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REPLAGAL is a brand name for Agalsidase Alfa, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: REPLAGAL (agalsidase alfa) is indicated for: long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency). REPLAGAL treatment should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations REPLAGAL is intended for long-term, chronic use REPLAGAL treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases Infusion of REPLAGAL at home may be considered for patients who are tolera ting their infusions well.
2 mg/kg body weight every other week by intravenous infusion over 40 minutes. 4 Administration 1. Calculate the dose and number of REPLAGAL vials needed. 2. 9%) sodium chloride solution for infusion. Care must be taken to ensure the sterility of the prepared solutions since REPLAGAL does not contain any preservative or bacterios tatic agent; aseptic technique must be observed.
Once diluted, the solution should be mixed gently but not shaken. 3. The solution should be inspected visually for particulate matter and discoloration prior to administration. 4. Administer the infusion solution over a period of 40 minutes using an intravenous line with an integral filter.
Since no preservative is present, it is recommended that administration is started as soon as possible. After dilution, the product should be administered immediately. 5. Do not infuse REPLAGAL concomitantly in the same intravenous line with other agents.
6. For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
) Idiosyncratic infusion-related reactions In adult and pediatric patients treated with REPLAGAL in clinical studies idiosyncratic infusion - related reactions were very commonly reported. The most common symptoms have been rigors, headache, nausea, pyrexia, flushing and fatigue.
Serious infusion reactions have been reported uncommonly; symptoms reported include pyrexia, rigors, tachycardia, urticaria, nausea/vomiting, angioneurotic edema with throat tightness, stridor and swollen tongue. Other infusion-related symptoms may include dizziness and hyperhidrosis.
Infusion reactions may be associated with hemodynamic stress triggering cardiac events in patients with pre -existing cardiac manifestations of Fabry disease. The onset of infusion-related reactions has generally occurred within the first 2-4 months after initiation of treatment with REPLAGAL although later onset (after 1 year) has been reported as well.
These effects have decreased with time. If mild or moderate acute infusion reactions occur, medical attention must be sought immediately and appropriate actions instituted. The infusion can be temporarily interrupted (5 to 10 minutes) until symptoms subside and the infusion may then be restarted.
Mild and transient effects may not require medical treatment or discontinuation of the infusion. In addition, oral or intravenous pre- treatment with antihistamines and/or corticosteroids, from 1 to 24 hours prior to infusion may prevent subsequent reactions in those cases where symptomatic treatment was required.
(see 8 ADVERSE REACTIONS) Antibodies to the protein As with all protein pharmaceutical products, patients may develop antibodies to the protein. 4% of male patients treated with REPLAGAL after 12 months of treatment. (see 8 ADVERSE REACTIONS, Immunogenicity) Renal No dose adjustment is necessary in patients with renal impairment.
Driving and Operating Machinery REPLAGAL has no or negligible influence on the ability to drive and use machines. Hepatic/Biliary/Pancreatic No studies have been performed in patients with hepatic impairment. Immune Hypersensitivity reactions Hypersensitivity reactions have been reported.
If severe hypersensitivity or anaphylactic reactions occur, the administration of REPLAGAL should be discontinued immediately and appropriate treatment initiated. The current medical standards for emergency treatment are to be observed.
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REPLAGAL is contraindicated in patients with severe allergic reactions to the active substance or to any ingredient in the formulation or components of the container of REPLAGAL. 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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The presence of extensive renal damage (eGFR < 60 mL/min) may limit the renal response to enzyme replacement therapy, possibly due to underlying irreversible pathological changes. In such cases, the loss of renal function remains within the expected range of the natural progression of the disease.
Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is required. 1 Pregnant Women There is very limited data on pregnancies exposed to REPLAGAL. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/fetal development when exposed during organogenesis.
2 Breast-feeding It is not known whether REPLAGAL is excreted in human milk. Caution should be exercised when prescribing REPLAGAL to nursing mothers. 3 Pediatrics Pediatrics (<18 years of age): The experience in children is limited.
2 mg/kg every other week for one to 4 years, no unexpected safety issues were encountered. 4 Geriatrics Geriatrics (>65 years of age): Studies specifically in patients over the age of 65 years old have not been performed and no dosage regimen can presently be recommended in these patients as safety and efficacy have not yet been established.
1 Adverse Reaction Overview The most common adverse reactions (occurring in at least 10% of patients) reported in patients treated with REPLAGAL in clinical studies were headache, nasopharyngitis, nausea, diarrhea, vomiting, cough, pain in limb, pyrexia, arthralgia, dizziness, back pain, fatigue, paraesthesia, pharyngitis, rigors, chest pain, neuropathic pain, abdominal pain, pain, peripheral edema, asthenia, myalgia, dyspnea, fatigue aggravated, rash, hypoesthesia, palpitations, tinnitus, flushing, peripheral swelling, tremor, and tinnitus aggravated.
The most serious adverse reactions in patients include abdominal discomfort, abdominal pain, anaphylactic reaction, arthralgia, asthenia, atrial fibrillation, chest pain, chest tightness, cough, diarrhea, dyspnea, erythema, heart failure, hypersensitivity, hypertension, hypoesthesia, malaise, myocardial ischemia, nasopharyngitis, nausea, neuropathic pain, palpitations, pyrexia, tachyarrhythmia, tachycardia, throat tightness, tremor, ventricular extrasystoles, and vomiting.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 7% of patients) in adults patients treated with REPLAGAL. 2 mg/kg every other week in 11 clinical trials (1 Phase I/II trial, 7 Phase II trials and 3 Phase III trials), ranging in treatment durations of at least 9-51 weeks to 3 years.
These clinical trials included 21 patients with history of end-stage renal disease, 24 pediatric patients (7 to 17 years of age) and 17 female patients. Information is presented by system organ class and frequency (very common ≥1/10; common ≥1/100, <1/10).
Table 2 – Adverse Reactions Reported (≥1%) for REPLAGAL in Clinical Studies System Organ Class & Adverse Reaction Frequency Category Number and Frequency by Subjects N=177 […]