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Adria

Drug Description
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Adriamycin PFS®

doxorubicin hydrochloride injection, USP

FOR INTRAVENOUS USE ONLY

WARNING

  1. Severe local tissue necrosis will occur if there is extravasation during administration (see DOSAGE AND ADMINISTRATION). Doxorubicin must not be given by the intramuscular or subcutaneous route.
  2. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of doxorubicin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at 450 mg/m2 and 6 to 20% at 500 mg/m2.* The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 450 mg/m2. "Risk factors (active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, concomitant use of other cardiotoxic drugs) may increase the risk of cardiac toxicity. Cardiac toxicity with doxorubicin may occur at lower cumulative doses whether or not cardiac risk factors are present." Pediatric patients are at increased risk for developing delayed cardiotoxicity.
  3. Secondary acute myelogenous leukemia (AML) has been reported in patients treated with anthracyclines, including doxorubicin (see ADVERSE REACTIONS). The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging anti-neoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The rate of developing treatment-related leukemia was estimated in an analysis of 1474 breast cancer patients who received adjuvant treatment with doxorubicin-containing regimens (i.e., FAC) in clinical trials. The estimated risk of developing treatment-related leukemia at 10 years was 2.5% for the 810 patients receiving radiotherapy plus chemotherapy and 0.5% for the 664 patients receiving chemotherapy alone. The overall risk was estimated at 1.5% at 10 years for the entire patient population. Pediatric patients are also at risk of developing secondary AML.
  4. Dosage should be reduced in patients with impaired hepatic function.
  5. Severe myelosuppression may occur.
  6. Doxorubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

*Data on file at Pharmacia & Upjohn

DRUG DESCRIPTION

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius.

Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine.

Chemically, doxorubicin hydrochloride is (8S,10S)-10-[(3-Amino-2, 3,6-trideoxy-a-L-lyxo-hexopyranosyl) -oxy]-8-glycoloyl- 7,8,9, 10-tetrahydro-6,8,11 -trihydroxy-1- methoxy-5, 12-naphthacenedione hydrochloride. The structural formula is as follows:

Adriamycin

Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix. The anthracycline ring is lipophilic, but the saturated end of the ring system contains abundant hydroxyl groups adjacent to the amino sugar, producing a hydrophilic center. The molecule is amphoteric, containing acidic functions in the ring phenolic groups and a basic function in the sugar amino group. It binds to cell membranes as well as plasma proteins.

It is supplied in the hydrochloride form as a sterile red-orange lyophilized powder containing lactose and as a sterile parenteral, isotonic solution with sodium chloride for intravenous use only.

Adriamycin (DOXOrubicin HCI) for Injection, USP:

Each 10 mg lyophilized vial contains 10 mg of Doxorubicin Hydrochloride, USP and 50 mg of Lactose Monohydrate, NF.

Each 20 mg lyophilized vial contains 20 mg of Doxorubicin Hydrochloride, USP and 100 mg of Lactose Monohydrate, NF.

Each 50 mg lyophilized vial contains 50 mg of Doxorubicin Hydrochloride, USP and 250 mg of Lactose Monohydrate, NF.

Adriamycin (DOXOrubicin HCI) Injection, USP:

Each 2 mg/mL, 5 mL (10 mg) vial contains 10 mg Doxorubicin Hydrochloride, USP; Sodium Chloride 0.9% (to adjust tonicity) and Water for Injection q.s.; pH adjusted to 3 using Hydrochloric Acid.

Each 2 mg/mL, 10 mL (20 mg) vial contains 20 mg Doxorubicin Hydrochloride, USP; Sodium Chloride 0.9% (to adjust tonicity) and Water for Injection q.s.; pH adjusted to 3 using Hydrochloric Acid.

Each 2 mg/mL, 25 mL (50 mg) vial contains 50 mg Doxorubicin Hydrochloride, USP; Sodium Chloride 0.9% (to adjust tonicity) and Water for Injection q.s.; pH adjusted to 3 using Hydrochloric Acid.

Each 2 mg/mL, 100 mL (200 mg) multiple dose vial contains 200 mg Doxorubicin Hydrochloride, USP; Sodium Chloride 0.9% (to adjust tonicity) and Water for Injection q.s.; pH adjusted to 3 using Hydrochloric Acid.

Brand Name: Adria
Generic Name: Doxorubicin hydrochloride

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