AGALSIDASE BETA - INJECTION

AGALSIDASE BETA - INJECTION

PHONETIC PRONUNCIATION: (a-GAL-si-dase BAY-ta)

COMMON BRAND NAME(S): Fabrazyme

GENERIC NAME(S): agalsidase beta

Uses

USES: This medication is used to treat a certain inherited disorder (Fabry disease) that causes buildup of a certain fat substance (GL-3) in some parts of your body. Worsening of this disorder can lead to kidney disease, heart attack, or stroke. Agalsidase beta works by replacing an enzyme that your body lacks, which helps break down the fat substance (GL-3) in your body. This can help prevent symptoms such as pain (especially in the hands and feet), dark red spots on the skin, a decreased ability to sweat, cloudiness of the front part of the eye, stomach/intestinal problems, ringing in the ears (tinnitus), and hearing loss.


How to use AGALSIDASE BETA - INJECTION

HOW TO USE: This medication is given by slow injection into a vein as directed by your doctor, usually every 2 weeks. The injection is given by a health care professional. The dosage is based on your medical condition, weight, and response to treatment. To help prevent reaction during the injection, your doctor will prescribe medications (such as acetaminophen, antihistamine) for you before the injection. Carefully follow your doctor's directions for taking all your medications. Tell your doctor right away if you have symptoms during the injection, such as chills, flushing, nausea, vomiting, dizziness, numbness/tingling, shortness of breath, headache, or chest/abdominal pain. Your doctor may stop or slow the injection for a time, and/or give other medications if needed. Use this medication regularly to get the most benefit from it. It may help to mark your calendar when to receive each dose. Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

SIDE EFFECTS: See also How to Use section. Injection reactions commonly occur. Pain at the injection site, fever, tiredness, muscle pain, dizziness, or cold symptoms (such as runny/stuffy nose, cough) may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: swelling feet/legs/hands. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using agalsidase beta, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant before using this medication. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for AGALSIDASE BETA - INJECTION

Agalsidase Beta (Injection) is a medication used for the treatment of Fabry disease, a rare genetic disorder that affects various organs in the body. It is an enzyme replacement therapy that replaces the deficient enzyme responsible for the build-up of a substance called globotriaosylceramide (GL-3) in the body.

Agalsidase Beta (Injection) works by delivering the missing enzyme (alpha-galactosidase A) to the body, which helps break down the GL-3 substance that accumulates in the cells. By reducing the buildup of GL-3, Agalsidase Beta helps improve the symptoms and slow down the progression of Fabry disease.

Common side effects of Agalsidase Beta may include infusion-related reactions such as fever, chills, flushing, headache, nausea, vomiting, fatigue, and allergic reactions. These reactions usually occur during or shortly after the infusion and are generally manageable with proper medical care.

Agalsidase Beta is administered as an intravenous infusion (injection) in a healthcare setting under the supervision of a healthcare professional experienced in enzyme replacement therapy. The dosage and infusion frequency are determined by the treating physician based on the individual patient's needs.

The duration of treatment with Agalsidase Beta varies depending on the individual patient's condition and response to therapy. It is usually a lifelong therapy that requires regular infusions at specified intervals, as determined by the treating physician.

Agalsidase Beta is not a cure for Fabry disease, but it is an effective treatment that can help alleviate symptoms and slow down the progression of the disease. It is important to continue the prescribed treatment as directed by the healthcare provider to achieve the maximum benefits of the therapy.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.