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Taliglucerase alfa (Injection) (Injectable)

(ELELYSO)
Taliglucerase alfa (By injection)
Taliglucerase Alfa (tal-i-GLOO-ser-ase AL-fa)Treats type 1 Gaucher disease.
Elelyso

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 taliglucerase alfa.

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 is usually given every other week. Each treatment usually takes 60 to 120 minutes.
  • A nurse or other health provider will give you this medicine.
  • You may also receive medicines to help prevent side effects from the injection.

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 had an allergic reaction to other medicines used for Gaucher disease.
  • This medicine may cause a rare but serious allergic reaction called an infusion reaction.
  • Your doctor will check your progress and the effects of this medicine at regular visits. 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
  • Chest pain or discomfort, trouble breathing
  • Fast, slow, or pounding heartbeat
  • Lightheadedness, dizziness, fainting

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

  • Headache
  • Muscle or joint pain
  • Nausea, vomiting, or stomach pain
  • Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
  • Tiredness
  • Warmth or redness in your face, neck, arms, or upper chest

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