Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is very important that you understand the requirements of the Fabhalta® REMS program, and become familiar with the Fabhalta® medication guide. 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.

You may take this medicine with or without food.

Swallow the capsule whole. Do not open, break, or chew it.

Tell your doctor if you are changing treatment from eculizumab or ravulizumab to Fabhalta®.

  • Switching from eculizumab to Fabhalta®: You should start taking Fabhalta® no later than 1 week after your last dose of eculizumab.
  • Switching from ravulizumab to Fabhalta®: You should start taking Fabhalta® no later than 6 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 oral dosage form (capsule):
    • For paroxysmal nocturnal hemoglobinuria (PNH) and proteinuria:
      • Adults—200 milligrams (mg) 2 times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If a dose is missed, take it as soon as possible even if it is almost time for your next dose. Then, take the next dose at the regular scheduled time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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Do not keep outdated medicine or medicine no longer needed.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.