Doxorubicin liposomal injection
A colorless or nearly colorless transparent liquid.
Nombre del Producto: Inyección de doxorrubicina liposomal
Specification: 10ml 20mg
Standard: State Standard
AIDS-Related Kaposi’s Sarcoma
DOXIL is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
DOXIL, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
Dosage and administration
The recommended dose of DOXIL 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 of DOXIL is 20 mg/m² intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.
The recommended dose of DOXIL 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 DOXIL after bortezomib on day 4 of each cycle.
The following adverse reactions are discussed in more detail in other sections of the labeling.
Secondary Oral Neoplasms
The most common adverse reactions ( > 20%) observed with DOXIL areasthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation,anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia andanemia.
It is contraindicated in patients who have a history of severe hypersensitivit y reactions, including anaphylaxis, to doxorubicin HCl
Liposomal doxorubicin may cause heart problems, including possibly fatal heart failure. Heart problems may occur during liposomal doxorubicin therapy or months to years after receiving this medication. Your risk of developing heart problems depends on your dose, medical history (including previous heart disease, radiation therapy in the chest area), and previous use of this and other drugs (including daunorubicin andcyclophosphamide). Children are at higher risk and should be monitored later in life for delayed heart problems. See also Side Effects section.
This medication may cause certain severe (rarely fatal) blood disorders(bone marrow suppression leading to low red blood cells/white blood cells /platelets). This can lower your body's ability to fight infection and stop bleeding. Tell your doctor immediately if you develop any signs of infection (e.g., fever, chills, persistent sore throat), unusual tiredness, or easy bleeding/bruising.
While this drug is first being given into your vein, this medication may cause severe (rarely fatal) reactions, including allergic reactions. Tell your doctor immediately if you experience flushing, trouble breathing, swelling of the face, tightness in the chest/throat, chills, back pain, severe dizziness, or fast heartbeat. See also Side Effects section.
Mechanism Of Action
The active ingredient of DOXIL is doxorubicin HCl. The mechanism of action of doxorubicin HCl is thought to be related to its ability to bind DNA and inhibitnucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitoticactivity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations.