CAELYX CONCENTRATE FOR INFUSION 2 MG/ML

GLAXOSMITHKLINE MANUFACTURING S.P.A. (PARMA, ITALY) - ITALYSIMTRA DEUTSCHLAND GMBH (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Nov 16, 1998
Approval ID: 47bdc172eb90aaef
Company: GLAXOSMITHKLINE MANUFACTURING S.P.A. (PARMA, ITALY) - ITALYSIMTRA DEUTSCHLAND GMBH (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 47bdc172eb90aaef
Drug Name: CAELYX CONCENTRATE FOR INFUSION 2 MG/ML
Product Name: CAELYX CONCENTRATE FOR INFUSION 2 MG/ML
Approval Number: SIN10426P
Approval Date: 1998-11-16
Registrant: BAXTER HEALTHCARE (ASIA) PTE LTD
Licence Holder: BAXTER HEALTHCARE (ASIA) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: DOSAGE AND ADMINISTRATION: CAELYX* exhibits unique pharmacokinetic properties and must not be used interchangeably with other formulations of doxorubicin hydrochloride. CAELYX* should only be administered under the supervision of a qualified oncologist specialized in the administration of cytotoxic agents. Breast/Ovarian Cancer: CAELYX* is administered intravenously at a dose of 50 mg/m2 once every four weeks for as long as the disease does not progress and the patient continues to tolerate treatment. For doses <90 mg: dilute CAELYX* in 250 ml Dextrose 5 % in Water. For doses ≥90 mg: dilute CAELYX* in 500 ml Dextrose 5 % in Water. To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute. If no infusion reaction is observed, subsequent CAELYX* infusions may be administered over a 60 minute period. In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an infusion reaction as follows: 5 % of the total dose was infused slowly over the first 15 minutes. If tolerated without reaction, the infusion rate was doubled for the next 15 minutes. If tolerated, the infusion was completed over the next hour for a total infusion time of 90 minutes. Subsequent CAELYX* infusions may be administered over a 60 minute period. AIDS-KS patients: CAELYX* should be administered intravenously at 20mg/m2 every two-to-three weeks. Intervals shorter than 10 days should be avoided as drug accumulation and increased toxicity cannot be ruled out. Patients should be treated for two-to-three months to achieve a therapeutic response. Treatment should be continued as needed to maintain a therapeutic response. CAELYX*, diluted in 250 ml Dextrose 5% in Water, is administered by intravenous infusion over 30 minutes. All patients: If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate. DO NOT administer as a bolus injection or undiluted solution. It is recommended that the CAELYX* infusion line be connected through the side port of an intravenous infusion of Dextrose 5% in Water to achieve further dilution and minimize the risk of thrombosis and extravasation. The infusion may be given through a peripheral vein. CAELYX* must not be given by the intramuscular or subcutaneous route. Do not use with in-line filters. To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or hematologic toxicity, the dose may be reduced or delayed. Guidelines for CAELYX* dose modification secondary to these adverse effects are provided in the tables below. The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC). The tables for PPE (Table 2) and stomatitis (Table 3) provide the schedule followed for dose modification in clinical trials in the treatment of breast or ovarian cancer (modification of the recommended 4 week treatment cycle): If these toxicities occur in patients with AIDS-related KS, the recommended 2 to 3 week treatment cycle can be modified in a similar manner. The table for hematologic toxicity (Table 4) provides the schedule followed for dose modification in clinical trials in the treatment of patients with breast or ovarian cancer only. Dose modification in patients with AIDS-KS is addressed in ADVERSE EFFECTS. Guidelines For CAELYX* Dose Modification <img src="/TGIF/Caelyx-Table2_160724.png" alt="Caelyx Dosage Table 2" /> <img src="/TGIF/Caelyx-Table3_160724.png" alt="Caelyx Dosage Table 3" /> <img src="/TGIF/Caelyx-Table4_160724.png" alt="Caelyx Dosage Table 4" /> Patients with impaired hepatic function: CAELYX* pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the