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Fabrazyme

Fabrazyme

Agalsidase-beta

Agalsidase beta belongs to the group of medications known as enzyme replacement therapy. It is used as enzyme replacement therapy for people with Fabry disease, which is a genetic disorder where the levels of alpha-galactosidase (an enzyme that breaks down fats) is low or absent.

Available form

Powder

Dosage

5mg, 35mg

Manufacturers

Sanofi-aventis

Generic brand of

Agalsidase-beta

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Fabrazyme information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

The usual dose of agalsidase beta is 1 mg per kilogram of body weight given every 2 weeks as an infusion into a vein.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important Fabrazyme (Agalsidase-beta) be given exactly as recommended by your doctor. If you miss an appointment to receive agalsidase beta, contact your doctor as soon as possible to reschedule your appointment. If you are receiving Fabrazyme (Agalsidase-beta) at home and miss a dose, contact your doctor.

Vials of Fabrazyme (Agalsidase-beta) are stored in the refrigerator. After prepared for an infusion, Fabrazyme (Agalsidase-beta) should be used immediately.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Fabrazyme (Agalsidase-beta). If you are concerned about side effects, discuss the risks and benefits of Fabrazyme (Agalsidase-beta) with your doctor.

The following side effects have been reported by at least 1% of people taking Fabrazyme (Agalsidase-beta). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

anxiety
back pain
decreased hearing
Depression
difficulty sleeping
pain, including muscle and neck pain
ringing in the ears
skin rash
stomach discomfort
symptoms of an infection (cough, runny nose, sore throat)
toothache

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

chest tightness
dizziness or lightheadedness
fast heartbeat
infusion-related reactions (e.g., chills, Fever, feeling hot or cold, high blood pressure, nausea, vomiting, flushing, burning sensation, fatigue, pain, headache, chest pain, itchy skin)
signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
skin abrasions due to skin scratching
swelling of the legs, feet, or hands
symptoms of Anemia (e.g., paleness, shortness of breath, fast heartbeat)
throat tightness

Stop taking the medication and seek immediate medical attention if any of the following occur:

symptoms of a serious allergic reaction (e.g., shortness of breath; difficulty breathing; wheezing; Hives; swelling of the face, lips, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Fabrazyme (Agalsidase-beta).

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fabrazyme (Agalsidase-beta).

Allergic and infusion-related reactions: Fabrazyme (Agalsidase-beta) can cause allergic reactions, some of which can be severe. You will receive Fabrazyme (Agalsidase-beta) under close medical supervision, especially at the beginning of treatment.

Most people develop antibodies when treated with enzyme replacement therapy. If you develop antibodies to agalsidase beta, you might experience allergic side effects such as an infusion-related reaction. The antibodies are not likely to stop Fabrazyme (Agalsidase-beta) from working and will decrease with time.

Infusion-related reactions can include chills, fever, increased blood pressure, feeling hot or cold, burning sensations, nausea, vomiting, flushing, fatigue, pain, headache, chest pain, or itchy skin, and usually within the first 3 months of treatment. If you experience an infusion-related reaction, your doctor can decrease the infusion rate or treat the reaction with other medications (e.g., Acetaminophen, Ibuprofen, antihistamines, or corticosteroids).

Heart rhythm: Agalsidase beta can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death.

If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Fabrazyme (Agalsidase-beta) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fabrazyme (Agalsidase-beta), and whether any special monitoring is needed.

Pregnancy: Fabrazyme (Agalsidase-beta) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Fabrazyme (Agalsidase-beta), contact your doctor immediately.

Breast-feeding: It is not known if agalsidase beta passes into breast milk. If you are a breast-feeding mother and are taking Fabrazyme (Agalsidase-beta), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Fabrazyme (Agalsidase-beta) have not been established for children under 8 years of age.

Seniors: The safety and effectiveness of using Fabrazyme (Agalsidase-beta) have not been established for seniors.

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