The most serious and common adverse drug reactions reported with agalsidase beta are infusion-related, consisting primarily of fever and chills or rigors, as well as tachycardia, hypertension, tightness of the throat, chest pain or tightness, dyspnea, abdominal pain, pruritus, urticaria, nausea and vomiting, lip or ear edema, and rash. These reactions occurred during the infusion and ceased when the infusion was stopped or when the rate was slowed. Although these effects diminished with continued use of agalsidase beta, infusion reactions may persist with extended durations of treatment.
Table 1 presents a summary of adverse drug effects experienced in more than 10% of agalsidase patients in clinical trials.
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Table 1 Treatment-Related Adverse Events Reported in 10% or More of All Patients Given Agalsidase beta in a Placebo-Controlled Study
| Agalsidase | ||
| Placebo |
beta |
|
| (n = 29) | (n = 29) | |
| Adverse Drug Event | No.(%) | No.(%) |
| Body as a whole | ||
| Chest pain | 3 (10) |
5 (17) |
| Fever | 5 (17) |
14 (48) |
| Pain | 3 (10) |
6 (21) |
| Pallor | 1 (3) |
4 (14) |
| Rigors | 4 (14) |
15 (52) |
| Temperature-change | ||
| sensation | 1 (3) |
5 (17) |
| Cardiovascular | ||
| Cardiomegaly | 1 (3) |
3 (10) |
| Hypertension | 0 |
3 (10) |
| Hypotension | 2 (7) |
4 (14) |
| Edema-dependent | 1 (3) |
6 (21) |
| Central and peripheral nervous system | ||
| Dizziness | 2 (7) |
4 (14) |
| Headache | 11 (38) |
13 (45) |
| Paresthesia | 2 (7) |
4 (14) |
| Gastrointestinal system | ||
| Dyspepsia | 1 (3) |
3 (10) |
| Nausea | 4 (14) |
8 (28) |
| Musculoskeletal system | ||
| Arthrosis | 0 |
3 (10) |
| Skeletal pain | 0 |
6 (21) |
| Psychiatric | ||
| Anxiety | 5 (17) |
8 (28) |
| Depression | 1 (3) |
3 (10) |
| Respiratory system | ||
| Bronchitis | 1 (3) |
3 (10) |
| Pharyngitis | 2 (7) |
8 (28) |
| Rhinitis | 7 (24) |
11 (38) |
There are no known contraindications to the use of agalsidase beta. The safety and effectiveness of agalsidase beta have not been established in children under age 16 or in elderly patients older than age 65. No drug interaction studies or in vitro metabolism studies have been performed to date.
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CONCLUSION
Agalsidase beta is currently the only FDA-approved therapy for Fabry disease. Placebo-controlled trials with agalsidase beta are ongoing and will address further clinical benefits such as renal and cardiac events and/or cerebrovascular disease progression.
The agent has been able to significantly reduce micro-vascular endothelial deposits of GL-3 in the kidney, heart, and skin of Fabry disease patients. It is associated with mild-to-moderate infusion reactions of fever and rigors in approximately 50% of patients. These reactions decline with continued use of the agent, but serious infusion reactions may persist with continued use.
The treatment of Fabry disease has traditionally been symptomatic for the various clinical manifestations. Enzyme replacement therapy with agalsidase beta addresses the underlying enzyme deficiency and reverses the pathological mani-festations.
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Experts have recommended agalsidase beta for all males with Fabry disease, including those with end-stage renal disease who are receiving dialysis or who are transplant recipients, as well as for symptomatic female carriers. Males should
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