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Ravulizumab-cwvz (By injection)

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

Treats paroxysmal nocturnal hemoglobinuria (PNH).

Brand Name(s):

Ultomiris

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. You should not receive it if you had an allergic reaction to ravulizumab-cwvz, or if you have a meningococcal infection. You should not receive this medicine if you have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with ravulizumab-cwvz is needed.

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. The medicine must be injected slowly, so your IV will need to stay in place for at least 2 hours.
  • Your doctor will monitor you for at least 1 hour for any unwanted effects after the infusion.
  • A nurse or other health provider will give you this medicine.
  • If you are changing treatment from Soliris® to Ultomiris™, you should start receiving Ultomiris™ 2 weeks after your last dose of Soliris®.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

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 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 for 2 weeks 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.
  • 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.

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
  • 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, sore throat, body aches

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

  • Pain in the arms or legs
  • 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


Last Updated: 6/18/2019

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