Pregnancy & Lactation: Risk data not available
What is Pegunigalsidase Alfa?
Pegunigalsidase alfa is used in adults to treat Fabry disease.
Pegunigalsidase alfa may also be used for purposes not listed in this medication guide.
Warnings
Tell your doctor if you have ever had:
- any reaction from enzyme replacement therapy (called IgG antidrug antibodies); or
- kidney problems.
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pegunigalsidase alfa on the baby.
How should I use Pegunigalsidase Alfa
Use Pegunigalsidase Alfa (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Pegunigalsidase alfa is injected into a vein usually once every 2 weeks. A healthcare provider will give you this injection.
You may be given other medications to help prevent serious side effects or an allergic reaction.
After receiving an injection, you will be watched closely to make sure you do not have serious side effects.
Doses are based on weight. Your dose may change if you gain or lose weight.
You will need frequent medical tests.
Call your doctor for instructions if you miss a dose for your pegunigalsidase alfa injection.
Pegunigalsidase Alfa side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Call your doctor at once if you have:
- kidney problems--swelling, urinating less, feeling tired or short of breath.
Your treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- cold symptoms such as stuffy nose, sneezing, sore throat;
- headache;
- tired feeling;
- nausea or diarrhea;
- back pain; or
- pain in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Pegunigalsidase Alfa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.