Gleostine
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Questions & Answers
Side Effects & Adverse Reactions
Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS). At the recommended dosage, courses of Gleostine should not be given more frequently than every 6 weeks.
The bone marrow toxicity of Gleostine is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose (see dosage adjustment table under DOSAGE AND ADMINISTRATION).
Pulmonary toxicity from Gleostine appears to be dose related (see ADVERSE REACTIONS).
Long-term use of nitrosoureas has been reported to be possibly associated with the development of secondary malignancies.
Liver and renal function tests should be monitored periodically (see ADVERSE REACTIONS).
Gleostine can cause fetal harm when administered to a pregnant woman. Lomustine is embryotoxic and teratogenic in rats and embryotoxic in rabbits at dose levels equivalent to the human dose. There are no adequate and well controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Gleostine has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors—both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures.
Hodgkin's disease—secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
History
There is currently no drug history available for this drug.
Other Information
GleostineTM (lomustine) (CCNU) is one of the nitrosoureas used in the treatment of certain neoplastic diseases. It is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea. It is a yellow powder with the empirical formula of C9H16ClN3O2 and a molecular weight of 233.71. Gleostine is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Gleostine is relatively insoluble in water (<0.05 mg per mL).
It is relatively un-ionized at a physiological pH.
Inactive ingredients in Gleostine Capsules are magnesium stearate and mannitol.
The structural formula is:
Gleostine is available in 10 mg, 40 mg, and 100 mg capsules for oral administration.
Sources
Gleostine Manufacturers
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Nextsource Biotechnology, Llc
![Gleostine (Lomustine) Capsule, Gelatin Coated [Nextsource Biotechnology, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gleostine | Nextsource Biotechnology, Llc
The recommended dose of Gleostine in adult and pediatric patients as a single agent in previously untreated patients is 130 mg/m2 as a single oral dose every 6 weeks (see PRECAUTIONS: Information for Patients and HOW SUPPLIED: Directions to the Pharmacist). In individuals with compromised bone marrow function, the dose should be reduced to 100 mg/m2 every 6 weeks. When Gleostine is used in combination with other myelosuppressive drugs, the doses should be adjusted accordingly. All doses of Gleostine must be rounded to the nearest 10 mg by the prescriber (see HOW SUPPLIED).
Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment:
Nadir After Prior Dose Percentage of Prior Dose
to be Given Leukocytes (/mm3) Platelets (/mm3) ≥4000 ≥100,000 100% 3000–3999 75,000–99,999 100% 2000–2999 25,000–74,999 70% <2000 <25,000 50%A repeat course of Gleostine should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm3; leukocytes above 4000/mm3), and this is usually in 6 weeks. Adequate number of neutrophils should be present on a peripheral blood smear. Blood counts should be monitored weekly and repeat courses should not be given before 6 weeks because the hematologic toxicity is delayed and cumulative.
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