GALSULFASE - INJECTION

GALSULFASE - INJECTION

PHONETIC PRONUNCIATION: (gal-SUL-fase)

COMMON BRAND NAME(S): Naglazyme

GENERIC NAME(S): galsulfase

Uses

USES: Galsulfase is used to treat a certain rare genetic problem (Maroteaux-Lamy syndrome - MLS). Galsulfase replaces a certain natural substance that is missing in people with MLS. This medication improves how far you can walk and the number of stairs you can climb up. Galsulfase does not correct the genetic problem, and treatment must be continued for life.


How to use GALSULFASE - INJECTION

HOW TO USE: This medication is given slowly into a vein as directed by your doctor, usually over 4 hours once a week. The dosage is based on your weight, medical condition, and response to treatment. If you are using this medication at home, galsulfase will be shipped to your home. A nurse will come to your home to give you the treatment and to monitor you afterward. Do not shake the medication. Galsulfase should be colorless or pale yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use it. Discard any unused prepared medication. Do not save for later use. Learn how to store and discard medical supplies safely. Galsulfase may cause side effects (such as fever, chills, rash, shortness of breath, nausea/vomiting, increased blood pressure, headache, chest pain, dizziness, weakness/tiredness, joint pain, flushing, coughing) while it is being given and for a short time after the infusion has stopped. Your doctor may decide to stop or slow down the medication infusion for a while if this happens. Tell your healthcare professional right away if you have any of these symptoms. Your doctor may direct you to take other medications (such as antihistamines, drugs for fever, or corticosteroids such as prednisone) to treat your reaction and before your next treatment(s) to prevent these reactions from happening again. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. Tell your doctor if your condition gets worse.

Side Effects

SIDE EFFECTS: See also How to Use section. Ear pain, eye redness/itching/discharge, or stomach/abdominal pain may 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: vision/hearing changes, back pain, inability to move arms/legs, inability to control urine/stool, signs of kidney problems (such as change in the amount of urine). 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 galsulfase, 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 (such as heart failure), lung problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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 GALSULFASE - INJECTION

Galsulfase Injection is a medication used to treat patients with a rare hereditary condition called mucopolysaccharidosis VI (MPS VI), also known as Maroteaux-Lamy syndrome. It is an enzyme replacement therapy that helps to replace the missing or deficient enzyme in the body.

Galsulfase Injection contains the active ingredient galsulfase, which is a form of the enzyme called N-acetylgalactosamine-4-sulfatase. This enzyme helps to break down certain substances in the body that accumulate in MPS VI patients. By replacing the missing enzyme, Galsulfase Injection helps to reduce the symptoms associated with MPS VI.

Galsulfase Injection is given through a needle into a vein (intravenous infusion). The infusion is usually done once a week in a medical setting by a healthcare professional.

The most common side effects of Galsulfase Injection include fever, headache, nausea, vomiting, diarrhea, rash, itching, and injection site reactions. These side effects are usually mild and temporary.

The duration of treatment with Galsulfase Injection depends on the individual's response to the medication and the severity of their MPS VI. It is typically a lifelong treatment, and regular monitoring and assessment by a healthcare professional are necessary.

Yes, Galsulfase Injection is approved for use in children with MPS VI. The dosage and administration may vary based on the weight and age of the child. It is important to consult with a healthcare professional regarding the appropriate use of Galsulfase Injection in children.

There are no known drug interactions with Galsulfase Injection. However, it is always important to inform your healthcare provider about all the medications, vitamins, and supplements you are taking to avoid any potential interactions.

If you miss a dose of Galsulfase Injection, it is important to contact your healthcare provider for further instructions. Do not double the dose to make up for the missed dose.

Galsulfase Injection is not a cure for MPS VI. It is an enzyme replacement therapy that helps to manage the symptoms of the condition. It is important to continue the treatment as prescribed by a healthcare professional to maintain the benefits.

Galsulfase injection is used to treat a specific enzyme deficiency called mucopolysaccharidosis VI (MPS VI) or Maroteaux-Lamy syndrome. It helps improve walking and stair-climbing ability in patients with this condition.

Galsulfase injection works by replacing the missing or deficient enzyme in patients with MPS VI. This enzyme helps break down substances in the body called glycosaminoglycans (GAGs), which can accumulate and cause damage in various tissues.

The recommended dosage of Galsulfase injection is 1 mg/kg of body weight, administered once a week as an intravenous infusion. The infusion should be given over a period of 3 to 4 hours.

Common side effects of Galsulfase injection include fever, rashes, headache, nausea, vomiting, diarrhea, joint pain, and infusion-site reactions. Serious side effects may include allergic reactions or anaphylaxis. It is important to seek medical attention if any severe or persistent side effects occur.

Galsulfase injection has not been studied in pregnant or breastfeeding women. It is recommended to discuss the potential risks and benefits with a healthcare provider before using this medication in these situations.

The duration of treatment with Galsulfase injection depends on the individual patient and their response to therapy. It is usually a long-term treatment, requiring weekly infusions for the foreseeable future.

Galsulfase injection can interact with certain medications. It is important to inform the healthcare provider about all the medications, supplements, or herbal products being taken to avoid any potential drug interactions.

Coverage for Galsulfase injection varies depending on the insurance plan. It is recommended to check with the insurance provider or pharmacy to determine the coverage and potential out-of-pocket costs.

Galsulfase injection should be stored refrigerated at 2-8°C (36-46°F) and protected from light. It should not be frozen. The medication should be used within 24 hours once the vial has been opened.



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.