Topotecan (Page 5 of 5)

14.3 Cervical Cancer

The efficacy of topotecan was evaluated in a multi-center, randomized (1:1), open-label study (Study GOG 0179) conducted in 147 patients with histologically confirmed Stage IV-B, recurrent, or persistent cervical cancer considered not amenable to curative treatment with surgery and/or radiation. Patients were randomized to topotecan (0.75 mg/m2 once daily intravenously for 3 consecutive days starting on Day 1 of a 21-day cycle) with cisplatin (50 mg/m2 intravenously on Day 1) or cisplatin as a single agent. Fifty-six percent of patients treated with topotecan with cisplatin and 56% of patients treated with cisplatin had received prior cisplatin with or without other agents as first-line chemotherapy. The efficacy outcome measure was OS.

Median OS of eligible patients receiving topotecan with cisplatin was 9.4 months (95% CI: 7.9, 11.9) compared with 6.5 months (95% CI: 5.8, 8.8) among patients randomized to cisplatin alone with a log rank P -value of 0.033 (significance level was 0.044 after adjusting for the interim analysis). The unadjusted hazard ratio for OS was 0.76 (95% CI: 0.59, 0.98).

Figure 1. Kaplan-Meier Curves for Overall Survival in Cervical Cancer in Study GOG 0179

figure 1
(click image for full-size original)

15 REFERENCES

  1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16 HOW SUPPLIED/STORAGE AND HANDLING

Topotecan Injection is supplied in 4 mg/4 mL (1 mg/mL topotecan free base) single-dose vials. Each vial contains 4 mL of the sterile, clear, light yellow to greenish solution.

NDC 0703-4714-01 (Package of 1 Single-Dose Vial NDC 0703-4714-71)

Store refrigerated between 2°C and 8°C (36°F and 46°F) in the original carton to protect from light. Discard unused portion.

Topotecan Injection is a cytotoxic drug. Follow applicable handling and disposal procedures.1

17 PATIENT COUNSELING INFORMATION

Myelosuppression

Advise patients of the risks of myelosuppression and instruct them to notify their healthcare provider promptly for fever, other signs of infection, or bleeding [see Warnings and Precautions (5.1)].

Interstitial Lung Disease (ILD)

Inform patients of the risks of severe ILD. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus. Advise women to contact their healthcare provider if they become pregnant, or if pregnancy is suspected during treatment with Topotecan Injection [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)].

Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of Topotecan Injection [see Use in Specific Populations (8.1, 8.3)].

Advise males with a female partner of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of Topotecan Injection [see Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1)].

Lactation

Advise women to discontinue breastfeeding during treatment and for 1 week after the last dose of Topotecan Injection [see Use in Specific Populations (8.2)].

Infertility

Advise male and female patients of the potential risk for impaired fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

Asthenia and Fatigue

Advise patients of the risk of asthenia or fatigue. These symptoms may impair the ability to safely drive or operate machinery.

Teva Pharmaceuticals USA, Inc.North Wales, PA 19454

Package/Label Display Panel

NDC 0703-4714-01

Rx only

Topotecan

Injection

4 mg/4 mL

(1 mg/mL)

Must dilute before intravenous

infusion.

Store refrigerated between

2°C and 8°C (36°F and 46°F)

in the original carton to

protect from light.

Cytotoxic Agent

Single-Dose Vial. Discard unused

portion.

Sterile

TEVA

1
(click image for full-size original)

TOPOTECAN topotecan injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-4714
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPOTECAN HYDROCHLORIDE (TOPOTECAN) TOPOTECAN 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
TARTARIC ACID
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Product Characteristics
Color YELLOW (clear, light yellow to greenish) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-4714-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0703-4714-71)
1 NDC:0703-4714-71 4 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0703-4714-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022453 05/21/2013
Labeler — Teva Parenteral Medicines, Inc. (794362533)

Revised: 06/2019 Teva Parenteral Medicines, Inc.

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