Ceenu (Lomustine / Lomustine / Lomustine) - Indications and Dosage

INDICATIONS AND USAGE

CeeNU has been shown to be useful asa single agent in addition to other treatment modalities, or in establishedcombination therapy with other approved chemotherapeutic agents in the following:

Braintumors —both primary and metastatic, in patients who have already receivedappropriate surgical and/or radiotherapeutic procedures.

Hodgkin’sDisease —secondary therapy in combination with other approved drugsin patients who relapse while being treated with primary therapy, or who failto respond to primary therapy.

DOSAGE AND ADMINISTRATION

The recommended dose of CeeNU in adultand pediatric patients as a single agent in previously untreated patientsis 130 mg/m² as a single oral dose every 6 weeks.In individuals with compromised bone marrow function, the dose should be reducedto 100 mg/m² every 6 weeks. When CeeNU is usedin combination with other myelosuppressive drugs, the doses should be adjustedaccordingly.

Doses subsequent to the initial dose shouldbe adjusted according to the hematologic response of the patient to the precedingdose. The following schedule is suggested as a guide to dosage adjustment:

NadirAfter Prior Dose		Percentageof Prior Dose to be Given
Leukocytes	Platelets
>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 CeeNU should not be given untilcirculating blood elements have returned to acceptable levels (platelets above100,000/mm³; leukocytes above 4000/mm³),and this is usually in 6 weeks. Adequate number of neutrophils shouldbe present on a peripheral blood smear. Blood counts should be monitored weeklyand repeat courses should not be given before 6 weeks because the hematologictoxicity is delayed and cumulative.

HOW SUPPLIED

CeeNU^® (lomustine) Capsules are available in individual bottles of 20 capsules each.

NDC 0015-3032—20	100 mg capsules (Green/Green)
NDC 0015-3031—20	40 mg capsules (White/Green)
NDC 0015-3030—20	10 mg capsules (White/White)

Stability

CeeNUCapsules are stable for the lot life indicated on package labeling when storedin well-closed containers at 25°C (77°F); excursions permitted to 15°C–30°C(59°F–86°F) [see USP Controlled Room Temperature]. Avoid excessive heat (over40°C, 104°F).

Directions to the Pharmacist

The total dose prescribed by the physiciancan be obtained (to within 10 mg) by determining the appropriate combinationof capsule strengths. Only the appropriate number of CeeNU capsules requiredfor a single administration should be dispensed.

Theappropriate number of capsules of each size should be placed in a single vial.Each color-coded capsule is imprinted with the dose in milligrams. In orderto provide the proper dose of CeeNU, patients should be aware that there maybe 2 or more different types and colors of capsules in the container. Patientsshould be told that CeeNU is taken as a single oral dose and will not be repeatedfor at least 6 weeks.

Caution should be exercised whenhandling CeeNU Capsules. Procedures for proper handling and disposal of anticancerdrugs should be utilized. Several guidelines on this subject have been published.^1-4 Tominimize the risk of dermal exposure, always wear impervious gloves when handlingbottles containing CeeNU Capsules. CeeNU Capsules should not be broken. Personnelshould avoid exposure to broken capsules. If contact occurs, wash immediatelyand thoroughly. More information is available in the references listed below.