Proper Use

Drug information provided by: IBM Micromedex

A nurse or other trained health professional may give you this medicine. It is given through a needle placed under your skin, usually in the stomach, thighs, hips or upper arm. It must be given slowly, so the needle will have to stay in place using an infusion pump for at least 30 minutes (for 2 infusion sites) or at least 60 minutes (for 1 infusion site).

You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine and the infusion pump.

It is very important that you understand the requirements of the Empaveli™ REMS program, and become familiar with the Empaveli™ 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 and patient instructions if you do not have one.

If you use this medicine at home, you will be shown the body areas where the infusion can be given. Use a different body area each time you give yourself an injection. Keep track of where you give each injection to make sure you rotate body areas. This will help prevent skin problems. Do not inject into areas where the skin is tender, red, bruised, or hard or in areas with tattoos, scars, or stretch marks.

Allow this medicine to warm to room temperature for 30 minutes before using it. Do not warm it in any other way.

Check the liquid in the vial. It should be clear and colorless to slightly yellow solution. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.

Tell your doctor if you are changing treatment from eculizumab or ravulizumab to Empaveli™.

  • Switching from eculizumab to Empaveli™: At first, you should start receiving Empaveli™ while you continue your treatment with eculizumab. Then after 4 weeks, you should stop receiving eculizumab before you continue your treatment with Empaveli™.
  • Switching from ravulizumab to Empaveli™: You should start receiving Empaveli™ 4 weeks after your last dose of ravulizumab.

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 (solution):
    • For paroxysmal nocturnal hemoglobinuria (PNH):
      • Adults—1080 milligrams (mg) injected under the skin 2 times a week.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

If you miss a dose of this medicine, use it as soon as possible. Do not double doses.

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, away from direct light, until you are ready to use it. Throw away any unused medicine.