COMPLETE PRODUCT INFORMATION

INDICATIONS

Breast Cancer

  • First-line treatment of metastatic or recurrent breast cancer
  • Second-line treatment of metastatic breast cancer after failure of standard chemotherapy

Lung Cancer

  • First-line treatment of locally advanced or metastatic non-small cell lung cancer

Ovarian cancer

  • First-line treatment in combination with other chemotherapeutic agents



DOSAGE AND ADMINISTRATION

Breast Cancer

First-line treatment of metastatic or recurrent breast cancer

The recommended regimen for Genexol-PM is 300mg/m2 administered by intravenous infusion over 3 hours every 3 weeks.

Genexol-PM therapy does not require premedication. However, premedication may be given approximately 30 minutes prior to Genexol-PM administration, depending on the judgement of physicians in order to minimize the possibility of severe hypersensitivity reactions. Such premedication may consist of hydrocortisone 100mg IV (or its equivalent), pheniramine maleate 45.5mg IV (or its equivalent), and cimetidine 300mg or ranitidine 50mg IV (or its equivalent).

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Second-line treatment of metastatic breast cancer after failure of standard chemotherapy

The recommended dose of the solution in this clinical trial was 300mg/m2 given by intravenous infusion over 3 hours every 3 weeks.

The administration of the solution could be delayed up to 3 weeks, however, in case that a patient’s hematogenous functions do not show remarkable recovery within 3 days before the resumption of next administration cycle, or that when a clinician determines that additional injection needs to be postponed for the sake of his patient’s medical condition. In other words, the patient should not be rechallenged with next injection cycle until neutrophils counts reach a level of at least 1.5×109/L, and platelet counts exceed 100×109/L.

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Lung Cancer

First-line treatment of locally advanced or metastatic non-small cell lung cancer

Genexol-PM is administered by intravenous infusion over 3 hours every 3 weeks according to the following dose instructions, followed by cisplatin 60mg/m2 intravenous infusion.

All patients should be premedicated approximately 30 minutes prior to Genexol-PM administration in order to prevent severe hypersensitivity reactions. The premedication may consist of hydrocortisone 100mg IV (or its equivalent), pheniramine maleate 45.5mg IV (or its equivalent), and cimetidine 300 mg or ranitidine 50mg IV (or its equivalent). Ondansetron 8mg IV (or its equivalent) may be administered as prophylactic anti-emetics prior to cisplatin administration.

Administration dose for the first cycle: 230 mg/m2

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Ovarian Cancer

First-line treatment in combination with other chemotherapeutic agents

The recommended regimen for Genexol-PM is 260mg/m2 administered by intravenous infusion over 3 hours every 3 weeks, followed by the intravenous infusion of carboplatin AUC 5mg/mL•min.

All patients should be premedicated approximately 30 minutes prior to Genexol-PM administration in order to prevent severe hypersensitivity reactions. The premedication may consist of hydrocortisone 100mg IV (or its equivalent), pheniramine maleate 45.5mg IV (or its equivalent), and cimetidine 300 mg or ranitidine 50mg IV (or its equivalent).

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CONTRAINDICATIONS


  • PAXUS™PM should not be administered to patients who have a history of severe hypersensitivity reactions to paclitaxel or to any ingredient in the formulation. For a complete listing of ingredients, see the Dosage Forms, Composition and Packaging section.
  • PAXUS™PM should not be used in patients with severe myelosuppression (baseline neutrophil counts < 1,500 cells/mm3). Myelosuppression is a dose-limiting toxicity and may accompany infection and become severe.
  • PAXUS™PM should not be used in patients who accompany infection. (Infection may be worsen by myelosuppression.)
  • PAXUS™PM should not be used in pregnant women or child-bearing potential women.


WARNING AND PRECAUTION

PAXUS™PM should be administered under the supervision of a physician with experiences of the use of chemotherapeutic agents. As adverse events may occur even at the beginning or low-dose administration, patients should be fully aware of precautions.

