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TOPOTECAN Patient Counseling Information (topotecan injection)

17 PATIENT COUNSELING INFORMATION

Myelosuppression

Inform patients that topotecan decreases blood cell counts such as white blood cells, platelets, and red blood cells. Advise patients 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 with Topotecan Injection and for 6 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

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

Lactation

Advise women to discontinue breastfeeding during treatment with Topotecan Injection and for at least 1 week after the last dose [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 that topotecan may cause asthenia or fatigue. These symptoms may impair the ability to safely drive or operate machinery.

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