Galsulfase

Galsulfase is an enzyme used to treat some of the symptoms of a genetic condition called Maroteaux-Lamy syndrome (mucopolysaccharidosis). Galsulfase improves walking and stair-climbing capacity.

• Galsulfase is available under the following different brand names: Naglazyme

Common side effects of Galsulfase include:

• headache
• joint pain
• eye redness
• nausea
• vomiting
• stomach pain
• diarrhea
• runny or stuffy nose
• sore throat
• cough
• ear pain
• rash or itching
• injection site reactions (pain, redness, swelling, or other irritation)

Serious side effects of Galsulfase include:

• apnea
• pyrexia
• respiratory distress
• chest pain
• dyspnea
• laryngeal edema
• conjunctivitis

Rare side effects of Galsulfase include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 1 mg/mL

Mucopolysaccharidosis (MPS) VI

Adult dosage

• 1 mg/kg IV infusion every week
• Pretreat with antihistamines with or without antipyretics 30-60 minutes before infusion

Pediatric dosage

• Children younger than 5 years: Safety & efficacy not established
• Children older than 5 years: 1 mg/kg IV infusion every week
• Pretreat with antihistamines with or without antipyretics 30-60 minutes before infusion

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Galsulfase has no noted severe interactions with any other drugs
• Galsulfase has no noted serious interactions with any other drugs
• Galsulfase has no noted moderate interactions with any other drugs
• Galsulfase has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None listed in the manufacturer's label

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Galsulfase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Galsulfase?”

Cautions

• Anaphylaxis and severe allergic reactions have been observed during and up to 24 hours after infusion; some reactions were life-threatening and included anaphylaxis, shock, respiratory distress, dyspnea, bronchospasm, laryngeal edema, and hypotension
• Type III immune complex-mediated reactions, including membranous glomerulonephritis, were observed with enzyme replacement therapies
• Use caution in patients susceptible to fluid volume overload (eg, weight 20 kg and less, acute underlying respiratory illness, compromised cardiac and/or respiratory function) because CHF may occur
• Because of the potential for infusion reactions, patients should receive antihistamines with or without antipyretics prior to infusion; infusion reactions may still occur despite premedication; decrease the rate of infusion in case of reactions or discontinue immediately if the reaction is severe; use caution with readministration
• Sleep apnea is common in patients with MPS VI and antihistamine pretreatment may increase the risk for apneic episodes
• Spinal or cervical cord compression (SCC) with resultant myelopathy is a known and serious complication of MPS VI; SCC is expected to occur in the natural history of the disease, including in patients on galsulfase; there are postmarketing reports of onset or worsening of SCC requiring decompression surgery
• Consider postponing the treatment in patients with acute febrile or respiratory illness
• Excess agitation of the solution before or after dilution may denature and inactivate Galsulfase
• A registry has been created to track the drug’s adverse effects, and monitor therapeutic responses during long-term treatment; may contact 1-800-983-4587 or at www.naglazyme.com/en/clinical-resources/surveillance-program.aspx

Pregnancy and Lactation

• Available data from case reports and postmarketing experience with use in pregnant women are insufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinical considerations
  • Pregnancy can exacerbate preexisting clinical manifestations of MPS and lead to adverse pregnancy outcomes for both the mother and fetus
• Lactation
  • There are no data on the presence of galsulfase in human milk and its effects on the breastfed infant or milk production
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant from any underlying maternal condition