WARNING

Eculizumab is a medication used to treat certain rare blood disorders, such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Like any medication, it comes with potential risks. Some of the risks associated with Eculizumab injection include:

• Infections: Eculizumab can increase the risk of serious infections, particularly with certain types of bacteria. Patients may need to be monitored closely for signs of infection while taking this medication.
• Meningococcal Infections: There is a significantly increased risk of meningococcal infections in patients receiving Eculizumab. Vaccination against meningococcal bacteria is generally recommended before starting treatment with Eculizumab.
• Hypertension: Eculizumab may cause an increase in blood pressure, which may require monitoring and management.
• Thrombosis: Blood clotting events, including thrombotic microangiopathy, have been reported in patients receiving Eculizumab. Close monitoring for signs of thrombosis is necessary during treatment.
• Hemolysis: In patients with PNH, Eculizumab works by inhibiting the destruction of red blood cells. However, in some cases, hemolysis (breakdown of red blood cells) may still occur, leading to anemia and other complications.
• Infusion Reactions: Some patients may experience infusion-related reactions, such as fever, chills, nausea, headache, or rash, during or after receiving Eculizumab injections.
• Immunosuppression: Eculizumab suppresses the activity of the complement system, which plays a role in the body’s immune response. This may increase the risk of certain infections and impair the body’s ability to fight off pathogens.
• Other Adverse Effects: Other potential adverse effects of Eculizumab include abdominal pain, diarrhea, fatigue, and back pain.

It’s important for patients to discuss the potential risks and benefits of Eculizumab with their healthcare provider before starting treatment. Close monitoring and adherence to recommended vaccination schedules can help mitigate some of the risks associated with this medication.

Why is this medication prescribed?

Eculizumab injection is prescribed for the treatment of certain rare and serious blood disorders, including:

• Paroxysmal Nocturnal Hemoglobinuria (PNH): PNH is a rare, acquired blood disorder characterized by the destruction of red blood cells, leading to symptoms such as fatigue, shortness of breath, and anemia. Eculizumab works by inhibiting the destruction of red blood cells, thereby reducing hemolysis and its associated symptoms.
• Atypical Hemolytic Uremic Syndrome (aHUS): aHUS is another rare disorder characterized by the formation of blood clots in small blood vessels, leading to kidney damage and other complications. Eculizumab is used to prevent the formation of these blood clots and reduce the risk of kidney damage and other serious complications.

How should this medicine be used?

Eculizumab injection is typically administered by a healthcare professional, usually in a hospital or clinic setting. Here are some general guidelines on how Eculizumab injection is used:

• Preparation: Before administering Eculizumab, the healthcare provider will ensure that the medication is prepared correctly according to the manufacturer’s instructions. This may involve diluting the medication to the appropriate concentration for infusion.
• Administration: Eculizumab is administered intravenously (IV), meaning it is delivered directly into a vein. The healthcare provider will insert a needle into a vein, usually in the arm, and connect it to an IV line.
• Infusion: The diluted Eculizumab solution is slowly infused into the vein over a period of time. The infusion process may take several hours, depending on the dosage and the patient’s tolerance.
• Monitoring: During the infusion, the healthcare provider will closely monitor the patient for any signs of adverse reactions or complications, such as infusion-related reactions or changes in vital signs.
• Frequency: The dosing schedule for Eculizumab can vary depending on the specific condition being treated and the patient’s response to treatment. Initially, patients may receive weekly infusions for several weeks, followed by maintenance infusions every 2 to 4 weeks thereafter.
• Vaccination: Before starting treatment with Eculizumab, patients should receive appropriate vaccinations against meningococcal bacteria to reduce the risk of meningococcal infections. This is particularly important because Eculizumab treatment can increase the risk of severe meningococcal infections.
• Follow-up: Patients receiving Eculizumab should attend all scheduled follow-up appointments with their healthcare provider. These appointments may involve monitoring blood tests and other assessments to evaluate the patient’s response to treatment and assess for any potential side effects or complications.

It’s essential for patients to follow their healthcare provider’s instructions carefully regarding the use of Eculizumab and to communicate any concerns or side effects promptly. Any questions about the medication or its administration should be discussed with a healthcare professional.

Other uses for this medicine

Some potential off-label uses for Eculizumab injection may include:

• Hemolytic uremic syndrome (HUS) associated with conditions other than aHUS, such as Shiga toxin-producing Escherichia coli (STEC) infection-related HUS.
• Antibody-mediated rejection (AMR) in kidney transplantation.
• Myasthenia gravis, particularly in cases with refractory symptoms or complications such as thrombotic microangiopathy.
• Other complement-mediated diseases or disorders, including certain types of glomerulonephritis or autoimmune conditions.

What special precautions should I follow?

