Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 10mg/mL
Paroxysmal Nocturnal Hemoglobinuria
Indicated for paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
Doses 1-4: 600 mg IV qWeek for first 4 weeks, followed by
Dose 5: 900 mg IV 1 week later, THEN
900 mg IV q2Weeks thereafter
Administer at recommended dosage regimen time points, or within two days of these time points
Hemolytic Uremic Syndrome
Indicated for treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy; effectiveness based on the effects on thrombotic microangiopathy and renal function
Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by
Dose 5: 1200 mg IV 1 week later, THE
1200 mg IV q2Weeks thereafter
Myasthenia Gravis
Indicated for generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive
Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by
Dose 5: 1200 mg IV 1 week later, THEN
1200 mg IV q2Weeks thereafter
Administer at recommended dosage regimen time points, or within two days of these time points
Neuromyelitis Optica Spectrum Disorder
Indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by
Dose 5: 1200 mg IV 1 week later, THEN
1200 mg IV q2Weeks thereafter
Administer at recommended dosage regimen time points, or within two days of these time points
Dosage Modifications
Supplemental dosing required for aHUS, gMG, or NMOSD in the setting of concomitant support with plasma exchange or plasma infusion (plasmapheresis or plasma exchange; fresh frozen plasma infusion)
Plasmapheresis or plasma exchange
- ≥300 mg most recent dose: Give 300 mg per each session within 60 minutes following completion
- ≥600 mg most recent dose: Give 600 mg per each session within 60 minutes following completion
Fresh frozen plasma infusion
- 300 mg most recent dose: Give 300 mg per infusion of FFP; administer 60 minutes prior to each infusion of FFP
Dosing Considerations
Limitation of use
- Not indicated for the treatment of patients with Shiga toxin E coli related hemolytic uremic syndrome (STEC-HUS)
Recommended vaccination and prophylaxis
- Vaccinate patients according to current ACIP guidelines to reduce risk of serious infection
- Provide two weeks of antibacterial drug prophylaxis to patients if therapy must be initiated immediately and vaccines are administered less than two weeks before starting therapy
- Healthcare professionals who prescribe therapy must enroll in the Soliris REMS
Degos Disease (Off-label)
Doses 1-4: 600 mg IV q7days for 4 wk
Dose 5 and thereafter: Wait 7 days following 4th dose, then administer 900 mg IV for 5th dose, then 900 mg IV q14days thereafter
This dosage regimen is for PNH, in cases of Degos disease the dosing can reach 1200 mg/dose
Orphan Designations
Dermatomyositis
Idiopathic membranous glomerular nephropathy
Renal transplantation: prevention of delayed graft function
Shiga-Toxin producing Escherichia coli hemolytic uremic syndrome
Orphan sponsor
- Alexion Pharmaceuticals, Inc; 352 Knotter Drive; Cheshire, CT 06410
Dosage Forms & Strengths
injectable solution
- 10mg/mL
Hemolytic Uremic Syndrome
Indicated for treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy; effectiveness based on the effects on thrombotic microangiopathy and renal function
5 to <10 kg
- 300 mg IV infusion once then, THEN
- 300 mg (second dose) after 7 days, THEN
- 300 mg every 21 days THEREAFTER
10 to <20 kg
- 600 mg IV infusion once, THEN
- 300 mg (second dose) after 7 days, THEN
- 300 mg every 14 days THEREAFTER
20 to <30 kg
- 600 mg IV infusion q7days for 2 weeks, THEN
- 600 mg (third dose) after 7 days, THEN
- 600 mg q14days THEREAFTER
30 to <40 kg
- 600 mg IV infusion q7days for 2 weeks, THEN
- 900 mg (third dose) after 7 days, THEN
- 900 mg every 14 days THEREAFTER
>40 kg
- 900 mg IV infusion q7days for 4 weeks, THEN
- 1200 mg (fifth dose) after 7 days, THEN
- 1200 mg q14days THEREAFTER
Administer at recommended dosage regimen time points, or within two days of these time points
Supplemental Doses After PE/PI
Supplemental dosing required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange; or fresh frozen plasma infusion)
Plasmapheresis or plasma exchange
- ≥300 mg most recent dose: Give 300 mg per each session within 60 minutes following completion
- ≥600 mg most recent dose: Give 600 mg per each session within 60 minutes following completion
Fresh frozen plasma infusion
- 300 mg most recent dose: Give 300 mg per infusion of FFP; administer 60 minutes prior to infusion of FFP
Dosing Considerations
Limitation of use
- Not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)
Adverse Effects
>10%
Paroxysmal Nocturnal Hemoglobinuria
- Headache (44%)
- Nasopharyngitis (23%)
- Back pain (19%)
- Nausea (16%)
- Cough (12%)
- Fatigue (12%)
Hemolytic Uremic Syndrome
