ALDURAZYME laronidase 2.9 mg/5mL Injection, Solution, Concentrate, 5 mL — NDC 58468-0070-1 (Billing 58468-0070-01)
This is a package of 5 mL of ALDURAZYME laronidase 2.9 mg/5mL Injection, Solution, Concentrate from Genzyme Corporation, marketed since Apr 2003 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 58468-0070-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 58468 labeler · 0070 product · 1 package
- Package marketed since
- Apr 30, 2003
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 5 mL per package
- Barcode (UPC-A, from the NDC)
- 3 5846800701 8
- Medicaid fills, this package
- 474 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 052085
- GCN: 19585
- HICL (First Databank): 025177
- AHFS class code: 44:00.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Laronidase injection is used to treat people with Hurler and Hurler-Scheie syndrome (mucopolysaccharidosis type I [MPS I)]; an inherited condition in which the body doesn't break down certain sugar substances in the body called glycosaminoglycans [GAG]). Laronidase injection is in a class of medications called enzymes. It works by helping to reduce the levels of glycosaminoglycans in the body.
Read the full MedlinePlus article ↗- It treats MPS I, a rare inherited condition in which your body lacks an enzyme. Aldurazyme is used for the Hurler and Hurler-Scheie forms, and for the Scheie form when symptoms are...
- It is given through a vein once a week, usually over about 3 to 4 hours. You may get an antihistamine about an hour before. If you miss a dose, restart as soon as possible and keep...
- How is it given and how long does it take?
- The most common are infusion reactions such as fever, chills, flushing, faster heartbeat, and changes in blood pressure or oxygen. Rash, headache, and cold-like infections can also...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $216.99 | $1,084.96 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1931 | $41.487 / J1931 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 58468-0070-01 You're viewing this Main listing | 5 mL in 1 VIAL, GLASS | 2003-04-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Aldurazyme 2.9 mg/5mLthis 58468-0070-01 | Genzyme | 5 ml | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Laronidase inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, and ACUTE RESPIRATORY COMPLICATIONS ASSOCIATED WITH ADMINISTRATION WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, and ACUTE RESPIRATORY COMPLICATIONS ASSOCIATED WITH ADMINISTRATION See full prescribing information for complete boxed warning . Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment.
( 5.1 ) Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions and require additional monitoring. Appropriate respiratory support should be available during infusion. ( 5.2 ) Hypersensitivity Reactions Including Anaphylaxis Patients treated with ALDURAZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis.
Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during ALDURAZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reactions, a desensitization procedure to ALDURAZYME may be considered [see Warnings and Precautions (5.1) ] .
Acute Respiratory Complications Associated with Administration Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions and require additional monitoring [see Warnings and Precautions (5.2) ] .
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ALDURAZYME ® is indicated for the treatment of: adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and patients with the Scheie form of MPS I who have moderate to severe symptoms. ALDURAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for the treatment of adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for the treatment of patients with the Scheie form of MPS I who have moderate to severe symptoms.
( 1 ) Limitations of Use: The risks and benefits of treating mildly affected patients with the Scheie form have not been established. ( 1 ) ALDURAZYME has not been evaluated for effects on the central nervous system manifestations of the disorder. ( 1 ) Limitations of Use The safety and effectiveness of treating mildly affected patients with the Scheie form have not been established.
The effect of ALDURAZYME on central nervous system manifestations of the disorder has not been determined.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For pretreatment recommendations, see Full Prescribing Information. ( 2.1 ) The recommended dosage is 0.58 mg/kg administered once weekly as an intravenous infusion. ( 2.2 ) For dosage and administration modifications due to hypersensitivity reactions or infusion-associated reactions (IARs), see Full Prescribing Information.
( 2.3 ) For instructions on preparation, storage, and administration, see Full Prescribing Information. ( 2.4 , 2.5 , 2.6 )
2.1Recommendations Prior to ALDURAZYME Treatment Premedication Prior to ALDURAZYME administration, consider premedicating with antihistamines, with or without antipyretics, 60 minutes before the start of infusion [see Warnings and Precautions (5.1 , 5.4) ]. Medical Support Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during ALDURAZYME administration.
