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 this medication.
Allergic reactions: Some people may develop a serious allergic reaction to this medication. This reaction can occur up to 24 hours after receiving a dose of galsulfase. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, get immediate medical attention.
Infusion-related reactions: As with other enzyme therapies, galsulfase can cause severe infusion-related reactions, including severe allergic reactions. Your health care provider will closely monitor you during and after the infusion, and may give you other medications before you receive the galsulfase, to prevent these reactions.
If you experience symptoms of an infusion reaction, such as fever, chills, difficulty breathing, tightness of chest or throat, stomach upset, and rash, tell your health care provider immediately. Symptoms can usually be reduced by slowing down or temporarily stopping the medication, as well as using other medications, to treat the reaction.
It is important to take the medication(s) recommended by your doctor before your infusion of galsulfase. If you experience a severe infusion reaction, your doctor will give you additional medications to treat the reaction. Ask your doctor for more information.
Spinal cord compression: Maroteaux-Lamy syndrome often causes pressure on the spinal cord. This is normal in the progression of the illness, however it may develop or become worse with the use of galsulfase. Report any symptoms of back pain, paralysis, or being unable to hold urine or stools to your doctor immediately. These are possible symptoms of compression of the spinal cord and may become a medical emergency if not treated as soon as possible.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if galsulfase passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Seniors: The safety and effectiveness of using this medication have not been established for seniors. Clinical trials treated people less than 30 years of age.