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Pegunigalsidase Alfa Injection (PEGUNIGALSIDASE ALFA - INJECTION)

For genetic disorder.

Brand Name(s): Elfabrio

Generic Name: Pegunigalsidase alfa-iwxj

Instructions

This is an IV medicine. It is given through a sterile tube directly into the vein by a healthcare provider.

This medicine is given gradually through the IV line.

This medicine should be given by a trained health care provider.

If using this medicine at home, ask your doctor, nurse, or pharmacist to show you or a family member how to use this medicine correctly.

You must be monitored by a health care professional during and after each dose is given.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Tell doctor or nurse right away if fever, chills, feeling of heat or flushing, coughing, chest pain, dizziness, fainting, headache, nausea or vomiting, itching, swelling of the face or throat, or trouble breathing develop while the medicine is being given. The medicine may need to be stopped or given at a slower rate.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • back pain
  • lack of energy and tiredness

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • pain in the abdomen
  • chest pain
  • feeling cold
  • diarrhea
  • dizziness
  • feeling of heat or flushing
  • headaches
  • slow heartbeat
  • pain, redness, swelling near injection
  • muscle pain
  • nausea and vomiting
  • rapid heartbeat
  • runny or stuffy nose
  • shakiness
  • shortness of breath
  • numbness or tingling of the skin
  • skin tingling, burning or prickly feeling

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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