- Hypertension (47%)
- Headache (41%)
- Diarrhea (35%)
- Anemia (35%)
- Vomiting (29%)
- Upper respiratory infection (29%)
- UTI (24%)
- Leukopenia (24%)
- Fatigue (18%)
- Peripheral edema (18%)
- Pyrexia (18%)
- Cough (12%)
Generalized myasthenia gravis
- Headache (26%)
- Nasopharyngitis (24%)
- Diarrhea (15%)
- Musculoskeletal pain (15%)
- Arthralgia (12%)
- Upper respiratory tract infection (11%)
1-10%
Paroxysmal Nocturnal Hemoglobinuria
- Constipation
- Flu-like illness
- Myalgia
- Pain
- Various infections (eg, HSV)
- Serious or fatal meningococcal infections
Hemolytic Uremic Syndrome
- Pharyngolaryngeal pain
- Vertigo
- Pain in extremity
Generalized myasthenia gravis
- Nausea (10%)
- Contusion (8%)
- Herpes simplex virus infections (8%)
- Peripheral edema (8%)
- Abdominal pain (8%)
- Pyrexia (7%)
Frequency Not Defined
As with all proteins, there is a potential for immunogenicity
Fatal or serious infections: Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria sicca/subflava, Neisseria spp unspecified
Warnings
Black Box Warnings
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris; meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early
Comply with most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies
Immunize patients with meningococcal vaccines at least 2 weeks prior to administering first dose of the drug, unless the risks of delaying therapy outweigh risk of developing a meningococcal infection
Vaccination reduces, but does not eliminate, risk of meningococcal infections; monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected
Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS); prescribers must enroll in the program by telephone: 1-888-SOLIRIS (1- 888-765-4747) or at www.solirisrems.com
Contraindications
Documented hypersensitivity
Unresolved serious Neisseria meningitidis infection or patients who are unvaccinated against N meningitidis (unless risk of delaying treatment outweigh the risk for meningococcal infection)
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 hr 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 general U.S. population annual rate
- Revaccinate for meningococcal disease in accordance with 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 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, 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 & Lactation
Pregnancy
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
Animal studies using a mouse analogue of the eculizumab molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose
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 from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Monoclonal blocking antibody to complement protein C5; inhibits cleavage to C5a and C5b, thus preventing terminal complement complex C5b-9, thereby preventing RBC hemolysis
Inhibits terminal complement mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS
Pharmacokinetics
Peak serum concentration (at week 26): 194 mcg/mL
Trough concentration (at week 26): 97 mcg/mL
Vd: 7.7 L
Half-Life: 8-15 days
Half-Life following plasma exchange: 1.26 hours
Clearance: 22 mL/hr/70 kg
Clearance following plasma exhange: 3660 mL/hr
Administration
IV Compatibility
0.9% NaCl, 0.45% NaCl, D5W, or Lactated Ringers
IV Preparation
Withdraw the required drug amount and transfer dose to an infusion bag
Dilute eculizumab to a final concentration of 5 mg/mL by adding equal volume of diluent to drug volume (see IV Compatibility); see prescribing information for further information
Gently invert the infusion bag containing the diluted solution to ensure thorough mixing of the product and diluent
Discard any unused portion left in a vial, as the product contains no preservatives
Prior to administration, admixture should come to room temperature 18-25°C (64-77°F)
Do not be heated in a microwave or with any heat source other than ambient air temperature
IV Administration
Prescribers must enroll in Risk Evaluation and Mitigation Strategy (REMS) program
Do not administer as IV push or bolus injection
Administer at recommended dosage regimen time points, or within 2 days of these time points
Adults: Infuse IV over at least 35 min; may slow/stop infusion if adverse effect occurs, but total infusion time should not exceed 2 hr
Children: Infuse IV over 1-4 hr via gravity feed, a syringe-type pump, or an infusion
Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion-related reaction
Storage
Unused vials
- Store in refrigerator at 2-8ºC (36-46ºF); do not freeze or shake
- Protect from light
- Store in original carton at controlled room temperature (not more than 25°C[77°F]) for only a single period up to 3 days
- Do not use beyond the expiration date stamped on the carton
Diluted solutions
