Crovalimab-akkz injection

IMPORTANT WARNING:

Receiving crovalimab-akkz 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) or other serious infections during your treatment or for some time afterward. These infections may cause death in a short period of time. You will need to receive certain vaccines at least 2 weeks before you begin your treatment with crovalimab-akkz injection to decrease the risk that you will develop this type of infection. If you have received these vaccines 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 crovalimab-akkz injection right away, you will receive your vaccine(s) as soon as possible but will need to take an antibiotic for as long as your doctor recommends.

Even if you receive the meningococcal vaccine, there is still a risk that you may develop meningococcal disease during or after your treatment with crovalimab-akkz 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; fever with high heart rate; 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 crovalimab-akkz injection. Your doctor will not give you crovalimab-akkz 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 11 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 Piasky REMS has been set up to decrease the risks of receiving crovalimab-akkz injection. You can only receive crovalimab-akkz 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 crovalimab-akkz 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 (https://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 crovalimab-akkz.

WHY is this medicine prescribed?

Crovalimab-akkz injection is used 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). Crovalimab-akkz 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.

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?

Crovalimab-akkz injection comes as a solution (liquid) to be injected intravenously (into a vein) and subcutaneously (under the skin) by a doctor or nurse in a medical office. The first dose is usually given intravenously over 60 to 90 minutes. After the first dose, it is usually given subcutaneously on days 2, 8, 15, and 22, and then once a week thereafter.

Crovalimab-akkz injection may cause serious allergic reactions. Your doctor will watch you carefully while you are receiving crovalimab-akkz injection. 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; feeling dizzy or lightheaded; rash; hives; chest pain; difficulty breathing; shortness of breath; swelling of your face, tongue, or throat; or fever or chills.

What SPECIAL PRECAUTIONS should I follow?

Before receiving crovalimab-akkz injection,

• tell your doctor and pharmacist if you are allergic to crovalimab-akkz, any other medications, or any of the ingredients in crovalimab-akkz 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 conditions.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while receiving crovalimab-akkz injection, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are receiving crovalimab-akkz injection and for 9 months after your final treatment dose.

• you should know that your condition may cause too many red blood cells to break down after you stop receiving crovalimab-akkz injection. Your doctor will monitor you carefully and may order laboratory tests during the first 20 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.

• you should know that crovalimab-akkz injection may serious immune system reactions in the first 30 days of therapy, especially if you have been taking certain other medications. Your doctor may monitor you carefully for about 30 days after you start your treatment. Tell your doctor if you are receiving or have received treatment with any other complement inhibitor medications. Ask your doctor if you are not sure if you have been treated with another complement inhibitor medication. Call your doctor immediately or get emergency medical treatment if you develop any of the following symptoms: muscle, joint, or bone pain; rash, itching, or other skin problem; fever; numbness or tingling in the hands and feet; unusual tiredness or weakness; headache; or stomach pain.

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 crovalimab-akkz injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

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

• diarrhea
• nausea
• redness or pain near the injection site (for the subcutaneous injection)
• swelling of the arms, hands, feet, ankles, or lower legs
• runny nose

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

• sore throat, cough, fever, chills, burning or pain when urinating, and other signs of infection
• nosebleed

Crovalimab-akkz injection 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 (https://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 may order certain lab tests to check your body's response to crovalimab-akkz 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.