Proper Use

Drug information provided by: Merative, Micromedex®

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV will need to stay in place for at least 2 hours.

You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

Your doctor will monitor you for at least 1 hour after the infusion for any unwanted effects.

It is very important that you understand the requirements of the Ultomiris® REMS program, and become familiar with the Ultomiris® Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

If you are changing treatment from Soliris® to Ultomiris®, you should start receiving Ultomiris® 2 weeks after your last dose of Soliris®.

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.

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.

To use the prefilled cartridge with on-body injector:

  • 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. This will help prevent skin problems from the injections. Do not inject into areas where the skin is tender, bruised, red, hard, or in areas with scars, stretch marks, moles, or excess hair.
  • 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.
  • Use a new needle and cartridge each time you inject your medicine.
  • 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.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injectable dosage form (prefilled cartridge with on-body injector):
    • For paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS):
      • From intravenous (an IV placed into one of your veins) to subcutaneous (injected under the skin):
        • Adults weighing 40 kilograms (kg) or more—490 milligrams (mg) prefilled cartridge with on-body injector injected under your skin at different body areas once a week 8 weeks after your last dose.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original carton until you are ready to use it. Protect 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.