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eculizumab (Rx)Brand and Other Names:Soliris

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10mg/mL
more...

Paroxysmal Nocturnal Hemoglobinuria

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 thereafater

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

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

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

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

1200 mg q14days THEREAFTER

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

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

Myasthenia gravis

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

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

5 to <10 kg

  • 300 mg IV infusion once then, THEN
  • 300 mg (second dose) after 7 days, THE
  • 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

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
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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%)

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

Frequency Not Defined

As with all proteins, there is a potential for immunogenicity

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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

Contraindications

Documented hypersensitivity

Unresolved serious Neisseria meningitidis infection or patients who are unvaccinated against N. meningitidis (unless risk of delaying treatment outwiegh the risk for meningococcal infection)

Cautions

Discontinue if being treated for serious meningococcal infection

Caution with any systemic infection

Increased risk of susceptibility to infections

Meningococcal infection may occur and become rapidly life-threatening or fatal if not recognized and treated early

Supplement dose with plasma infusion or exchange

Only administer as an IV infusion, do not give IVP or bolus

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Pregnancy & Lactation

Pregnancy Category: C; based on animal data, may cause fetal harm

Lactation: excretion in milk unknown; use with caution

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 Administration

Dilute to 5 mg/mL by first adding dose to infusion bag, and then add appropriate amount of D5W, NS, ½NS, or Ringers

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

Administer by IV infusion, do NOT give IV push or bolus

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Images

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Formulary

FormularyPatient Discounts

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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