Caelyx Injection

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 ). …

• 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 ] . …

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 ).

• 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. …

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.

• 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 ] . …

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 …

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. …

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 ). …

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 ). …

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. …

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. …

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.