2.2Recommended Dosage and Administration The recommended dosage of ALDURAZYME is 0.58 mg/kg (actual body weight) administered once weekly as an intravenous infusion. ALDURAZYME injection must be diluted with 0.9% Sodium Chloride Injection to a final volume of 50 mL, 100 mL or 250 mL as determined by the patient's body weight and cardiopulmonary condition: Patients with a body weight equal to or greater than 2 kg and less than 4 kg should receive a total volume of 50 mL; patients with a body weight equal to or greater than 4 kg and up to 20 kg should receive a total volume of 100 mL; and those patients with a body weight greater than 20 kg should receive a total volume of 250 mL [see Dosage and Administration (2.6) ].
For patients with underlying cardiac or respiratory compromise and weighing up to 30 kg, physicians may consider diluting ALDURAZYME in a volume of 100 mL and administering at a decreased infusion rate [see Dosage and Administration (2.6) ]. The initial infusion rate of ALDURAZYME is 10 mcg/kg/hr and may be increased every 15 minutes during the first hour, as tolerated, to a maximum infusion rate of 200 mcg/kg/hr. The maximum rate is then maintained for the remainder of the infusion (2 to 3 hours) [see Dosage and Administration (2.6) , Warnings and Precautions (5.2 , 5.3) ] .
If one or more doses are missed, restart ALDURAZYME treatment as soon as possible and maintain the 1-week interval between infusions thereafter. Do not double a dose to compensate for a missed dose.
2.3Administration Modifications due to Hypersensitivity or Infusion Associated Reaction In the event of a severe hypersensitivity reaction (e.g., anaphylaxis) or severe infusion-associated reaction (IAR), immediately discontinue ALDURAZYME administration and initiate appropriate medical treatment. For additional recommendations in the event of a severe hypersensitivity reaction, [ see Warnings and Precautions (5.1) ]. In the event of a mild to moderate hypersensitivity reaction or a mild to moderate IAR, consider temporarily holding the infusion for 15 to 30 minutes, or slowing the infusion rate by 25% to 50% [ see Dosage and Administration (2.6) ] , and initiating appropriate medical treatment [see Warnings and Precautions (5.1 , 5.4) ] .
If symptoms persist despite holding or slowing the infusion, stop the infusion and monitor the patient. Consider re-initiating the infusion within 7 to 14 days using the incremental rate steps table [see Dosage and Administration (2.6) ] , up to 25% or 50% of the rate at which the reaction occurred with appropriate premedication. If symptoms subside after holding the infusion, resume infusion at a 25% to 50% reduced rate as tolerated.
Alternatively, if symptoms subside after slowing the infusion, complete infusion at the reduced rate as tolerated. Starting with next infusion, increase the infusion rate by increments of 25% as tolerated until the recommended infusion rate is reached. Closely monitor the patient.
2.4Preparation Instructions Prepare ALDURAZYME using low-protein-binding containers. There is no… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 2.9 mg/5 mL (0.58 mg/mL) of laronidase as a colorless to pale yellow, clear to slightly opalescent solution in a single-dose vial. Injection: 2.9 mg/5 mL (0.58 mg/mL) of laronidase in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of Acute Respiratory Complications: Patients with acute febrile or respiratory illness at the time of ALDURAZYME infusion may be at greater risk for infusion reactions. Consider delaying ALDURAZYME infusion. Sleep apnea is common in MPS I patients.
Consider evaluating airway patency prior to initiation of treatment with ALDURAZYME. Appropriate respiratory support should be available during infusion. ( 5.2 ) Risk of Acute Cardiorespiratory Failure: Patients susceptible to fluid overload may be at increased risk for serious exacerbation of their cardiac or respiratory status during infusions.
Consider a decreased total infusion volume and infusion rate when administering ALDURAZYME to these patients. Appropriate medical monitoring and support measures should be available during infusion. ( 2.2 , 5.3 ) Infusion Reactions: If severe IARs occur, discontinue ALDURAZYME and initiate appropriate medical treatment.
