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HYCAMTIN Injection

HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: •. Patients with metastatic ovarian cancer after disease progression on or.



Hycamtin INN-Topotecan

HYCAMTIN 1 mg powder for concentrate for solution for infusion The contents of HYCAMTIN 4 mg vials must be reconstituted with 4 ml water for injections.



HYCAMTIN

WARNING. 7. HYCAMTIN (topotecan hydrochloride) for Injection should be administered under the. 8 supervision of a physician experienced in the use of cancer 



HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights

See full prescribing information for HYCAMTIN FOR INJECTION. HYCAMTIN® (topotecan) for injection for intravenous use. Initial U.S. Approval: 1996. WARNING: 



HYCAMTIN® POWDER FOR INJECTION

29 Aug 2019 Combination therapy (cervical carcinoma) - It is recommended that topotecan in combination with cisplatin for the treatment of cervical cancer ...



topotecan injection

Topotecan Injection is indicated for the treatment of chemotherapy-sensitive small cell lung cancer (SCLC) after failure of first-line chemotherapy.



1 Topotecan Hydrochloride for Injection

Topotecan Hydrochloride for Injection. HYCAMTIN® HYCAMTIN in combination with cisplatin is indicated for the treatment of patients with.



Hycamtin INN-Topotecan

Hycamtin® 1 mg powder for concentrate for solution for infusion Mild pain and inflammation at the site of injection. •. Itchy rash (or hives).



Hycamtin® (topotecan)

7 Jan 2019 Hycamtin 4 mg powder for injection: 2 vials per 7 days. B. Max Units (per dose and over time) [Medical Benefit]:. Cervical Cancer.



022453Orig1s000

3 Oct 2012 Topotecan Injection. Generic Name. Topotecan hydrochloride. Reference Listed Drug. Hycamtin. ®. NDA 20671. Proposed Indication.



HIGHLIGHTS OF PRESCRIBING INFORMATION

HYCAMTIN®for injection as a single agent is indicated for the treatment ofpatients with metastatic ovarian cancerafter disease progression onor after initial or subsequentchemotherapy 1 2 Small Cell Lung Cancer HYCAMTIN for injection as a single agent is indicated for the treatment of patients with small cell lung



HIGHLIGHTS OF PRESCRIBING INFORMATION

HYCAMTIN for injection is a cytotoxic drug Follow applicable handling and disposal procedures 1 3 DOSAGE FORMS AND STRENGTHS For injection: 4 mg (free base) of topotecan as a light yellow to



HIGHLIGHTS OF PRESCRIBING INFORMATION

HYCAMTIN for injection as a single agent is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after



HIGHLIGHTS OF PRESCRIBING INFORMATION

HYCAMTIN® (topotecan hydrochloride) for Injection Initial U S Approval: 1996 WARNING: BONE MARROW SUPPRESSION See full prescribing information for complete boxed warning Do not give HYCAMTIN



1 HY:LXX PRESCRIBING INFORMATION HYCAMTIN - Food and Drug

HYCAMTIN (topotecan hydrochloride) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity HYCAMTIN for Injection is supplied as a sterile



HIGHLIGHTS OF PRESCRIBING INFORMATION - Novartis

HYCAMTIN® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy 2 DOSAGE AND ADMINISTRATION 2 1 Recommended Dosage



Clinical Policy: Topotecan (Hycamtin) - Envolvehealthcom

Hycamtin (topotecan) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks Topotecan binds to the topoisomerase I- DNA complex and prevents re-ligation of these single-strand breaks



SAFETY DATA SHEET

Product identifier HYCAMTIN INJECTABLE Other means of identification Not available Synonym(s) HYCAMTIN INFUSION 1 MG/3 ML * HYCAMTIN INJECTION 1 MG/3 ML * HYCAMTIN INJECTION 4 MG/5 ML * HYCAMTIN INJECTION (CONTAINING 10 TOPOTECAN) * TOPOTECAN FORMULATED PRODUCT Recommended use Medicinal Product



CENTER FOR DRUG EVALUATION AND RESEARCH - Food and Drug

Hycamtin® The proposed drug product is in the same dosage form (i e injectable solution) containing the same active ingredient at the same concentration after reconstitution as the RLD and is



HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not

HYCAMTIN capsules are indicated for the treatment of relapsed small cell lung cancer in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy 2 DOSAGE AND ADMINISTRATION 2 1 Recommended Dosing The recommended dose of HYCAMTIN capsules is 2 3 mg/m 2 /day orally once daily for 5



Searches related to hycamtin injectable filetype:pdf

Hycamtin for injection is indicated: • As a single agent for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy • As a single agent for the treatment of patients with small cell lung cancer with platinum-

Is Hycamtin approved in the US?

  • HYCAMTIN (topotecan hydrochloride) for Injection Initial U.S. Approval: 1996 BONE MARROW SUPPRESSION See full prescribing information for complete boxed warning. 2 6 8 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use (HYCAMTIN) safely and effectively.

What is Hycamtin Capsules?

  • ------------------------------INDICATIONS AND USAGE--------------------------- HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). (1) ---------------------------DOSAGE AND ADMINISTRATION----------------------

How long does it take for Hycamtin to work?

  • Following administration of HYCAMTIN capsules at doses of 1.2 to 3.1 mg/m2(0.52 to 1.35 times the recommended dose) administered daily for 5 days, the area under the curve (AUC) increased proportionally with dose. Absorption The time to the peak plasma concentrations is between 1 to 2 hours following oral administration.

Can Hycamtin Capsules cause infertility?

  • HYCAMTIN capsules may damage spermatozoa, resulting in possible genetic and fetal abnormalities. Advise males with a female partner of reproductive potential to use effective contraception during treatment with HYCAMTIN capsules and for 3 months after the last dose [see Nonclinical Toxicology (13.1)]. Infertility Females
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