VePesid Side Effects

Generic Name: etoposide

Please note - some side effects for VePesid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of VePesid - for the Consumer

VePesid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using VePesid:

Appetite loss; bruising; diarrhea; hair loss; increased sweating; nausea; voice changes; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; cough; decreased ability to fight infection; dizziness; fever; loss of consciousness; seizure; sore throat; sores on the mouth or lips; temporary blindness; tingling of the fingers or toes; unusual bruising or bleeding; unusual tiredness.

VePesid Side Effects - for the Professional

VePesid

The following data on adverse reactions are based on both oral and intravenous administration of VePesid as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.

Hematologic Toxicity

Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported.

The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with VePesid in association with other antineoplastic agents.

Gastrointestinal Toxicity

Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion.

Allergic Reactions

Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous VePesid and in less than 1% of the patients treated with the oral capsules. These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually normalizes within a few hours after cessation of the infusion. Anaphylactic-like reactions have occurred during the initial infusion of VePesid.

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. In addition, an apparent hypersensitivity-associated apnea has been reported rarely.

Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported.

Alopecia

Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients.

Other Toxicities

The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.

Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with VePesid. Metabolic acidosis has also been reported in patients receiving higher doses.

The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when VePesid was used either orally or by injection as a single agent.

Side Effects by Body System

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 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 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 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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