VePesid Side Effects

Generic name: etoposide

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

Some side effects of VePesid 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 etoposide: intravenous solution, oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking etoposide (the active ingredient contained in VePesid) fever, chills, sweating, fast heartbeats, fainting; hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, chills, 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;

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

• vision problems;

• seizure (convulsions);

• sudden chest pain or discomfort, wheezing, dry cough or hack; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, stomach pain;

• diarrhea, constipation;

• trouble swallowing;

• unusual or unpleasant taste in your mouth;

• numbness or tingly feeling;

• mild itching or skin rash; or

• temporary hair loss.

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 etoposide: intravenous powder for injection, intravenous solution, oral capsule

Hematologic

Hematologic toxicity including leukopenia with WBC counts less than 1,000 WBC/mm3 (3% to 17%), or less than 4,000 WBC/mm3 (60% to 91%), thrombocytopenia with platelet counts less than 50,000 platelets/mm3 (1% to 20%), or less than 100,000 platelets/mm3 (22% to 41%), and anemia (up to 33%) have been reported.

Myelosuppression is dose related and dose limiting. Granulocyte nadirs occur 7 to 14 days after drug administration and usually recover within 20 days. Platelet nadirs occur 9 to 16 days after drug administration. Bone marrow recovery is usually complete by the 20th day. No cumulative toxicity has been reported. Fever and infection have been reported in patients with neutropenia.

Acute leukemia (with or without a preleukemic phase) has been reported rarely in patients treated with etoposide (the active ingredient contained in VePesid) in combination with other antineoplastic agents.

Etoposide induced leukemia has features distinct from the syndrome of secondary leukemia associated with alkylating agents. The secondary leukemia that may occur in patients receiving etoposide features a shorter latency period; a predominance of monocytic or myelomonocytic features; and frequent cytogenic abnormalities involving 11q23.

In five single-agent studies of etoposide phosphate used in the treatment of a variety of tumor types, WHO grade III or IV leukopenia, and granulocytopenia were reported more frequently among elderly patients.

Elderly patients may also be more sensitive to myelosuppression.

In one study, six of seven patients treated with 60 mg/m2/day dosages for 5 days developed bone marrow suppression. Three of the six patients developed life-threatening leukopenia, two with sepsis, one of which ended in septic death.

Gastrointestinal

Gastrointestinal side effects primarily including nausea and vomiting (31% to 43%) have been reported. Abdominal pain (up to 2%), anorexia (10% to 13%), diarrhea (1% to 13%), stomatitis (1% to 6%) and dysphagia have also been reported. Constipation has been reported infrequently. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion.

The severity of nausea and vomiting is generally mild to moderate. This effect can be prevented by the use of oral phenothiazines in most cases, if necessary. Treatment discontinuation is required in approximately 1% of patients.

Elderly patients may be more sensitive to gastrointestinal effects.

Cardiovascular

Cardiovascular side effects including transient hypotension following rapid intravenous administration (1% to 2%) has been reported. Transient hypertension, congestive heart failure, and arrhythmias have been reported rarely.

In one study of 5 day continuous infusion in 17 patients, 2 patients suffered myocardial infarction and one patient suffered congestive failure during treatment.

Hypersensitivity

Hypersensitivity side effects including anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea and/or hypotension (0.7% to 2%) have been reported. Hypertension and/or flushing have also been reported. Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain and/or loss of consciousness have sometimes occurred in association with the above reactions. An apparent hypersensitivity-associated apnea has been reported rarely. At least one hypersensitivity-associated death has been reported. Rash, urticaria, and/or pruritus have infrequently been reported.

At investigational dosages, a generalized pruritic erythematous macropapular rash, consistent with perivasculitis, has been reported.

Dermatologic

Dermatologic side effects including reversible alopecia (8% to 66%), sometimes progressing to total baldness, have been reported. Pruritus, phlebitis, hyperpigmentation and radiation recall dermatitis have been reported rarely.

In one study of 21 consecutive days of etoposide therapy, alopecia occurred in 11 of the 12 patients at risk for this toxicity (four had pre-existing alopecia, and two were inevaluable due to early death).

Elderly patients may be more sensitive to alopecia.

Hepatic

Hepatic toxicity (up to 3%) has generally been reported in patients receiving higher than recommended dosages. One report notes three cases of severe hepatocellular injury induced by standard dosages.

Other

Other side effects including aftertaste, fever, dysphagia, transient cortical blindness, and optic neuritis have been reported infrequently. Although the drug is not considered to be vesicant, chemical phlebitis has been reported in association with etoposide (the active ingredient contained in VePesid) infusion.

Metabolic acidosis has been reported in patients receiving higher than recommended dosages.

Respiratory

Respiratory side effects including a case report of fatal (biopsy-proven) pulmonary toxicity associated with the use of etoposide (the active ingredient contained in VePesid) in a SCLC patient have been reported.

General

General side effects including asthenia have been reported.

In five single-agent studies of etoposide phosphate used in the treatment of a variety of tumor types, asthenia was reported more frequently among elderly patients.

Immunologic

Immunologic side effects including infectious complications have been reported.

Elderly patients may be more sensitive to infectious complications.

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