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TREOSULFAN FOR is a brand name for Treosulfan, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TREOSULFAN FOR INJECTION (treosulfan for injection) is indicated in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) • in adult patients with AML or MDS at increased risk for standard conditioning therapies, • in pediatric patients…
Verbatim from this product's HC label. Tap a section to expand.
Note:
TREOSULFAN FOR INJECTION manufactured by Marcan Pharmaceuticals Inc. is only available in the 5 g/vial strength. 1 Dosing Considerations Administration of TREOSULFAN FOR INJECTION should be supervised by a physician experienced in conditioning treatment followed by alloHSCT.
2 Recommended Dose and Dosage Adjustment TREOSULFAN FOR INJECTION is given in combination with fludarabine. The recommended dose and schedule of administration is: • Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -4, -3, -2) before stem cell infusion (day 0).
5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²; • Treosulfan should be administered before fludarabine on days -4, -3, -2 (FT10 regimen).
Health Canada has not authorized the use of TREOSULFAN FOR INJECTION in children less than 1 year of age. No dose adjustment is necessary for mild or moderate liver or renal impairment, but treosulfan is contraindicated in patients with severe impairment (see section CONTRAINDICATION).
3 Administration TREOSULFAN FOR INJECTION is for intravenous use as a two-hour infusion. Intravenous administration should be performed using a safe technique to avoid extravasation. When handling treosulfan, inhalation, skin contact or contact with mucous membranes should be avoided.
Pregnant personnel should be excluded from handling cytotoxics. Consider providing prophylactic anti-emetic therapy during TREOSULFAN FOR INJECTION treatment. 9% Sodium Chloride Injection or 5% Glucose Injection or Water for Injection.
Serious Warnings and Precautions: • Myelosuppression • Causes severe and prolonged myelosuppression. • Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression Treosulfan for Injection Page 6 of 27 TREOSULFAN FOR INJECTION is dissolved in its original glass container by shaking with solvent.
Reconstituted solutions of TREOSULFAN FOR INJECTION may be combined into a larger glass vial, EVA bag or PE bag. In case solubility issues are observed when shaking, prolonged standing time or slight warming of the reconstituted solution (hand warm) are useful to improve solubility.
1 Adverse Reaction Overview Profound myelosuppression/pancytopenia is the desired therapeutic effect of conditioning therapy and occurs in all patients. Blood cell counts usually recover after HSCT. 9%. 4%. 2 Clinical Trial Adverse Reactions (Adults) Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials 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 is useful for identifying drug-related adverse events and for approximating rates. 14/L Trial II) in a total of 551 adult patients where a conditioning regimen of treosulfan plus fludarabine was compared to a reduced intensity conditioning regimen consisting of busulfan plus fludarabine (NCT00822393).
Median age of patients in the whole group was 60 years (range 31 -70); 61% of patients were male; the underlying diseases were acute myeloid leukemia (64%) and myelodysplastic syndromes (36%). 2 mg/kg on 2 consecutive days. Fludarabine was added in both groups at a dose of 30 mg/m² on 5 consecutive days.
3 Less Common Clinical Trial Adverse Reactions (Adults) Additional Adverse Reactions observed with treosulfan-based conditioning followed by alloHSCT in 5 clinical trials in adult patients by System Organ Class and Preferred Term. g.
atrial fibrillation, sinus arrhythmia), cardiac arrest, cardiac failure, myocardial infarction, pericardial effusion Eye disorders: Dry eye Gastrointestinal disorders: Oral pain, gastritis, dyspepsia, dysphagia, gastrointestinal hemorrhage, mouth hemorrhage, abdominal distension, esophageal or gastrointestinal pain, dry mouth, neutropenic colitis, esophagitis, anal inflammation, mouth ulceration Treosulfan for Injection Page 13 of 27 General disorders and administration site conditions: Edema, non-cardiac chest pain, injection site reaction, feeling cold Hepatobiliary disorders: Veno-occlusive liver disease, hepatotoxicity, hepatic failure, hepatomegaly, hepatic pain Immune system disorders: Hypersensitivity Infections and infestations: Sepsis, septic shock Investigations: Alkaline phosphatase increased, C reactive protein increased, weight decreased, blood creatinine increased, blood lactate dehydrogenase increased Metabolism and nutrition disorders: Hyperglycemia, acidosis, impaired glucose tolerance, electrolyte imbalance Musculoskeletal and connective tissue disorders: Myalgia, muscular weakness Neoplasms benign, malignant and unspecified (including cysts and polyps) : Treatment related second malignancy Nervous system disorders: Peripheral sensory neuropathy, intracranial hemorrhage, encephalopathy, […]
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information [Section 3]. The following warnings pertain to different physiologic effects of TREOSULFAN FOR INJECTION in the setting of alloHSCT. General Treosulfan is considered an irritant. Intravenous application should be performed using a safe technique.
