Topotecan Hydrochloride (Hycamtin)

Trade Name : HYCAMTIN

Novartis Pharmaceuticals Corporation

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 4 mg/4mL

TOPOTECAN HYDROCHLORIDE Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Topotecan Hydrochloride (Hycamtin) which is also known as HYCAMTIN and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 4 mg/4mL per ml. Read more

Topotecan Hydrochloride (Hycamtin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm and platelet counts greater than or equal to 100,000/mm. Monitor blood cell counts .
  • WARNING: MYELOSUPPRESSION
  • See full prescribing information for complete boxed warning.
  • HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm and platelet counts greater than or equal to 100,000/mm. Monitor blood cell counts (, ).
  • HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of:
  • nttttttttttPatients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ()
  • nttttttttttPatients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ()
  • nttttttttttPatients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin ()nttttttttt
  • No data
  • Ovarian Cancer and Small Cell Lung Cancer:
  • Cervical Cancer:
  • Renal Impairment:
  • For injection: 4 mg (free base) of topotecan as a light yellow to greenish lyophilized powder in single-dose vial for reconstitution.
  • For injection:
  • 3
  • HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions .
  • nttttttttttHistory of severe hypersensitivity reactions to topotecan ()nttttttttt
  • No data
  • Interstitial Lung Disease (ILD):
  • Extravasation and Tissue Injury:
  • Embryo-Fetal Toxicity:
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Ovarian Cancer
  • SCLC
  • Cervical Cancer
  • To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .
  • No data
  • Lactation:
  • 8.2
  • Overdoses (up to 10-fold of the recommended dose) have occurred in patients receiving intravenous topotecan. The primary complication of overdosage is myelosuppression. Elevated hepatic enzymes, mucositis, gastrointestinal toxicity, and skin toxicity have occurred with overdosages. If an overdose is suspected, monitor the patient closely for myelosuppression and institute supportive-care measures as appropriate.
  • Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is ()-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1-pyrano[3u2019,4u2019:6,7] indolizino [1,2-]quinoline-3,14-(4,12)-dione monohydrochloride. The molecular formula is CHNOu2022HCl and the molecular weight is 457.9 g/mol. It is soluble in water and melts with decomposition at 213u00baC to 218u00baC.
  • Topotecan hydrochloride has the following structural formula:
  • HYCAMTIN (topotecan) for injection, for intravenous use is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each 4 mg vial contains 4 mg topotecan hydrochloride as free base. The reconstituted solution ranges in color from yellow to yellow-green.
  • Inactive ingredients are mannitol, 48u00a0mg, and tartaric acid, 20u00a0mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH. The solution pH ranges from 2.5 to 3.5.
  • No data
  • Carcinogenicity testing of topotecan has not been performed. Topotecan is known to be genotoxic to mammalian cells and is a probable carcinogen. Topotecan was mutagenic to L5178Y mouse lymphoma cells and clastogenic to cultured human lymphocytes with and without metabolic activation. It was also clastogenic to mouse bone marrow. Topotecan did not cause mutations in bacterial cells.
  • Topotecan given to female rats prior to mating at an intravenous dose of 1.4 mg/m [about equal to the clinical dose based on body surface area (BSA)] caused superovulation possibly related to inhibition of follicular atresia. This dose given to pregnant female rats also caused increased pre-implantation loss. Studies in dogs given at an intravenous dose of 0.4 mg/m (about 0.25 times the clinical dose based on BSA) of topotecan daily for a month suggest that treatment may cause an increase in the incidence of multinucleated spermatogonial giant cells in the testes.
  • No data
  • No data
  • HYCAMTIN for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder for reconstitution in 4-mg (free base) single-dose vials.nttttt
  • NDC 0078-0674-61 (package of 1)
  • Store between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F) [see USP Controlled Room Temperature] in original carton. Protect from light.
  • HYCAMTIN for injection is a cytotoxic drug. Follow applicable handling and disposal procedures.n
  • Myelosuppression
  • Inform patients that HYCAMTIN 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 .
  • 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 .
  • 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 HYCAMTIN for injection .
  • Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of HYCAMTIN for injection .
  • Advise males with a female partner of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of HYCAMTIN for injection .
  • Lactation
  • Advise women to discontinue breastfeeding during treatment and for 1 week after the last dose of HYCAMTIN for injection .
  • Infertility
  • Advise male and female patients of the potential risk for impaired fertility .
  • Asthenia and Fatigue
  • Advise patients that HYCAMTIN for injection may cause asthenia or fatigue. These symptoms may impair the ability to safely drive or operate machinery.
  • Distributed by: Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2019-115
  • PRINCIPAL DISPLAY PANEL
  • Arrayn- NDC 0078-0674-61
  • Arrayn- 4 mg
  • Arrayn- HYCAMTINn
  • Arrayn- TOPOTECAN
  • Arrayn- FOR INJECTION
  • Arrayn- For Intravenous Use
  • Arrayn- 1 x 4 mg Single-Dose Vial
  • R only
  • NOVARTIS

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