AMONAFIDE

NSC - 308847

SMILES: CN(C)CCN1C(=O)c2cccc3cc(N)cc(C1=O)c23

Chemical Name: 5-Amino-2-[2-(dimethylamino)ethyl]-1 H-benz[de]isoquinoline-1,3(2H)-dione

Other Names: Nafidimide, Amonafide HC1 (USAN)
(NSC - 621093)

CAS Registry Number: 69408-81-7

Molecular Formula: C16H17N3O2    M.W.: 283.3

How Supplied: Sterile, 500 mg (as the base), vial: supplied as
a yellow to orange or red -orange lyophilized powder with
sodium hydroxide to adjust pH in 30 mL flint vials.

Solution Preparation: 500 mg/vial: Constitution with 9.6 mL
of Sterile Water for Injection, USP, or 0.9% Sodium Chloride
Injection, USP, results in a solution containing 50 mg /mL of
amonafide with sodium hydroxide to adjust to pH 5 to 7. The
constituted solution may vary in color from yellow to red-orange
or red.

Storage: Store the intact vials under refrigeration (2-8 °C).

Stability: Shelf-life surveillance of the intact vials is ongoing.
Intact vials are stable for at least 3 years at room temperature
(22-25 °C) and under refrigeration (2-8 °C). The intact vials
are stable for at least one year at elevated temperature (50 °C).

Amonafide is stable in aqueous phosphate-buffered solutions
over a pH range of 5.4 to 9.4 exhibiting little or no
decomposition over 8 hours at 90 °C. However, at lower pH
values increased rates of decomposition occur.

When constituted as directed with Sterile Water for Injection,
USP, or 0.9% Chloride Injection, USP, amonafide solutions
exhibit no decomposition over 14 days at room temperature or
under refrigeration.

Further dilution to a concentration of 0.25 mg/mL in 0.9%
Sodium Chloride Injection, USP, in glass or PVC containers
results in a solution which exhibits no decomposition over 14
days of storage at room temperature or under refrigeration.

Note: Amonafide is very unstable in dextrose-containing
solutions. Approximately 25 to 35% decomposition
occurs over 24 hours at room temperature in 5%
Dextrose Injection, USP, 5% Dextrose in 0.9% Sodium
Chloride Injection, USP, and 5% Dextrose in 0.45%
Sodium Chloride Injection, USP. The dextrose content
may be catalyzing the degradation.

  CAUTION: The single-use lyophilized dosage
  form contains no antibacterial preservatives.
  Therefore, it is advised that the constituted
  product be discarded within 8 hours of initial
  entry.

Route of Administration: Intravenous