Eculizumab

Eculizumab is a prescription medicine used to treat the symptoms of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, myasthenia gravis, and neuromyelitis optica spectrum disorder.

• Eculizumab is available under the following different brand names: Soliris

Adult and pediatric dosage

Injectable solution

• 10mg/mL

Paroxysmal Nocturnal Hemoglobinuria

Adult dosage

• Doses 1-4: 600 mg IV every week for first 4 weeks, followed by
• Dose 5: 900 mg IV 1 week later, THEN
• 900 mg IV every 2 weeks thereafter
• Administer at recommended dosage regimen time points, or within two days of these time points

Hemolytic Uremic Syndrome

Adult dosage

• Doses 1-4: 900 mg IV every week for first 4 weeks, followed by
• Dose 5: 1200 mg IV 1 week later, THEN
• 1200 mg IV every 2 weeks thereafter

Pediatric dosage

• Children weighing 5 to less than 10 kg
  • 300 mg IV infusion once then, THEN
  • 300 mg (second dose) after 7 days, THEN
  • 300 mg every 21 days THEREAFTER
• Children weighing 10 to less than 20 kg
  • 600 mg IV infusion once, THEN
  • 300 mg (second dose) after 7 days, THEN
  • 300 mg every 14 days THEREAFTER
• Children weighing 20 to less than 30 kg
  • 600 mg IV infusion every 7 days for 2 weeks, THEN
  • 600 mg (third dose) after 7 days, THEN
  • 600 mg every 14 days THEREAFTER
• Children weighing 30 to less than 40 kg
  • 600 mg IV infusion every 7 days for 2 weeks, THEN
  • 900 mg (third dose) after 7 days, THEN
  • 900 mg every 14 days THEREAFTER
• Children weighing more than 40 kg
  • 900 mg IV infusion every 7 days for 4 weeks, THEN
  • 1200 mg (fifth dose) after 7 days, THEN
  • 1200 mg every 14 days THEREAFTER
  • Administer at recommended dosage regimen time points, or within two days of these time points

Myasthenia Gravis

Adult dosage

• Doses 1-4: 900 mg IV every week for first 4 weeks, followed by
• Dose 5: 1200 mg IV 1 week later, THEN
• 1200 mg IV every 2 weeks thereafter
• Administer at recommended dosage regimen time points, or within two days of these time points

Neuromyelitis Optica Spectrum Disorder

Adult dosage

• Doses 1-4: 900 mg IV every week for first 4 weeks, followed by
• Dose 5: 1200 mg IV 1 week later, THEN
• 1200 mg IV every 2 weeks thereafter
• Administer at recommended dosage regimen time points, or within two days of these time points

Limitations of Use

• Not indicated for the treatment of patients with Shiga toxin E.coli related hemolytic uremic syndrome (STEC-HUS)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Eculizumab include:

• headache,
• dizziness,
• flu symptoms (fever, tiredness, aches, cough, sore throat),
• runny or stuffy nose,
• sinus pain,
• painful urination,
• nausea,
• vomiting,
• diarrhea,
• stomach pain,
• swelling in the legs or feet,
• bruising,
• muscle or joint pain,
• back pain,
• severe headache,
• blurred vision, and
• pounding in the neck or ears.

Serious side effects of Eculizumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• headache,
• skin rash,
• headache with nausea and vomiting,
• body ache,
• flu symptoms,
• confusion,
• increased sensitivity to light,
• stiffness in the neck or back,
• pain or burning when urinating,
• little or no urination,
• painful or difficult urination,
• swelling in the feet or ankles,
• tiredness,
• short of breath,
• pale skin,
• unusual tiredness,
• lightheadedness,
• cold hands and feet,
• easy bruising,
• unusual bleeding,
• confusion,
• chest pain, and
• seizure.

Rare side effects of Eculizumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Eculizumab has no noted severe interactions with any other drugs.
• Eculizumab has no noted serious interactions with any other drugs.
• Eculizumab has no noted moderate interactions with any other drugs.
• Eculizumab has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Documented hypersensitivity
• Unresolved serious Neisseria meningitidis infection or patients who are unvaccinated against N meningitidis (unless the risk of delaying treatment outweigh the risk for meningococcal infection)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Eculizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Eculizumab?”

Cautions

• Discontinue if being treated for serious meningococcal infection
• Supplement dose with plasma infusion or exchange
• Only administer as an IV infusion, do not give IVP or bolus (see Administration)
• Infusion-related reactions may occur; continue monitoring for 1 hour after completion of infusion
• Serious meningococcal infections risk and prevention
  • Life-threatening and fatal meningococcal infections have occurred; the treatment increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis); therapy is associated with an approximate 2,000-fold increased risk of meningococcal disease in comparison to the general U.S. population annual rate
  • Revaccinate for meningococcal disease by ACIP recommendations, considering the duration of therapy
  • Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection suspected
  • Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early
  • Discontinue therapy in patients who are undergoing treatment for serious meningococcal infections
• Other infections
  • Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, reported
  • The drug blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria
  • Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients; children receiving therapy may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib)
  • Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines; use caution when administering therapy to patients with any systemic infection
• Monitoring disease manifestations after therapy discontinuation
  • Treatment discontinuation for PNH
    • Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis
  • Treatment Discontinuation for HUS
    • After discontinuing Soliris, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks
    • Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis
    • The following changes in laboratory parameters may also identify a TMA complication, the occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during treatment
    • If TMA complications occur after therapy discontinuation, consider reinstitution of treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures

Pregnancy and Lactation

• PNH and aHUS disease registries collect pregnancy outcomes in women exposed to eculizumab during pregnancy, contact www.pnhregistry.com or www.ahusregistry.com, or call (215)-616-3558
• In cases where gMG patients become pregnant, call (215)-616-3558
• There are no available data on eculizumab use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage
• Advise pregnant women of the potential risk to a fetus
• Lactation
  • There is no information regarding the presence of eculizumab in human milk, the effects on the breastfed infant, or the effects on milk production
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or the underlying maternal condition