DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Vepesid (Etoposide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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. (See WARNINGS.)

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.

ADVERSE DRUG EFFECTPERCENT RANGE OF
REPORTED INCIDENCE
Hematologic toxicity
   Leukopenia (less than 1,000 WBC/mm3)3–17
   Leukopenia (less than 4,000 WBC/mm3)60–91
   Thrombocytopenia (less than 50,000 platelets/mm3)1–20
   Thrombocytopenia (less than 100,000 platelets/mm3)22–41
   Anemia0–33
Gastrointestinal toxicity
   Nausea and vomiting31–43
   Abdominal pain0–2
   Anorexia10–13
   Diarrhea1–13
   Stomatitis1–6
   Hepatic0–3
Alopecia8–66
Peripheral neurotoxicity1–2
Hypotension1–2
Allergic reaction1–2



REPORTS OF SUSPECTED VEPESID SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Vepesid. The information is not vetted and should not be considered as verified clinical evidence.

Possible Vepesid side effects / adverse reactions in 28 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-10

Patient: 28 year old female

Reactions: Live Birth, Pregnancy, Premature Delivery

Suspect drug(s):
Cisplatin
    Indication: Ovarian Neoplasm

Bleomycin Sulfate
    Indication: Ovarian Neoplasm

Vepesid
    Indication: Ovarian Neoplasm



Possible Vepesid side effects / adverse reactions in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-03

Patient: female weighing 2.0 kg (4.4 pounds)

Reactions: Respiratory Distress

Suspect drug(s):
Cisplatin

Bleo

Vepesid



Possible Vepesid side effects / adverse reactions in 28 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-03

Patient: 28 year old female weighing 57.0 kg (125.4 pounds)

Reactions: Caesarean Section, Live Birth, Maternal Exposure During Pregnancy, Premature Delivery, Neutrophil Count Decreased, Pregnancy

Suspect drug(s):
Cisplatin
    Indication: Ovarian Neoplasm
    Start date: 2010-05-10
    End date: 2010-08-13

Bleo
    Indication: Teratoma
    Start date: 2010-05-11
    End date: 2010-08-10

Cisplatin
    Indication: Teratoma
    Start date: 2010-05-10
    End date: 2010-08-13

Vepesid
    Indication: Ovarian Neoplasm
    Start date: 2010-05-10
    End date: 2010-08-13

Vepesid
    Indication: Teratoma
    Start date: 2010-05-10
    End date: 2010-08-13

Bleo
    Indication: Ovarian Neoplasm
    Start date: 2010-05-11
    End date: 2010-08-10



See index of all Vepesid side effect reports >>

Drug label data at the top of this Page last updated: 2006-12-08

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017