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(DOX-oh-ROO-bih-sin)
Doxil
Solution for injection
equivalent to 2 mg/mL doxorubicin HCl in 10 mL single-use vials.
Class: Antineoplastic
Anthracycline antibiotic encapsulated in Stealth liposomes

 Actions Liposomal doxorubicin displayed linear pharmacokinetics. Disposition occurred in 2 phases after liposomal doxorubicn administration, with a relatively short first phase (» 5 hr) and a prolonged second phase (» 55 hr) that accounted for the majority of the AUC.

 Indications AIDS-related Kaposi’s sarcoma; refractory metastatic ovarian carcinoma.

 Contraindications None well documented.

 Route/Dosage

Kaposi’s Sarcoma

ADULTS: IV Note: The dose of liposomal doxorubicin is different from the dose of conventional doxorubicin.

20 mg/m2/dose over 30 min q 3 wk, for as long as the patient responds satisfactorily and tolerates treatment. Do not adminster as a bolus injection or an undiluted solution. Rapid infusion may increase the risk of infusion-related reactions.

Paclitaxel- and Platinum-Refractory Metastatic Ovarian Cancer

ADULTS: IV 50 mg/m2/dose over 1 hr q 4 wk. Give min 4 courses, continuing therapy until disease progression occurs.

Alternative dose schedules

ADULTS: IV Alternative dosing schedules are recommended for patients with palmar-plantar erythrodysesthesia, hematological toxicity, or stomatitis.

Dosage Adjustment for Impaired Hepatic Function

If serum bilirubin is 1.2 to 3 mg/dL, give 50% of adjusted dose from prior course. If serum bilirubin is > 3 mg/dL, give 25% of adjusted dose from prior course.

Lifetime Cumulative Doses Above Which Frequency of Cardiotoxicity Increases

ADULTS: IV £ 500 mg/m2.

Adults who have received mediastinal radiation or other cardiotoxic drugs: IV £ 400 mg/m2.

Adults > 70 yr with or without mediastinal radiation: IV £ 300 mg/m2.

Interactions

Digoxin

Doxorubicin may decrease oral absorption of digoxin tablets.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Cardiomyopathy; chest pain; hypotension; tachycardia. CNS: Asthenia; headache; dizziness; somnolence; emotional lability. DERMATOLOGIC: Palmar-plantar skin eruptions; alopecia; rash; itching; radiation recall reactions. ENDOCRINE: Hyperglycemia; albuminuria. GI: Nausea; vomiting; elevated LFTs; diarrhea; stomatitis; glossitis; oral moniliasis; constipation; anorexia; abdominal pain. HEMATOLOGIC: Bone marrow suppression. MUSCULOSKELETAL: Back pain. RESPIRATORY: Dyspnea. OTHER: Flushing; shortness of breath; facial swelling; headache; chills; back pain; chest or throat tightness; hypotension.

 Precautions

Pregnancy: Category D. Lactation: Discontinue nursing prior to taking this drug. Children: Safety and efficacy not established. Acute infusion-associated reactions: Flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and hypotention have occurred. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction resolves by slowing the infusion rate. Doxorubicin liposomal dose: The dose of liposomal doxorubicin is different from the dose of conventional doxorubicin. Extravasation risk: Local irritation of phelebitis may occur. Refer to your institution specific protocol. Hepatic and renal function: Assess hepatic and renal function before initiating therapy. Impaired hepatic function: Reduce dosage in patients with impaired hepatic function. Mucositis: May occur 5 to 10 days after administration. Myelosuppression: Severe myelosuppression may occur. It appears to be dose-limiting. Leukopenia, anemia, and thrombocytopenia can also be expected. Myocardial toxicity: Serious irreversible myocardial toxicity with delayed CHF often unresponsive to supportive therapy may occur as total dosage of liposomal doxorubicin approaches 550 mg/m2. Prior use of other anthracyclines or anthracenediones will reduce the total dose of doxorubicin HCl that can be given without cardiac toxicity. Cardiac toxicity also may occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphmide therapy. Palmar-plantar erythrodysesthesia: Generally seen after ³ 6 wk of treatment. Radiation therapy: Recall of skin reaction. Substitution of liposomal doxorubicin: Accidental substitution of liposomal doxorubicin for conventional doxorubicin has resulted in severe side effects. Do not substitute on a mg per mg basis.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Refrigerate unopened vials. Prolonged freezing (> 1 mo) can adversely affect the drug.
  • Dilute the desired dose of liposomal doxorubicin (max 90 mg) in 250 mL of 5% Dextrose before administration. Do not use with in-line filters.
  • Refrigerate diluted solutions at 2° to 8°C (36° to 46°F), and administer within 24 hr. Avoid freezing. Short-term freezing (< 1 mo) does not appear to have a deleterious effect on liposomal doxorubicin.
  • Diluted solutions are preservative-free. Discard within 24 h of preparation.
  • Administer by IV infusion over 30 to 60 min. Do not administer via small peripheral veins.
  • Do not mix with other drugs. Do not use with any diluent other than 5% Dextrose Injection. Do not use any bacteriostatic agents, such as benzyl alcohol.
  • For ovarian carcinoma, initiate the infusion at a rate of 1 mg/min to reduce the risk of infusion reactions.

