eculizumab (Rx)

Brand and Other Names:Soliris
  • Print

Dosing & Uses

AdultPediatric

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

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

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

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)

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)
Next:

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

Previous
Next:

Warnings

Black Box Warnings

Increases the risk of meningococcal infections

Vaccinate with a meningococcal vaccine at least 2 weeks prior to receiving the first dose; revaccinate according to current medical guidelines for vaccine use

Monitor for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary

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 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

Increased risk of susceptibility to infections

Meningococcal infection may occur and become rapidly life-threatening or fatal if not recognized and treated early ( see Black Box Warnings)

Supplement dose with plasma infusion or exchange

Only administer as an IV infusion, do not give IVP or bolus (see Administration)

Risk of other infections, including encapsulated bacteria (eg, Streptococcus pneumoniae, H influenzae) is increased with eculizumab; caution with any systemic infection

Infusion-related reactions may occur; continue monitoring for 1 hr after completion of infusion

Serious infections with Neisseria species (other than N. meningitides), including disseminated gonococcal infections, reported

Monitoring disease manifestations after treatment discontinuation

  • Treatment discontinuation for PNH: Monitor patients for at least 8 weeks to detect hemolysis
  • Treatment discontinuation for aHUS: Monitor patients for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 week
Previous
Next:

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.

Previous
Next:

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

Previous
Next:

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

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
Previous
Next:

Images

BRAND FORM. UNIT PRICE PILL IMAGE
Soliris intravenous
-
300 mg/30 mL vial

Copyright © 2010 First DataBank, Inc.

Previous
Next:

Patient Handout

Patient Education
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). Seek immediate medical attention if you develop any signs of a severe infection (including meningitis), such as high fever, chills, severe headache, persistent nausea/vomiting, stiff neck, mental/mood changes (e.g., 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 (e.g., 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 persist or worsen, 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 fever, persistent cough/sore throat, 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 that you are using this medication.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. Do not have other immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or 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 not known whether 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: Laboratory and/or medical tests (such as LDH levels, kidney function, complete blood count, blood pressure) should be performed periodically during treatment and for 8 or 12 weeks after stopping treatment to monitor your progress or check for side effects. 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 August 2021. Copyright(c) 2021 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.

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.