Ravulizumab-cwvz (rav-ue-LIZ-ue-mab - cwvz)

Treats paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

Brand Name(s):

Ultomiris

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly. The IV will usually remain in place for 1 hour or less. In some cases, the IV may need to remain in place up to 4 hours.
• A nurse or other health provider will give you this medicine.
• Your doctor will monitor you for at least 1 hour after the infusion for any unwanted effects.
• If you are changing treatment from Soliris® to Ultomiris®, you should receive your starting dose of Ultomiris® at your next scheduled dose of Soliris®.
• 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.

• Some medicines can affect how ravulizumab-cwvz works. Tell your doctor if you are also receiving other medicines for myasthenia gravis, including efgartigimod or immunoglobulin injection.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have a fever, or any kind of infection.
• Do not breastfeed during treatment with this medicine and for 8 months after the last dose.
• This medicine can increase your risk for serious infections, including meningococcal 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 medicines to prevent infections if you are to use this medicine right away. You will also 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 8 months after your last dose. Show the card to any doctor who treats you.
• You could develop hemolysis (breakdown of red blood cells) when you stop receiving this medicine. Your doctor will monitor you for at least 16 weeks after the last dose.
• You could also develop a condition called thrombotic microangiopathy (TMA) when you stop receiving this medicine for aHUS.
• This medicine can also cause an infusion 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.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blurred vision, slow or fast heartbeat
• Chest pain, trouble breathing, dizziness, lightheadedness, or fainting, lower back pain
• 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
• Unusual bleeding or bruising

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

• Diarrhea, constipation, stomach pain
• Hair loss
• Mild headache
• Pain in the arms, legs, or joints
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

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