PAXUS™PM must be administered as a diluted solution. Severe hypersensitivity reactions characterized by anaphylaxis, dyspnea, hypotension requiring treatment, angioedema, and generalized urticaria were observed in 4.9% of patients in clinical study of PAXUS™PM for breast cancer.

If severe hypersensitivity reactions occur, the discontinuation of drug and the following treatment should be given;

  • IV infusion of pheniramine maleate 45.5 mg (or its equivalent)
  • Administration of epinephrine or its equivalent until the resolution of hypersensitivity reactions or total 6 doses, IV administration at hypotension which does not respond to epinephrine or its equivalent.
  • Spray of albuterol or its equivalent at stridor which does not respond to adrenaline or its equivalent
  • Infusion of methylprednisolone 125 mg or its equivalent to prevent recurrent or advanced allergy.

When premedication is determined to be necessary to minimize the risk of severe hypersensitivity reactions in breast cancer, premedication may be given approximately 30 minutes prior to therapy, including hydrocortisone 100 mg IV (or its equivalent), pheniramine maleate 45.5 mg IV (or its equivalent), and cimetidine 300 mg or ranitidine 50 mg IV (or its equivalent).

PAXUS™PM should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm3. Bone marrow suppression (primarily neutropenia) is a dose-dependent and a dose-limiting toxicity.

Frequent monitoring of blood counts should be instituted during PAXUS™PM treatment. Patients should not be re-treated with subsequent cycles of PAXUS™PM until neutrophil counts recover to a level >1500 cells/mm3 and platelet counts recover to a level > 100,000 cells/mm3.

Hematologic

PAXUS™PM therapy should not be administered to patients with baseline neutrophil counts less than 1,500 cells/mm3.

In order to monitor the occurrence of myelotoxicity, it is recommended to check frequent peripheral blood cell counts for all patients receiving PAXUS™PM. Patients should not be rechallenged with subsequent cycles of PAXUS™PM until the recovery of neutrophils to a level of 1,500 cells/mm3 and platelets to a level of 100,000 cells/mm3.

When severe neutropenia (< 500 cells/mm3) occurs during PAXUS™PM therapy, dose reduction by 20% is recommended for subsequent courses. (see Dosage and Administration).

Hepatic

The use of PAXUS™PM has not been studied in patients with hepatic dysfunction. It is reported that the toxicity of paclitaxel is enhanced in patients with elevated liver enzymes. Caution should be taken and dose reduction should be considered in patients with moderate or severe hepatic dysfunction.

Neurologic

Peripheral neuropathy was frequently observed, but was hardly developed to severe symptom. The occurrence of grade 1 or 2 peripheral neuropathy does not require dose modification. For patients with grade 3 neurologic toxicity, a dose reduction of 20% should be considered. For patients with grade 4 neurologic toxicity, discontinuation of the therapy should be considered.

Hypersensitivity reactions

Minor symptoms such as flushing, skin reactions, dyspnea, hypotension, or tachycardia do not require interruption of therapy. However, severe reactions such as hypotension requiring treatment, dyspnea requiring bronchodilators, angioedema, or generalized urticaria require immediate discontinuation of PAXUS™PM and aggressive symptomatic therapy.

Patients who have developed severe hypersensitivity reactions should not be rechallenged with drug.

Injection site reaction

Injection site reactions including extravasation were usually mild and consisted of erythema, tenderness, skin discoloration, or swelling at the injection site. Recurrence of skin reactions at a site of previous extravasation following administration of PAXUS™PM at a different site has been reported rarely. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.

Special Populations

Pregnant women: PAXUS™PM may cause fetal harm in a pregnant woman. Paclitaxel has been shown to be embryo and feto-toxic in rabbits and to decrease fertility in rats. No study involving paclitaxel therapy in pregnant women has been reported. Women of childbearing potential should be advised to avoid becoming pregnant.

Nursing women: PAXUS™PM should not be administered to nursing mothers and nursing should be discontinued during the therapy.

Pediatrics: The safety and effectiveness of PAXUS™PM in pediatric patients have not been evaluated.



Brand Name: PAXUS™ PM (South East Asia), GENEXOL® PM (Korea & other territories)