Description
Pegunigalsidase alfa-iwxj injection is used to treat Fabry disease, which is an inherited disease caused by the lack of an enzyme called alpha-galactosidase A in the body. This enzyme is necessary for your body. Pegunigalsidase alfa-iwxj is used to help replace this enzyme.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of pegunigalsidase alfa-iwxj injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of pegunigalsidase alfa-iwxj injection in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart problems—Use with caution. May be at a higher risk of severe complications from infusion reaction.
- Kidney disease—Use with caution. May make this condition worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV will need to stay in place for at least 1½ hours every 2 weeks.
Your doctor will give you other medicines (eg, allergy medicine, fever medicine, steroid) before starting treatment with this medicine.
Missed Dose
Call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, chest pain, dizziness, flushing, headache, trouble breathing, hives, itching, or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or trouble breathing after receiving this medicine.
Check with your doctor right away if you have cloudy or bloody urine, high blood pressure, or swelling of the face, feet, or lower legs. These maybe symptoms of serious kidney problem.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Back pain
- bloody or cloudy urine
- burning, numbness, tingling, or painful sensations
- chest tightness
- chills
- cough
- ear congestion
- fast heartbeat
- fever
- flushing
- headache
- loss of voice
- muscle aches
- nausea and vomiting
- nerve pain
- pain in the arms, legs, lower back, bottom, or hips
- skin itching, rash, or redness
- sneezing
- sore throat
- stuffy or runny nose
- swelling of the face, throat, or tongue
- trouble breathing
- trouble swallowing
- unsteadiness or awkwardness
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
Incidence unknown
- Blurred vision
- chest pain or discomfort
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shakiness in the legs, arms, hands, or feet
- slow or irregular heartbeat
- sweating
- swelling of the face, feet, or lower legs
- trembling or shaking of the hands or feet
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More Common
- Diarrhea
- pain or tenderness around the eyes and cheekbones
- stomach pain
Incidence not known
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty in moving
- joint pain
- lack or loss of strength
- muscle cramps, pains, or stiffness
- sneezing
- swollen joints
- throat irritation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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