 Assessment/Interventions

  • Infusion reactions have occurred with liposomal doxorubicin, usually during the first dose. They do not appear to occur with later infusions if not present initially. Infusion reactions usually subside within several hours to days after stopping the infusion. In some patients, the reaction ceases when the infusion rate is decreased. They presumably represent a reaction to liposomal doxorubicin.
  • Consider measuring left ventricular ejection fraction (LVEF) as the patient approaches the maximum cumulative total doxorubicin dose.
  • Obtain a CBC, including platelet counts, frequently and at a minimum prior to each dose.
  • Monitor white blood cell and platelet counts and Hbg/Hct. Hematologic toxicity may require dose reduction or suspension or delay of liposomal doxorubicin therapy. Persistent severe myelosuppression may result in superinfection or hemorrhage.
  • Prior to dosing, evaluate hepatic function using clinical laboratory tests such as AST, ALT, alkaline phosphatase, and bilirubin.
  • Acute left ventricular failure has occurred, particularly in patients who have received total dosage exceeding the recommended limit of 550 mg/m2. This limit appears to be lower (400 mg/m2) in patients who received radiotherapy to the mediastinal area. Take into account the total dose of drug of any previous or concomitant therapy with other potentially cardiotoxic agents such as cyclophosphamide or daunorubicin. Cardiomyopathy or CHF may occur several weeks after drug discontinuation and is often unresponsive to medical or physical therapy. A baseline cardiac evaluation with an ECG, LVEF), and an echocardiogram (ECHO) or multigated radionuclide (MUGA) scans, is recommended especially in patients with risk factors for increased cardiac toxicity (eg, preexisting heart disease, mediastinal irradiation, concurrent cyclophosphamide therapy). Obtain subsequent evaluation at a cumulative dose of doxorubicin of ³ 400 mg/m2 and periodically therafter during the course of therapy. Pediatric patients are at increased risk for developing delayed cardiotoxicity following doxorubicin administration. Doxorubicin cardiomyopathy is associated with persistent reduction in voltage of the QRS wave, prolongation of the systolic time interval, and reduction of ejection fraction. In adults, a 10% decline in LVEF to below the lower limit of normal, an absolute LVEF of 45%, or a 20% decline in LVEF at any level is indicative of deterioration in cardiac function. In pediatric patients, a drop in fractional shortening (FS) by an absolute value of ³ 10 percentile units or < 29% and a decline in LVEF of 10 percentile units or an LVEF £ 55%. Preliminary evidence suggests cardiotoxicity may be reduced and total dosage safely increased by giving the drug on a weekly schedule or as a prolonged (48 to 96 hr) continuous infusion.
  • Extravasation at injection site with or without a stinging or burning sensation may occur. If any signs of extravasation occur, terminate the infusion immediately and restart in another vein. The application of ice over the site of extravasation for » 30 min may be helpful in alleviating the local reaction. Fo not give IM or SC.
  • Adiminstration of live vaccines to immunosuppressed patients may be hazardous.
OVERDOSAGE: SIGNS & SYMPTOMS
  Acute overdosage enhances the toxic effects of mucositis, leukopenia, and thrombocytopenia.

 Patient/Family Education

  • Doxorubicin may cause red discoloration of the urine for 1 to 2 days after administration.

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