Ravulizumab-cwvz Injection

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.

Ravulizumab-cwvz injection is used in adults and children 1 month of age and older 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 injection is also used in adults to treat a certain form of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness). 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. It works by disrupting communication between nerves and muscles in people with MG.

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. Ravulizumab-cwvz injection also comes in an on-body delivery system (on-body injector with a prefilled cartridge) to be injected subcutaneously (just under the skin).

If ravulizumab-cwvz injection is given intravenously to treat adults with PNH, aHUS, or MG, it is usually given every 8 weeks starting 2 weeks after your first dose. If ravulizumab-cwvz injection is given intravenously to treat children with PNH or aHUS, it is usually given every 4 or 8 weeks, depending on their body weight, starting 2 weeks after the first dose.

If ravulizumab-cwvz injection (in an on-body delivery system) is used to treat adults with PNI or aHUS, it is usually given subcutaneously once a week. For a full dose, you will need to use 2 separate on-body delivery systems and inject the contents of each delivery system subcutaneously over about 10 minutes. The 2 injections can be given at the same time or you may inject them one right after the other. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ravulizumab-cwvz injection for subcutanous injection exactly as directed. Do not use more or less of this medication or use it more often or for a longer period of time than prescribed by your doctor.

Your doctor may decide to allow you or a caregiver to perform the subcutaneous injections using the on-body delivery system at home. Your healthcare provider will show you how to prepare and perform the injections at home. Ask your pharmacist or doctor for a copy of the manufacturer's instructions for use information for the patient. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Ravulizumab-cwvz injection comes in single-use on-body delivery systems (on-body injector with prefilled cartridge). Remove 2 on-body delivery systems from the refrigerator and allow them to warm to room temperature for at least 45 minutes away from direct sunlight before you inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Dispose of used on-body delivery systems in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Check the cartridge to be sure that the expiration date printed on the cartridge has not passed. Look closely at the liquid in the cartridge. The liquid should be clear and colorless to slightly yellow and should not be cloudy or discolored or contain large particles. Do not shake or drop the on-body injector or cartridge or allow the injector to get wet. Call your pharmacist if there are any problems with the package or the cartridge and do not inject the medication.

You can apply the on-body injector anywhere on the front of your thighs (upper leg), upper arm, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. Choose a different spot each time you apply the on-body injector. Do not inject into an area where the skin is tender, bruised, red, hard, or not intact, or where you have scars, stretch marks, tatoos, excessive hair, or moles.

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 or tell you to remove the on-body delivery system 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; bad taste in the mouth; lower back pain; pain with the infusion; drowsiness; or feeling faint.

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

Before receiving ravulizumab-cwvz injection,

• tell your doctor and pharmacist if you are allergic to ravulizumab-cwvz, any other medications, acrylic adhesives, 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.

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

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

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
• rash, itching, redness, swelling, bruising, or pain near the injection site (for the subcutaneous injection)

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).

Keep on-body delivery system in the carton it came in, tightly closed, and out of reach of children. Store it in a refrigerator and protect from light. If it is removed from the refrigerator, it can be stored at room temperature in the original container for up to 3 days. Dispose of ravulizumab-cwvz injection if it has been left at room temperature more than 3 days. Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.

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