing side effects and may adjust your treatment regimen if necessary.

What should I know about storage and disposal of this medication?

Storage and disposal of Empaveli:

• Storage: Empaveli should be stored in its original carton under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake the vial. Keep Empaveli out of reach of children and pets.
• Disposal: Unused or expired Empaveli should be disposed of properly according to local regulations. Do not dispose of Empaveli in household trash or pour it down the drain. Consult with your healthcare provider or pharmacist for guidance on proper disposal methods.

In case of emergency/overdose

In case of an emergency or overdose, contact your healthcare provider, local emergency services, or go to the nearest emergency room immediately. It’s important to seek medical attention if you suspect an overdose or experience severe adverse reactions.

What other information should I know?

• Empaveli is intended for intravenous (IV) infusion and should be administered by a healthcare professional in a clinical setting.
• Patients should be monitored for signs and symptoms of infusion-related reactions, infections, hypersensitivity reactions, thromboembolic events, and liver function abnormalities during Empaveli treatment.
• Patients receiving Empaveli may need regular blood tests to monitor their blood cell counts and liver function.
• Vaccination against meningococcal infection is recommended before starting Empaveli treatment.
• Women of childbearing age should use effective contraception during Empaveli treatment and for at least 8 weeks after the last dose.
• Inform all healthcare providers involved in your care that you are receiving Empaveli, including dentists and emergency room personnel.
• Follow your healthcare provider’s instructions carefully regarding Empaveli treatment, including dosage, administration, and monitoring.

Always consult with your healthcare provider or pharmacist if you have any questions or concerns about Empaveli or its use. They can provide personalized advice and guidance based on your individual circumstances.