( 5.4 )
5.1Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions including anaphylaxis have been reported in patients during or up to 3 hours after ALDURAZYME infusions. Some of these reactions were life-threatening and included respiratory failure, respiratory distress, stridor, tachypnea, bronchospasm, obstructive airways disorder, hypoxia, hypotension, bradycardia, and urticaria. In clinical studies and postmarketing safety experience with ALDURAZYME, approximately 1% of patients experienced severe or serious hypersensitivity reactions.
In patients with MPS I, pre-existing upper airway obstruction may have contributed to the severity of some reactions. Prior to ALDURAZYME administration, consider premedicating patients with antihistamines, with or without antipyretics, 60 minutes before the start of infusion. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during ALDURAZYME administration.
Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment. Exercise caution if epinephrine is being considered for use in patients with MPS I due to the increased prevalence of coronary artery disease in these patients.
Interventions have included resuscitation, mechanical ventilatory support, emergency tracheotomy, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and intravenous corticosteroids [see Adverse Reactions (6) ]. Consider the risks and benefits of re-administering ALDURAZYME following severe hypersensitivity reactions (including anaphylaxis). Patients may be rechallenged using slower infusion rates.
In patients with severe hypersensitivity reaction, desensitization measures to ALDURAZYME may be considered. If the decision is made to readminister ALDURAZYME, ensure the patient tolerates the infusion. If the patient tolerates the infusion, the rate may be increased to reach the recommended rate.
If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate [see Dosage and Administration (2.3) ].
5.2Acute Respiratory Complications Associated with Administration One patient with acute bronchitis and hypoxia experienced increased tachypnea during the first ALDURAZYME infusion that resolved without intervention. The patient's respiratory symptoms returned within 30 minutes of completing the infusion and responded to bronchodilator therapy. Approximately 6 hours after the infusion, the patient experienced coughing, then respiratory arrest, and died.
Patients with an acute febrile or respiratory illness at the time of ALDURAZYME infusion may be at greater risk for infusion reactions. Careful consideration should be given to the patient's clinical status prior to administration… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Serious and or clinically significant adverse reactions described elsewhere in labeling include: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Acute Respiratory Complications Associated with Administration [see Warnings and Precautions (5.2) ] Acute Cardiorespiratory Failure [see Warnings and Precautions (5.3) ] Infusion-Associated Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥10%) in patients: 6 months of age and older are: infusion reactions (pyrexia, chills, blood pressure increased, tachycardia, and oxygen saturation decreased).
( 6.1 ) 6 years and older are: rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Serious adverse reactions reported with ALDURAZYME treatment during clinical trials were anaphylactic and hypersensitivity reactions. The most common adverse reactions were infusion reactions.
The frequency of infusion reactions decreased over time with continued use of ALDURAZYME, and the majority of reactions were classified as being mild to moderate in severity. Clinical Trials in Patients 6 Years and Older A 26-week, double-blind, placebo-controlled clinical study (Study 1) of ALDURAZYME was conducted in 45 patients with MPS I, ages 6 to 43 years old, gender evenly distributed (N=23 females and 22 males). Of these 45 patients, 1 was clinically assessed as having Hurler form, 37 Hurler-Scheie, and 7 Scheie.
Patients were randomized to receive either 0.58 mg/kg intravenously of ALDURAZYME per week for 26 weeks or placebo. All patients were treated with antipyretics and antihistamines prior to the infusions. Infusion reactions were reported in 32% (7 of 22) of ALDURAZYME-treated patients.
The most common adverse reactions reported in patients who received ALDURAZYME were flushing, pyrexia, headache, and rash. Flushing occurred in 5 patients (23%) receiving ALDURAZYME; the other reactions were less frequent. Less common infusion reactions included angioedema (including face edema), hypotension, paresthesia, feeling hot, hyperhidrosis, tachycardia, vomiting, back pain, and cough.