CAELYX* dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2 – 3.0 mg/dl, the first dose is reduced by 25 %. If the bilirubin is > 3.0 mg/dl, the first dose is reduced by 50 %. If the patient tolerates the first dose without an increase in serum bilirubin or liver enzymes, the dose for cycle 2 can be increased to the next dose level, i.e., if reduced by 25% for the first dose, increase to full dose for cycle 2; if reduced by 50% for the first dose, increase to 75% of full dose for cycle 2. The dosage can be increased to full dose for subsequent cycles if tolerated. CAELYX* can be administered to patients with liver metastases with concurrent elevation of bilirubin and liver enzymes up to 4 x the upper limit of the normal range. Prior to CAELYX* administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin. Patients with impaired renal function: As doxorubicin is metabolised by the liver and excreted in the bile, dose modification should not be required with CAELYX*. Population-based analysis confirms that changes in renal function over the range tested (estimated creatinine clearance 30–156 ml/min) do not alter the pharmacokinetics of CAELYX*. No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min. AIDS-KS patients with splenectomy: As there is no experience with CAELYX* in patients with splenectomy, treatment with CAELYX* is not recommended. Pediatric patients: Limited Phase I safety data indicate that doses up to 60 mg/m2 every 4 weeks are well tolerated in pediatric patients; however, effectiveness in patients less than 18 years of age has not been established. Elderly patients: Population-based analysis demonstrates that age across the range tested (21–75 years) does not significantly alter the pharmacokinetics of CAELYX*. Instructions for use/handling DO NOT USE MATERIAL THAT SHOWS EVIDENCE OF PRECIPITATION OR ANY OTHER PARTICULATE MATTER. Caution should be exercised in handling CAELYX* solution. The use of gloves is required. If CAELYX* comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water. CAELYX* should be handled and disposed of in a manner consistent with that of other anticancer drugs. Determine the dose of CAELYX* to be administered (based upon the recommended dose and the patient’s body surface area). Take the appropriate volume of CAELYX* up into a sterile syringe. Aseptic technique must be strictly observed since no preservative of bacteriostatic agent is present in CAELYX*. The appropriate dose of CAELYX* must be diluted in Dextrose 5% in Water prior to administration. For doses <90 mg, dilute CAELYX* in 250 ml, and for doses ≥90 mg, dilute CAELYX* in 500 ml of Dextrose 5 % in Water. The use of any diluent other than Dextrose 5% in Water for infusion, or the presence of any bacteriostatic agent such as benzyl alcohol may cause precipitation of CAELYX*. It is recommended that the CAELYX* infusion line be connected through the side port of an intravenous infusion of Dextrose 5% in Water. The infusion may be given through a peripheral vein. Do not use with in-line filters.
Route Of Administration: INTRAVENOUS
Indication Info: INDICATIONS AND USAGE: CAELYX*, as monotherapy, is indicated for the treatment of metastatic breast cancer. CAELYX* is indicated for the treatment of advanced ovarian cancer in women who have failed a first-line platinum based chemotherapy regimen. CAELYX* is also indicated for AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. CAELYX* may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracyclines).
Contraindications: CONTRAINDICATIONS: CAELYX* is contraindicated in patients who have hypersensitivity reactions to its components or to doxorubicin HCl. CAELYX* should not be administered during pregnancy or while breast-feeding. CAELYX* should not be used to treat AIDS-KS that may be effectively treated with local therapy or systemic alfa-interferon.
Atc Code: L01DB01
Atc Item Name: doxorubicin
Pharma Manufacturer Name: BAXTER HEALTHCARE (ASIA) PTE LTD

Active Ingredients

Doxorubicin Hydrochloride

2.00 mg/ml

Doxorubicin Hydrochloride

2.00 mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 16, 1998

Approval ID

47bdc172eb90aaef

Type

Therapeutic

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