Thiotepa

• Do not administer live or attenuated viral or bacterial vaccines to a patient treated with this medication until the immunosuppressive effects have resolved.
• Treatment with this drug can be responsible for skin discoloration, blistering, desquamation, pruritus and peeling that could be severe in the groin, skin folds, axillae in the neck area, and under dressings.
• Instruct patients to shower or bathe with the water at least a couple of times daily through 48 hours after the administration of this drug.
• Patients must be monitored for the serum transaminases and bilirubin daily through BMT Day +28, and provide supportive care to patients who develop hepatic veno-occlusive disease.
• Febrile reactions and discharge from a subcutaneous lesion can occur as the result of the breakdown of the tumor tissue.
• Patients must be informed about developing low blood cell counts and required for a hematopoietic progenitor cell infusion.
• In some patients prolonged apnea occurred when succinylcholine was administered before surgery, following combined use of the thiotepa 15 mg and other anticancer agents.
• Patients must be instructed in order to report to their doctor in the event of the bleeding or fever.
• Counsel patients on the symptoms of hypersensitivity and to seek emergency help if they experience any of these symptoms.
• Advise males with the female sexual partners about reproductive potential in order to use effective contraception during the treatment with this drug and for at least 12 months after the final dose of the Thiotepa.
• It may cause fetal harm. Females taking this medicine must be instructed in order to avoid pregnancy while on the treatment with Thiotepa and for minimum six months after the final dose of it.
• Females should be advised to report pregnancy as soon as possible.
• Patients should be instructed that this medicine may produce infertility. Male patients must be informed about the possibility of the sperm conservation prior to the initiation of the therapy.
• Advise patients to avoid breastfeeding while receiving this medication.
• Inform patients that this medicine may increase the risk of secondary malignancy.

Care should be exercised in the handling of THIOTEPA. Vials should not be opened or crushed. Store permitted between 2°C to 8°C (36° to 46°F). Do not freeze it.

• In vitro studies suggest that thiotepa is metabolized by CYP3A4 and CYP2B6 to its active metabolite TEPA. Avoid coadministration of strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with thiotepa due to the potential effects on efficacy as well as toxicity. Consider alternative drugs with no or minimal potential to inhibit or induce CYP3A4. If concomitant use of strong CYP3A4 modulators cannot be avoided, monitor for adverse drug reactions.
• Use of thiotepa together with cyclophosphamide in patients decreases the conversion of cyclophosphamide to the active metabolite, 4-hydroxycyclophosphamide; the effect seems sequence-dependent with a greater decrement in the conversion to 4-hydroxycyclophosphamide when thiotepa is used 1.5 hours prior to the intravenous use of cyclophosphamide in comparison with the administration of thiotepa following intravenous cyclophosphamide. The decrease in the level of 4-hydroxycyclophosphamide may potentially decrease the efficacy of cyclophosphamide treatment.