Soliris 300 mg/30 mL intravenous solution

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Medication name

Generic name:
Eculizumab - injection

Pronunciation
(e-kue-LIZ-oo-mab)

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. Therefore, 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).

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.

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 your doctor has prescribed this medication because he or she 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

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish 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).

Important note

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.

Information last revised July 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.