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TEPADINA
Bladder, kidney, and other urologic cancers
Breast cancer
Gynecologic cancers
Organ rejection prophylaxis
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Drug Name:

TEPADINA Rx

Generic Name and Formulations:
Thiotepa 15mg, 100mg; per vial; lyophilized pwd for IV, intravesical, or intracavitary administration after reconstitution and dilution.

Company:
Adienne Pharma & Biotech

Therapeutic Use:

Indications for TEPADINA:

Superficial papillary carcinoma of the urinary bladder. Intracavitary effusion due to neoplasm of serosal cavities.

Adult:

60mg once weekly for 4 weeks; may repeat up to a total of 3 courses. Retain in bladder for 2hrs. Intracavitary administration: 0.6–0.8mg/kg every 1–4 weeks through same tube used to remove fluid from cavity. Maintenance doses: adjust no sooner than weekly based on blood counts.

Children:

Not established.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (eg, rifampin, phenytoin); consider alternatives; if use unavoidable, monitor closely. May potentiate CYP2B6 substrates. May reduce efficacy of cyclophosphamide.

Pharmacological Class:

Alkylating agent.

Adverse Reactions:

Neutropenia, anemia, thrombocytopenia, elevated ALT/AST, elevated bilirubin, mucositis, CMV infection, hemorrhage, diarrhea, hematuria, rash; carcinogenicity, secondary malignancy, CNS toxicity, possible infertility.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Indications for TEPADINA:

Adenocarcinoma of the breast. Intracavitary effusion due to neoplasm of serosal cavities.

Adult:

Initially 0.3–0.4mg/kg IV given at 1–4 week intervals. Intracavitary administration: 0.6–0.8mg/kg every 1–4 weeks through same tube used to remove fluid from cavity. Maintenance doses: adjust no sooner than weekly based on blood counts.

Children:

Not established.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (eg, rifampin, phenytoin); consider alternatives; if use unavoidable, monitor closely. May potentiate CYP2B6 substrates. May reduce efficacy of cyclophosphamide.

Pharmacological Class:

Alkylating agent.

Adverse Reactions:

Neutropenia, anemia, thrombocytopenia, elevated ALT/AST, elevated bilirubin, mucositis, CMV infection, hemorrhage, diarrhea, hematuria, rash; carcinogenicity, secondary malignancy, CNS toxicity, possible infertility.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Indications for TEPADINA:

Adenocarcinoma of the ovary. Intracavitary effusion due to neoplasm of serosal cavities.

Adult:

Initially 0.3–0.4mg/kg IV given at 1–4 week intervals. Intracavitary administration: 0.6–0.8mg/kg every 1–4 weeks through same tube used to remove fluid from cavity. Maintenance doses: adjust no sooner than weekly based on blood counts.

Children:

Not established.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (eg, rifampin, phenytoin); consider alternatives; if use unavoidable, monitor closely. May potentiate CYP2B6 substrates. May reduce efficacy of cyclophosphamide.

Pharmacological Class:

Alkylating agent.

Adverse Reactions:

Neutropenia, anemia, thrombocytopenia, elevated ALT/AST, elevated bilirubin, mucositis, CMV infection, hemorrhage, diarrhea, hematuria, rash; carcinogenicity, secondary malignancy, CNS toxicity, possible infertility.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Indications for TEPADINA:

To reduce risk of graft rejection when used with high-dose busulfan and cyclophosphamide, as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) for children with class 3 beta-thalassemia.

Adult:

Not applicable.

Children:

Give as IV infusion over 3hrs. 5mg/kg approx. 12hrs apart on Day -6 before allogeneic HSCT in combination with high-dose busulfan and cyclophosphamide. See full labeling.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (eg, rifampin, phenytoin); consider alternatives; if use unavoidable, monitor closely. May potentiate CYP2B6 substrates. May reduce efficacy of cyclophosphamide.

Pharmacological Class:

Alkylating agent.

Adverse Reactions:

Neutropenia, anemia, thrombocytopenia, elevated ALT/AST, elevated bilirubin, mucositis, CMV infection, hemorrhage, diarrhea, hematuria, rash; carcinogenicity, secondary malignancy, CNS toxicity, possible infertility.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

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