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Doxorubicin

Doxorubicin hydrochloride for injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for.

Prescription medicine Intravenous Safety alerts on record

How to use Doxorubicin

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Serious warning: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1% to 20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. …
Who it is for

Doxorubicin hydrochloride for injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ). …

How to take it and how often
  • Single agent : 60 to 75 mg/m 2 given intravenously every 21 days
  • In combination: 40 to 75 mg/m 2 given intravenously every 21 to 28 days
  • Discontinue doxorubicin hydrochloride for injection in patients who develop signs or symptoms of cardiomyopathy
  • Reduce dose in patients with hepatic impairment
  • Recommended Dosage for Adjuvant Breast Cancer The recommended dosage of doxorubicin hydrochloride for injection is 60 mg/m 2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles
  • Recommended Dosage for Other Cancers The recommended dosage of doxorubicin hydrochloride for injection when used as a single agent is 60 mg/m 2 to 75 mg/m 2 intravenously every 21 days
  • The recommended dosage of doxorubicin hydrochloride for injection, when administered in combination with other chemotherapy drugs, is 40 mg/m 2 to 75 mg/m 2 intravenously every 21 to 28 days
  • Consider use of the lower doxorubicin hydrochloride for injection dose in the recommended dosage range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients
  • Cumulative doses above 550 mg/m 2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions ]
  • Dosage Modifications for Adverse Reactions Cardiomyopathy Discontinue doxorubicin hydrochloride for injection in patients who develop signs or symptoms of cardiomyopathy [see Warnings and Precautions ] . …
Strengths it comes in

Doxorubicin Hydrochloride for Injection, USP: Vials contain 20 mg/vial and 50 mg/vial of doxorubicin hydrochloride, USP as a red to orange-red lyophilized cake or powder in single-dose vials for reconstitution. For Injection: 20 mg/vial and 50 mg/vial as a lyophilized powder in single-dose vials for reconstitution ( 3 ).

Children
  • Based on post-marketing reports, pediatric patients treated with doxorubicin hydrochloride are at risk for developing late cardiovascular dysfunction
  • Risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy
  • Long-term periodic cardiovascular monitoring is recommended for all
  • Pediatric patients who have received doxorubicin hydrochloride. …
Older adults

Clinical experience in patients who were 65 years of age and older who received doxorubicin hydrochloride-based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients.

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Cardiomyopathy Advise patients that doxorubicin hydrochloride for injection can cause irreversible myocardial damage and to contact a healthcare provider for symptoms of heart failure during or after treatment [see Warnings and Precautions ]
  • Secondary Malignancy Advise patients of the increased risk of treatment-related leukemia [see Warnings and Precautions ] . …
Talk to a doctor first if

Doxorubicin hydrochloride for injection is contraindicated in patients with: Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] Recent (occurring within the past 4 to 6 weeks) myocardial infarction [see Warnings and Precautions (5.1) ] Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] Severe hypersensi …

Medicines it may not mix with

Avoid concomitant use of doxorubicin hydrochloride with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp ( 7.1 ). Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction ( 5.1 , 7.2 ). 7.1 Effect of Other Drugs on Doxorubicin Hydrochloride for Injection Inhibitors of CYP3A4, CYP2D6, and P-gp Concomitant use of doxorubicin hydrochloride with inhibitors of CYP3A4, CYP2D6, or P-glycoprotein (P-gp), increased concentrations of doxorubicin, which may increase the incidence and severity of adverse reactions of doxorubicin hydrochloride. …

Warnings

Radiation-Induced Toxicity: Can be increased by the administration of doxorubicin hydrochloride for injection. Radiation recall can occur in patients who receive doxorubicin hydrochloride for injection after prior radiation therapy ( 5.7 ). Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms ( 5.8 , 8.1 , 8.3 ). …

Possible side effects

The following clinically significant adverse reactions are described elsewhere in the labeling. Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1) ] Secondary Malignancies [see Warnings and Precautions (5.2) ] Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3) ] Severe Myelosuppression [see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.7) ] The most common (> 10%) adverse reactions are alopecia, nausea and vomiting ( 6.1 ). …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action, doxorubicin hydrochloride for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride for injection during the 1 st trimester. …

If you take too much

Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m 2 ) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis. The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-05-29.

Brands around the world

Products with Doxorubicin as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDE 2 mg/mL · Injectable, Liposomal · NorthStar RxLLC
NDC 72603-200Label
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDE 2 mg/mL · Injection, Powder, Lyophilized, For Solution · Hikma Pharmaceuticals USA Inc.
NDC 0143-9092Label
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDE 2 mg/mL · Injection, Suspension, Liposomal · BluePoint Laboratories
NDC 68001-706Label
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDE 2 mg/mL · Injectable, Liposomal · BluePoint Laboratories
NDC 68001-703Label
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDE 2 mg/mL · Injectable, Liposomal · Zydus Lifesciences Limited
NDC 49315-008Label

Nigeria (NAFDAC)

NAFDACCaelyx Injection B4-8252NAFDACAdriblastina CS 10 mg/5 mL Injection B4-1159NAFDACAdriblastina CS 50 mg/25 mL Injection B4-1160

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDCU.S. FDA Class II
24 Aug 2023 · Baxter Healthcare Corporation · TerminatedCGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323U.S. FDA Class III
17 Nov 2020 · Fresenius Kabi USA, LLC · TerminatedCross Contamination with Other Products: trace amounts of octreotide found during testing
Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE; Doxorubicin 75 MG / 37.5 ML IVP SYRINGE; Doxorubicin 125 MG / 62.5 ML SYRINGE IVP; Doxorubicin 93 MG U.S. FDA Class II
12 Jun 2019 · Infusion Options, Inc. · TerminatedLack of Assurance of Sterility
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 DoxU.S. FDA Class II
12 Jun 2019 · Infusion Options, Inc. · TerminatedLack of Assurance of Sterility

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Doxorubicin

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Doxorubicin

What is Doxorubicin used for?

Doxorubicin hydrochloride for injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wi (From the official U.S. FDA label.)

How do I take Doxorubicin?

Follow your prescription or the leaflet in your pack. The official label says: Single agent : 60 to 75 mg/m 2 given intravenously every 21 days ( 2.1 ). In combination: 40 to 75 mg/m 2 given intravenously every 21 to 28 days ( 2.1 ). Discontinue doxorubicin hydrochloride for injection in patients who develop signs or symptoms of cardiomyopathy ( 2.2 ). Reduce dose in patients with hepatic impairment ( 2.3 ). 2.1 Recommended Dosage for Adjuvant Breast Canc…

Do I need a prescription for Doxorubicin?

Usually yes. Doxorubicin is a prescription medicine in most countries. Rules differ by country.

What brands contain Doxorubicin?

Doxorubicin is sold under names such as Caelyx, Adriamycin, Doxil, Doxorubicin Hydrochloride. Brand names differ between countries.

How can I check that my Doxorubicin is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.