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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 (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 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.
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.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving crovalimab-akkz injection,
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:
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:
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 (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 http://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.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list 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, Inc. 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, Inc. 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, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. 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: September 20, 2024.