TEPADINA (thiotepa)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Anemia
Bone marrow depression
Increased risk of bleeding
Infection
Leukopenia
Pregnancy
Thrombocytopenic disorder

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Child-pugh class B hepatic impairment
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Disease of liver

There are 44 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Anemia Cytomegalovirus disease Hemorrhage Hyperbilirubinemia Infection Leukopenia Neutropenic disorder Stomatitis Thrombocytopenic disorder	Hyperuricemia Immunosuppression Injection site sequelae Intracranial bleeding

Rare/Very Rare

Anaphylaxis Ascites Blistering skin Bradycardia Cerebrovascular accident Chronic heart failure Coma Cystitis Dyspnea Encephalopathy Enterocolitis Hemorrhagic cystitis Hepatic veno-occlusive disease Hepatomegaly Laryngeal edema Leukemia Malignant lymphoma Multiple organ failure Pericardial effusion Pericarditis Post-transplant lymphoproliferative disease Pulmonary hypertension Renal failure Seizure disorder Stevens-johnson syndrome Subdural intracranial hemorrhage Suicidal ideation Toxic epidermal necrolysis Vision impairment Wheezing

There are 43 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Hematuria Skin rash	Acute abdominal pain Alopecia Amenorrhea Anorexia Blurred vision Conjunctivitis Dizziness Dyschromia Fatigue Fever General weakness Headache disorder Hyponatremia Irregular menstrual periods Nausea Oligospermia Pruritus of skin Skin inflammation Urinary retention Urticaria Vomiting

Rare/Very Rare
Abnormal desquamation Acute cognitive impairment Allergic dermatitis Asthma Behavioral disorders Blepharoptosis Bradykinesia Delirium Depression Drowsy Dysphagia Dysuria Gait abnormality Gastritis Hallucinations Hearing loss Indifference Malaise Memory impairment

Thiotepa can cause fetal harm when administered to pregnant women. In mice, intraperitoneal administration of thiotepa at doses exceeding or equal to 1 mg/kg (3.2 mg/m2; eightfold lower than the maximum recommended therapeutic dose in humans based on body surface area) were associated with teratogenicity. Teratogenicity also was reported in rats receiving intraperitoneal administration of thiotepa at doses exceeding or equal to 3 mg/kg (21 mg/m2; approximately equal to the maximum recommended therapeutic dose in humans based on body surface area).

Lethality was observed in rabbits receiving thiotepa at doses of 3 mg/kg (41 mg/m2; approximately twice the maximum recommended therapeutic dose in humans based on body surface area). The manufacturer recommends that an effective method of contraception be used during therapy with the drug if either the patient or the sexual partner is of childbearing potential. There are no adequate and controlled studies to date using thiotepa in pregnant women.

When the drug is administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient and sexual partner should be informed of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during thiotepa therapy.

It is not known whether thiotepa is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity of thiotepa if it were distributed, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.