Special Precautions for Eculizumab Injection:

• Risk of Infections: Eculizumab can increase the risk of serious infections, particularly meningococcal infections. Patients should be vaccinated against meningococcal bacteria before starting treatment and receive booster vaccinations as recommended. Additionally, patients and caregivers should be educated about the signs and symptoms of infections and instructed to seek prompt medical attention if they occur.
• Monitoring: Regular monitoring is necessary during Eculizumab therapy to assess for effectiveness, adverse effects, and any signs of complications. This may include laboratory tests to monitor blood counts, kidney function, and complement activity.
• Meningococcal Prophylaxis: Due to the increased risk of meningococcal infections, patients receiving Eculizumab may require antibiotic prophylaxis against Neisseria meningitidis. This may be recommended for the duration of treatment and for a period after discontinuation, as determined by a healthcare provider.
• Infusion-related Reactions: Patients should be monitored for infusion-related reactions during Eculizumab administration. These reactions may include fever, chills, nausea, vomiting, headache, rash, or difficulty breathing. If such reactions occur, appropriate management measures should be taken, and the infusion may need to be interrupted or discontinued.
• Thrombosis Risk: Patients should be monitored for signs of thrombosis, including blood clots, stroke, or heart attack, while receiving Eculizumab therapy. Any new or worsening symptoms should be reported to a healthcare provider promptly.
• Pregnancy and Breastfeeding: The safety of Eculizumab use during pregnancy and breastfeeding has not been established. Women of childbearing potential should use effective contraception during treatment and discuss the potential risks and benefits with their healthcare provider.
• Other Medications: Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking, as some may interact with Eculizumab.

It’s important for patients to discuss any questions or concerns about Eculizumab injection and its potential risks and benefits with their healthcare provider before starting treatment.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Eculizumab injection. However, maintaining a balanced and healthy diet is generally advisable for overall well-being and to support the management of underlying medical conditions.

What should I do if I forget a dose?

If you miss a dose of Eculizumab injection, contact your healthcare provider or treatment facility promptly to reschedule the missed dose. It’s essential to adhere to the prescribed dosing schedule to maintain the effectiveness of the treatment. Do not attempt to administer the missed dose yourself or adjust the dosing schedule without consulting a healthcare professional.

What side effects can this medication cause?

Eculizumab injection, like any medication, can cause side effects. While not everyone experiences these side effects, some potential ones include:

• Infusion-related reactions: These may include fever, chills, nausea, vomiting, headache, dizziness, fatigue, itching, rash, or difficulty breathing during or shortly after the infusion.
• Infections: Eculizumab may increase the risk of infections, particularly bacterial infections. Symptoms of infections may include fever, chills, sore throat, cough, or flu-like symptoms.
• Meningococcal infections: There is an increased risk of meningococcal infections with Eculizumab. Symptoms may include fever, headache, stiff neck, confusion, sensitivity to light, and rash.
• Thrombosis: Blood clotting events, including thrombotic microangiopathy, have been reported in patients receiving Eculizumab.
• Hypertension: Eculizumab may cause an increase in blood pressure.
• Hemolysis: In patients with PNH (Paroxysmal Nocturnal Hemoglobinuria), Eculizumab may cause hemolysis (breakdown of red blood cells), leading to anemia and related symptoms.
• Other side effects: Additional side effects may include abdominal pain, diarrhea, back pain, joint pain, muscle spasms, insomnia, and peripheral edema (swelling in the arms or legs).

It’s important to note that this list does not include all possible side effects of Eculizumab. Some individuals may experience side effects not listed here. If you experience any concerning symptoms while receiving Eculizumab injection, it’s essential to notify your healthcare provider promptly. They can provide guidance on managing side effects and determine if any further medical attention is necessary.

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

Storage and Disposal of Eculizumab Injection:

• Storage: Eculizumab injection should be stored in the refrigerator at a temperature of 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the medication in its original carton to protect it from light. Do not shake the vial. If the medication is accidentally frozen, do not use it, and contact your healthcare provider or pharmacist for guidance.
• Disposal: Unused or expired Eculizumab should be disposed of properly according to local regulations or guidelines. Your healthcare provider or pharmacist can provide instructions on safe disposal methods. Do not dispose of medications by flushing them down the toilet or pouring them into a drain unless instructed to do so.

In case of emergency/overdose

In case of an emergency or suspected overdose of Eculizumab injection, seek immediate medical attention or contact a poison control center. It’s essential to inform healthcare providers about the specific medication taken, the amount ingested (if known), and any symptoms experienced.

What other information should I know?

• Monitoring: Your healthcare provider will monitor your response to Eculizumab therapy regularly. This may include blood tests to assess your blood counts, kidney function, and other parameters relevant to your condition.
• Vaccination: As mentioned earlier, it’s important to receive vaccinations against meningococcal bacteria before starting treatment with Eculizumab. Additionally, keep up-to-date with recommended vaccinations as advised by your healthcare provider.
• Medical Alert: Inform healthcare providers, including dentists and emergency responders, that you are receiving Eculizumab therapy. Carry a medical alert card or wear a medical alert bracelet indicating that you are being treated with Eculizumab, especially in case of emergencies.
• Follow-Up: Attend all scheduled follow-up appointments with your healthcare provider. These appointments are essential for monitoring your response to treatment, evaluating for any side effects or complications, and adjusting your treatment plan as needed.
• Patient Support: Consider joining patient support groups or organizations dedicated to individuals with conditions such as PNH or aHUS. These groups can provide valuable information, resources, and support from others who may be undergoing similar experiences.

Always follow your healthcare provider’s instructions and recommendations regarding the use of Eculizumab injection and any other medications or treatments. If you have any questions or concerns, don’t hesitate to discuss them with your healthcare team.