Thioplex Side Effects

Generic name: thiotepa

Note: This document contains side effect information about thiotepa. Some of the dosage forms listed on this page may not apply to the brand name Thioplex.

Some side effects of Thioplex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to thiotepa: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking thiotepa (the active ingredient contained in Thioplex) hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• bloody, black, or tarry stools;

• cough up blood or vomit that looks like coffee grounds;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• painful or difficult urination;

• urinating less than usual;

• severe nausea or vomiting; or

• pain, burning, irritation, or skin changes where the injection was given.

Less serious side effects of thiotepa may include:

• headache, dizziness, feeling weak or tired;

• blurred vision;

• mild nausea, mild stomach pain, occasional vomiting;

• eye redness, puffy eyelids;

• temporary hair loss;

• mild rash or itching;

• mild pain where the medicine was injected;

• skin discoloration; or

• missed menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to thiotepa: injectable powder for injection

Hematologic

Hematologic side effects have included bone-marrow depression, which is the most serious complication of excessive thiotepa (the active ingredient contained in Thioplex) therapy, or sensitivity to the effects of thiotepa. If proper precautions are not observed, leukopenia, thrombocytopenia and/or anemia may develop. The nadir in the leukocyte and platelet counts generally occur in 7 to 10 days and 21 days respectively.

Death has occurred after intravesical administration, caused by bone-marrow depression from systemically absorbed drug. However, if the drug is administered by intracavitary or intravesical injection, myelosuppression is not predictable. Death from septicemia and hemorrhage has occurred as a direct result of hematopoietic depression. Thiotepa is highly toxic to the hematopoietic system.

Pancytopenia has been reported. One case report was of early onset life-threatening pancytopenia following a total dosage of 120 mg.

In one study of 670 bladder installations in 72 patients, the white blood cell or platelet count decreased to below normal in 18% of the patients (3.9% of the installations). None of these decreased counts lead to any problems other than delays in therapy.

New York Hospital reviewed its records of patients who received at least one intravesicular installation of thiotepa for localized bladder cancer. Ten of 25 consecutive patients had at least one episode of acute myelosuppression. Thrombocytopenia occurred in 9 patients, leukopenia in 5, and anemia in 2.

Oncologic

Oncologic side effects have included cases of myelodysplastic syndromes and acute nonlymphocytic leukemia. Carcinogenicity has been reported in animal studies.

In mice, repeated IP administration produced a significant increase in the combined incidence of squamous-cell carcinomas of the skin, preputial gland, and ear canal, and combined incidence of lymphoma and lymphocytic leukemia. In other studies in mice, repeated IP administration resulted in an increased incidence of lung tumors. In rats, repeated IP administration produced significant increases in the incidence of squamous-cell carcinomas of the skin or ear canal, combined hematopoietic neoplasms, and uterine adenocarcinomas. Thiotepa given intravenously to rats produced an increased incidence of malignant tumors (abdominal cavity sarcoma, lymphosarcoma, myelosis, seminoma, fibrosarcoma, salivary gland hemangioendothelioma, mammary sarcoma, pheochromocytoma) and benign tumors. The lowest reported carcinogenic dosages in mice and rats are approximately 7-fold and 6-fold less than the maximum recommended human therapeutic dose based on body-surface area.

General

General side effects including fatigue and weakness have been reported. Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue.

Hypersensitivity

Allergic reactions including rash, urticaria, laryngeal edema, asthma, hives, anaphylactic shock, and wheezing have been reported.

Local

Local reactions including contact dermatitis and pain at the injection site have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and anorexia have been reported. Abdominal pain has been reported, particularly after intravesical administration.

Renal

Renal side effects including dysuria and urinary retention have been reported. There have been rare reports of chemical or hemorrhagic cystitis following intravesical administration.

A case of renal failure due to a reaction causing urethral obstruction (following a bladder installation) has been reported.

Respiratory

Respiratory side effects including prolonged apnea has been reported when succinylcholine was administered prior to surgery, followed by the combined use of thiotepa (the active ingredient contained in Thioplex) and other anticancer agents.

Nervous system

Neurologic side effects including dizziness, headache, blurred vision, lower extremity weakness, pain, and paresthesia have been reported. Spinal cord demyelination may occur after intrathecal administration.

Dermatologic

Dermatologic side effects including alopecia and dermatitis have been reported. Skin depigmentation has been reported following topical use.

Genitourinary

Genitourinary side effects including amenorrhea, interference with spermatogenesis and sterility have been reported.

Ocular

Ocular side effects including conjunctivitis have been reported. Following ocular administration, periorbital depigmentation has been reported.

Other

An in vitro study has shown that the drug causes chromosomal aberrations of the chromatid type and that the frequency of induced aberrations increases with the age of the subject.

Other side effects include a mutagenic effect in vitro assays including those on human lymphocytes.

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