Dosing and uses of Tespa, Thioplex (thiotepa)
Adult dosage forms and strengths
powder for injection
- 15mg
Bladder Cancer
Intravesical (superficial bladder cancer): 30-60 mg in 30-60 mL NS qWeek for 4 weeks; retain for 2 hours; if patient can not retain for 2 hr, dilute and use successive doses in 30 mL of sodium chloride 0.9% instead of 60 mL
Ovarian Cancer
0.3-0.4 mg/kg q1-4Weeks OR 0.2 mg/kg for 4-5 days q2-4Weeks
Effusions
Intracavitary: 0.6-0.8 mg/kg or 30-60 mg weekly
Leptomeningeal Metastases
1-10 mg/m² intrathecal in qWeek to 2 times/week as 1 mg/mL in sterile water for injection
High-dose IV Therapy for Bone Marrow Transplant
500 mg/m², up to 1,125 mg/m²
General Dosing Information
Refer to individual protocols
IM (unlabeled): 15-30 mg in various schedules
Interpericardial (unlabeled): 15-30 mg
Intratumor (unlabeled): 0.6-0.8 mg/kg q1-4Weeks
Monitor
CBC
Discontinue if WBC <3000/mm³ or platelets <150,000/mm³
Renal function
Renal Impairment
Caution; may require lower dose; limit use to cases where benefit outweigh risk
Hepatic Impairment
Caution; may require lower dose; limit use to cases where benefit outweigh risk
Other Indications & Uses
Bladder cancer, breast or ovary adenocarcinoma, Hodgkin's disease, NHL (largely superseded by other drugs)
Control of malignant pericardial/pleural/peritoneal effusions (intracavitary)
Off-label: meningeal neoplasms
Pediatric dosage forms and strengths
powder for injection
- 15mg
Sarcomas (Unlabeled)
25-65 mg/m² IV q3-4weeks
Hematopoietic Stem Cell Transplantation (Unlabeled)
300 mg/m qDay for 3 days (900 mg/m total) in chemotherapy combinations have been used
Geriatric dosage forms and strengths
Bladder cancer
Intravesical (superficial bladder cancer): 30-60 mg in 30-60 mL NS qWeek for 4 weeks; retain for 2 hours; if patient can not retain for 2 hr, dilute and use successive doses in 30 mL of sodium chloride 0.9% instead of 60 mL
Ovarian cancer
0.3-0.4 mg/kg q1-4Weeks OR 0.2 mg/kg for 4-5 days q2-4Weeks
Effusions
Intracavitary: 0.6-0.8 mg/kg or 30-60 mg weekly
Leptomeningeal metastases
1-10 mg/m² intrathecal in qWeek to 2 times/week as 1 mg/mL in sterile water for injection
High-dose IV therapy for bone marrow transplant
500 mg/m², up to 1,125 mg/m²
Tespa, Thioplex (thiotepa) adverse (side) effects
Frequency not defined
Asthenia
Fatigue
Seizures
Fever
Nausea
Vomiting
Loss of appetite
Stomatitis
Diarrhea
Myelosuppression
Leukemia
Immune hypersensitivity reaction
Oligozoospermia
Amenorrhea
Alopecia (slow)
Hyperpigmentation
Rash
Injection site pain
Warnings
Contraindications
Hypersensitivity
Hepatic, renal, bone marrow damage (maybe used in low dose if benefit>risk)
Cautions
Avoid pregnancy
May be mutagenic and teratogenic
Myelosuppression may occur
Secondary malignancies may develop (potentially carcinogenic)
Caution in hepatic impairment (may require dose reduction; use may also be contraindicated depending on type of hepatic impairment)
Caution in renal impairment (may require dose reduction; use may also be contraindicated depending on type of hepatic impairment)
Use appropriate precautions for handling and disposaL
Pregnancy and lactation
Pregnancy category: d
Lactation: not known if excreted in breast milk, do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Tespa, Thioplex (thiotepa)
Mechanism of action
Alkylating agent that produces crosslinking of DNA strands by reacting with phosphate groups to inhibit protein synthesis, DNA, and RNA
Pharmacokinetics
Half-life elimination: 2.4 hour (parent drug), 17.6 hr (metabolite)
Metabolism: Liver
Total body clearance: 446-419 mL/min
Excretion: Urine
Dialyzable: Yes
Administration
IV Incompatibilities
Additive: cisplatin
Y-site: cisplatin, filgrastim, minocycline, vinorelbine
IV Compatibilities
Solution: D5W(?), NS(?)
Y-site (partial list): acyclovir, allopurinol, ampicillin/sulbactam, bleomycin, carboplatin, clindamycin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, dopamine, etoposide, etoposide phosphate, filgrastim, fluconazole, fluorouracil, gemcitabine, heparin, idarubicin, lorazepam, MgSO4, metronidazole, mitomycin, morphine, ondansetron, KCl, prochlorperazine, teniposide, tobramycin, vancomycin, vinblastine, vincristine
IV Preparation
Reconstitute in 1.5 mL SWI to 10 mg/mL which is stable for 8 hr at refrigeration; further dilution in NS, D5W, or LR should be used immediately (within 1 hr of preparation)
Standard IV dilution
- IVP: use 10 mg/mL solution
- IVPB: dose/250 mL D5W; further dilution in NS, D5W, or LR should be used immediately (within 1 hr of preparation)
- Continuous 24 hr IV infusion Dose >250 mg: QS to 50 mL (total volume) in NSDose 230-250 mg: QS to 45 mL (total volume) in NSDose 200-230 mg: QS to 40 mL (total volume) in NS
IV Administration
Administer over 1 min
Solutions should be filtered through a 0.22 micron filter prior to administration
1 mg/mL solution is considered isotonic
Storage
Store intact vials under refrigeration (2-8°C)
Protect from light