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FASTURTEC is a brand name for Rasburicase, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FASTURTEC (Rasburicase for injection) is indicated for: • the treatment and prophylaxis of hyperuricemia in pediatric and adult cancer patients. 1.1 Pediatrics Pediatrics (1 month – 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Fasturtec in pediatric patients…
Verbatim from this product's HC label. Tap a section to expand.
3 Reconstitution 07/2023
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. FASTURTEC (Rasburicase for Injection) Page 9 of 24 Adverse events were reported in pediatric and adult patients in various clinical efficacy and safety studies, as well as in one study, which was specifically designed to collect further safety and tolerability data of Fasturtec (rasburicase for injection).
In a study of 28 healthy volunteers, only two adverse events (headache of moderate intensity) were reported. In the clinical studies in patients, the adverse events that were judged to be at least in part related to Fasturtec include: allergic reactions, including anaphylaxis (with signs and symptoms which include chest pain, dyspnea, hypotension and/or urticaria), rash, rhinitis, bronchospasm, diarrhea, fever, headache, nausea, and vomiting.
The incidence of these events is presented in the table below. 3% The following additional adverse events occurred in >5% of patients (not considered related to Fasturtec treatment): abdominal pain, anemia, back pain, constipation, coughing, dyspnea, epistaxis, granulocytopenia, hyperglycemia, hypertension, hypocalcemia, hypotension, injection site pain, injection site reaction, mucositis, pain, pharyngitis, sepsis, skeletal pain, thrombocytopenia.
5 Post-Market Adverse Reactions Hematologic: Uncommon cases of hemolysis which could be related to G6PD deficiency and methemoglobinemia have been reported.
Immune system disorders:
, 10 CLINICAL PHARMACOLOGY]. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Hypersensitivity Reactions: Fasturtec can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Fasturtec if a serious hypersensitivity reaction occurs (see 7 WARNINGS AND PRECAUTIONS, General) • Hemolysis: Do not administer Fasturtec to patients with glucose-6phosphate dehydrogenase (G6PD) deficiency.
Immediately and permanently discontinue Fasturtec if hemolysis occurs. , patients of African or Mediterranean ancestry) prior to starting Fasturtec therapy (see 7 WARNINGS AND PRECAUTIONS, Hematologic). • Methemoglobinemia: Fasturtec can result in methemoglobinemia in some patients.
Immediately and permanently discontinue Fasturtec if methemoglobinemia occurs (see 7 WARNINGS AND PRECAUTIONS, Hematologic). • Interference with uric acid measurements: Fasturtec enzymatically degrades uric acid in blood samples left at room temperature.
Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. 7 Drug-Laboratory Test Interactions). 20 mg/kg daily for up to 7 days. Administration of Fasturtec does not require a change in chemotherapy timing or schedule and chemotherapy may be initiated as soon as four hours after the first dose.
Age and gender do not significantly affect the pharmacokinetics of Fasturtec in patients as indicated by population pharmacokinetic analysis. • Fasturtec must first be reconstituted in the solvent provided. The reconstituted solution must then be diluted in sterile normal saline solution for injection and administered intravenously over 30 minutes.
5 mg of Fasturtec and mix by swirling very gently. Do not vortex. The required quantity of solution (according to the patient’s weight and the dose per kilogram) is to be further diluted with 50 mL sterile normal saline solution. This final solution is to be infused over 30 minutes.
Fasturtec (rasburicase for injection) should not be administered to patients with a known history of: • anaphylactic reactions or hypersensitivity reactions to Fasturtec or any of the excipients. Studies have not been conducted in patients with severe allergies or asthma.
• glucose-6-phosphate dehydrogenase deficiency (G6PD) or other cellular metabolic disorders known to cause hemolytic anemia [See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Allergic reactions, mainly including rash and urticarial have been reported. Cases of rhinitis, bronchospasm, and hypotension have been reported. Cases of anaphylaxis and/or anaphylactic shock with potential fatal outcome have been reported.
FASTURTEC (Rasburicase for Injection) Page 10 of 24 Nervous system disorders:
Cases of convulsions and involuntary muscle contraction have been reported.
No filters should be used for the infusion. The reconstituted or diluted solution should be used immediately (within 3 hours), as Fasturtec does not contain any bacteriostatic agents. Although not recommended, they may be stored for up to 24 hours at 2-8°C.
4 Administration Caution: Fasturtec (rasburicase for injection) should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. DO NOT ADMINISTER AS A BOLUS INFUSION.
Fasturtec should be infused through a separate infusion line. If use of a separate line is not possible, the line should be flushed with at least 15 mL of saline solution prior to and after infusion with Fasturtec. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
40 mg/kg/day. According to the mechanism of action of Fasturtec, an overdose will lead to low or undetectable plasma uric acid concentrations and increased production of hydrogen peroxide. Patients suspected of receiving an overdose should be monitored for hemolysis and general supportive measures should be initiated as no specific antidote FASTURTEC (Rasburicase for Injection) Page 6 of 24 for Fasturtec has been identified For management of a suspected drug overdose, contact your regional poison control centre.
3 mg of disodium phosphate dodecahydrate. 0 mg poloxamer 188 (anti-aggregation agent). Description The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous infusion following reconstitution. 5 mg rasburicase as a sterile lyophilized powder and 3 ampoules of 1 mL sterile solvent.
The powder is supplied in a 3 mL colourless glass vial with a rubber stopper and the solvent in a 2 mL clear glass ampoule. 5 mg rasburicase as a sterile lyophilized powder and 3 ampoules of 1 mL sterile solvent. The powder is supplied in a 2 mL colourless glass vial with a rubber stopper and the solvent in a 2 mL clear glass ampoule.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. 5 mg/vial Powder: Disodium phosphate dodecahydrate, L- alanine, mannitol Sterile solution: poloxamer 188, sterile water for injection, USP FASTURTEC (Rasburicase for Injection) Page 7 of 24 The safety and efficacy of Fasturtec has been established for a treatment duration of up to seven days.
Because the safety and efficacy of other schedules have not been established, dosing beyond seven days or administration of more than one course of Fasturtec is not currently recommended pending further clinical studies. Therefore, repeated treatment with interruptions is not recommended.
Carcinogenesis and […]