- Store in refrigerator at 2-8°C (36-46°F) for up to 24 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Soliris intravenous - | 300 mg/30 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
eculizumab intravenous
ECULIZUMAB - INJECTION
(e-kue-LIZ-oo-mab)
COMMON BRAND NAME(S): Soliris
WARNING: Eculizumab can lower your body's ability to fight an infection. It can increase your chance of getting a very serious (possibly fatal) brain/spinal cord infection (meningitis). Get medical help right away if you develop any signs of a severe infection (including meningitis), such as nausea/vomiting that doesn't stop, high fever, chills, severe headache, stiff neck, mental/mood changes (such as confusion), eye sensitivity to light.You should receive the vaccine for meningitis (meningococcal vaccine) at least 2 weeks before receiving this medication. If you have been previously vaccinated for meningitis, ask your doctor if you need to be vaccinated again before receiving this medication. The vaccine will protect most people, but meningitis may occur even in people who have been vaccinated. You should still watch for signs of meningitis even if you receive the vaccine. Consult your doctor for more details.
USES: This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder can cause a decrease in red blood cells (anemia). This medication helps to block the decrease in red blood cells and can improve the symptoms of anemia (such as tiredness, shortness of breath) and decrease the need for blood transfusions.This medication may also be used to treat a certain immune system disorder (atypical Hemolytic Uremic Syndrome). It helps to prevent blood clots caused by this disorder.Eculizumab is also used to treat a certain muscle condition (generalized Myasthenia Gravis). It may help to improve symptoms of this condition (such as difficulty swallowing, trouble breathing).Eculizumab is also used to treat a certain nervous system disorder that affects the spinal cord and eye nerve (neuromyelitis optica spectrum disorder). It may help to reduce the number of hospital stays due to the disease.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start receiving eculizumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is given by injection into a vein by a health care professional as directed by your doctor. It is usually given every 7 days for 5 weeks, then every 14 days. The dosage is based on your medical condition. For children, the dosage is also based on the weight.Infusion reactions may occur while you are receiving this medication. Tell your doctor right away if you have symptoms such as throat swelling, shortness of breath, chest pain/tightness, dizziness, or feeling faint.Do not stop receiving this medication without consulting your doctor. Your condition may become worse when the drug is stopped. If you do stop receiving the medication, you may need to be monitored by your doctor for at least 8 or 12 weeks to make sure that your condition does not worsen. Consult your doctor for more details and for symptoms to watch out for.Tell your doctor if your condition does not improve or worsens.
SIDE EFFECTS: See also Warning section.Headache, tiredness, diarrhea, nausea/vomiting, or muscle pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of infection (such as cough/sore throat that doesn't go away, fever, painful/frequent urination), muscle cramps, swelling hands/ankles/feet, fast heartbeat, signs of kidney problems (such as change in the amount of urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using eculizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection (especially of meningitis), vaccination history (especially for meningitis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Eculizumab can make you more likely to get certain infections (such as gonorrhea). Talk to your doctor for more details.You may be vaccinated against certain infections before starting this medication. Tell your health care professional that you are using eculizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as LDH levels, kidney function, complete blood count, blood pressure) should be done while you are using this medication and for 8 or 12 weeks after stopping treatment. Keep all medical and lab appointments. Consult your doctor for more details.You will be provided with a Patient Safety Card with a list of symptoms you must watch for. Carry the Patient Safety Card with you at all times while you are receiving this medication and for 3 months after stopping this medication. If you develop any of the listed symptoms, you should get medical help right away.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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