Trade Name: TEPADINA

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, POWDER, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 15 mg/1

Storage and handling

THIOTEPA Alkylating Activity [MoA],Alkylating Drug [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of THIOTEPA (TEPADINA) which is also known as TEPADINA and Manufactured by Amneal Biosciences LLC. It is available in strength of 15 mg/1.

THIOTEPA (TEPADINA) 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.

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  • WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY
  • These highlights do not include all the information needed to use TEPADINAu00ae safely and effectively. See full prescribing information for TEPADINAu00ae.n nTEPADINAu00ae (thiotepa) for injection, for intravenous, intracavitary, or intravesical use.n nnitial U.S. Approval: 1959n
  • WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY
  • TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of TEPADINA [see n ] n
  • TEPADINA should be considered potentially carcinogenic in humans [see n ] n
  • TEPADINA (thiotepa) is an alkylating drug indicated:
  • To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1, 14)
  • For treatment of adenocarcinoma of the breast or ovary. (1.2)
  • For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3)
  • For treatment of superficial papillary carcinoma of the urinary bladder. (1.4)
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  • The recommended dose of TEPADINA for class 3 beta-thalassemia is two administrations of 5 mg/kg given intravenously approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide. (2.1)
  • The recommended dose of TEPADINA for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. (2.1)
  • The recommended dose of TEPADINA for treatment of malignant effusions is 0.6 to 0.8 mg/kg intracavitary. (2.1)
  • The recommended dose of TEPADINA for treatment of superficial papillary carcinoma of the urinary bladder is 60 mg in 30 to 60 mL of Sodium Chloride Injection into the bladder by catheter. (2.1)
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  • For injection: 15 mg, lyophilized white powder in single-dose vial for reconstitution. (3)
  • For injection: 100 mg, lyophilized white powder in single-dose vial for reconstitution. (3)
  • TEPADINA is contraindicated in:
  • Hypersensitivity to the active substance (4).
  • Concomitant use with live or attenuated vaccines (4).
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  • Cutaneous toxicity: Cleanse skin at least twice daily through 48 hours after the last dose of TEPADINA. (5.3)
  • Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy. (5.8)
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • The most common adverse reactions (incidence greater than 10%) were neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash. (6.1)
  • To report SUSPECTED ADVERSE REACTIONS, contact ADIENNE at 844-668-3940 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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  • See 17 for PATIENT COUNSELING INFORMATION
  • Lactation: Breastfeeding is not recommended. (8.2)
  • Moderate or severe renal impairment: Monitor patients more frequently for toxicity. (8.6, 12.2)
  • Moderate or severe hepatic impairment: Monitor patients more frequently for toxicity. (8.7, 12.2)
  • There is no experience with overdoses of thiotepa. The most important adverse reactions expected in case of overdose are myeloablation and pancytopenia n n n n n n n n . There is no known antidote for thiotepa. Monitor the hematological status closely and provide vigorous supportive measures as medically indicated.n n nn n nn
  • TEPADINA (thiotepa) is an alkylating agent. TEPADINA (thiotepa) for injection is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution.
  • TEPADINA is available in a single-dose vial containing:
  • Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula:
  • Thiotepa has the molecular formula Cn n n n n n n Hn n n n n n n Nn n n n n n n PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52u00b0C to 57u00b0C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium.n n nn n nn
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  • In mice, repeated intraperitoneal (IP) administration of thiotepa (1.15 or 2.3 mg/kg three times per week for 52 or 43 weeks, respectively) produced a significant increase in the combined incidence of squamous-cell carcinomas of the skin, preputial gland, and ear canal, and combined incidence of lymphoma and lymphocytic leukemia. In other studies in mice, repeated IP administration of thiotepa (4 or 8 mg/kg three times per week for 4 weeks followed by a 20 week observation period or 1.8 mg/kg three times per week for 4 weeks followed by a 35 week observation period) resulted in an increased incidence of lung tumors. In rats, repeated IP administration of thiotepa (0.7 or 1.4 mg/kg three times per week for 52 or 34 weeks, respectively) produced significant increases in the incidence of squamous-cell carcinomas of the skin or ear canal, combined hematopoietic neoplasms, and uterine adenocarcinomas. Thiotepa given intravenously (IV) to rats (1 mg/kg once per week for 52 weeks) produced an increased incidence of malignant tumors (abdominal cavity sarcoma, lymphosarcoma myelosis, seminoma, fibrosarcoma, salivary gland hemangioendothelioma, mammary sarcoma, pheochromocytoma) and benign tumors.
