Paxus PM Special Precautions

PAXUS PM should be given carefully in the following patients; Patients with myelosuppression. (The risk of myelosuppression may be increased.)
Patients with liver dysfunction. (As metabolism function may be decreased, severe adverse reactions may occur.)
Patients with renal dysfunction. (As renal dysfunction may be decreased, severe adverse events may occur.)
Patients with interstitial pneumonia or pulmonary fibrosis. (The risk of symptoms may be increased.)
General Precautions: The efficacy of PAXUS PM is based on the response rates of metastatic or recurrent breast cancer study and locally advanced or metastatic NSCLC study. No controlled randomized trial was reported proving clinical benefits such extension of the duration of overall survival.
As adverse events may occur even at the beginning or low-dose administration, patients should be fully aware of precautions.
Hematology: 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.
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.
Nervous system: Peripheral neuropathy was frequently observed, but was hardly developed to severe symptom. In moderate or severe toxicities, dose should be reduced by 20% for subsequent courses.
Hepatic system: Caution should be taken and dose reduction should be considered in patients with moderate or severe hepatic dysfunction.
Injection site reaction: Injection site reactions including extravasation were usually mild and consisted of erythema, tenderness, skin discoloration, or swelling at the injection site. These reactions have been observed more frequently with the 24-hour infusion than with the 3-hour infusion. Recurrence of skin reactions at a site of previous extravasation following administration of PAXUS PM at a different site (i.e., RECALL) has been reported rarely. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.
Use in Children: The safety in premature infant, newborn infant, infant, toddler, or pediatric patients has not been established.
Use in the Elderly: As decreased physiologic function and frequent myelosuppression is frequent in geriatric patients, dose and dosing interval should be careful and laboratory tests (e.g. blood test, hepatic function test, renal function test) should be frequently performed.