Teniposide Side Effects

Some side effects of teniposide 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 teniposide: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking teniposide: hives; difficulty 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, itching, body aches, flu symptoms, sores in your mouth and throat;

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

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

• fast or pounding heartbeats, wheezing, chest tightness, trouble breathing;

• severe headache, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats;

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

• feeling like you might pass out; or

• severe nausea and vomiting.

Less serious side effects of teniposide may include:

• mild headache;

• drowsiness, dizziness, feeling tired or weak;

• mild nausea, stomach pain, loss of appetite;

• constipation, diarrhea;

• temporary hair loss; or

• mild skin rash.

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 teniposide: intravenous solution

Hematologic

Hematologic side effects have included bone marrow suppression which is the most significant toxicity associated with teniposide therapy. Hematologic effects including neutropenia (less than 2,000 ANC/mcL), leukopenia (less than 3,000 WBC/mcL), anemia (88%), thrombocytopenia (less than 100,000 platelets/mcL) (85%), myelosuppression (unspecified) (75%), and bleeding (5%) have been reported. Sepsis, sometimes fatal, may be a consequence of severe myelosuppression.

Hypersensitivity

Hypersensitivity side effects (5%) have been reported. These have included some potentially life threatening hypersensitivity reactions with anaphylaxis-like symptoms.

The hypersensitivity reaction may include chills, fever, urticaria, tachycardia, bronchospasm, dyspnea, hypertension or hypotension, and facial flushing. Treatment for a severe hypersensitivity reaction include prompt use of antihistamines, corticosteroids, epinephrine, intravenous fluids, and other supportive measures.

One analysis of hypersensitivity reactions to teniposide concluded that the frequency of the reactions is substantially higher in patients with neuroblastoma and brain tumors.

Cardiovascular

Cardiovascular side effects including hypotension/cardiovascular (2%) have been reported. One episode of sudden death attributable to probable arrhythmia and intractable hypotension has also been reported.

Oncologic

Oncologic side effects include one report of a relative risk of developing secondary acute nonlymphocytic leukemia approximately twelve times that of patients treated with less intensive schedules.

The patients in the report were children with acute lymphoblastic leukemia in remission who received teniposide plus other chemotherapeutic agents at weekly or twice weekly doses.

Compounds with similar mechanisms of action and mutagenicity profiles have been carcinogenic. Teniposide should be considered to be a potential carcinogen. Teniposide has been shown to be mutagenic in various bacterial and mammalian genetic toxicity tests.

Gastrointestinal

Gastrointestinal side effects including mucositis (76%), diarrhea (33%), and nausea/vomiting (29%) have been reported.

Immunologic

Immunologic side effects including infection (12%) have been reported.

Dermatologic

Alopecia, which sometimes progressed to total baldness, was usually reversible.

Dermatologic side effects including alopecia (9%) and rash (3%) have been reported.

General

General side effects including fever and asthenia have been reported.

Nervous system

Nervous system side effects have included headache, confusion, neurotoxicity and, at investigational high doses, acute CNS depression has been reported.

Other

Other side effects have included three case reports of somnolence, hypotension, and metabolic acidosis which have been reported with teniposide doses at three to five times the standard dose.

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