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Idamycin

GUIDELINES FOR DOSING AND ADMINISTRATION

Table of Contents

Dosage Regimen

The following dose schedule is for previously untreated adult patients with AML.[10]

TABLE 33: IDAMYCIN~ DOSING REGIMEN[10]

RECOMMENDED INDUCTION DOSING AND ADMINISTRATION

IDAMYCIN®, 12 mg/m≤/dx3d slow IV (10-15 minutes) when used in combination with Ara-C

Dosage reduction - In patients with hepatic impairment, a dose reduction of 50% should be considered if the bilirubin level exceeds 2.5 mg/dL. IDAMYCIN should not be administered if the bilirubin level exceeds 5 mg/dL. When required, administration of a second induction course should be delayed in patients who experienced severe mucositis, until full recovery, and a dose reduction of 25% is recommended in these patients.

The benefit of consolidation in prolonging the duration of remission and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation. (PIease see full prescribing information for doses used in U.S. clinical trials.)

Preparation And Administration

Caution in handling of the powder and preparation of the solution must be exercised as skin reactions associated with IDAMYCIN may occur. Skin accidentally exposed to IDAMYCIN should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

For information on reconstitution, warnings, and additional dosing and administration, please see full prescribing information.

IDAMYCIN is structurally related to daunomycin and other napthacenequinones. It is physically incompatible with heparin, and prolonged contact with alkaline solutions will result in degradation. Tables 34 and 35 show the compatibilities and incompatibilities of IDAMYCIN with drugs commonly used in the treatment of AML.

TABLE 34: DRUGS FOUND TO BE PHYSICALLY COMPATIBLE WITH IDAMYCIN®*[10]

DRUG

TESTED CONCENTRATION (mg/mL)

AMIKACIN

5

CINETIDINE

6

CYCLOPHOSPHAMIDE

4

CYTARABINE

6

DIPHENHYDRAMINE

50 AND 1

DROPERIDOL

2.5 AND 0.04

ERYTHROMYCIN

2

MAGNESIUM SULFATE

2

MANNITOL

12.5

METOCLOPRAMIDE

5

POTASSIUM CHLORIDE

0.03 mEq

RANITIDINE

1

TPN

C

*It should be noted that although two drugs are reported to be physicaly compatibe, it does not impy that they are chemically campatible C- (ingredients per liter) dextrose 250 g, amino acids 60 g, MVI 1 unit, trace elements 2nd, phytonadione 1 mg, magnesium sulfate 2 g, calcium gluconate 1 g, sodium chloride 100 mEq, potassium chloride 30 mEq.


TABLE 35: DRUGS FOUND TO BE PHYSICALLY INCOMPATIBLE WITH IDAMYCIN[10]


CONCENTRATION TESTED(mg/mL)

OBSERVED INCOMPATIBILITY

ACYCLOVIR

5

precipitate @ 12 minutes

AMPICILLIN/SULBACTAM

30

precipitate @ 20 minutes

CEFAZOLIN

20

precipitate @ 60 minutes

CEFTAZIDIME

20

precipitate @ 24 hours

CLINDAMYCIN

12

immecliate precipitate

DEXAMETHASONE

0.2

precipitate @ 12 hours

DEXAMETHASONE

10

precipitate @ 20 minutes

ETOPOSIDE

0.4

gas formation

FUROSEMIDE

0.8

precipitate @ 24 hours

FUROSEMIDE

10

immediate precipitate

GENTAMICIN

3

color change

HEPARIN

100 µ/mL

precipitate @ 12 minutes

HEPARIN

1000 µ/mL

precipitate @ 20 minutes

HYDROCORTISONE

2

precipitate @ 20 minutes

HYDROCORTISONE

50

precipitate @ 20 minutes

IMIPENEM/CILASTIN

5

precipitate @ 24 hours

LORAZEPAM

2

color change

MEPERIDINE

1

color change

MEPERIDINE

50

color change

METHOTREXATE

25

color change

MEZLOCILLIN

60

immecliate precipitate

SODIUM BICARBONATE

0.09 mEq/mL

precipitate @ 20 minutes

VANCOMYCIN

4

color change

VINCRISTINE

1

color change



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