Liposomal Doxorubicin IV Infusion 50 mg/25 ml

Liposomal Doxorubicin 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).

Liposomal Doxorubicin IV Infusion 50 mg/25 ml
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Liposomal Doxorubicin IV Infusion 50 mg/25 ml
Generic	Doxorubicin Hydrochloride Liposome
Weight	50 mg/25 ml
Type	IV Infusion
Therapeutic Class	Anti neoplastic preparations
Manufacturer	Sun Pharmaceutical (Bangladesh) Ltd.
Available Country	Bangladesh
Last Updated:	October 19, 2023 at 6:27 am

Uses

Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection is indicated for the treatment of:Ovarian Cancer: Liposomal Doxorubicin 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 more

Dosage

Liposomal Doxorubicin 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 Liposomal Doxorubicin 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 Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection in pediatric patients have not been established. Preparation: Dilute Liposomal Doxorubicin 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 Liposomal Doxorubicin 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 changes

Precaution

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 Liposomal Doxorubicin 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 Liposomal Doxorubicin 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 Liposomal Doxorubicin 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, Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection can cause fetal harm when administered to a pregnant woman; avoid the use of Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection during the 1st trimester.Lactation: It is not known whether Liposomal Doxorubicin 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 Liposomal Doxorubicin 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 Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection.Contraception: Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection can cause fetal harm when administered to a pregnant woman. Liposomal Doxorubicin 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, Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection may cause infertility and result in amenorrhea. Liposomal Doxorubicin 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 Liposomal Doxorubicin 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 Liposomal Doxorubicin IV Infusion 50 mg/25 ml injection.