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Ravulizumab-cwvz Injection

(rav" ue liz' ue mab)

Brand Name(s): Ultomiris®

IMPORTANT WARNING:

Receiving ravulizumab-cwvz injection may increase the risk that you will develop a meningococcal infection (an infection that may affect the covering of the brain and spinal cord and/or may spread through the bloodstream) during your treatment or for some time afterward. Meningococcal infections may cause death in a short period of time. You will need to receive a meningococcal vaccine at least 2 weeks before you begin your treatment with ravulizumab-cwvz injection to decrease the risk that you will develop this type of infection. If you have received this vaccine in the past, you may need to receive a booster dose before you begin your treatment. If your doctor feels that you need to begin treatment with ravulizumab-cwvz injection right away, you will receive your meningococcal vaccine as soon as possible and take an antibiotic for 2 weeks.

Even if you receive the meningococcal vaccine, there is still a risk that you may develop meningococcal disease during or after your treatment with ravulizumab-cwvz injection. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help: headache that comes along with nausea or vomiting, fever, a stiff neck, or a stiff back; fever; rash and fever; confusion; muscle aches and other flu-like symptoms; or if your eyes are sensitive to light.

Tell your doctor if you have fever or other signs of infection before you begin your treatment with ravulizumab-cwvz injection. Your doctor will not give you ravulizumab-cwvz injection if you already have a meningococcal infection.

Your doctor will give you a patient safety card with information about the risk of developing meningococcal disease during or for a period of time after your treatment. Carry this card with you at all times during your treatment and for 8 months after your treatment. Show the card to all healthcare providers who treat you so that they will know about your risk.

A program called Ultomiris REMS has been set up to decrease the risks of receiving ravulizumab-cwvz injection. You can only receive ravulizumab-cwvz injection from a doctor who has enrolled in this program, has talked to you about the risks of meningococcal disease, has given you a patient safety card, and has made sure that you received a meningococcal vaccine.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ravulizumab-cwvz and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving ravulizumab-cwvz injection.

WHY is this medicine prescribed?

Ravulizumab-cwvz injection is used in adults to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body). Ravulizumab-cwvz injection is also used in adults and children 1 month of age and older to treat atypical hemolytic uremic syndrome (aHUS; an inherited condition in which small blood clots form in the body and may cause damage to the blood vessels, blood cells, kidneys, and other parts of the body). Ravulizumab-cwvz is in a class of medications called monoclonal antibodies. It works by blocking the activity of the part of the immune system that may damage blood cells in people with PNH and that causes clots to form in people with aHUS.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ravulizumab-cwvz injection comes as a solution (liquid) to be injected intravenously (into a vein) over about 2–4 hours by a doctor or nurse in a medical office. It is usually given every 8 weeks starting 2 weeks after your first dose. Children may receive ravulizumab-cwvz injection every 4 or 8 weeks, depending on their body weight, starting 2 weeks after the first dose.

Ravulizumab-cwvz injection may cause serious allergic reactions. Your doctor will watch you carefully while you are receiving ravulizumab-cwvz injection and for 1 hour after you receive the medication. Your doctor may slow or stop your infusion if you have an allergic reaction. If you experience any of the following symptoms, tell your doctor immediately: chest pain; difficulty breathing; shortness of breath; swelling of your face, tongue, or throat; lower back pain; pain with the infusion; or feeling faint.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ravulizumab-cwvz injection,

  • tell your doctor and pharmacist if you are allergic to ravulizumab-cwvz, any other medications, or any of the ingredients in ravulizumab-cwvz injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had any other medical condition(s).
  • tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while receiving ravulizumab-cwvz injection, call your doctor.
  • tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving ravulizumab-cwvz and for 8 months after your final treatment dose.
  • if you are being treated for PNH, you should know that your condition may cause too many red blood cells to break down after you stop receiving ravulizumab-cwvz injection. Your doctor will monitor you carefully and may order laboratory tests for at least 16 weeks after you finish your treatment. Call your doctor right away if you develop any of the following symptoms: extreme tiredness; blood in urine; stomach pain; difficulty swallowing; an inability to get or keep an erection; shortness of breath; pain, swelling, warmth, redness, or tenderness in one leg only; slow or difficult speech; weakness or numbness of an arm or leg; or any other unusual symptoms.
  • if you are being treated for aHUS, you should know that your condition may cause blood clots to form in your body after you stop receiving ravulizumab-cwvz injection. Your doctor will monitor you carefully and may order laboratory tests for at least 12 months after you finish your treatment. Call your doctor right away if you develop any of the following symptoms: sudden trouble speaking or understanding speech, confusion, sudden weakness or numbness of an arm or leg (especially on one side of the body) or of the face, sudden trouble walking, dizziness, loss of balance or coordination, fainting, seizures, chest pain, difficulty breathing, or any other unusual symptoms.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of ravulizumab-cwvz injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Ravulizumab-cwvz may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • nausea
  • vomiting
  • constipation
  • headache
  • muscle or joint pain
  • pain in the arms or legs
  • runny nose
  • pain or swelling in the nose or throat
  • cough
  • dizziness
  • painful or difficult urination
  • hair loss
  • dry skin
  • decreased appetite
  • tiredness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or HOW sections, call your doctor immediately or get emergency medical treatment:

  • fever or other signs of infection
  • stomach pain

Ravulizumab-cwvz may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ravulizumab-cwvz injection.

Ask your pharmacist any questions you have about ravulizumab-cwvz injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.


This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists® represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists® makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists® does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

Pronunciation Guide for Drug Names is used with permission. © 2009. The United States Pharmacopeial Convention. All Rights Reserved.

AHFS® Patient Medication Information™. © Copyright, 2020. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2020.