Other reported adverse reactions included bronchospasm, dyspnea, urticaria and pruritus. Table 2 enumerates adverse reactions and selected laboratory abnormalities that occurred during the 26-week placebo-controlled study (Study 1) that were reported in at least 2 patients more in the ALDURAZYME group than in the placebo group. Table 2: Adverse Reactions that Occurred in at Least 2 Patients More in the ALDURAZYME Group than in the Placebo Group Among Adult and Pediatric Patients with MPS I in Study 1 ALDURAZYME N=22 n (%) Placebo N=23 n (%) Blood and lymphatic system disorders Thrombocytopenia 2 (9) 0 Eye disorders Corneal opacity 2 (9) 0 General disorders and administration site conditions Chest pain 2 (9) 0 Face edema 2 (9) 0 Gravitational edema 2 (9) 0 Injection site pain 2 (9) 0 Injection site reaction 4 (18) 2 (9) Hepatobiliary disorders Hyperbilirubinemia 2 (9) 0 Infections and infestations Abscess 2 (9) 0 Upper respiratory tract infection 7 (32) 4 (17) Nervous system disorders Hyperreflexia 3 (14) 0 Paresthesia 3 (14) 1 (4) Skin and subcutaneous tissue disorders Rash 8 (36) 5 (22) Vascular disorders Hypotension 2 (9) 0 Poor venous access 3 (14) 0 All 45 patients who completed the placebo-controlled study (Study 1) continued treatment in an open-label, uncontrolled extension study (Study 2).
All patients received ALDURAZYME 0.58 mg/kg of bod… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from the MPS I Registry pregnancy sub-registry, published case reports, and the global pharmacovigilance database with ALDURAZYME use in more than 30 pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The continuation of treatment for MPS I during pregnancy should be individualized to the pregnant woman. Untreated MPS I may result in adverse pregnancy and infant outcomes ( see Clinical Considerations ).
No evidence of fetal harm has been observed in rats when laronidase was administered during organogenesis at doses up to 6.2 times the recommended human dose (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Pregnancy can exacerbate preexisting clinical manifestations of MPS and lead to adverse pregnancy outcomes for both mother and fetus. Data Animal Data When laronidase was administered to pregnant female rats during organogenesis (gestation days [GD] 7-17) at doses of 0, 0.036, 0.36 or 3.6 mg/kg/day intravenously (equivalent to 7.3, 73.1, 730.8 units/kg/day) decreased maternal body weight gains and food consumption were observed with no corresponding effects on reproductive and litter parameters including number and distribution of corpora lutea, implantations and early and late resorptions at doses up to 3.6 mg/kg/day (6.2 times the recommended human dose of 0.58 mg/kg on a mg/kg basis).
Laronidase has not been evaluated for effects on embryo-fetal development in any other species.
8.2Lactation Risk Summary Available information from one mother: infant pair are insufficient to evaluate the presence or absence of laronidase in human milk. No adverse effects have been reported in breastfed infants in postmarketing cases of ALDURAZYME use in lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ALDURAZYME and any potential adverse effects on the breastfed child from ALDURAZYME or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of ALDURAZYME have been established for the treatment of pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and the treatment of pediatric patients with the Scheie form of MPS I who have moderate to severe symptoms. The safety and effectiveness ALDURAZYME for the treatment of mildly affected pediatric patients with the Scheie form have not been established. Use of ALDURAZYME for these indications is supported by evidence from an adequate and well-controlled clinical study (Study1) with an open label extension (Study 2) in adult and pediatric patients with MPS I, and from an open label, uncontrolled clinical study in pediatric patients with MPS I, 6 months to 5 years of age (Study 3).
The safety and effectiveness of ALDURAZYME in pediatric patients 6 months of age to 5 years of age was found to be similar to pediatric patients 6 to 18 years of age and adults for these indications [see Adverse Reactions (6.1) , Clinical Studies (14) ].
8.5Geriatric Use Clinical studies of ALDURAZYME did not include patients 65 years of age and older to determine if they respond differently from younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from the MPS I Registry pregnancy sub-registry, published case reports, and the global pharmacovigilance database with ALDURAZYME use in more than 30 pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The continuation of treatment for MPS I during pregnancy should be individualized to the pregnant woman. Untreated MPS I may result in adverse pregnancy and infant outcomes ( see Clinical Considerations ).
