- Fatal anaphylactic reactions have occurred during infusion; discontinue the treatment immediately and initiate appropriate medical support if such reactions occur
- Type III immune complex-mediated reactions, including glomerulonephritis may occur during therapy; if such reactions occur, discontinue therapy and initiate appropriate medical treatment. Consider the risks and benefits of re-administration of the drug
- Sleep apnea is common in MPS VI patients; antihistamine pretreatment may increase the risk of apneic episodes. Evaluate airway patency prior to initiation of therapy
- Patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep should have these facilities readily available during infusion in case of an infusion reaction, or extreme drowsiness/sleep induced by antihistamine use
- Therapy may cause severe infusion reactions; patients should take antihistamines with or without antipyretics prior to infusion. Drug-related infusion reactions generally reduce with slowing or with temporary interruption of infusion and administration of additional antihistamines, antipyretics, and occasionally corticosteroids
- If severe infusion reactions occur, discontinue therapy and initiate appropriate medical treatment. Consider the risks and benefits of re-administration of the drug
- Spinal or cervical cord compression (SCC) with resultant myelopathy is a serious complication of MPS VI and SCC is expected to occur in the natural course of the disease, even in patients who are taking galsulfase. Postmarketing reports of onset or worsening of SCC requiring decompression surgery has been reported hence monitor patients for signs and symptoms of spinal/cervical cord compression including back pain, paralysis of limbs below the level of compression, urinary and fecal incontinence
Cautions: Use cautiously in
- Acute underlying respiratory illness
- Patients weighing <20 kg
- Compromised cardiac and/or respiratory function
- Acute febrile illness
Pregnancy Category:B
Breastfeeding: Safety unknown. Manufacturer advises caution.
