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Soliris: Uses, Side Effects & Dosage | Healio

Topics Soliris Brand Names Bkemv, Epysqli, Soliris Generic Name eculizumab Phonetic Name (e-kue-LIZ-oo-mab) Clinical Uses This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder can cause a decrease in red

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Topics

Soliris

Brand Names

Bkemv, Epysqli, Soliris

Generic Name

eculizumab

Phonetic Name

(e-kue-LIZ-oo-mab)

Clinical 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. This monograph is about the following eculizumab products: eculizumab, eculizumab-aagh, eculizumab-aeeb.

Dosage and Administration

Preparations

  • 10 mg Brand(s): /mL (300 Soliris(R), Alexion concentrate, mg) for IV infusion only

Administration Notes

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. 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 get better or if it gets worse.

Missed Dose Instructions

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.

Label Warnings

Do not shake Keep in refrigerator. Do not freeze. Protect from light If brought to room temperature, see product package for storage instructions. Discard unused portion after the expiration date of _______________.

Indications

  • atypical hemolytic uremic syndrome
  • myasthenia gravis
  • paroxysmal nocturnal hemoglobinuria
  • anti-acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis
  • neuromyelitis optica spectrum disorder with anti-aquaporin-4 (AQP4) antibodies

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. This monograph is about the following eculizumab products: eculizumab, eculizumab-aagh, eculizumab-aeeb.

Contraindications

  • meningococcal meningitis
  • meningococcemia
  • infection

Common Adverse Effects

  • Acute abdominal pain
  • Back pain
  • Constipation
  • Cough
  • Diarrhea
  • Fatigue
  • Fever
  • Headache disorder
  • Musculoskeletal pain
  • Myalgia
  • Nausea
  • Pharyngitis
  • Sinusitis
  • Upper respiratory infection
  • Urinary tract infection
  • Vomiting
  • Alopecia
  • Anorexia
  • Arthralgia
  • Bronchitis
  • Bruising
  • Cellulitis
  • Cystitis
  • Dizziness
  • Dry skin
  • Dysgeusia
  • Dyspnea
  • General weakness
  • Hematoma
  • Hordeolum
  • Influenza
  • Migraine
  • Muscle spasm
  • Ocular discharge
  • Pain
  • Pain in oropharynx
  • Pruritus of skin
  • Rhinitis
  • Skin photosensitivity
  • Skin rash
  • Stomatitis
  • Tachycardia
  • Vertigo
  • Abdominal distension
  • Abnormal hepatic function tests
  • Blurred vision
  • Conjunctivitis
  • Depression
  • Dysuria
  • Gastroesophageal reflux disease
  • Gingival pain
  • Nasal congestion
  • Palpitations
  • Paresthesia
  • Peripheral edema

Serious Adverse Effects

  • Anemia
  • Hypertension
  • Aspergillosis
  • Cataracts
  • Herpes simplex infection
  • Hypersensitivity drug reaction
  • Hypotension
  • Infection
  • Leukopenia
  • Lymphopenia
  • Viral infection
  • Anaphylaxis
  • Cardiomyopathy
  • Cholestatic hepatitis
  • Drug-induced hepatitis
  • Goiter
  • Gonococcal meningitis
  • Hearing loss
  • Meningitis
  • Meningococcemia
  • Septic shock
  • Systemic lupus erythematosus
  • Thrombocytopenic disorder

Elderly Precautions

Pregnancy Precautions

PrecautionSeverityNarrativeECULIZUMABRequires a Risk/Benefit AssessmentLimited human data do not suggest a clear association for developmental toxicity. Animal data suggest developmental toxicity at doses less than10 times the maximum recommended human dose. Paroxysmal nocturnal hemoglobinuria is associated with adverse maternal outcomes (e.g. thrombosis, bleeding, infection, miscarriage), and adverse fetal outcomes (e.g. fetal death, premature delivery). Atypical hemolytic uremic syndrome is associated with adverse maternal outcomes (e.g. preeclampsia, preterm delivery), and adverse fetal/neonatal outcomes (e.g. IUGR, fetal death, low birth weight). Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes.

Lactation Precautions

SeverityNarrativePrecautionLIMITED DATA SUGGEST ONE BREASTMILK SAMPLE WITH LOW LEVEL DETECTED

Pediatric Precautions

SeverityNarrativeManagement or Monitoring PrecautionEnsure vaccinations (N. meningitidis, Hib, S. pneumoniae) are given prior to treatment initiation per ACIP guidelines. Not approved for myasthenia gravis age < 6 years in pediatrics.

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.

Drug Interactions Table

Storage Requirements

Not applicable. This medication is given in a clinic and will not be stored at home.

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Selected from data included with permission and copyrighted by FDB, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution in professional health care settings.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of your healthcare professional. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you. You should consult your healthcare professional before taking any drug, changing your diet or commencing or discontinuing any course of treatment. See our full terms of use.

This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment.

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Source-derived material selected through this article’s indexed topics.

Related questions

01Q. How is eculizumab administered in AQP4 antibody positive NMOSD?

Eculizumab is supplied in 300 mg vials (30 mL of a 10 mg/mL solution) and is administered via intravenous infusion over 35 minutes. We suggest administration at an infusion center to allow for patient monitoring given the relative newness of the medication for this indication. Dosing regimen consists of:

Source: my.clevelandclinic.org ↗
02How does Soliris compare with Ultomiris (ravulizumab-cwvz)?

Soliris and Ultomiris are both used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). These conditions are caused by overactivity in your immune system (your body’s defense system). Soliris is also used to treat certain other conditions. Soliris and Ultomiris both work in the same way. They reduce activity in part of your immune system called the complement system. Both drugs block a protein in the complement system called C5. These drugs can cause similar side effects, including a raised risk of serious meningococcal infections. Both drugs have a boxed warning about this side effect. A boxed warning is the most serious warning from the FDA about drug side effects that can be dangerous. Soliris and Ultomiris are both administered by intravenous (IV) infusion. Soliris is usually given once every 2 weeks, while Ultomiris is a longer-acting drug and is usually given once every 4 to 8 weeks. To find out more about how Soliris compares with Ultomiris, talk with your doctor. Soliris can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Soliris. These lists do not include all possible side effects. For more information about the possible side effects of Soliris, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome. Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Soliris, you can do so through MedWatch.

Source: www.medicalnewstoday.com ↗
03How does Soliris compare with pegcetacoplan (Empaveli)?

Both Soliris and pegcetacoplan (Empaveli) are drugs that can be used to treat paroxysmal nocturnal hemoglobinuria (PNH). Empaveli is only used for PNH, but Soliris also has other uses as well. Soliris is given by intravenous (IV) infusion (an injection into a vein given over a period of time). Empaveli is given as a subcutaneous infusion (injection under the skin given over a period of time). A doctor or other healthcare professional will usually administer Soliris. But after training, you can self-administer Empaveli. Soliris is typically given once every 2 weeks, while you can self-administer Empaveli twice per week. These medications work in a similar way in your body and can cause some similar side effects. For example, both drugs have a boxed warning* for an increased risk of meningococcal infections. But they can also cause some different side effects as well. To find out more about how these drugs compare, talk with your doctor. * A boxed warning is a serious warning from the Food and Drug Administration (FDA). For more information, see the “What should be considered before using Soliris?” section.

Source: www.healthline.com ↗
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