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Ravulizumab-cwvz (By injection)

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

Treats paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG).

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 exact dose and tell you how often it should be given. This medicine is given through a needle placed in a vein or as a shot under your skin, usually in the stomach, thighs, or upper arms. If the medicine is given through a needle placed into one of your veins, it must be given slowly, so the needle will have to remain in place for at least 2 hours.
  • A nurse or other health provider will give you this medicine.
  • You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
  • This medicine is available in two forms: a vial (glass container) or a prefilled cartridge with on-body injector. The prefilled cartridge with on-body injector is the dosage form you can use at home.
  • Your doctor will monitor you for at least 1 hour for any unwanted effects after the infusion.
  • Allow the prefilled cartridge with on-body injector to warm to room temperature for 45 minutes, without removing the medicine from the carton, before you use it. Do not warm the medicine in any other way or return to the refrigerator.
  • Check the liquid in the cartridge. It should be clear and colorless to slightly yellow. Do not use the medicine if it is cloudy, discolored, or has flakes or large particles in it. Do not shake.
  • You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into areas where the skin is tender, bruised, red, hard, or in areas with scars, stretch marks, moles, or excess hair.
  • If you are changing treatment from Soliris® to Ultomiris™, you should start receiving Ultomiris™ 2 weeks after your last dose of Soliris®.
  • Use a new needle and syringe each time you inject your medicine. Use each cartridge only one time.
  • Do not use the cartridge if it is cracked, broken, or if there are missing pieces. Do not remove the needle cover until you are ready to use it.
  • 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.
  • If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in its original carton until you are ready to use it. Protect it from light. If removed from the refrigerator, you may store it at room temperature for up to 3 days. Do not return to the refrigerator. Throw away unused cartridge after 3 days.
  • Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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 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.
  • 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 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: 12/4/2023

 
 
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