If extravasation is suspected, general safety measures should be implemented. No specific measure has been proven to be recommendable. 6% of patients in the treosulfan treatment group. 8% of patients, respectively). 8% of patients in the treosulfan treatment group.
5% of patients in the treosulfan treatment group. Carcinogenesis and Mutagenesis Secondary malignancies are well-established complications in long-term survivors after alloHSCT. The possible risk of a second malignancy should be explained to the patient.
On the basis of human data, treosulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen Group 1. Treosulfan for Injection Page 8 of 27 Cardiovascular Patients with severe cardiac impairment diagnosed by ECG and left ventricular ejection fraction (LVEF) < 40% or with severe pulmonary impairment were excluded from the pivotal clinical study and therefore the safety and efficacy of treosulfan for injection in these patients have not been established.
g. 0% of the adult patients treated with treosulfan-based conditioning regimen, respectively. 14/L Trial II), although none was considered related to treosulfan. No thorough clinical QT/QTc study was performed to rule out the effect of treosulfan for injection on in vivo QT prolongation.
In vitro studies on electrophysiological activity of treosulfan on key cardiac ion channels and tests of proarrhythmic potential in human induced pluripotent stem cell (iPS) derived cardiomyocytes, using a microelectrode array (MEA) assay, did not reveal dose - limiting functional or structural changes.
Treosulfan 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 Dosage Forms, Strengths, Composition and Packaging.
• Active non-controlled infectious disease • Severe concomitant cardiac, lung, liver, and renal impairment • Fanconi anemia and other DNA breakage repair disorders • Pregnancy • Administration of live vaccine Treosulfan for Injection Page 5 of 27
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8 mL 50 mg/mL The reconstituted solution of TREOSULFAN FOR INJECTION is stable for 24 hours if stored at 15°C to 30°C. Do not store under refrigeration (2°C - 8°C) as this might result in the formation of precipitate. Do not use if the solution contains a precipitate [see STORAGE, STABILITY AND DISPOSAL(11)] In the absence of compatibility studies, treosulfan must not be mixed with other medicinal products.
5 Missed Dose A missed dose would increase the risk for a primary graft failure.
Driving and Operating Machinery Treosulfan has moderate influence on the ability to drive and use machines. It is likely that certain adverse reactions of treosulfan like nausea, vomiting or dizziness could affect these functions. Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Gastrointestinal Oral mucositis (including high-grade severity) is a very common undesirable effect of treosulfan - based conditioning followed by alloHSCT (8). g. topical antimicrobials, barrier protectants, ice and adequate oral hygiene) is recommended.
Graft vs Host Diseases Graft vs. Host Disease (GvHD) is commonly observed in patients treated with an allogeneic HSCT. Respective results obtained with 10 g/m²/d x 3 regimen are shown in the following table. 0750 Hepatic Transaminases, bilirubin, gamma-glutamyl transferase and alkaline phosphatase are commonly Treosulfan for Injection Page 9 of 27 increased in patients treated with treosulfan-based conditioning.
Hematologic Profound myelosuppression with pancytopenia is the desired therapeutic effect of treosulfan - based conditioning treatment, occurring in all patients. It is therefore recommended to monitor blood cell counts frequently until recovery of the hematopoietic system.
17/M) the risk of infection is increased. Prophylactic or empiric anti-infective treatment (bacterial, viral, fungal) should therefore be considered. Growth factors (G-CSF, GM-CSF), platelet and/or red blood cell support should be given as indicated.
4) Patients receiving TREOSULFAN FOR INJECTION should be monitored daily with a complete blood count, including differential count and quantitative platelet count, until engraftment has been demonstrated. To detect hepatotoxicity, serum transaminases, alkaline phosphatase, and bilirubin should be evaluated daily through transplant day 28.
Cardiac function should be monitored regularly in patients receiving TREOSULFAN FOR INJECTION. 0% of the adult patients treated with treosulfan-based conditioning regimen, respectively. 14/L Trial II). In only one patient, who experienced encephalitis infection and […]