Warnings:

Ravulizumab-cwvz can lower your body's ability to fight infections. This increases your chance of getting very serious (possibly fatal) infections (especially meningitis or sepsis). Get medical help right away if you develop symptoms 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 vaccinated for meningitis in the past, ask your doctor if you should get another vaccination (booster shot) before receiving this medication. Vaccines may not fully protect everyone who receives them, so you should still watch for signs of meningitis after you get the vaccine.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Ultomiris REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

How to use Ultomiris Vial

Read the Medication Guide provided by your pharmacist. Carry the Patient Safety Card with you at all times during treatment and for 8 months after your last dose of ravulizumab-cwvz. If you have any questions, ask your doctor or pharmacist.

This medication is given by slow injection into a vein by a health care professional as directed by your doctor. After the first dose, it is usually given 2 weeks later, then every 4 or every 8 weeks. The dosage is based on your medical condition, weight, and response to treatment.

Reactions may happen with your injection. To monitor you and decrease your risk of a serious reaction, you should remain in the hospital or clinic for at least 1 hour after your injection. Tell your health care professional right away if you have symptoms such as low back pain, pain with the injection, chest pain, shortness of breath, or feeling faint.

Do not stop using this medication without consulting your doctor. Your condition may become worse when the drug is stopped. If you do stop using this medication, your doctor will monitor you for at least 16 weeks to make sure your condition does not get worse. Consult your doctor for more details.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

See also Warning and How to Use sections.

Headache, nausea, diarrhea, dizziness, or muscle/joint 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.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

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 ravulizumab-cwvz, 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, vaccinations.

Ravulizumab-cwvz can make you more likely to get certain infections (such as flu, colds, meningitis). 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 live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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. Because of the possible risk to the infant, breastfeeding while using this drug and for 8 months after the last dose is not recommended. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

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.

Does Ultomiris Vial interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker

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

Lab and/or medical tests (such as LDH levels, complete blood count) should be done while you are using this medication, and for 4 to 12 months after stopping treatment, depending on your condition. Keep all medical and lab appointments.

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.

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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.