Thiotepa for injection is contraindicated in: Patients with severe hypersensitivity to thiotepa [see Warnings and Precautions (5.2)] Concomitant use with live or attenuated vaccines [see Warnings and Precautions (5.4)]
WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY • Thiotepa 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 thiotepa [see Warnings and Precautions (5.1) ] • Thiotepa should be considered potentially carcinogenic in humans [see Warnings and Precautions (5.7)]
Thiotepa for injection is contraindicated in: Patients with severe hypersensitivity to thiotepa [see Warnings and Precautions (5.2)] Concomitant use with live or attenuated vaccines [see Warnings and Precautions (5.4)]
For injection, 15 mg, lyophilized white powder in single-dose vial for reconstitution For injection, 100 mg, lyophilized white powder in single-dose vial for reconstitution
There is no experience with overdoses of thiotepa. The most important adverse reactions expected in case of overdose are myeloablation and pancytopenia [see Nonclinical Toxicology (13.2)] . There is no known antidote for thiotepa. Monitor the hematological status closely and provide vigorous supportive measures as medically indicated.
Thiotepa-for-Injection-15mg-vial-label Thiotepa-for-Injection-100mg-vial-label Thiotepa-for-Injection-15mg-carton-label Thiotepa-for-Injection-100mg-carton-label
| Class | Version | Type | Effective |
|---|---|---|---|
| THIOTEPA Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b9d03845-c04b-46cb-bb7e-9c6cffe3c163 | Product name | 4 | 20250618 |
| d48e4a3f-d6a3-47a1-9357-dd5939f6049d | Product name | 1 | 20250227 |
| d4b5276b-261e-446e-ba03-7cf7bbc1d8af | Product name | 3 | 20220718 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72205-045-01 | Thiotepa | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | 2 | |
| 72205-045-01 | Thiotepa | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | 2 | |
| 72205-046-01 | Thiotepa | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | 2 | |
| 72205-046-01 | Thiotepa | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72205-045 | THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250419_b702dcc9-dd0e-4386-b1e2-f20562fd2ad9.zip |
| 72205-046 | THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250419_b702dcc9-dd0e-4386-b1e2-f20562fd2ad9.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72205-045-01 | EA - Each | 72205-045 | bfcb725e-0810-45c3-bf73-1cb1af263a0c | 1 | 2020-04-20 |
| 72205-046-01 | EA - Each | 72205-046 | c61a28ed-5e7a-4906-aa4d-fbf05f5ef5fe | 1 | 2020-04-20 |
| Name | UNII | Kind |
|---|---|---|
| THIOTEPA | 905Z5W3GKH | ACTIB |
| THIOTEPA | 905Z5W3GKH | ACTIB |
WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY • Thiotepa 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 thiotepa [see Warnings and Precautions (5.1) ] • Thiotepa should be considered potentially carcinogenic in humans [see Warnings and Precautions (5.7)]
For injection, 15 mg, lyophilized white powder in single-dose vial for reconstitution For injection, 100 mg, lyophilized white powder in single-dose vial for reconstitution
Thiotepa for injection is contraindicated in: Patients with severe hypersensitivity to thiotepa [see Warnings and Precautions (5.2)] Concomitant use with live or attenuated vaccines [see Warnings and Precautions (5.4)]
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Infection [see Warnings and Precautions (5.1)] Hypersensitivity [see Warnings and Precautions (5.2)] Cutaneous Toxicity [see Warnings and Precautions (5.3)] Hepatic Veno-Occlusive Disease [see Warnings and Precautions (5.5) ] Central Nervous System Toxicity [see Warnings and Precautions (5.6) ] Carcinogenicity [see Warnings and Precautions (5.7 )]
There is no experience with overdoses of thiotepa. The most important adverse reactions expected in case of overdose are myeloablation and pancytopenia [see Nonclinical Toxicology (13.2)] . There is no known antidote for thiotepa. Monitor the hematological status closely and provide vigorous supportive measures as medically indicated.
Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for injection, USP is available in a single-dose vial containing: 15 mg thiotepa. After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. 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 C 6 H 12 N 3 PS, and a molecular weight of 189.22, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in alcohol, in chloroform and in ether; soluble in water and methanol. 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.
Thiotepa 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 [see Table 1] ), intravenous thiotepa 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. Efficacy was based on the incidence of graft rejection (primary or late rejection). The incidence of graft rejection in these 25 patients using thiotepa was 0% (95% CI: [0, 0.12]). Of the 51 patients who received the same preparative regimen, historically, without thiotepa, the incidence of graft rejection reported was 25.5% (95% CI: [0.13, 0.37]).
1. OSHA Hazardous Drugs. OSHA. [Accessed from http://www.osha.gov/SLTC/hazardousdrugs/index.html] .
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 [see Warnings and Precautions (5.2) ] . 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 [see Warnings and Precautions (5.1) ] . Females and Males of Reproductive Potential Thiotepa can cause fetal harm. Advise females receiving thiotepa to avoid pregnancy during thiotepa treatment and for at least 6 months after the final dose of thiotepa [see Warnings and Precautions (5.8) ] . Advise males with female sexual partners of reproductive potential to use effective contraception during thiotepa treatment and for at least 1 year after the final dose of thiotepa [see Use in Specific Populations (8.3) ] . Advise females to report pregnancy immediately [see Warnings and Precautions (5.8) ] . Advise patients that thiotepa can produce infertility. Inform male patients about the possibility of sperm conservation before the start of therapy [see Use in Specific Populations (8.3) ] . Lactation Advise patients to avoid breastfeeding while receiving thiotepa [see Use in Specific Populations (8.2) ] . Secondary malignancies Inform patients that thiotepa can increase the risk of secondary malignancy [see Warnings and Precautions (5.7) ] . Manufactured by: MSN Laboratories Private Limited Telangana – 509 228, INDIA Distributed by: Novadoz Pharmaceuticals LLC. Piscataway, NJ 08854-3714 Issued on: 04/2024
Thiotepa-for-Injection-15mg-vial-label Thiotepa-for-Injection-100mg-vial-label Thiotepa-for-Injection-15mg-carton-label Thiotepa-for-Injection-100mg-carton-label