No evidence of fetal harm has been observed in rats when laronidase was administered during organogenesis at doses up to 6.2 times the recommended human dose (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Pregnancy can exacerbate preexisting clinical manifestations of MPS and lead to adverse pregnancy outcomes for both mother and fetus. Data Animal Data When laronidase was administered to pregnant female rats during organogenesis (gestation days [GD] 7-17) at doses of 0, 0.036, 0.36 or 3.6 mg/kg/day intravenously (equivalent to 7.3, 73.1, 730.8 units/kg/day) decreased maternal body weight gains and food consumption were observed with no corresponding effects on reproductive and litter parameters including number and distribution of corpora lutea, implantations and early and late resorptions at doses up to 3.6 mg/kg/day (6.2 times the recommended human dose of 0.58 mg/kg on a mg/kg basis).
Laronidase has not been evaluated for effects on embryo-fetal development in any other species.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ALDURAZYME have been established for the treatment of pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and the treatment of pediatric patients with the Scheie form of MPS I who have moderate to severe symptoms. The safety and effectiveness ALDURAZYME for the treatment of mildly affected pediatric patients with the Scheie form have not been established. Use of ALDURAZYME for these indications is supported by evidence from an adequate and well-controlled clinical study (Study1) with an open label extension (Study 2) in adult and pediatric patients with MPS I, and from an open label, uncontrolled clinical study in pediatric patients with MPS I, 6 months to 5 years of age (Study 3).
The safety and effectiveness of ALDURAZYME in pediatric patients 6 months of age to 5 years of age was found to be similar to pediatric patients 6 to 18 years of age and adults for these indications [see Adverse Reactions (6.1) , Clinical Studies (14) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of ALDURAZYME did not include patients 65 years of age and older to determine if they respond differently from younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAG). Mucopolysaccharidosis I (MPS I) is characterized by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyzes the hydrolysis of terminal α-L-iduronic acid residues of dermatan sulfate and heparan sulfate. Reduced or absent α-L-iduronidase activity results in the accumulation of the GAG substrates, dermatan sulfate and heparan sulfate, throughout the body and leads to widespread cellular, tissue, and organ dysfunction.
The rationale of ALDURAZYME therapy in MPS I is to provide exogenous enzyme for uptake into lysosomes and increase the catabolism of GAG. ALDURAZYME uptake by cells into lysosomes is most likely mediated by the mannose-6-phosphate-terminated oligosaccharide chains of laronidase binding to specific mannose-6-phosphate receptors. Because many proteins in the blood are restricted from entry into the central nervous system (CNS) by the blood brain barrier, effects of intravenously administered ALDURAZYME on cells within the CNS cannot be inferred from activity in sites outside the CNS.
The ability of ALDURAZYME to cross the blood brain barrier has not been evaluated in animal models or in clinical studies.
12.2Pharmacodynamics The pharmacodynamic effect of ALDURAZYME was assessed by reductions in urinary GAG levels. The responsiveness of urinary GAG to dosage alterations of ALDURAZYME is unknown, and the relationship of urinary GAG to other measures of clinical response has also not been established [see Clinical Studies (14) ] .
12.3Pharmacokinetics The pharmacokinetics of laronidase were evaluated in 6-year-old or older patients (N=10 to 12) with MPS I who received 0.58 mg/kg of body weight once weekly of ALDURAZYME as a 4-hour infusion in the placebo-controlled clinical study (Study 1). After the 1 st , 12 th , and 26 th weekly infusions, the mean maximum plasma concentrations (C max ) ranged from 1.2 to 1.7 mcg/mL for the 3 time points. The mean area under the plasma concentration-time curve (AUC ∞ ) ranged from 4.5 to 6.9 mcg ∙ hour/mL.
The mean volume of distribution (V z ) ranged from 0.24 to
0.60L/kg. Mean plasma clearance (CL) ranged from 1.7 to 2.7 mL/min/kg, and the mean elimination half-life (t 1/2 ) ranged from 1.5 to 3.6 hours. The pharmacokinetics of laronidase were evaluated in 6-year-old or younger patients (N=7 to 9) with MPS I disease who received 0.58 mg/kg of body weight once weekly of ALDURAZYME as a 4-hour infusion in the open label clinical study (Study 3).
