Etopophos Side Effects

Please note - some side effects for Etopophos 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 Etopophos - for the Consumer

Etopophos

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 Etopophos:

Appetite loss; back pain; blue or purple discoloration of the skin; diarrhea; hair loss; increased sweating; nausea; tightness in throat; 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; fever; leukemia; liver problems; loss of consciousness; low blood pressure; pain, redness, or swelling at injection site; sore throat; sores on the mouth or lips; temporary blindness; tingling of the fingers or toes; unusual bruising or bleeding; unusual tiredness.

Etopophos Side Effects - for the Professional

Etopophos

Etopophos has been found to be well tolerated as a single agent in clinical studies involving 206 patients with a wide variety of malignancies, and in combination with cisplatin in 60 patients with small cell lung cancer. The most frequent clinically significant adverse experiences were leukopenia and neutropenia.

The incidences of adverse experiences in the table that follows are derived from studies in which Etopophos was administered as a single agent. A total of 98 patients received total doses at or above 450 mg/m2 on a 5 consecutive day or day 1, 3, and 5 schedule during the first course of therapy.

Since etoposide phosphate is converted to etoposide, those adverse experiences that are associated with VePesid can be expected to occur with Etopophos.

Hematologic Toxicity

Myelosuppression after Etopophos administration is dose related and dose limiting with the leukocyte nadir counts occurring from day 15 to day 22 after initiation of drug therapy, granulocyte nadir counts occurring day 12-19 after initiation of drug therapy, and platelet nadirs occurring from day 10-15. Bone marrow recovery usually occurs by day 21 but may be delayed, 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 following etoposide administration.

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.

Blood Pressure Changes

In clinical studies, 151 patients were treated with Etopophos with infusion times ranging from 30 minutes to 3.5 hours. Sixty-three patients received Etopophos as a 5-minute bolus infusion. Four patients experienced one or more episodes of hypertension and eight patients experienced one or more episodes of hypotension, which may or may not be drug related. One episode of hypotension was reported among those patients who received a 5-minute bolus infusion. If clinically significant hypotension or hypertension occurs with Etopophos, appropriate supportive therapy should be initiated.

Allergic Reactions

Anaphylactic-type reactions characterized by chills, rigors, tachycardia, bronchospasm, dyspnea, diaphoresis, fever, pruritus, hypertension or hypotension, loss of consciousness, nausea, and vomiting have been reported to occur in 3% (7/245) of all patients treated with Etopophos. Facial flushing was reported in 2% and skin rashes in 3% of patients receiving Etopophos. 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 initial infusion.

Anaphylactic-like reactions have occurred during the initial infusion of Etopophos. 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 44% of patients.

Other Toxicities

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

The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2081 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.