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Indications & Uses
L-DOX is indicated for:
Pharmacology
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from Streptomyces Peucetius var. Caesius. Doxorubicin Hydrochloride Liposome injection is Doxorubicin Hydrochloride encapsulated in Stealth Liposomes and given intravenously. More than 90 % of the drug is encapsulated in the Stealth Liposomes. The active ingredient of the injection is Doxorubicin Hydrochloride.
The mechanism of action of Doxorubicin Hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have shown rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations.
Doxorubicin Hydrochloride Liposome injection shows linear pharmacokinetics over the range of 10 to 20 mg/m2. After administration, disposition occurs in two phases. The first phase is relatively short (5 hours), and the second is prolonged (55 hours) and accounts for the majority of the area under the curve (AUC).
Distribution: Direct measurement shows that at least 90% of the drug remains Liposome-encapsulated while it circulates (the assay used cannot quantify less than 5 to 10% free doxorubicin).
Metabolism: Doxorubicinol, the major metabolite of Doxorubicin, was detected at concentrations of 0.8 to 26.2 ng/mL in the plasma of patients who received 10 or 20 mg/m2 Doxorubicin Hydrochloride Liposome injection.
Excretion: The plasma clearance of total Doxorubicin Hydrochloride Liposome injection was 0.041 L/h/m2 at a dose of 20 mg/m2. After administration of Doxorubicin Hydrochloride, the plasma clearance of doxorubicin is 24 to 35 L/h/m2.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For ovarian cancer, the recommended dose of Doxorubicin Hydrochloride Liposome is 50 mg/m2, given intravenously over 60 minutes every 28 days. It continues until the disease progresses or the toxicity becomes unacceptable.
In AIDS-related Kaposi's sarcoma, the recommended dose is 20 mg/m2, given intravenously over 60 minutes every 21 days. Again, this goes on until disease progression or unacceptable toxicity.
For multiple myeloma, the recommended dose is 30 mg/m2, given intravenously over 60 minutes on day 4 of each 21-day cycle. This is for eight cycles, or until disease progression or unacceptable toxicity. Give it after Bortezomib on day 4 of each cycle.
Guidelines on dose modification have been proposed because Doxorubicin Hydrochloride Liposome injection shows nonlinear pharmacokinetics at 50 mg/m2. A dose adjustment can therefore cause a greater change, out of proportion to the adjustment, in plasma concentration and exposure to the drug. Patients should be monitored carefully for toxicity. Adverse events such as Palmar Plantar Erythema (PPE), hematologic toxicities and stomatitis may be managed by delaying the dose or adjusting it. After the first appearance of a Grade 2 or higher adverse event, the dose should be adjusted and/or delayed as described in the following tables, and it should not be increased at any time.
The safety and effectiveness of Doxorubicin Hydrochloride Liposome injection in pediatric patients have not been established.
Side Effects
Side effects of Doxorubicin Hydrochloride Liposome include an 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, and skin changes.
Cautions & Contraindications
Warnings & Precautions
Cardiomyopathy: Doxorubicin Hydrochloride Liposome (PLD Hydrochloride) can cause damage to the heart muscle, including acute left ventricular failure. Infusion-related reactions: these can include 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 meant PLD injection had to be stopped in 4.2% of patients. Secondary oral neoplasms: after the medicine came into use, secondary oral cancers, mainly squamous cell carcinoma, were reported in patients who had been exposed to PLD injection for a long time (more than one year). Embryo-fetal toxicity: pregnant women should be told that there is a potential risk to the fetus. Women and men who could have children should be advised to use effective contraception during treatment with PLD injection and for 6 months after it.
Contraindications
Doxorubicin Hydrochloride Liposome must not be given to patients who have had a severe hypersensitivity reaction, including anaphylaxis, to Doxorubicin Hydrochloride.
Pregnancy & Breastfeeding
Pregnancy: Going by findings in animals and by how the medicine works, Doxorubicin Hydrochloride Liposome injection can harm the fetus when it is given to a pregnant woman. Avoid using it during the 1st trimester. Lactation: It isn't known whether the injection is present in human milk. Many drugs, including anthracyclines, are excreted in human milk, and the injection could cause serious adverse reactions in breastfed infants, so stop breastfeeding during treatment. Females and Males of Reproductive Potential: Pregnancy testing. Verify the pregnancy status of females of reproductive potential before starting the injection. Contraception: Doxorubicin Hydrochloride Liposome injection can cause fetal harm when given to a pregnant woman. It may also damage spermatozoa and testicular tissue, which could result in genetic fetal abnormalities. Infertility: In females of reproductive potential, the injection may cause infertility and amenorrhea. It may also result in oligospermia, azoospermia and permanent loss of fertility.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep unopened vials of PLD injection in a refrigerator at 2-8°C. Don't freeze them. Prolonged freezing may harm liposomal drug products, but short-term freezing (less than 1 month) does not appear to damage PLD injection.
Drug Interactions
Common questions about L-DOX 50 mg/25 ml
What is L-DOX 50 mg/25 ml IV Infusion?
L-DOX 50 mg/25 ml IV Infusion is a medicine that contains Doxorubicin Hydrochloride Liposome. It is made by Beacon Pharmaceuticals PLC. It belongs to the Anti neoplastic preparations group of medicines.
What is L-DOX used for?
L-DOX is used for: Cancer.
What are the side effects of L-DOX?
Side effects of Doxorubicin Hydrochloride Liposome include an 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, and skin changes.
Can I take L-DOX during pregnancy or while breastfeeding?
Pregnancy: Going by findings in animals and by how the medicine works, Doxorubicin Hydrochloride Liposome injection can harm the fetus when it is given to a pregnant woman. Avoid using it during the 1st trimester. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store L-DOX?
Keep unopened vials of PLD injection in a refrigerator at 2-8°C. Don't freeze them.
Can I take other medicines with L-DOX?
Some medicines can interact with Doxorubicin Hydrochloride Liposome, for example: Doxorubicin Hydrochloride. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for L-DOX?
L-DOX is a prescription (Rx) medicine. Take it as your doctor advises.