After the 26 th infusion, the 95% confidence interval of the geometric mean values of PK parameters ranged from 0.6 to 1.6 mcg/mL for the maximum plasma concentrations (C max ), from 1.3 to 4.4 mcg ∙ hour/mL for area under the plasma concentration-time curve (AUC ∞ ), from 0.12 to
0.56L/kg for volume of distribution (V z ), from 2.2 to 7.7 mL/min/kg for plasma clearance (CL), and from 0.3 to 1.9 hours for elimination half-life (t 1/2 ).
12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of ALDURAZYME or of other laronidase products. In clinical studies 1, 2, 3 [see Clinical Studies (14.1 , 14.2) ] and a dose-ranging clinical study that enrolled 8 patients between 3 to 17 years old who received once weekly intravenous doses of 0.58 mg/kg of ALDURAZYME, 70 of 73 (96%) of ALDURAZYME-treated patients developed IgG anti-laronidase antibodies (referred to as ADA).
The 3 patients who did not develop ADA were patients with Hurler-Scheie forms of MPS I. In the 70 patients who developed ADA, the onset of ADA positivity in most patients occurred within 2 months after star… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAG). Mucopolysaccharidosis I (MPS I) is characterized by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyzes the hydrolysis of terminal α-L-iduronic acid residues of dermatan sulfate and heparan sulfate. Reduced or absent α-L-iduronidase activity results in the accumulation of the GAG substrates, dermatan sulfate and heparan sulfate, throughout the body and leads to widespread cellular, tissue, and organ dysfunction.
The rationale of ALDURAZYME therapy in MPS I is to provide exogenous enzyme for uptake into lysosomes and increase the catabolism of GAG. ALDURAZYME uptake by cells into lysosomes is most likely mediated by the mannose-6-phosphate-terminated oligosaccharide chains of laronidase binding to specific mannose-6-phosphate receptors. Because many proteins in the blood are restricted from entry into the central nervous system (CNS) by the blood brain barrier, effects of intravenously administered ALDURAZYME on cells within the CNS cannot be inferred from activity in sites outside the CNS.
The ability of ALDURAZYME to cross the blood brain barrier has not been evaluated in animal models or in clinical studies.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING ALDURAZYME (laronidase) injection is supplied as a colorless to pale yellow, clear to slightly opalescent solution in single-dose, clear Type I glass vial. Each vial contains 2.9 mg/5 mL (0.58 mg/mL) of laronidase. The closure consists of a siliconized butyl stopper and an aluminum seal with a plastic flip-off cap.
ALDURAZYME is available as: One single-dose vial in a carton (NDC 58468-0070-1) Refrigerate vials of ALDURAZYME at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light.
This product contains no preservatives.
📦 Storage and Handling ▾
Refrigerate vials of ALDURAZYME at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. This product contains no preservatives.
📋 Description ▾
11 DESCRIPTION ALDURAZYME (laronidase) is a polymorphic variant of the human enzyme α-L-iduronidase that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. α-L-iduronidase (glycosaminoglycan α-L-iduronohydrolase, EC 3.2.1.76) is a lysosomal hydrolase that catalyzes the hydrolysis of terminal α-L-iduronic acid residues of dermatan sulfate and heparan sulfate. Laronidase is a glycoprotein with a molecular weight of approximately 83 kD. The predicted amino acid sequence of the recombinant form, as well as the nucleotide sequence that encodes it, are identical to a polymorphic form of human α-L-iduronidase.
The recombinant protein is comprised of 628 amino acids after cleavage of the N-terminus and contains 6 N-linked oligosaccharide modification sites. Two oligosaccharide chains terminate in mannose-6-phosphate sugars. ALDURAZYME has a specific activity of approximately 172 U/mg.
ALDURAZYME, for intravenous infusion, is supplied as a sterile, nonpyrogenic, colorless to pale yellow, clear to slightly opalescent solution that must be diluted prior to administration in 0.9% Sodium Chloride Injection, USP. The solution in each vial contains a nominal laronidase concentration of 0.58 mg/mL and a pH of approximately 5.5. The extractable volume of 5 mL from each vial provides 2.9 mg laronidase, 43.9 mg sodium chloride, 63.5 mg sodium phosphate monobasic monohydrate, 10.7 mg sodium phosphate dibasic heptahydrate, and 0.05 mg polysorbate 80.
