ravulizumab-cwvz 300 mg/30 mL (10 mg/mL) intravenous solution

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Medication name

Generic name:
Ravulizumab-cwvz - injection

Pronunciation
(RAV-ue-LIZ-ue-mab)

Brand name(s)
Ultomiris

Warning

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.

Uses

Ravulizumab-cwvz is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce 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. Ravulizumab-cwvz belongs to a class of medications known as monoclonal antibodies.

How to use

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 to 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 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.

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.

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

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

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 right away 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 October 2019.

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.