  • The lowest reported carcinogenic dose in mice (1.15 mg/kg, 3.68 mg/mn n n n n n n ) is approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area. The lowest reported carcinogenic dose in rats (0.7 mg/kg, 4.9 mg/mn n n n n n n ) is approximately 6-fold less than the maximum recommended human therapeutic dose based on body-surface area.n n nn n nn
  • Thiotepa was mutagenic in n n n n n n n assays in n n n n n n n , Chinese hamster lung and human lymphocytes. Chromosomal aberrations and sister chromatid exchanges were observed n n n n n n n with thiotepa in bean root tips, human lymphocytes, Chinese hamster lung, and monkey lymphocytes.n n nn n nn
  • Mutations were observed with oral thiotepa in mouse at doses > 2.5 mg/kg (8 mg/mn n n n n n n ). The mouse micronucleus test was positive with intraperitoneal administration of > 1 mg/kg (3.2 mg/mn n n n n n n ). Other positive n n n n n n n chromosomal aberration or mutation assays included n n n n n n n , Chinese hamster marrow, murine marrow, monkey lymphocyte, and murine germ cell.n n nn n nn
  • Thiotepa impaired fertility in male mice at oral or intraperitoneal doses u2265 0.7 mg/kg (2.24 mg/mn n n n n n n ), approximately 12-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa (0.5 mg) inhibited implantation in female rats when instilled into the uterine cavity. Thiotepa interfered with spermatogenesis in mice at IP doses u2265 0.5 mg/kg (1.6 mg/mn n n n n n n ), approximately 17-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa interfered with spermatogenesis in hamsters at an IP dose of 1 mg/kg (4.1 mg/mn n n n n n n ), approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area. n n nn n nn
  • TEPADINA was evaluated in a retrospective study of pediatric patients with class 3 beta-thalassemia who underwent allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) from a human leukocyte antigen (HLA)-identical sibling donor. Twenty-five patients (10 male and 15 female) of median age 10 years (range, 5-16 years) were treated with intravenous busulfan at weight-based dosing from Day -10 to Day -7 pretransplant [n n n n n n n ]), intravenous TEPADINA 5 mg/kg twice on Day -6, intravenous cyclophosphamide 40 mg/kg/day on Day -5 to Day -2, and marrow infusion on Day 0. All patients had also received precytoreduction with hydroxyurea, azathioprine and fludarabine prior to start of the preparative regimen.n n nn n nn
  • Efficacy was based on the incidence of graft rejection (primary or late rejection). The incidence of graft rejection in these 25 patients using TEPADINA was 0% (95% CI: [0, 0.12]). Of the 51 patients who received the same preparative regimen, historically, without TEPADINA, the incidence of graft rejection reported was 25.5% (95% CI: [0.13, 0.37]).
  • 1. OSHA Hazardous Drugs. OSHA. [Accessed from n n n n n n n ].n n nn n nn
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  • Hypersensitivity
  • Counsel patients on the signs and symptoms of hypersensitivity and to seek immediate emergency assistance if they develop any of these signs and symptoms n .n
  • Myelosuppression
  • Inform patients of the possibility of developing low blood cell counts and the need for hematopoietic progenitor cell infusion. Instruct patients to immediately report to their healthcare provider if bleeding or fever occurs n .n
  • Females and Males of Reproductive Potential
  • TEPADINA can cause fetal harm. Advise females receiving TEPADINA to avoid pregnancy during TEPADINA treatment and for at least 6 months after the final dose of TEPADINA n .n
  • Advise males with female sexual partners of reproductive potential to use effective contraception during TEPADINA treatment and for at least 1 year after the final dose of TEPADINA n .n
  • Advise females to report pregnancy immediately n .n
  • Advise patients that TEPADINA can produce infertility. Inform male patients about the possibility of sperm conservation before the start of therapy n .n
  • Lactation
  • Advise patients to avoid breastfeeding while receiving TEPADINA n .n
  • Secondary malignancies
  • Inform patients that TEPADINA can increase the risk of secondary malignancy n .n
  • Distributed by:
  • Amneal Pharmaceuticals LLC
  • Bridgewater, NJ 08807
  • for
  • ADIENNE SA
  • Switzerland
  • (Logo ADIENNE)
  • Rev. 03-2020
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