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Topotecan (Hycamtin)

Trade Name : HYCAMTIN

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 0.25 mg/1

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 (Hycamtin) which is also known as HYCAMTIN and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 0.25 mg/1 per ml. Read more

Topotecan (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 of greater than or equal to 1,500/mm and platelet counts of greater than or equal to 100,000/mm. Monitor blood cell counts (, ).
  • 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.
  • HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). ()
  • No data
  • nttttttttttThe recommended dosage is 2.3 mg/m/day orally once daily for 5 consecutive days starting on Day 1 of a 21-day cycle. ()
  • Renal Impairment:
  • Capsules
  • Capsules:
  • 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 ()
  • No data
  • Diarrhea:
  • Interstitial Lung Disease (ILD):
  • Embryo-Fetal Toxicity:
  • The following serious adverse reactions are described elsewhere in the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .
  • The most common Grade 3 or 4 hematologic adverse reactions (incidence > 20%) were neutropenia, anemia, and thrombocytopenia.
  • The most common (incidence > 10%) non-hematologic adverse reactions (all Grades) were nausea, diarrhea, vomiting, alopecia, fatigue, and anorexia. ()
  • P-glycoprotein or Breast Cancer Resistance Protein Inhibitor
  • Concomitant use of a P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitor increases topotecan AUC , which may increase the risk of adverse reactions. Avoid concomitant use HYCAMTIN capsules with P-gp inhibitors or BCRP inhibitors.
  • nttttttttttAvoid concomitant use of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors with HYCAMTIN capsules. (, )
  • No data
  • Lactation:
  • 8.2
  • Overdoses (up to 5-fold of the prescribed dose) have occurred in patients receiving HYCAMTIN capsules. The primary complication of overdosage is myelosuppression. Mucositis 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[3',4':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 213u00b0C to 218u00b0C.
  • Topotecan hydrochloride has the following structural formula:
  • HYCAMTIN capsules, contain topotecan hydrochloride, the content of which is expressed as topotecan free base. Each 0.25 mg and 1 mg capsule contain topotecan hydrochloride equivalent to 0.25 mg and 1 mg topotecan free-base, respectively. The excipients are gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. The capsules are imprinted with edible black ink. The 1 mg capsules also contain red iron oxide.
  • No data
  • Carcinogenicity testing of topotecan has not been done. Nevertheless, 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 0.6 times the 2.3 mg/m oral 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 an intravenous dose of 0.4 mg/m (about 0.2 times the 2.3 mg/m oral 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.
  • The efficacy of HYCAMTIN capsules was studied in 141 patients with relapsed SCLC in a randomized, controlled, open-label trial (Study 478). The patients were prior responders (complete or partial) to first-line chemotherapy, were not considered candidates for standard intravenous chemotherapy and had relapsed at least 45 days from the end of first-line chemotherapy. Patients were randomized 1:1 to HYCAMTIN capsules (2.3 mg/m orally once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle) with best supportive care (BSC) or BSC alone. The major efficacy outcome measure was overall survival (OS).
  • Patients randomized to HYCAMTIN capsules with BSC received a median of 4 courses (range: 1 to 10) and maintained a median dose intensity of 3.77 mg/m/week. The median patient age in patients receiving HYCAMTIN capsules with BSC and BSC alone was 60 years and 58 years, while the percentage of patients aged greater than or equal to 65 years was 34% and 29%, respectively. The majority of patients were White (99%) and male (73%). In the HYCAMTIN capsules with BSC arm, 68% of patients had extensive disease and 28% had liver metastasis. In the BSC alone arm, 61% had extensive disease and 20% had liver metastases. Eighty percent of patients receiving HYCAMTIN capsules with BSC previously received carboplatin or cisplatin and 77% of patients in the BSC alone arm received prior carboplatin or cisplatin. In the arm receiving HYCAMTIN capsules with BSC, 18% of patients had prior carboplatin and 62% had prior cisplatin. In the BSC-alone arm, 26% of patients had prior carboplatin and 51% had prior cisplatin.
  • The arm receiving HYCAMTIN capsules with BSC showed a statistically significant improvement in OS compared with the BSC-alone arm (Log-rank P = 0.0104). Efficacy results are shown in Table 3 and Figure 1.
  • Figure 1. Kaplan-Meier Curves for Overall Survival in Small Cell Lung Cancer in Study 478
  • No data
  • The 0.25 mg HYCAMTIN capsules are opaque white to yellowish-white imprinted with HYCAMTIN and 0.25 mg and are available in bottles of 10: NDC 0078-0672-01.
  • The 1 mg HYCAMTIN capsules are opaque pink imprinted with HYCAMTIN and 1 mg and are available in bottles of 10: NDC 0078-0673-01.
  • Store refrigerated 2u00baC to 8u00baC (36u00baF to 46u00baF) protected from light in the original carton.
  • HYCAMTIN is a cytotoxic drug. Follow applicable special handling and disposable procedures.n
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).ntttttt
  • Myelosuppression
  • Inform patients that HYCAMTIN decreases blood cell counts, such as white blood cells, platelets, and red blood cells. Instruct patients to notify their healthcare provider promptly for fever or other signs of infection .
  • Diarrhea
  • Inform patients that HYCAMTIN capsules can cause diarrhea which may be severe and life-threatening. Instruct patients how to manage and/or prevent diarrhea and to inform their physician if severe diarrhea occurs during treatment with HYCAMTIN capsules .ntttttt
  • 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 capsules .
  • Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of HYCAMTIN capsules .
  • 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 capsules .
  • Lactation
  • Advise women to discontinue breastfeeding during treatment and for 1 week after the last dose of HYCAMTIN capsules .
  • Infertility
  • Advise male and female patients of the potential risk for impaired fertility .
  • Distributed by: Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2018-112
  • No data
  • Principal Display Panel
  • NDC 0078-0672-01
  • HYCAMTINn
  • (topotecan) Capsules
  • 0.25 mg
  • R only
  • 10 Capsules
  • Novartis
  • Principal Display Panel
  • NDC 0078-0673-01
  • HYCAMTINn
  • (topotecan) Capsules
  • 1 mg
  • R only
  • 10 Capsules
  • Novartis

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