Thiotepa

Indications
 Intravesical
Bladder cancer
Adult: Up to 60 mg instilled in 30-60 mL of sterile water or sodium chloride 0.9% into the bladder of patient previously dehydrated for 8-12 hr and retained for 2 hr. Reposition patient every 15 minutes for max area contact. May be repeated once a wk for up to 4 wk. For prophylaxis of recurrence after surgical removal of bladder cancer: Up to 60 mg may be instilled at intervals of 1-2 wk, for up to 8 instillations.
Elderly: Initiate at lower dose.
Renal impairment: Dose adjustment may be needed.
Hepatic impairment: Dose adjustment may be needed.
Intracavitary
Malignant effusions
Adult: Up to 60 mg in 20-60 mL of sterile water may be instilled after aspiration.
Elderly: Initiate at lower dose.
Renal impairment: Dose adjustment may be needed.
Hepatic impairment: Dose adjustment may be needed.
Urethral
Condyloma acuminata
Adult: Instill 60 mg wkly into urethra.
Elderly: Initiate at lower dose.
Renal impairment: Dose adjustment may be needed.
Hepatic impairment: Dose adjustment may be needed.
Intravenous
Breast cancer
Adult: Dosage must be individualised. Usual range: 0.3-0.4 mg/kg via rapid IV admin every 1-4 wk. Avoid admin if WBC or platelet counts fall below acceptable levels. Stop treatment if WBC falls rapidly.
Elderly: Initiate at lower dose.
Renal impairment: Dose adjustment may be needed.
Hepatic impairment: Dose adjustment may be needed.
Intravenous
Ovarian carcinoma
Adult: Dosage must be individualised. Usual range: 0.3-0.4 mg/kg via rapid IV admin every 1-4 wk. Avoid admin if WBC or platelet counts fall below acceptable levels. Stop treatment if WBC falls rapidly.
Elderly: Initiate at lower dose.
Renal impairment: Dose adjustment may be needed.
Hepatic impairment: Dose adjustment may be needed.
Ophthalmic
Reduction of recurrence following surgical removal of pterygium
Adult: As 0.05% eye drops in sterile Ringer's solution: Instill every 3 hr for up to 6 wk after surgical removal of pterygium to reduce the possibility of recurrence.
Renal impairment: Dose adjustment may be needed.
Hepatic impairment: Dose adjustment may be needed.

Special Populations: Dose reduction in renal and hepatic impairment.

Reconstitution: Reconstituted by adding 1.5 ml of sterile water for injection to a vial containing 15 mg of the drug or 3 ml of sterile water for injection to a vial containing 30 mg of the drug. This produces a solution with 10 mg of thiotepa per mL which should be filtered with a pore size of 0.22 micron. Reconstituted solution is hypotonic and should be further diluted with 0. 9% sodium chloride before use. If larger volumes of solution are needed for intracavitary, IV infusion, or perfusion therapy, the reconstituted solution may be diluted with sodium chloride, dextrose, dextrose and sodium chloride, Ringer's or lactated Ringer's injection. For local admin, thiotepa may be mixed with 2% procaine hydrochloride inj and/or 0.1% (1:1000) epinephrine hydrochloride inj.
Incompatibility: Y-site incompatibility: Minocycline, vinorelbine, cisplatin and filgrastim. Admixture incompatibility: Cisplatin.
Contraindications
 Pregnancy; lactation; hypersensitivity; severe myelosuppression with leukocyte count <3000 cells/mm3 or platelet count <150,000 cells/mm3.
Warnings / Precautions
 Elderly; child; preexisting renal, hepatic and bone marrow function impairment. Monitor for fever, chills, sore throat, discoloration of urine, black stools or unusual bleeding or easy bruising. Monitor blood counts before initiation, at least wkly during and at least 3 wk after discontinuation of therapy; monitor hepatic and renal function.
Adverse Reactions
 GI disturbances; fatigue, weakness, headache and dizziness; hypersensitivity reactions; blurred vision and conjunctivitis; amenorrhoea, impaired fertility; local irritation, frank chemical or haemorrhagic cystitis; depigmentation of periorbital skin (eye drops).
Potentially Fatal: Bone marrow depression, mutagenesis, teratogenesis and carcinogenesis.
Overdose Reactions
 Overdosage symptoms are mainly extensions of common adverse reactions, especially leukopenia and thrombocytopenia, anaemia. No known antidote but whole blood or platelet transfusions have been beneficial in patients with haematopoietic toxicity. Thiotepa is removed by dialysis.
Drug Interactions
 Concomitant use of other alkylating agents or irradiation enhance effect. Prolongs action of succinylcholine and other neuromuscular-blocking agents due to inhibition of plasma pseudocholinesterase. Increased risk of myelosuppression when used with colony-stimulating factors (such as filgrastim, lenograstim) 24 hr before to 24 hr after admin of cytotoxic chemotherapy. Coadmin with cyclophosphamide inhibit the metabolism of cyclophosphamide to its active metabolite and decrease both its efficacy and toxicity.
See Below for More thiotepa Drug Interactions
Food Interactions
 Black cohosh, dong quai in oestrogen-dependent tumors.
Mechanism of Actions
 Thiotepa is an ethyleneimine alkylating agent which interferes with DNA replication and transcription of RNA, resulting in the disruption of nucleic acid function. It is also immunosupressive. It may control malignant effusion by a direct antineoplastic effect after intracavitary admin. Low pH enhances reactivity of thiotepa. It has generally been replaced by cyclophosphamide and other drugs.
Onset:
Absorption: GI: incomplete and unreliable. IM: variable. Through serous membranes eg. the bladder and pleura: absorption to some extent.
Metabolism: Extenive metabolised to active and inactive metabolites.
Excretion: Excreted in urine as unchanged drug and metabolites.
Storage Conditions
 Intracavitary: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light. Intravenous: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light. Intravesical: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light. Ophthalmic: Unconstituted powder: Store at 2-8°C. Urethral: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light.
ATC Classification
 L01AC01 - thiotepa ; Belongs to the class of alkylating agents, ethylene imines. Used in the treatment of cancer.
Storage
 Intracavitary: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light. Intravenous: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light. Intravesical: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light. Ophthalmic: Unconstituted powder: Store at 2-8°C. Urethral: Unconstituted powder: Store at 2-8°C; reconstituted (with sterile water for injection): store in a fridge and use within 8 hr; reconstituted solutions further diluted with sodium chloride Injection: used immediately. Protect from light.
Available As
  • Thiotepa 15 mg
  • Thiotepa 5 mg

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