Aldurazyme (laronidase)

Dosage of laronidase is expressed in mg. The specific activity of laronidase is 172 units/mg.

Laronidase is administered by IV infusion after dilution.

If >=1 doses of laronidase are missed, therapy should be restarted as soon as possible with maintenance of the 1-week interval between infusions thereafter. Clinicians should not double a dose to compensate for a missed dose.

Laronidase injection concentrate should be stored at 2-8degreesC and should not be frozen, shaken, or used beyond the expiration date.

No dosing information is available for this tab.

No formal drug interaction studies have been performed.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

There are no moderate interactions for this drug.

*None.

• Acute asthma attack

• Bronchospastic pulmonary disease
• Chronic obstructive pulmonary disease
• Pre-existing fluid retention

• Chronic heart failure
• Sleep apnea

The most common adverse effects reported in >=10% of patients >=6 months of age include infusion reactions (e.g., pyrexia, chills, increased blood pressure, tachycardia, and decreased oxygen saturation).

The most common adverse effects reported in >=10% of patients >=6 years of age include rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access.

More Frequent

• Abscess
• Chest pain
• Hyperbilirubinemia
• Hypotension
• Injection site sequelae
• Skin rash
• Thrombocytopenic disorder

Less Frequent

• Angioedema
• Bronchospastic pulmonary disease
• Dyspnea
• Urticaria

Rare or Very Rare

• Anaphylaxis
• Bradycardia
• Cyanosis
• Hypersensitivity drug reaction
• Laryngeal edema
• Tachycardia

More Frequent

• Corneal opacity
• Facial edema
• Fever
• Flushing
• Headache disorder
• Hyperreflexia
• Hypertension
• Paresthesia
• Upper respiratory infection
• Varicose veins

Less Frequent

• Cough
• Pallor
• Pruritus of skin
• Tremor
• Wheezing

Rare or Very Rare

• Acute abdominal pain
• Arthralgia
• Chills
• Diarrhea
• Erythema
• Fatigue
• Nausea
• Peripheral edema
• Vomiting

No enhanced messaging available.

Safety and efficacy of laronidase have been established in pediatric patients with Hurler and Hurler-Scheie forms of MPS I and pediatric patients with Scheie form of MPS I who have moderate to severe symptoms. Clinical data supporting use of laronidase for these indications include evidence from an adequate and well-controlled clinical study with an open-label extension in adults and pediatric patients with MPS I, and an open-label uncontrolled study involving pediatric patients (6 months to 5 years of age) with MPS I. The safety and efficacy of laronidase in pediatric patients 6 months to 5 years of age were found to be similar to pediatric patients 6-18 years of age and adults for these indications.

No drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes was identified in pregnant women from clinical data within the MPS I Registry pregnancy sub-registry, published case reports, and a global pharmacovigilance database. The decision to continue laronidase therapy during pregnancy should be individualized. Adverse pregnancy and infant outcomes may occur due to untreated MPS I. Administration of laronidase during organogenesis at doses up to 6.2 times the recommended human dose in rats did not reveal evidence of fetal harm.

Pregnant women with MPS I and clinicians are encouraged to enroll in the MPS I pregnancy sub-registry by calling 1-800-745-4447 ext. 15500 or visiting https://www.registrynxt.com.

Clinical data are insufficient to evaluate the presence or absence of laronidase in human milk. In the postmarketing setting, no adverse effects were reported in breastfed infants of lactating women administered laronidase. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for laronidase and any potential adverse effects on the breastfed child from the drug or the underlying maternal condition.

Lactating women with MPS I and clinicians are encouraged to enroll in the MPS I Registry by calling 1-800-745-4447 ext. 15500 or visiting https://www.registrynxt.com.

Patients >=65 years of age were not included in clinical studies of laronidase to determine if these patients respond differently than younger patients.