L-DOX IV Infusion 50 mg/25 ml
L-DOX IV Infusion 50 mg/25 ml Uses, Dosage, Side Effects, Food Interaction and all others data.
20 mg Injection: Each 10 ml contains Doxorubicin Hydrochloride USP 20 mg (as pegylated Liposome).50 mg Injection: Each 25 ml contains Doxorubicin Hydrochloride USP 50 mg (as pegylated Liposome).Trade Name | L-DOX IV Infusion 50 mg/25 ml |
Generic | Doxorubicin Hydrochloride Liposome |
Weight | 50 mg/25 ml |
Type | IV Infusion |
Therapeutic Class | Anti neoplastic preparations |
Manufacturer | Beacon Pharmaceuticals PLC |
Available Country | Bangladesh |
Last Updated: | October 19, 2023 at 6:27 am |
Uses
L-DOX IV Infusion 50 mg/25 ml injection is indicated for the treatment of:Ovarian Cancer: L-DOX IV Infusion 50 mg/25 ml injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy ... Read moreDosage
L-DOX IV Infusion 50 mg/25 ml dosage
Ovarian Cancer Patients: The recommended dose is 50 mg/m2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.AIDS-Related Kaposi’s Sarcoma: The recommended dose is 20 mg/m2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.Multiple Myeloma: The recommended dose is 30 mg/m2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer it after Bortezomib on day 4 of each cycle.Dose Modification: Guidelines have been proposed since L-DOX IV Infusion 50 mg/25 ml injectionexhibits nonlinear pharmacokinetics at 50 mg/m2. Dose adjustments may thus result in non-proportional greater change in plasma concentration and exposure to the drug. Patients should be carefully monitored for toxicity. Adverse events such as Palmar Plantar Erythema (PPE), hematologic toxicities, and stomatitis may be managed by dose delays and adjustments. Subsequent to the first appearance of a Grade 2 or higher adverse event, dosing should be adjusted and or delayed as described in the following tables and should not be increased at any given time.Pediatric Use: The safety and effectiveness of L-DOX IV Infusion 50 mg/25 ml injection in pediatric patients have not been established. Preparation: Dilute L-DOX IV Infusion 50 mg/25 ml doses up to 90 mg in 250 mL of 5% Dextrose Injection, USP prior to administration. Dilute doses exceeding 90 mg in 500 mL of 5% Dextrose Injection, USP prior to administration. Refrigerate diluted L-DOX IV Infusion 50 mg/25 ml at 2°C to 8°C and administer within 24 hours.Administration: Administer the first dose at an initial rate of 1 mg/min. If no infusion-related adverse reactions are observed, increase the infusion rate to complete the administration of the drug over one hour. Do not rapidly flush the infusion line. Do not mix it with other drugs.Side Effects
Increased risk of getting an infection Breathlessness and looking pale Tiredness and weakness Feeling or being sick Inflammation of the lining of the mouth, throat, food pipe and stomach Soreness, redness and peeling of your hands and feet Loss of appetite Hair loss Diarrhea or constipation Pain in different parts of the body Skin changesPrecaution
Cardiomyopathy: Doxorubicin Hydrochloride can cause myocardial damage, including acute left ventricular failure.Infusion-Related Reactions: Flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension.Hand-Foot Syndrome (HFS): HFS or other skin toxicity required discontinuation of L-DOX IV Infusion 50 mg/25 ml injection in 4.2% of patients.Secondary Oral Neoplasms: Secondary oral cancers, primarily squamous cell carcinoma, have been reported from post-marketing experience in patients with long-term (more than one year) exposure to L-DOX IV Infusion 50 mg/25 ml injection.Embryo-Fetal Toxicity: Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during and for 6 months after treatment with L-DOX IV Infusion 50 mg/25 ml injection.Interaction
Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride. Pegylated Liposomal Doxorubicin, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies.Pregnancy & Breastfeeding use
Pregnancy: Based on findings in animals and its mechanism of action, L-DOX IV Infusion 50 mg/25 ml injection can cause fetal harm when administered to a pregnant woman; avoid the use of L-DOX IV Infusion 50 mg/25 ml injection during the 1st trimester.Lactation: It is not known whether L-DOX IV Infusion 50 mg/25 ml injection is present in human milk. Because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from L-DOX IV Infusion 50 mg/25 ml injection, discontinue breastfeeding during treatment with it.Females and Males of Reproductive Potential: Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating L-DOX IV Infusion 50 mg/25 ml injection.Contraception: L-DOX IV Infusion 50 mg/25 ml injection can cause fetal harm when administered to a pregnant woman. L-DOX IV Infusion 50 mg/25 ml injection may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities.Infertility: In females of reproductive potential, L-DOX IV Infusion 50 mg/25 ml injection may cause infertility and result in amenorrhea. L-DOX IV Infusion 50 mg/25 ml injection may result in oligospermia, azoospermia, and permanent loss of fertility.Contraindication
It is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis to Doxorubicin Hydrochloride.Storage Condition
Store unopened vials of L-DOX IV Infusion 50 mg/25 ml injection at 2-8°C. Do not Freeze. Prolonged freezing may adversely affect liposomal drug products; however, short-term freezing (less than 1 month) does not appear to have a deleterious effect on L-DOX IV Infusion 50 mg/25 ml injection.Innovators Monograph
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