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FABRAZYME is a brand name for Agalsidase Beta, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FABRAZYME (agalsidase beta) is indicated for: • long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. 1.1 Pediatrics Pediatrics (≥8 years of age): The safety and efficacy of Fabrazyme has been demonstrated in Fabry patients at least 8 years of age. (see 7 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Pre-treatment considerations: As a preventive measure, it is recommended that patients are treated with antipyretics prior to an infusion. If an infusion-associated reaction occurs, regardless of pretreatment, the adverse events have been successfully managed by decreasing the infusion Product Monograph of FABRAZYME (Agalsidase Beta) Page 5 of 35 rate, temporarily stopping the infusion, and/or administering non-steroidal anti-inflammatory drugs, antipyretics, antihistamines and/or corticosteroids to ameliorate the symptoms.
In clinical trials, pretreatment with an antipyretic and/or an antihistamine was used to manage a single or recurrent mild-moderate infusion-associated reaction(s). Pretreatment with an antihistamine, antipyretic and/or corticosteroid was used to manage a single or recurrent mild-moderate infusion- associated reaction(s).
The selection of pretreatment medication and dose should be based on the patient age, weight and severity of the reaction. The time of administration should be based on the onset of action of the medication selected. A decrease in infusion rate should also be considered.
If the infusion proceeds without incident, consideration may be given to increasing infusion rates in a stepwise manner and to reducing premedication. • Rechallenge considerations: Patients who have had a positive skin test to Fabrazyme or who have tested positive for anti-Fabrazyme IgE may be successfully rechallenged with Fabrazyme.
01 mg/min). 25 mg/min), as tolerated. • Renal Disease: No changes in dose are necessary for patients with renal insufficiency. 0 mg/kg body weight infused every 2 weeks as an IV infusion. 25 mg/min (15 mg/hr). The infusion rate may be slowed in the event of infusion-associated reactions.
08 mg/min (increments of 3 to 5 mg/hr) with each subsequent infusion. 25 mg/min (15 mg/hr). 5 hours (based on individual patient tolerability). 2 μm) • Administration set with flow-regulating device or intravenous infusion pump and tubing • IV kit • Anaphylaxis kit • Angiocatheter • Gloves • Alcohol wipes • Arm board • Medication label Reconstitution and Dilution (using Aseptic Technique) 1.
Fabrazyme vials and diluent should be allowed to reach room temperature prior to reconstitution (approximately 30 minutes). 0 mg/kg. Select the appropriate number of vials so that the total number of mg is equal to or greater than the patient’s number of kg of body weight.
) In clinical trials, infusion-associated reactions were the most frequently reported related adverse events occurring in patients treated with Fabrazyme. 2 Clinical Trial Adverse Reactions) Infusion site reactions and catheter complications (including pain, infiltration at the IV site, bleeding and infection) would not be unexpected given the route of drug administration.
1 Dosing Considerations for recommended preventative measures for IARs. IARs have occurred in some patients after receiving pretreatment with antipyretics, antihistamines, and/or oral Product Monograph of FABRAZYME (Agalsidase Beta) Page 10 of 35 steroids.
IARs declined in frequency with continued use of Fabrazyme. However, IARs may still occur despite extended duration of Fabrazyme treatment. 2 Clinical Trial Adverse Reactions). Driving and Operating Machinery No studies on the ability to drive or use heavy machinery have been conducted with Fabrazyme.
2 CLINICAL PHARMACOLOGY - Pharmacokinetics). IgG seroconversion in pediatric patients was associated with prolonged half-life of Fabrazyme [see 10 CLINICAL PHARMACOLOGY - Pharmacokinetics]. Among patients treated with Fabrazyme in clinical trials, approximately 4% of patients developed IgE or skin test reactivity specific to Fabrazyme.
Physicians should consider testing for IgE (see 7 WARNINGS AND PRECAUTIONS - Monitoring and Laboratory Tests) in patients who experienced suspected allergic reactions and consider the risks and benefits of continued treatment in patients with anti-Fabrazyme IgE.
