Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 10mg/mL
Biosimilars to Soliris
- Bkemv (eculizumab-aeeb)
- Epysqli (eculizumab-aagh)
Paroxysmal Nocturnal Hemoglobinuria
Soliris, Bkemv, or Epysqli
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 2 days of these time points
Hemolytic Uremic Syndrome
Soliris, Bkemv, or Epysqli
Indicated for treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by
Dose 5: 1,200 mg IV 1 week later, THEN
1,200 mg IV q2Weeks thereafter
Administer at recommended dosage regimen time points, or within 2 days of these time points
Myasthenia Gravis
Soliris or Epysqli
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: 1,200 mg IV 1 week later, THEN
1,200 mg IV q2Weeks thereafter
Administer at recommended dosage regimen time points, or within 2 days of these time points
Neuromyelitis Optica Spectrum Disorder
Soliris only
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: 1,200 mg IV 1 week later, THEN
1,200 mg IV q2Weeks thereafter
Administer at recommended dosage regimen time points, or within 2 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
Available only through a REMS program
Limitation of use
- Not indicated for treatment of patients with Shiga toxin E coli related hemolytic uremic syndrome (STEC-HUS)
Recommended vaccination and prophylaxis
- Vaccinate according to current ACIP guidelines to reduce risk of serious infection in patients taking complement inhibitors
- Provide 2 weeks of antibacterial drug prophylaxis if therapy must be initiated immediately and vaccines are administered ≤2 weeks before starting therapy
Degos Disease (Off-label)
Doses 1-4: 600 mg IV qWeek for 4 weeks
Dose 5 and thereafter: Wait 7 days following 4th dose, then administer 900 mg IV for 5th dose, then 900 mg IV q2Weeks thereafter
This dosage regimen is for PNH, in cases of Degos disease the dosing can reach 1,200 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
Biosimilars to Soliris
- Bkemv (eculizumab-aeeb)
- Epysqli (eculizumab-aagh)
Hemolytic Uremic Syndrome
Soliris, Bkemv, or Epysqli
Indicated for treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
5 to <10 kg
- 300 mg IV qWeek for first 2 weeks, THEN 300 mg IV q3Weeks thereafter
10 to <20 kg
- Dose 1: 600 mg IV, followed by
- Dose 2: 300 mg IV 1 week later, THEN
- 300 mg IV q2Weeks thereafter
20 to <30 kg
- 600 mg IV qWeek for first 3 weeks, THEN 600 mg IV q2Weeks thereafter
30 to <40 kg
- Doses 1 and 2: 600 mg IV qWeek for the first 2 weeks, followed by
- Dose 3: 900 mg IV 1 week later, THEN
- 900 mg IV q2Weeks thereafter
≥40 kg
- Doses 1-4: 900 mg IV qWeek for the first 4 weeks, followed by
- Dose 5: 1,200 mg IV 1 week later, THEN
- 1,200 mg IV q2Weeks thereafter
- Administer at recommended dosage regimen time points, or within 2 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
Available only through a REMS program
Limitation of use
- Not indicated for treatment of patients with Shiga toxin E coli related hemolytic uremic syndrome (STEC-HUS)
Recommended vaccination and prophylaxis
- Vaccinate according to current ACIP guidelines to reduce risk of serious infection
- Provide 2 weeks of antibacterial drug prophylaxis if therapy must be initiated immediately and vaccines are administered ≤2 weeks before starting therapy
Interactions
Interaction Checker
No Results
Contraindicated
Serious
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
eculizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious (6)
- axicabtagene ciloleucel
eculizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
eculizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
eculizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
eculizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
eculizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
eculizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (9)
- crovalimab
crovalimab, eculizumab. Other (see comment). Use Caution/Monitor. Comment: Crovalimab binds different epitopes on C5 compared to eculizumab and ravulizumab, which can lead to formation of drug-target-drug-complexes (DTDCs) when patients switch between crovalimab and either eculizumab or ravulizumab. Accumulation of immune complexes can lead to type III hypersensitivity. Carefully consider timing of switching from other C5 inhibitors; allow at least 5.5 half-lives from the last dose of a C5 inhibitor before initiating another C5 inhibitor.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of eculizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase
efgartigimod/hyaluronidase will decrease the level or effect of eculizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- isavuconazonium sulfate
eculizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ofatumumab SC
ofatumumab SC, eculizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of eculizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- trastuzumab
trastuzumab, eculizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, eculizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and eculizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
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
Postmarketing Reports
Cholestatic or mixed pattern liver injury with increased serum liver enzymes and bilirubin
Warnings
Black Box Warnings
Risk of serious infections caused by Neisseria meningitidis
- Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors; these infections may become rapidly life-threatening or fatal if not recognized and treated early
- Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks before first eculizumab dose, unless risks of delaying therapy outweigh risk of developing a serious infection
- Comply with current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies
- As a complement inhibitor, this drug increases risk of serious infections caused by Neisseria meningitidis
- Patients receiving this drug are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination; monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected
- 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
- Because of the risk of serious meningococcal infections, available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)
Contraindications
Initiation in patients with unresolved serious Neisseria meningitidis infection
Cautions
Discontinue if being treated for serious meningococcal infection
Supplement dose with plasma infusion or exchange
Infusion-related reactions may occur; continue monitoring for 1 hr after completing infusion
Serious meningococcal infections risk and prevention
- A complement inhibitor, this drug increases susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains
- Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors; contraindicated in patients with unresolved serious Neisseria meningitidis infection
- Complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks before initating first eculizumab dose, according to current ACIP recommendations for patients receiving a complement inhibitor
- Revaccinate patients in accordance with ACIP recommendations considering duration of therapy; note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from administration schedule in the vaccine prescribing information
- Various durations and regimens of antibacterial drug prophylaxis have been considered, but optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors
- Benefits and risks of treatment, as well as benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against known risks for serious infections caused by Neisseria meningitidis
- Vaccination does not eliminate risk of serious meningococcal infections, despite development of antibodies following vaccination
- Closely monitor for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected; inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur; promptly treat known infections
- Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early; consider interruption of therapy in patients who are undergoing treatment for serious meningococcal infection, depending on risks of interrupting treatment in the disease being treated
REMS
This drug is available only through a restricted program under a REMS, because of risk of serious meningococcal infections
Further information is available at
- www.UltSolREMS.com or 1-888-765-4747
- www.BKEMVREMS.com or 1-866-718-6927
- www.EPYSQLIREMS.com or 1-866-318-8144
-
Notable requirements of REMS include the following:
- Healthcare settings and pharmacies that dispense eculizumab must be certified in the REMS and must verify prescribers are certified
- Prescribers must enroll in the REMS.
- Prescribers must counsel patients about the risk of serious meningococcal infection
- Prescribers must provide the patients with the REMS educational materials
- Prescribers must assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of this drug
- Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently and the patient is not up to date with meningococcal vaccines according to current ACIP recommendations at least two weeks prior to first dose of this drug
- Patients must receive counseling from prescriber about the need to receive meningococcal vaccines per ACIP recommendations, the need to take antibiotics as directed by the prescriber, and signs and symptoms of meningococcal infection
- Patients must be instructed to carry Patient Safety Card with them at all times during and for 3 months following therapy
Other infections
- Serious infections with Neisseria species (other than N meningitidis), including disseminated gonococcal infections, have been reported
- The drug blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with N meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae
- Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients; children treated with this drug may be at increased risk of developing serious infections due to S pneumoniae and H influenzae type b (Hib)
- Administer vaccinations for prevention of S pneumoniae and Haemophilus influenzae type b infections according to ACIP recommendations; patients receiving this drug are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination
Monitoring disease manifestations after therapy discontinuation
-
Treatment discontinuation for PNH
- Monitor patients after discontinuing eculizumab for at least 8 weeks to detect hemolysis
-
Treatment discontinuation for HUS
- After discontinuing eculizumab, 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
- Laboratory parameters may also identify TMA complication, occurrence of 2, or repeated measurement of any 1 of the following: decreased platelet count by ≥25% compared to baseline or peak platelet count during treatment; increased serum creatinine or serum LDH by ≥25% compared to 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
Drug interactions overview
Concomitant use with neonatal Fc receptor antagonists may lower systemic exposure and reduce effectiveness of eculizumab; if coadministered, closely monitor for reduced eculizumab efficacy
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
Soliris or Bkemv
0.9% NaCl, 0.45% NaCl, D5W, or Ringer's Injection
Epysqli
0.9% NaCl, 0.45% NaCl, or D5W
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 patients for at least 1 hr after infusion for signs or symptoms of an infusion-related reaction
Storage
Unused vials
- Keep refrigerated (2-8ºC; 36-46ºF) in the original carton protected from light
- Do not freeze or shake
- Storage at at controlled room temperature varies for each product; see prescribing information for further information
- Do not use beyond the expiration date on the carton
Diluted solutions
- Store refrigerated (2-8°C; 36-46°F) for up to 24 hr (Soliris, Epysqli) or 64 hr (Bkemv) or at room temperature for up to 24 hr (Soliris, Bkemv, and Epysqli)
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.To receive eculizumab in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
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 using eculizumab and each time you get an infusion. Carry the Patient Safety Card with you at all times during treatment and for 3 months after your last dose of eculizumab. 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. Children's dosage is also based on weight.Infusion reactions may happen during the infusion of this drug. Tell your doctor right away if you have any symptoms of infusion reactions such as 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 and How to Use sections.Headache, diarrhea, nausea, or vomiting 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), swelling hands/ankles/feet, fast heartbeat, signs of kidney problems (such as change in the amount of urine).If you have used a similar medication recently (C5 inhibitors such as crovalimab, ravulizumab), you may be at increased risk for other immune system problems. Tell your doctor right away if you have symptoms such as: joint/muscle/bone pain, numbness/tingling of the hands/feet, unusual tiredness/weakness, stomach/abdominal pain.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).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.Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with 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 breastfeeding.
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 1-800-222-1222. Canada residents can call 1-844-764-7669.
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.
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 August 2024. Copyright(c) 2024 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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To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
