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

Applies to thiotepa: injection powder for solution.

Serious side effects of Tepadina

Along with its needed effects, thiotepa (the active ingredient contained in Tepadina) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking thiotepa:

More common

• Bleeding gums
• blood in the urine
• blurred or double vision
• confusion
• coughing up blood
• cracked lips
• diarrhea
• difficulty with breathing or swallowing
• difficulty with walking
• dizziness
• drooping eyelids
• headache, sudden, severe
• increased menstrual flow or vaginal bleeding
• jaw pain
• nausea and vomiting
• nosebleeds
• numbness or tingling in the fingers and toes
• pain in the fingers and toes
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• weakness

Incidence not known

• Absent, missed, or irregular menstrual periods
• blistering, peeling, or loosening of the skin
• bloated abdomen
• cough or hoarseness
• fast heartbeat
• fever or chills
• hives or welts, itching, or skin rash
• joint or muscle pain
• lower back or side pain
• pain and fullness in the right upper abdomen or stomach
• painful or difficult urination
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• stopping of menstrual bleeding
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain
• yellow eyes and skin

Other side effects of Tepadina

Some side effects of thiotepa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Abdominal or stomach pain
• blistering, burning, crusting, dryness, or flaking of the skin
• hair loss or thinning of the hair
• itching, scaling, severe redness, soreness, or swelling of the skin
• loss of appetite
• pain at the injection site
• stopping of menstrual bleeding
• weight loss

For Healthcare Professionals

Applies to thiotepa: injectable powder for injection, intravenous powder for injection.

Hematologic

Very common (10% or more): Leukopenia, thrombocytopenia, febrile neutropenia, anemia, pancytopenia

Granulocytopenia

Common (1% to 10%): Hemorrhage

Frequency not reported: Bone marrow depression, hematopoietic suppression,

thromboembolism, venous thromboembolism^[Ref]

Oncologic

Common (1% to 10%): Myelodysplastic syndrome, acute nonlymphocytic

leukemia^[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction (e.g., rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing)^[Ref]

Local

Very common (10% or more): Injection site edema, injection site inflammation, injection site pain

Frequency not reported: Contact dermatitis^[Ref]

Gastrointestinal

Very common (10% or more): Nausea, stomatitis, esophagitis, vomiting, diarrhea, abdominal pain, dyspepsia, enteritis, colitis, mucosal inflammation

Common (1% to 10%): Constipation, GI perforation, ileus

Uncommon (0.1% to 1%): GI ulcer

Frequency not reported: Oral mucositis^[Ref]

Renal

Very common (10% or more): Hemorrhagic cystitis (after intravesical or IV administration)

Common (1% to 10%): Oliguria, renal failure, cystitis, hematuria, dysuria, blood creatinine increased, blood urea increased

Frequency not reported: Urinary retention^[Ref]

Respiratory

Very common (10% or more): Idiopathic pneumonia syndrome, epistaxis

Common (1% to 10%): Pulmonary edema, cough, pneumonitis

Uncommon (0.1% to 1%): Hypoxia, pulmonary arterial hypertension

Frequency not reported: Apnea^[Ref]

Nervous system

Very common (10% or more): Dizziness, headache, encephalopathy, convulsion, paresthesia

Common (1% to 10%): Intracranial aneurysm, extrapyramidal disorder, cognitive disorder, cerebral hemorrhage

Frequency not reported: Leukoencephalopathy^[Ref]

Dermatologic

Very common (10% or more): Rash, alopecia, pruritus

Common (1% to 10%): Erythema

Uncommon (0.1% to 1%): Pigmentation disorder, erythrodermic psoriasis

Frequency not reported: Severe toxic skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, contact dermatitis), skin discoloration (following topical use or exposure), local irritation (comparable to mild radiation cystitis following bladder instillation)^[Ref]

Genitourinary

Very common (10% or more): Amenorrhea, azoospermia, vaginal hemorrhage

Common (1% to 10%): Impairment of fertility in male, female infertility, menopausal symptoms

Frequency not reported: Interference with spermatogenesis^[Ref]

Ocular

Very common (10% or more): Vision blurred, conjunctivitis

Common (1% to 10%): Cataract^[Ref]

Other

Very common (10% or more): Hearing impaired, ototoxicity, tinnitus, pyrexia, asthenia, chills, multi-organ failure, pain

Frequency not reported: Fatigue, weakness, febrile reaction, discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue^[Ref]

Immunologic

Very common (10% or more): Increased susceptibility to infections, sepsis, acute graft versus host disease, chronic graft versus host disease

Uncommon (0.1% to 1%): Toxic shock syndrome^[Ref]

Musculoskeletal

Very common (10% or more): Back pain, myalgia, arthralgia^[Ref]

Metabolic

Very common (10% or more): Anorexia, decreased appetite, hyperglycemia

Common (1% to 10%): Tumor lysis syndrome (occurring secondary to, spontaneous, or treatment related rapid destruction of malignant cells); features include hyperkalemia, hyperuricemia, and hyperphosphatemia with hypocalcemia (renal damage and arrhythmias can follow), weight increased, blood amylase increased^[Ref]

Psychiatric

Very common (10% or more): Confusion, mental status changes

Common (1% to 10%): Anxiety

Uncommon (0.1% to 1%): Delirium, nervousness, hallucination, agitation^[Ref]

Hepatic

Very common (10% or more): Venoocclusive liver disease, hepatomegaly, jaundice, blood bilirubin increased, transaminases increased, gamma

Glutamyltransferase, increased blood alkaline, phosphatase increased, aspartate aminotransferase increased^[Ref]

Cardiovascular

Very common (10% or more): Arrhythmia

Common (1% to 10%): Tachycardia, cardiac failure, lymphoedema, hypertension, embolism

Uncommon (0.1% to 1%): Cardiomyopathy, myocarditis^[Ref]

Endocrine

Common (1% to 10%): Hypopituitarism^[Ref]