MYLERAN Film-coated tablet (2020)
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Aspen Global Inc.
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BOXED WARNING SECTION
<b>MYLERAN is a potent drug. It should not be used unless a diagnosis of chronic myelogenous leukemia has been adequately established and the responsible physician is knowledgeable in assessing response ...
1. Description
MYLERAN (busulfan) is a bifunctional alkylating agent. Busulfan is known chemically as 1,4-butanediol dimethanesulfonate and has the following structural formula: CH<sub>3</sub>SO<sub>2</sub>O(CH<sub> ...
2. Clinical Pharmacology
Busulfan is a small, highly lipophilic molecule that easily crosses the blood brain barrier. Following absorption, 32% and 47% of busulfan are bound to plasma proteins and red blood cells, respectively. ...
3. Indications and Usage
MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
4. Contraindications
MYLERAN is contraindicated in patients in whom a definitive diagnosis of chronic myelogenous leukemia has not been firmly established. MYLERAN is contraindicated in patients who have previously suffered ...
5. Warnings
The most frequent, serious side effect of treatment with busulfan is the induction of bone marrow failure (which may or may not be anatomically hypoplastic) resulting in severe pancytopenia. The pancytopenia ...
6.1. General
The most consistent, dose-related toxicity is bone marrow suppression. This may be manifest by anemia, leukopenia, thrombocytopenia, or any combination of these. It is imperative that patients be instructed ...
6.2. Information for Patients
Patients beginning therapy with busulfan should be informed of the importance of having periodic blood counts and to immediately report any unusual fever or bleeding. Aside from the major toxicity of myelosuppression, ...
6.3. Laboratory Tests
It is recommended that evaluation of the hemoglobin or hematocrit, total white blood cell count and differential count, and quantitative platelet count be obtained weekly while the patient is on busulfan ...
6.4. Drug Interactions
Busulfan may cause additive myelosuppression when used with other myelosuppressive drugs. In one study, 12 of approximately 330 patients receiving continuous busulfan and thioguanine therapy for treatment ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
See WARNINGS section. The World Health Organization has concluded that there is a causal relationship between busulfan exposure and the development of secondary malignancies.
6.7. Pregnancy
Teratogenic Effects Pregnancy Category D. See WARNINGS section. Nonteratogenic Effects There have been reports in the literature of small infants being born after the mothers received busulfan during pregnancy, ...
6.9. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for busulfan in animal and human studies, a decision should be made whether to discontinue ...
6.10. Pediatric Use
See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.
6.11. Geriatric Use
Clinical studies of busulfan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...
7. Adverse Reactions
Hematological Effects The most frequent, serious, toxic effect of busulfan is dose-related myelosuppression resulting in leukopenia, thrombocytopenia, and anemia. Myelosuppression is most frequently the ...
9. Overdosage
There is no known antidote to busulfan. The principal toxic effects are bone marrow depression and pancytopenia. The hematologic status should be closely monitored and vigorous supportive measures instituted ...
10. Dosage and Administration
Busulfan is administered orally. The usual adult dose range for <em>remission induction</em> is 4 to 8 mg, total dose, daily. Dosing on a weight basis is the same for both pediatric patients and adults, ...
11. How Supplied
MYLERAN is supplied as white, film-coated, round, biconvex tablets containing 2 mg busulfan in amber glass bottles with child-resistant closures. One side is imprinted with GX EF3 and the other side is ...
12. Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
14. References
1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA. Oncology Nursing Society; 1999:32-41. 2. Recommendations for the safe handling of parenteral ...