crovalimab-akkz 340 mg/2 mL injection solution

Generic name:
Crovalimab - injection

Pronunciation
(kroe-VAL-i-mab)

Brand name(s)
Piasky

Crovalimab can lower your body's ability to fight infections. It can increase your chance of getting a very serious (possibly fatal) brain/spinal cord infection (meningitis). Get medical help right away if you develop any signs of a severe infection (including meningitis), such as nausea/vomiting that doesn't stop, high fever, chills, severe headache, stiff neck, mental/mood changes (such as confusion), muscle aches with flu-like symptoms, eye sensitivity to light.

You should get the vaccine for meningitis (meningococcal vaccine) at least 2 weeks before you start crovalimab. If you have been previously vaccinated for meningitis, ask your doctor if you need to be vaccinated again before using this medication. The vaccine will protect most people, but meningitis may occur even in people who have been vaccinated. You should still watch for signs of meningitis even if you receive the vaccine. Consult your doctor for more details.

To receive crovalimab in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Crovalimab is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to break down red blood cells, which results in anemia. Crovalimab works by helping to block the body's breakdown 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.

Read the Medication Guide provided by your pharmacist before you start using crovalimab and each time you get an injection. Carry the Patient Safety Card with you at all times during treatment and for 11 months after your last dose of crovalimab. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. On day 1, the first dose is given by a slow injection into a vein, usually over 60 to 90 minutes as directed by your doctor. Starting on day 2, all other doses are given by injection under the skin as directed by your doctor, usually once weekly for 5 doses, then once every 4 weeks. The dosage is based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug on day 1. Tell your doctor right away if you have any symptoms of infusion reactions such as headache, pain at the infusion site, swelling, bruising/bleeding, skin redness, itching, or rash. Your doctor may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

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 20 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.

See also Warning and How to Use sections.

Headache, diarrhea, pain at the injection site, or swelling hands/ankles/feet 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).

If you have used a similar medication recently (C5 inhibitors such as eculizumab, ravulizumab), you may be at increased risk for other immune system problems. Tell your doctor right away if you have symptoms such as:

• joint/muscle/bone pain
• numbness/tingling of the hands/feet
• unusual tiredness/weakness
• stomach/abdominal pain

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.

Before using crovalimab, 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

Crovalimab can make you more likely to get certain infections (such as flu, colds, meningitis). Talk to your doctor for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using crovalimab before having any immunizations/vaccinations. 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 is not recommended while using this drug and for 9 months after the last dose. Consult your doctor before breastfeeding.

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.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as LDH level, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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.

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

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).

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.