Skin testing can be considered based on the patient’s clinical presentation of symptoms. Patients who have had a positive skin test to Fabrazyme or who have tested positive for Fabrazyme- specific IgE antibody have been rechallenged with Fabrazyme using a rechallenge protocol (see 14 CLINICAL TRIALS).
Pediatrics and 14 CLINICAL TRIALS) Pediatrics (<8 years of age):
The safety and efficacy of Fabrazyme have not been studied in children below the age of 8 years. 2 Geriatrics (≥ 65 years of age) Clinical studies of Fabrazyme did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.
2 CONTRAINDICATIONS • Fabrazyme is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • As with any intravenous protein product, allergic-type hypersensitivity reactions have been observed in patients receiving Fabrazyme® infusions including anaphylaxis or anaphylaxis- like reactions.
1 Dosing Considerations • Pre-treatment considerations: As a preventive measure, it is recommended that patients are treated with antipyretics prior to an infusion. If an infusion-associated reaction occurs, regardless of pretreatment, the adverse events have been successfully managed by decreasing the infusion Product Monograph of FABRAZYME (Agalsidase Beta) Page 5 of 35 rate, temporarily stopping the infusion, and/or administering non-steroidal anti-inflammatory drugs, antipyretics, antihistamines and/or corticosteroids to ameliorate the symptoms.
In clinical trials, pretreatment with an antipyretic and/or an antihistamine was used to manage a single or recurrent mild-moderate infusion-associated reaction(s). Pretreatment with an antihistamine, antipyretic and/or corticosteroid was used to manage a single or recurrent mild-moderate infusion- associated reaction(s).
The selection of pretreatment medication and dose should be based on the patient age, weight and severity of the reaction. The time of administration should be based on the onset of action of the medication selected. A decrease in infusion rate should also be considered.
• Fabrazyme is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 mg/mL 2. Reconstitute each vial of Fabrazyme by slowly injecting the appropriate volume of Sterile Water for Injection, USP as indicated in Table 1 down the inside wall of each vial and not directly onto the lyophilized cake. Roll and tilt each vial gently.
Do not invert, swirl, or shake the vial. 0 mg/mL clear, colourless solution. Total extractable dose per vial is listed in the Approximate Available Volume column in Table 1. 3. Visually inspect the reconstituted vials for particulate matter and discolouration.
Do not use vials exhibiting particulate matter or discolouration. Report lot number to hospital pharmacist for vials exhibiting particulate matter or discolouration. Product Monograph of FABRAZYME (Agalsidase Beta) Page 7 of 35 4. After reconstitution, it is recommended to promptly dilute the vials.
Failure to promptly dilute the vials could result in particle formation. 5. 9 % Sodium Chloride Injection, USP to a total volume based on patient weight specified in Table below. To minimize the air/liquid interface, remove the airspace within the infusion bag prior to adding the reconstituted Fabrazyme.
Be sure to inject the reconstituted Fabrazyme solution directly into the sodium chloride solution. Total infusion volumes as low as 50 mL have been used in a clinical trial. Discard any vial with unused reconstituted solution. ). 1 – 100 250 > 100 500 6.
Gently invert infusion bag to mix the solution, avoiding vigorous shaking and agitation. Use immediately. 7. Fabrazyme should not be infused in the same intravenous line with other products. 8. The diluted solution should be filtered through an in-line low […]
Rechallenge should only occur under the direct supervision of qualified personnel, with appropriate medical support measures readily available. 1 Dosing Considerations) During the rechallenge with Fabrazyme, particular attention must be taken for a patient with severe congestive heart failure or severe ischemic heart disease requiring beta-adrenergic blocking agents as these patients did not participate in the trial.
Monitoring and Laboratory Tests IgG antibody testing:
Product Monograph of FABRAZYME (Agalsidase Beta) Page 11 of 35 It is suggested that patients be monitored periodically for IgG antibody formation.
