Rubex

Name: Rubex

Rubex Overview

Doxorubicin is a prescription medication used to treat certain types of cancer in adults and children including breast cancer, lung cancer, and ovarian cancer.  Doxorubicin belongs to a group of drugs called anthracylines, which slow and stop the growth of cancer cells.

This medication comes in an injectable form and is given by injection into a vein (intravenously) by a healthcare provider.

Common side effects of doxorubicin include hair loss, nausea, and vomiting.

 

Rubex Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • Paclitaxel
  • progesterone (Provera, Depo-Provera)
  • Verapamil
  • cyclosporine (Neoral, Sandimmune)
  • cytarabine (DepoCyt)
  • cyclophosphamide (Cytoxan)
  • phenobarbital
  • phenytoin (Dilantin)
  • streptozocin (Zanosar)
  • saquinavir

This is not a complete list of doxorubicin drug interactions. Ask your doctor or pharmacist for more information.

Rubex Usage

  • Your doctor will prescribe doxorubicin in an amount that is right for you.
  • Doxorubicin will be given to you by intravenous (IV) infusion into your vein.
  • Your doctor will do regular blood tests to check for side effects of doxorubicin.
  • Before receiving doxorubicin you may receive other medicines to prevent or treat side effects.
  • Caregivers of children receiving doxorubicin should take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.

Other Requirements

Keep all appointments with your doctor and the laboratory. Certain laboratory tests may be required to monitor your body's response to doxorubicin.

Precautions

General

Doxorubicin is not an anti-microbial agent.

Information for Patients

Rubex (doxorubicin hydrochloride for injection, USP) imparts a red coloration to the urine for 1 to 2 days after administration, and patients should be advised to expect this during active therapy.

Drug Interactions

Paclitaxel: Two published studies report that initial administration of paclitaxel infused over 24 hours followed by doxorubicin administered over 48 hours resulted in a significant decrease in doxorubicin clearance with more profound neutropenic and stomatitis episodes than the reverse sequence of administration.

Progesterone: In a published study, progesterone was given intravenously to patients with advanced malignancies (ECOG PS <2) at high doses (up to 10 g over 24 hours) concomitantly with a fixed doxorubicin dose (60 mg/m2) via bolus. Enhanced doxorubicin-induced neutropenia and thrombocytopenia were observed.

Verapamil: A study of the effects of verapamil on the acute toxicity of doxorubicin in mice revealed higher initial peak concentrations of doxorubicin in the heart with a higher incidence and severity of degenerative changes in cardiac tissue resulting in a shorter survival.

Cyclosporine: The addition of cyclosporine to doxorubicin may result in increases in AUC for both doxorubicin and doxorubicinol possibly due to a decrease in clearance of parent drug and a decrease in metabolism of doxorubicinol. Literature reports suggest that adding cyclosporine to doxorubicin results in more profound and prolonged hematologic toxicity than doxorubicin alone. Coma and/or seizures have also been described.

Literature reports have also described the following drug interactions: phenobarbital increases the elimination of doxorubicin, phenytoin levels may be decreased by doxorubicin, streptozocin (Zanosar®) may inhibit hepatic metabolism of doxorubicin, and administration of live vaccines to immunosuppressed patients including those undergoing cytotoxic chemotherapy may be hazardous.

Laboratory Tests

Initial treatment with doxorubicin requires observation of the patient and periodic monitoring of complete blood counts, hepatic function tests, and radionuclide left ventricular ejection fraction (see WARNINGS).

Like other cytotoxic drugs, doxorubicin may induce “tumor lysis syndrome” and hyperuricemia in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Formal long-term carcinogenicity studies have not been conducted with doxorubicin. Doxorubicin and related compounds have been shown to have mutagenic and carcinogenic properties when tested in experimental models (including bacterial systems, mammalian cells in culture, and female Sprague-Dawley rats).

The possible adverse effect on fertility in males and females in humans or experimental animals have not been adequately evaluated. Testicular atrophy was observed in rats and dogs.

A variant of chemotherapy-related acute non-lymphocytic leukemia has been reported to occur infrequently a few years after multiple drug treatment of some neoplasms, which sometimes included doxorubicin. The exact role of doxorubicin has not been elucidated.

Pediatric patients treated with doxorubicin or other topoisomerase II inhibitors are at a risk for developing acute myelogenous leukemia and other neoplasms. The extent of increased risk associated with doxorubicin has not been precisely quantified.

Pregnancy Category D

(See WARNINGS.)

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from doxorubicin, mothers should be advised to discontinue nursing during doxorubicin therapy.

Pediatric Use

Pediatric patients are at increased risk for developing delayed cardiotoxicity. Follow-up cardiac evaluations are recommended periodically to monitor for the delayed cardiotoxicity (see WARNINGS).

Doxorubicin, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure. It may also contribute to gonadal impairment, which is usually temporary.

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