Crovalimab-akkz (kroe-VAL-i-mab - akkz)

Treats paroxysmal nocturnal hemoglobinuria (PNH).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A nurse or other trained health professional will give you this medicine. It may be given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV may need to stay in place for at least 60 to 90 minutes. It may also be given as a shot under your skin, usually on the stomach.
• A nurse or other health provider will give you this medicine.
• If you are changing treatment from Soliris® or Ultomiris® to Piasky™, you should start receiving Piasky™ as soon as possible. Your doctor will monitor you for 30 days after you switch medicines.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, a fever, or any kind of infection.
• Do not breastfeed during treatment and for 9 months after the last dose.
• This medicine can increase your risk for serious infections, including meningococcal infection, gonorrhea, pneumonia, and flu-like infection. You will need to be vaccinated against meningococcal infection at least 2 weeks before you start treatment with this medicine. You may also be given antibiotic medicine to prevent infections if you are to use this medicine right away.
• You will be given a patient safety card that lists the symptoms of infection and what to do if you have them. Carry the card with you at all times during treatment and for 11 months after treatment. Show the card to any doctor who treats you.
• When you stop receiving this medicine, you may develop hemolysis (breakdown of red blood cells). Your doctor will need to monitor you closely for at least 20 weeks after you stop using this medicine.
• This medicine can also cause an infusion or injection-related reaction that can be life-threatening.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Confusion, sensitivity of the eye to light, severe headache, nausea, vomiting, stiff neck or back, muscle pains
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed or shot was given
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088