Fabry Registry:
The Fabry Registry is an ongoing, observational database that tracks natural history and outcomes of patients with Fabry disease. Participation is open to all physicians managing patients with Fabry disease. Physicians are encouraged to collaborate, share observations, and generate hypotheses for evaluation, as well as assist in the collection of clinical data in an effort to guide and assess future therapeutic interventions.
The primary objectives of the Registry are: • To enhance the understanding of the variability, progression and natural history of Fabry disease, including heterozygous females with the disease; • To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; • To characterize and describe the Fabry population as a whole; and • To evaluate the long-term safety and effectiveness of Fabrazyme7.
net. Reproductive Health There are no data for the potential impact of Fabrazyme treatment on male or female fertility or reproductive function. Caution should be exercised when Fabrazyme is used in patients of reproductive potential.
1 Pregnant Women There are no data for the use of Fabrazyme during human pregnancy. Caution should be exercised when Fabrazyme is used in patients of reproductive potential. See section 7 WARNINGS AND PRECAUTIONS – Monitoring and Laboratory Tests for information regarding the Fabry Registry, which is open to patients who become pregnant while taking Fabrazyme.
2 Breast-feeding It is not known whether Fabrazyme is secreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk. 3 Pediatrics Pediatrics (<8 years of age): The safety and efficacy of Fabrazyme in patients less than 8 years old have not been studied.
Pediatrics (≥8 years of age):
The safety and efficacy of Fabrazymewere assessed in an open-label study (AGAL-016-01) of 16 pediatric patients with Fabry disease who were ages 8 to 16 years at first treatment. The safety profile was found to be consistent with that seen in adults (see 8 ADVERSE REACTIONS).
4 Geriatrics Clinical studies of Fabrazyme did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. 75% of pediatric (8-16 years) and 67% of adolescent (≥16 years) and adult patients treated with Fabrazyme.
The most common serious adverse drug reactions requiring intervention [interruption or discontinuation of Fabrazyme (agalsidase beta)], hospitalization or medical treatment were also IARs, including urticaria, fever, chills, tachycardia, tightness in chest/throat, or […]
If the infusion proceeds without incident, consideration may be given to increasing infusion rates in a stepwise manner and to reducing premedication. • Rechallenge considerations: Patients who have had a positive skin test to Fabrazyme or who have tested positive for anti-Fabrazyme IgE may be successfully rechallenged with Fabrazyme.
01 mg/min). 25 mg/min), as tolerated. • Renal Disease: No changes in dose are necessary for patients with renal insufficiency. 0 mg/kg body weight infused every 2 weeks as an IV infusion. 25 mg/min (15 mg/hr). The infusion rate may be slowed in the event of infusion-associated reactions.
08 mg/min (increments of 3 to 5 mg/hr) with each subsequent infusion. 25 mg/min (15 mg/hr). 5 hours (based on individual patient tolerability). 2 μm) • Administration set with flow-regulating device or intravenous infusion pump and tubing • IV kit • Anaphylaxis kit • Angiocatheter • Gloves • Alcohol wipes • Arm board • Medication label Reconstitution and Dilution (using Aseptic Technique) 1.
Fabrazyme vials and diluent should be allowed to reach room temperature prior to reconstitution (approximately 30 minutes). 0 mg/kg. Select the appropriate number of vials so that the total number of mg is equal to or greater than the patient’s number of kg of body weight.
0 mg/mL 2. Reconstitute each vial of Fabrazyme by slowly injecting the appropriate volume of Sterile Water for Injection, USP as indicated in Table 1 down the inside wall of each vial and not directly onto the lyophilized cake. Roll and tilt each vial gently.
Do not invert, swirl, or shake the vial. 0 mg/mL clear, colourless solution. Total extractable dose per vial is listed in the Approximate Available Volume column in Table 1. 3. Visually inspect the reconstituted vials for particulate matter and discolouration.
Do not use vials exhibiting particulate matter or discolouration. Report lot number to hospital pharmacist for vials exhibiting particulate matter or discolouration. Product Monograph of FABRAZYME (Agalsidase Beta) Page 7 of […]