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Pegunigalsidase Alfa-iwxj (By injection)

Pegunigalsidase Alfa-iwxj (peg-ue-ni-GAL-si-dase AL-fa - iwxj)

Treats Fabry disease.

Brand Name(s):

Elfabrio

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 pegunigalsidase alfa-iwxj.

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. This medicine must be given slowly, so the needle will remain in place for at least 1½ hours.
  • A nurse or other health provider will give you this medicine.
  • You may also receive other medicines (including allergy medicine, fever medicine, steroids) before starting treatment with this medicine.
  • Missed dose: Call your doctor or pharmacist for instructions.

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 breastfeeding, or if you have kidney disease or heart problems.
  • This medicine may cause the following problems:
    • Infusion-related reactions, which can be life-threatening
    • Kidney problems
  • 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
  • Bloody or cloudy urine, swelling of the face, feet, or lower legs
  • Blurred vision, severe headache, slow or fast heartbeat, lightheadedness, dizziness
  • Fever, chills, cough, runny or stuffy nose, sore throat, body aches

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

  • Arm, leg, or back pain
  • Diarrhea, nausea
  • Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
  • Tiredness

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: 9/6/2024

 
 
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