Soliris Vial

GENERIC NAME(S): Eculizumab

OTHER NAME(S): Soliris Solution

WARNINGS:

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). Get medical help right away if you develop any signs of a severe infection (including meningitis), such as nausea/vomiting that doesn't stop, high fever, chills, severe headache, stiff neck, mental/mood changes (such as 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.

To receive eculizumab in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Who should not take Soliris Vial?

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Uses

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.

How to use Soliris Vial

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 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 improve or worsens.

Side Effects

Side Effects

See also Warning and How to Use sections.

Headache, tiredness, diarrhea, nausea/vomiting, or muscle pain may occur. If any of these effects last or get worse, 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 cough/sore throat that doesn't go away, fever, 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

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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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. Tell your health care professional that you are using eculizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as 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 unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Interactions

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

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Notes

Lab and/or medical tests (such as LDH levels, kidney function, complete blood count, blood pressure) should be done while you are using this medication and for 8 or 12 weeks after stopping treatment. Keep all medical and lab appointments. 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.Information last revised May 2024. Copyright(c) 2024 First Databank, Inc.

Images
Soliris 300 mg/30 mL intravenous solution
Soliris 300 mg/30 mL intravenous solutioniconicon
Soliris 300 mg/30 mL intravenous solution

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Soliris 300 mg/30 mL intravenous solution
Soliris 300 mg/30 mL intravenous solution

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This medicine is a colorless, clear, vial

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. 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 or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.