Allergy to penicillin and related antibiotics

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
  Alglucerase may be confused with agalsidase alfa, agalsidase beta, alglucosidase alfa
  Ceredase® may be confused with Cerezyme®

U.S. BRAND NAMES — Ceredase®

PHARMACOLOGIC CATEGORY
Enzyme

DOSING: ADULTS — Gaucher's disease: I.V.: Initial: 30-60 units/kg every 2 weeks; dosing is individualized based on disease severity; average dose: 60 units/kg every 2 weeks. Range: 2.5 units/kg 3 times/week to 60 units/kg once weekly to every 4 weeks. Once patient response is well established, dose may be reduced every 3-6 months to determine maintenance therapy.

DOSING: PEDIATRIC — Refer to adult dosing.

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free]:
  Ceredase®: 80 units/mL (5 mL) [contains human albumin 1%]

DOSAGE FORMS: CONCISE
Injection, solution [preservative free]:
  Ceredase®: 80 units/mL (5 mL)

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — I.V.: Infuse I.V. over 1-2 hours. Use of an in-line filter is recommended. Do not shake solution as it denatures the enzyme.

COMPATIBILITY — Stable in NS; do not mix with any other additives.

USE — Replacement therapy for Gaucher's disease (type 1)

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Peripheral edema

Central nervous system: Chills, fatigue, fever, headache, lightheadedness

Endocrine & metabolic: Hot flashes, menstrual abnormalities

Gastrointestinal: Abdominal discomfort, diarrhea, nausea, oral ulcerations, vomiting

Local: Injection site: Abscess, burning, discomfort, pruritus, swelling

Neuromuscular & skeletal: Backache, weakness

Miscellaneous: Dysosmia; hypersensitivity reactions (abdominal cramping, angioedema, chest discomfort, flushing, hypotension, nausea, pruritus, respiratory symptoms, urticaria); IgG antibody formation (~13%)

CONTRAINDICATIONS — Hypersensitivity to any component of the formulation

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Hypersensitivity reactions: Patients who develop IgG antibodies may be at a higher risk for developing hypersensitivity. Use with caution in patients with prior allergies to hCG.

Disease-related concerns: Androgen-sensitive malignancies: Use with caution in patients with androgen-sensitive malignancies.

Special populations: Pediatrics: Safety and efficacy have not been established in children <2 years of age (limited experience). May cause early virilization in males <10 years of age.

Dosage form specific issues: Placental tissue: Prepared from pooled human placental tissue that may contain the causative agents of some viral diseases.

DRUG INTERACTIONS — There are no known significant interactions.

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Animal studies have not been conducted.

LACTATION — Excretion in breast milk unknown/use caution

MONITORING PARAMETERS — CBC, platelets, liver function tests, IgG antibody formation, acid phosphatase (AP); MRI or CT of liver and spleen, skeletal x-rays, physical exam every 6-12 months

INTERNATIONAL BRAND NAMES — Ceredase (DE, ES, GB, NL)

MECHANISM OF ACTION — Alglucerase is a modified form of glucocerebrosidase; it is prepared from human placental tissue. Glucocerebrosidase is an enzyme deficient in Gaucher's disease. It is needed to catalyze the hydrolysis of glucocerebroside to glucose and ceramide.

PHARMACODYNAMICS / KINETICS — Half-life elimination: ~3-11 minutes