eculizumab (Rx)

Brand and Other Names:Soliris
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10mg/mL
more...

Paroxysmal Nocturnal Hemoglobinuria

Indicated for paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis

600 mg IV infusion over 35 minutes q7days for the first 4 weeks, THEN

900 mg (fifth dose) after 7 days, THEN

900 mg q14days 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

900 mg IV infusion over 35 minutes q7days for 4 weeks, THEN

1200 mg (5th dose) after 7 days, THEN

1200 mg q14days THEREAFTER

Administer at recommended dosage regimen time points, or within two days of these time points

Myasthenia Gravis

Indicated for generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive

900 mg IV infusion over 35 minutes q7days for 4 weeks, THEN

1200 mg (5th dose) after 7 days, THEN

1200 mg q14days THEREAFTER

Administer at recommended dosage regimen time points, or within two days of these time points

Dosage Modifications

Supplemental dosing required 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 or more most recent dose: Give 600 mg per each session within 60 minutes following completion

Fresh frozen plasma infusion

  • 300 mg or more most recent dose: Give 300 mg per each unit of FFP; administer 60 minutes prior to each 1 unit 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

Neuromyelitis optica

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
more...

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 or more most recent dose: Give 600 mg per each session within 60 minutes following completion

Fresh frozen plasma infusion

  • 300 mg or more most recent dose: Give 300 mg per each unit of FFP; administer 60 minutes prior to each 1 unit 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)
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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

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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
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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.

more...
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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

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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

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
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Images

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