ALDURAZYME does not contain preservatives; vials are for single dose only.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions (Including Anaphylaxis) and Infusion-Associated Reactions (IARs) Advise the patient or caregiver that reactions related to the infusion may occur during and up to 3 hours after ALDURAZYME treatment, including life-threatening hypersensitivity reactions, including anaphylaxis, and IARs. Inform the patient and caregiver of the signs and symptoms of hypersensitivity reactions and IARs and to seek medical care should signs and symptoms occur [see Warnings and Precaution (5.1 , 5.4) ] .
Cardiac and Respiratory Adverse Reactions Advise the patient and/or caregiver to report immediately to a healthcare provider if signs or symptoms of cardiac or respiratory decompensation occur during or following an infusion [see Warnings and Precautions (5.2 , 5.3) ]. Inform patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep to have these treatments readily available during infusion or extreme drowsiness/sleep induced by antihistamine use.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of laronidase were evaluated in 6-year-old or older patients (N=10 to 12) with MPS I who received 0.58 mg/kg of body weight once weekly of ALDURAZYME as a 4-hour infusion in the placebo-controlled clinical study (Study 1). After the 1 st , 12 th , and 26 th weekly infusions, the mean maximum plasma concentrations (C max ) ranged from 1.2 to 1.7 mcg/mL for the 3 time points. The mean area under the plasma concentration-time curve (AUC ∞ ) ranged from 4.5 to 6.9 mcg ∙ hour/mL.
The mean volume of distribution (V z ) ranged from 0.24 to
0.60L/kg. Mean plasma clearance (CL) ranged from 1.7 to 2.7 mL/min/kg, and the mean elimination half-life (t 1/2 ) ranged from 1.5 to 3.6 hours. The pharmacokinetics of laronidase were evaluated in 6-year-old or younger patients (N=7 to 9) with MPS I disease who received 0.58 mg/kg of body weight once weekly of ALDURAZYME as a 4-hour infusion in the open label clinical study (Study 3).
After the 26 th infusion, the 95% confidence interval of the geometric mean values of PK parameters ranged from 0.6 to 1.6 mcg/mL for the maximum plasma concentrations (C max ), from 1.3 to 4.4 mcg ∙ hour/mL for area under the plasma concentration-time curve (AUC ∞ ), from 0.12 to
0.56L/kg for volume of distribution (V z ), from 2.2 to 7.7 mL/min/kg for plasma clearance (CL), and from 0.3 to 1.9 hours for elimination half-life (t 1/2 ).
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The pharmacodynamic effect of ALDURAZYME was assessed by reductions in urinary GAG levels. The responsiveness of urinary GAG to dosage alterations of ALDURAZYME is unknown, and the relationship of urinary GAG to other measures of clinical response has also not been established [see Clinical Studies (14) ] .
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Clinical Studies in Patients 6 Years and Older Study 1 (NCT00912925) was a randomized, double-blind, placebo-controlled study in 45 patients with MPS I, including 1 patient with the Hurler form, 37 patients with Hurler-Scheie form, and 7 patients with Scheie form of MPS I. Among the 45 patients who completed Study 1, 22 (49%) were male and 23 (51%) were female ranging in age from 6 to 43 years with a mean age of 15.5 years. Thirty seven (82%) were White, 2 (4%) were Asian, 6 (13%) were Other and no patients were Black or African American.
For ethnicity, 4 (9%) were Hispanic. All patients had a baseline percent predicted forced vital capacity (FVC) less than or equal to 77%. Patients received ALDURAZYME intravenously at 0.58 mg/kg of body weight once weekly or placebo once weekly for 26 weeks.
All 45 randomized patients completed the study. The primary efficacy outcome assessments were percent predicted FVC and distance walked in 6 minutes (6-minute walk test). After 26 weeks, patients treated with ALDURAZYME showed improvement in percent predicted FVC and in 6-minute walk test compared to placebo-treated patients (see Table 3 ) .
