reformatory [5:<25 kg) or 250 mL (for patients weighing 25 kg). Gently rotate to distribute. Do not shake or agitate. Use immediately. Vials are for single use only; discard any unused product. Administration Administer using a low protein-binding infusion set with in-line low protein-binding 0.2 micrometer filter. Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to infusion. Patients> <25 kg: Infuse 100 mL solution at 3 mL/hour for the first 15 minutes. If well-tolerated, increase to 6 mL/hour for the next 15 minutes. If well-tolerated, increase rate every 15 minutes in 6 mL/hour increments; maximum infusion rate: 36 mL/hour. The total volume of the infusion should be delivered over 3.5 hours. Patients 25 kg: Infuse 250 mL solution at 6 ml/hour for the first 15 minutes. If well-tolerated, increase to 12 mL/hour for the next 15 minutes. If well-tolerated, increase rate every 15 minutes in 12 mL/hour increments; maximum infusion rate: 72 mL/hour. The total volume of the infusion should be delivered over 4.5 hours. The infusion can be slowed, temporarily stopped, or discontinued if a hypersensitivity reaction occurs. Discontinue immediately if severe reaction occurs. Do not infuse with other products in the infusion tubing. Administration should be completed within 48 hours from time of dilution. Storage Prior to use, store intact vials under refrigeration at 2 C to 8 C (36 F to 46 F); do not freeze or shake. Protect from light. Following dilution in NS, use immediately. If unable to use immediately, may store for up to 24 hours under refrigeration followed by up to 24 hours at 23 C to 27 C (73 F to 81 F) during administration. Drug Interactions There are no known significant interactions. Adverse Reactions >10%: Central nervous system: Headache (26%) Gastrointestinal: Vomiting (31%), nausea (24%), abdominal pain (21%) Hypersensitivity: Hypersensitivity reaction (19%) Miscellaneous: Fever (33%) 1% to 10%: Central nervous system: Chills (10%), fatigue (10%) Hypersensitivity: Anaphylaxis (8%; presenting as cough, erythema, throat tightness, urticaria, flushing, cyanosis, hypotension, rash, dyspnea, chest discomfort, and gastrointestinal symptoms) Immunologic: Immunogenicity ALERT: U.S. Boxed Warning Risk of anaphylaxis: Life-threatening anaphylactic reactions have occurred in some patients during elosulfase alfa infusions. Anaphylaxis, presenting as cough, erythema, throat tightness, urticaria, flushing, cyanosis, hypotension, rash, dyspnea, chest discomfort, and gastrointestinal symptoms (eg, nausea, abdominal pain, retching, vomiting) in conjunction with urticaria, have been reported to occur during elosulfase alfa infusions, regardless of duration of the course of treatment. Closely observe patients during and after elosulfase alfa administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring. Warnings/Precautions Concerns related to adverse effects: Antibody formation: All patients developed anti-drug antibodies and neutralizing antibodies during clinical trials; it is unknown if presence of antibodies is related to a higher risk of infusion reactions or clinical efficacy treatment effect, respectively. Hypersensitivity/anaphylactoid reactions: [U.S. Boxed Warning]: Serious hypersensitivity reactions, including life-threatening anaphylactic reactions have occurred, regardless of treatment course duration. Anaphylaxis may present as abdominal pain, chest discomfort, cough, cyanosis, dyspnea, erythema, flushing, hypotension, nausea, rash, retching, throat tightness, urticaria, and vomiting. Monitor closely during and after infusion. Appropriate medical support should be readily available. Patients with acute respiratory disease are at risk of serious acute exacerbation or respiratory compromise due to hypersensitivity; additional monitoring may be required. Discontinue immediately if anaphylactic or acute reaction occurs. Patients experiencing initial severe or refractory reactions may need prolonged monitoring. Use caution with readministration. Infusion reactions: Infusion-related reactions have been reported; may be sporadic and/or severe. Hypersensitivity reactions may occur as early as 30 minutes from the start of infusion and have also been reported as late as 6 days after infusion; reactions may occur as late as the 47th infusion. Patients should be premedicated with antihistamines with or without antipyretics prior to infusion; evaluate airway prior to therapy (due to possible effects of antihistamine use). In case of reaction, decrease the rate of infusion, temporarily discontinue the infusion, and/or administer additional antipyretics/antihistamines and possibly corticosteroids. Discontinue treatment immediately if severe reaction occurs; use caution with readministration. Disease-related concerns: Acute febrile/respiratory illness: Consider delaying treatment in patients with an acute febrile or respiratory illness; may be at increased risk of life-threatening complications from hypersensitivity reactions. Sleep apnea: Use with caution in patients with sleep apnea; antihistamine pretreatment may increase the risk of apneic episodes. Apnea treatment options (eg, supplemental oxygen or continuous positive airway pressure) should be readily available. Spinal/cervical cord compression: Patients with MPA IVA may experience spinal/cervical cord compression (SCC) as a part of their disease. Monitor patients for signs and symptoms of SCC (eg, back pain, limb paralysis, urinary and fecal incontinence). Monitoring Parameters Monitor for infusion/hypersensitivity reactions; signs/symptoms of spinal or cervical compression. Pregnancy Risk Factor C Pregnancy Considerations Adverse events were observed in some animal reproduction studies. Mucopolysaccharidosis type IVA (MPS IVA) has the potential to cause adverse events in both the mother and fetus. A pregnancy registry is available for women who may be exposed to elosulfase alfa for the treatment of MPS IVA during pregnancy (MARS@bmrn.com or 1-800-983-4587). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache or loss of strength and energy. Have patient report immediately to prescriber signs of infusion reaction (cough, skin redness, tightness in throat, flushing, blue/gray skin discoloration, severe dizziness, passing out, shortness of breath, angina, vomiting, or severe abdominal pain), swelling of arms or legs, cough, back pain, difficulty moving, or urinary or fecal incontinence (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Pregnancy Warnings Print this page Add to My Med List More about elosulfase alfa Side Effects During Pregnancy Dosage Information Support Group En Español 0 Reviews Add your own review/rating Drug class: lysosomal enzymes Consumer resources Elosulfase alfa Elosulfase alfa Intravenous (Advanced Reading) Professional resources Elosulfase Alfa (AHFS Monograph) Other brands: Vimizim Related treatment guides Mucopolysaccharidosis Type IV> ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Elosulfase alfa Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Lysosomal enzymes Related Drugs lysosomal enzymes Fabrazyme , Lumizyme , Aldurazyme , Myozyme , Elaprase , cerliponase alfa Mucopolysaccharidosis Type IV Vimizim , More...} } putting forward
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