ETOPOPHOS PRESERVATIVE FREE

Study 1 was a multicenter trial in patients, with previously untreated, small cell lung cancer, randomized (1:1) to receive either etoposide phosphate (80 mg/m 2 /day) plus cisplatin (20 mg/m 2 /day) for 5 days, or etoposide (80 mg/m 2 /day) plus cisplatin (20 mg/m 2 /day). The major efficacy outcome measure was objective response rate (ORR). Among the 121 patients enrolled, the median age was 64 years, 65% of patients were male, 89% were White, and ECOG performance score was 0 to 2. Study 1 demonstrated an overall response rate of 61% (95% confidence interval [CI] 47, 73) for patients treated...

The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Secondary leukemias [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Most common adverse reaction is neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact the Safety Call Center at 1-866-885-0690 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical tri...

ETOPOPHOS is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products [see Warnings and Precautions (5.3) ] . Hypersensitivity to etoposide products. ( 4 , 5.3 )

​ Myelosuppression : Obtain complete blood counts prior to each cycle and more frequently as clinically indicated. ( 5.1 ) Secondary leukemias : Can occur with long-term use. ( 5.2 ) Hypersensitivity reactions : Hypersensitivity reactions including anaphylaxis may occur. ( 5.3 ) Embryo-fetal toxicity : ETOPOPHOS can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with ETOPOPHOS and for 6 months after final dose. Advise males to ...

7 DRUG INTERACTIONS Warfarin: Co-administration of ETOPOPHOS with warfarin can result in elevated international normalized ratio (INR). Measure INR frequently. Warfarin: Co-administration can result in elevated international normalized ratio (INR). Measure INR frequently. ( 7 )