Table 3: Change from Baseline in FVC Forced Vital Capacity and 6 Minute Walk Distance in ALDURAZYME or Placebo Treated Adult and Pediatric Patients with MPS I over 26 Weeks (Study 1) ALDURAZYME ® (N=22) Placebo (N=23) Forced Vital Capacity (percent of predicted normal) Pretreatment Baseline Mean ± s.d. 48 ± 15 54 ± 16 Week 26 Mean ± s.d. 50 ± 17 51 ± 13 Change from Baseline to Week 26 Mean ± s.d.
1 ± 7 -3 ± 7 Median 1 -1 Difference in Change from Baseline to Week 26 Between Groups Mean 4 Median (95% CI) 2 (0.4, 7), p=0.02 By Wilcoxon Rank Sum Test 6-Minute Walk Distance (meters) Pretreatment Baseline Mean ± s.d. 319 ± 131 367 ± 114 Week 26 Mean ± s.d. 339 ± 127 348 ± 129 Change from Baseline to Week 26 Mean ± s.d.
20 ± 69 -18 ± 67 Median 28 -11 Difference in Change from Baseline to Week 26 Between Groups Mean 38 Median (95% CI) 39 (-2, 79), p=0.07 Evaluations of bioactivity were changes in liver size and urinary GAG levels. Liver size and urinary GAG levels decreased in patients treated with ALDURAZYME compared to patients treated with placebo. No patient in the group receiving ALDURAZYME reached the normal range for urinary GAG levels during this 6-month study.
Study 2 (NCT00146770) was a 182-week, open-label, uncontrolled extension study of all 45 patients who completed Study 1. Patients received ALDURAZYME intravenously at 0.58 mg/kg body weight once weekly. Forty (89%) patients completed the study through Week 182.
Five (11%) patients, all of whom received placebo in Study 1 and subsequently received Aldurazyme in Study 2 discontinued prematurely. Of these, 2 patients discontinued due to an adverse event, 2 patients due to patient wishes, and 1 patient due to pregnancy. For patients treated with ALDURAZYME, the mean increase in 6-minute walk test distance was maintained for an additional 182 weeks through completion of Study 2.
At the end of Study 2, the decrease in mean urinary GAG was similar to the decrease in urinary GAG reported in ALDURAZYME-treated patients at the end of Study 1. The relationship of urinary GAG to other measures of clinical response has not been established.
14.2Clinical Studies in Patients 6 Years and Younger Study 3 (NCT00146757) was a 52-week, open-label, uncontrolled clinical study in 20 patients with MPS I, including 16 patients (80%) with the Hurler form and 4 patients (20%) with the Hurler-Scheie form. Among the 20 patients who participated in Study 3, 12 (60%) were male and 8 (40%) were female ranging in age from 6 months to 5 years old with a mean age of 2.9 years. Eighteen (90%) were White, 1 (5%) were Black or African American and 1 (5%) were Other.
A total of 18 patients completed the study. All 20 patients received ALDURAZYME intravenously at 0.58 mg/kg of body weight once weekly for 26 weeks. After 26 weeks of treatment, 16 patients c… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies to evaluate the mutagenic and carcinogenic potential of laronidase have not been conducted. Laronidase at intravenous doses up to 3.6 mg/kg (6.2 times the recommended human dose) was found to have no effect on the fertility and reproductive performance of male and female rats.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies to evaluate the mutagenic and carcinogenic potential of laronidase have not been conducted. Laronidase at intravenous doses up to 3.6 mg/kg (6.2 times the recommended human dose) was found to have no effect on the fertility and reproductive performance of male and female rats.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 2.9 mg/5 mL Vial Label NDC 58468-0070-1 ALDURAZYME ® (LARONIDASE) 2.9 mg/5 mL (0.58 mg/mL) Injection For Intravenous Infusion after Dilution Rx Only PRINCIPAL DISPLAY PANEL - 2.9 mg/5 mL Vial Label
PRINCIPAL DISPLAY PANEL - 2.9 mg/5 mL Vial Carton NDC 58468-0070-1 ALDURAZYME ® (LARONIDASE) 2.9 mg/5 mL (0.58 mg/mL) Injection For Intravenous Infusion after Dilution One 5 mL single-dose vial Rx Only sanofi PRINCIPAL DISPLAY PANEL - 2.9 mg/5 mL Vial Carton
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