TEPADINA thiotepa injection powder for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THIOTEPA (UNII: 905Z5W3GKH) (THIOTEPA - UNII:905Z5W3GKH)

Available from:

ADIENNE SA

INN (International Name):

THIOTEPA

Composition:

THIOTEPA 15 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

TEPADINA- THIOTEPA INJECTION, POWDER, FOR SOLUTION
ADIENNE SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TEPADINA® SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TEPADINA®.
TEPADINA® (THIOTEPA) FOR INJECTION, FOR INTRAVENOUS, INTRACAVITARY,
OR INTRAVESICAL USE.
INITIAL U.S. APPROVAL: 1959
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 _WARNINGS AND
PRECAUTIONS (5.1)_]
TEPADINA SHOULD BE CONSIDERED POTENTIALLY CARCINOGENIC IN HUMANS [SEE
_WARNINGS AND PRECAUTIONS_
_(5.7)_]
INDICATIONS AND USAGE
TEPADINA (thiotepa) is an alkylating drug indicated: (1)
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)
DOSAGE AND ADMINISTRATION
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