Dosing & Uses
Dosage Forms & Strengths
powder for injection
Cancer of breast, ovary, prostate, stomach, thyroid; small cell cancer of lung, liver; squamous cell cancer of head and neck; multiple myeloma, Hodgkin's disease, lymphomas, ALL, AML
60 mg/m² IV q14Days OR
40-60 mg/m² IV q21-28Days OR
20 mg/m²/dose qweek
Hepatocellular Carcinoma (Orphan)
Orphan indication sponsor
- Delcath Systems, Inc; Rockefeller Center, 23rd Floor; New York, NY 10020
Dose adjustment not necessary
Serum bilirubin <1.2 mg/dL: Dose adjustment not necessary
Serum bilirubin 1.2-3 mg/dL [20.5-51.3 micromoles/L]: Give 50% dose
Serum bilirubin: 3.1-5 mg/dL [53-85.5 micromoles/L]: Give 25% dose
Severe hepatic impairment: Contraindicated
Limit lifetime cumulative dose to <550 mg/m² to reduce risk of cardiotox
Monitor: CBC, cardiac function, LFTs
Dosage Forms & Strengths
powder for injection
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
Hyperpigmentation of previously radiated areas
Black Box Warnings
The drug should be administered under the supervision of an experienced cancer chemotherapy physician
Cumulative dose-related cardiotoxicity may occur. Potentially fatal CHF may occur months to years after completion of therapy. The risk of developing CHF increases with increasing total cumulative doses of doxorubicin in excess of 450 mg/m².
Delayed cardiotoxicity may occur in patients with prior mediastinal irradiation, in those on concurrent cyclophosphamide therapy, or in those with preexisting heart disease. Toxicity may also occur at a lower cumulative dose in patients
For IV administration only. Severe local tissue damage will occur in extravasation. Do not administer IM or SC
Development of secondary acute myelogenous leukemia and myelodysplastic syndrome reported
Severe myelosuppression may occur
Reduce dose in hepatic dysfunction
Severe hepatic impairment
Baseline neutrophil count <1500/mm³
Recent MI or severe myocardial insufficiency
Prior treatment max dose of doxorubicin, daunorubicin, idarubicin, or other anthracyclines
Cardiomyopathy, CHF, impaired cardiac function
Risk of cardiotoxicity (cardiomyopathy, CHF)- may manifest months or even years after discontinuation
Risk of infusion reactions, myelosuppression
May cause tumor lysis syndrome and hyperuricemia
Secondary oral cancers, primarily squamous cell carcinoma, reported with long-term (ie, >1 yr)
Pediatric patients, elderly, liver impairment, concomitant radiotherapy
Not effective in malignant melanoma, kidney CA, bowel CA, brain tumors, CNS metastasis
Pregnancy & Lactation
Pregnancy Category: D
Lactation: Enters breast milk/not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Anthracycline; intercalates between DNA base pairs, impairs topoisomerase II function and inhibits replication & transcription
Protein Bound: 75%
Vd: 20-30 L/kg (700-1214 L/m²)
Half-Life: 1-3 hr
Clearance: 8-20 mL/min/kg
Excretion: Feces (40-50%); urine (5-12%)
Additive: aminophylline, dacarbazine/ondansetron(?), diazepam, fluorouracil
Syringe: cisplatin/mitomycin(?), fluorouracil (at high concs of both), furosemide, heparin
Y-site: allopurinol, amphotericin B cholesteryl sulfate, cefepime, furosemide(?), ganciclovir, heparin(?), piperacillin/tazobactam, propofol
Reconstitute with NS to a final concentration of 2 mg/mL
Protect from light
Reconstituted soln stable for 7 d at room temp if protected from light & 15 d at 2-8°C
Administered into the tubing of a freely running intravenous infusion of NS or D5W
Administer over 3-5 min with frequent checks of IV patency via visible blood return
Monitor for local erythematous streaking (flare rxn) along vein &/or facial flushing (may indicate too rapid administration)
Terminate injection or infusion immediately & aspirate back as much as possible
Apply cold pack w/ circulating ice water, ice pack or cryogel pack to extravasation site for 15-20 min QID x 24-48 hr
Elevate site for 48 hr, then resume normal activity
Extravasation of <1-2 mL often heal spontaneously. If >3 mL, ulceration may occur.
Protect site from heat & sunlight
Varied results in studies using 99% DMSO to treat extravasation, follow institutional policy
If pain, erythema, &/or swelling persist beyond 48 hr, refer pt immediately to plastic surgeon for consultation & possible debridement
See also Totect
Store intact vials of solution under refrigeration at 2-8°C
Protect from light
Store intact vials of lyophilized powder at room temp(15-30°C)
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.