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Nudoxa PEG

Nudoxa PEG

doxorubicin

Manufacturer:

Zydus Healthcare

Distributor:

Zydus Healthcare
Concise Prescribing Info
Contents
Doxorubicin HCl (pegylated liposomal)
Indications/Uses
Ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy. AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. In combination w/ bortezomib for patients w/ multiple myeloma who have not previously received bortezomib & have received at least 1 prior therapy.
Dosage/Direction for Use
IV Administer 1st dose at initial rate of 1 mg/min. Increase the infusion rate to complete over 1 hr if no infusion-related adverse reactions are observed. Ovarian cancer 50 mg/m2 IV over 60 min every 28 days until disease progression or unacceptable toxicity. AIDS-related Kaposi's sarcoma 20 mg/m2 IV over 60 min every 21 days until disease progression or unacceptable toxicity. Multiple myeloma 30 mg/m2 IV over 60 min on day 4 of each 21-day cycle for 8 cycles or until disease progression or unacceptable toxicity. Administer doxorubicin inj after bortezomib on day 4 of each cycle.
Contraindications
Special Precautions
Discontinue use if patient experiences serious or life-threatening infusion-related reactions. Risk of cardiomyopathy; patients who have received other anthracyclines or w/ prior mediastinal irradiation. Assess left ventricular cardiac function (eg, MUGA or echocardiogram) prior to initiation, during, & after treatment. Delay liposome inj for the 1st episode of grade ≥2 hand-foot syndrome (HFS). Discontinue treatment if HFS is severe & debilitating. Secondary oral cancer in long-term (>1 yr) exposure. Regularly examine for presence of oral ulceration or any oral discomfort that may be indicative of secondary oral cancer. Avoid use during 1st trimester of pregnancy. Discontinue breastfeeding during treatment. Use effective contraception during & for 6 mth following discontinuation of therapy in women of child-bearing potential or male partner. May cause infertility in female or male of reproductive potential.
Adverse Reactions
Cardiomyopathy, infusion-related reactions, HFS, secondary oral neoplasms.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Presentation/Packing
Form
Nudoxa PEG conc for soln for IV infusion 2 mg/mL
Packing/Price
10 mL x 1's
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