Teniposide: Difference between revisions
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*Patients being treated with teniposide injection should be observed frequently for [[myelosuppression]] both during and after therapy. Dose-limiting bone marrow suppression is the most significant toxicity associated with teniposide therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent dose of teniposide: hemoglobin, white blood cell count and differential, and platelet count. If necessary, repeat bone marrow examination should be performed prior to the decision to continue therapy in the setting of severe myelosuppression. | *Patients being treated with teniposide injection should be observed frequently for [[myelosuppression]] both during and after therapy. Dose-limiting bone marrow suppression is the most significant toxicity associated with teniposide therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent dose of teniposide: hemoglobin, white blood cell count and differential, and platelet count. If necessary, repeat bone marrow examination should be performed prior to the decision to continue therapy in the setting of severe myelosuppression. | ||
'''Physicians should be aware of the possible occurrence of a [[hypersensitivity]] reaction variably manifested by [[chills]], [[fever]], [[urticaria]], [[tachycardia]], [[bronchospasm]], [[dyspnea]], [[hypertension]], [[orhypotension]], [[rash]], and [[facial flushing]]. This reaction may occur with the first dose of teniposide and may be life threatening if not treated promptly with [[antihistamines]], [[corticosteroids]], [[epinephrine]], intravenous fluids, and other supportive measures as clinically indicated. The exact cause of these reactions is unknown. They may be due to the polyoxyl 35 castor oil componentof the vehicle or to teniposide itself. Patients who have experienced prior hypersensitivity reactions to teniposide are at risk for recurrence of symptoms and should only be retreatedreactions has been accomplished using measures described above. To date, there is no evidence to suggest cross-sensitization between teniposide and etoposide. | '''Physicians should be aware of the possible occurrence of a [[hypersensitivity]] reaction variably manifested by [[chills]], [[fever]], [[urticaria]], [[tachycardia]], [[bronchospasm]], [[dyspnea]], [[hypertension]], [[orhypotension]], [[rash]], and [[facial flushing]]. This reaction may occur with the first dose of teniposide and may be life threatening if not treated promptly with [[antihistamines]], [[corticosteroids]], [[epinephrine]], intravenous fluids, and other supportive measures as clinically indicated. The exact cause of these reactions is unknown. They may be due to the polyoxyl 35 castor oil componentof the vehicle or to teniposide itself. Patients who have experienced prior hypersensitivity reactions to teniposide are at risk for recurrence of symptoms and should only be retreatedreactions has been accomplished using measures described above. To date, there is no evidence to suggest cross-sensitization between teniposide and etoposide.''' | ||
One episode of sudden death, attributed to probable arrhythmia and intractable hypotension, has been reported in an elderly patient receiving teniposide combination therapy for a nonleukemicmalignancy.''' | '''One episode of sudden death, attributed to probable arrhythmia and intractable hypotension, has been reported in an elderly patient receiving teniposide combination therapy for a nonleukemicmalignancy.''' | ||
*Patients receiving teniposide treatment should be under continuous observation for at least the first 60 minutes following the start ofthe infusion and at frequent intervals thereafter. If symptoms or signs of anaphylaxis occur, the infusion should be stopped immediately, followed by the administration of [[epinephrine]], [[corticosteroids]], [[antihistamines]], [[pressor agents]], or [[volume expanders]] at the discretion of the physician. An aqueous solution of epinephrine 1:1000 and a source of oxygen should beavailable at the bedside. | *Patients receiving teniposide treatment should be under continuous observation for at least the first 60 minutes following the start ofthe infusion and at frequent intervals thereafter. If symptoms or signs of anaphylaxis occur, the infusion should be stopped immediately, followed by the administration of [[epinephrine]], [[corticosteroids]], [[antihistamines]], [[pressor agents]], or [[volume expanders]] at the discretion of the physician. An aqueous solution of epinephrine 1:1000 and a source of oxygen should beavailable at the bedside. | ||
*For parenteral administration, teniposide should be given only by slow intravenous infusion (lasting at least 30 to 60 minutes) since hypotension has been reported as a possible side effect of rapid intravenous injection, perhaps due to a direct effect of polyoxyl 35 castor oil. If clinically significant hypotension develops, the teniposide infusion should be discontinued. The blood pressure usually normalizes within hours in response to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. If the infusion is restarted, a slower administration rate should be used and the patient should be carefully monitored. | *For parenteral administration, teniposide should be given only by slow intravenous infusion (lasting at least 30 to 60 minutes) since hypotension has been reported as a possible side effect of rapid intravenous injection, perhaps due to a direct effect of polyoxyl 35 castor oil. If clinically significant hypotension develops, the teniposide infusion should be discontinued. The blood pressure usually normalizes within hours in response to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. If the infusion is restarted, a slower administration rate should be used and the patient should be carefully monitored. | ||
*Acute central nervous system depression, [[hypotension]], and [[metabolic acidosis]] have been observed in patients receiving investigational infusions of high-dose teniposide who were pretreated with [[antiemetic drugs]]. The depressant effects of the antiemetic agents and the alcohol content of the teniposide formulation may place patients receiving higher than recommended doses of teniposide a risk for central nervous system depression. | *Acute central nervous system depression, [[hypotension]], and [[metabolic acidosis]] have been observed in patients receiving investigational infusions of high-dose teniposide who were pretreated with [[antiemetic drugs]]. The depressant effects of the antiemetic agents and the alcohol content of the teniposide formulation may place patients receiving higher than recommended doses of teniposide a risk for central nervous system depression. | ||
|clinicalTrials=The table below presents the incidences of adverse reactions derived from an analysis of data contained within literature reports of 7 studies involving 303 pediatric patients in which teniposide was administered by injection as a single agent in a variety of doses and schedules for a variety of hematologic malignancies and solid tumors. The total number of patients evaluable for a given event was not 303 since the individual studies did not address the occurrence of each event listed. Five of these 7 studies assessed teniposide activity in hematologic malignancies, such as leukemia. Thus, many of these patients had abnormal hematologic status at start of therapy with teniposide and were expected to develop significant myelosuppression as an endpoint of treatment. | |||
[[file:Teniposide AR1.png|none|400px]] | |||
Hematologic Toxicity | |||
Teniposide, when used with other chemotherapeutic agents for the treatment of ALL, results in severe myelosuppression. Sepsis, sometimes fatal, may be a consequence of severe myelosuppression. Early onset of profound myelosuppression with delayed recovery can be expected when using the doses and schedules of teniposide necessary for treatment of refractory ALL, since bone marrow hypoplasia is a desired endpoint of therapy. The occurrence of acute non-lymphocytic leukemia (ANLL), with or without a preleukemic phase, has been reported in patients treated with teniposide in combination with other antineoplastic agents. (See PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility.) | |||
Gastrointestinal Toxicity | |||
Nausea and vomiting are the most common gastrointestinal toxicities, having occurred in 29% of evaluable pediatric patients. The severity of this nausea and vomiting is generally mild to moderate. | |||
Hypotension | |||
Transient hypotension following rapid intravenous administration has been reported in 2% of evaluable pediatric patients. One episode of sudden death, attributed to probable arrhythmia and intractable hypotension, has been reported in an elderly patient receiving teniposide combination therapy for a non-leukemic malignancy. | |||
No other cardiac toxicity or electrocardiographic changes have been documented. No delayed hypotension has been noted. | |||
Allergic Reactions | |||
Hypersensitivity reactions characterized by chills, fever, tachycardia, flushing, bronchospasm, dyspnea, rash, and blood pressure changes (hypertension or hypotension) have been reported to occur in approximately 5% of evaluable pediatric patients receiving intravenous teniposide. The incidence of hypersensitivity reactions to teniposide appears to be increased in patients with brain tumors and in patients with neuroblastoma. | |||
Central Nervous System | |||
Neurotoxicity has been reported, including severe cases of neuropathy, in patients receiving vincristine sulfate and teniposide concomitantly. | |||
Acute central nervous system depression and hypotension have been observed in patients receiving investigational infusions of high-dose teniposide who were pretreated with antiemetic drugs. The depressant effects of the antiemetic agents and the alcohol content of the teniposide formulation may place patients receiving higher than recommended doses of teniposide at risk for central nervous system depression. | |||
Alopecia | |||
Alopecia, sometimes progressing to total baldness, was observed in 9% of evaluable pediatric patients who received teniposide as single-agent therapy. It was usually reversible. | |||
Other Adverse Reactions | |||
The following adverse reactions have been reported: headache, confusion, and asthenia. Headache and confusion were associated with hypersensitivity reactions. | |||
|overdose=*Acute central nervous system depression, hypotension, and metabolic acidosis have been observed in patients who were receiving higher than recommended doses of teniposide, and who were also pretreated with antiemetic drugs. | |||
*There is no known antidote for teniposide overdosage. The anticipated complications of overdosage are secondary to bone marrow suppression. Treatment should consist of supportive care, including blood products and antibiotics as indicated. | |||
|alcohol=Alcohol-Teniposide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Teniposide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
__NOTOC__ | __NOTOC__ | ||
Revision as of 21:56, 11 February 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Teniposide is an antineoplastic and a mitotic inhibitor that is FDA approved for the treatment of childhood acute lymphoblastic leukemia. Common adverse reactions include diarrhea, inflammatory disease of mucous membrane, nausea, vomiting, anemia, leukopenia, thrombocytopenia and infectious disease.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Teniposide FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Teniposide in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Teniposide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Teniposide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Teniposide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Teniposide in pediatric patients.
Contraindications
- Teniposide is generally contraindicated in patients who have demonstrated a previous hypersensitivity to teniposide and/or polyoxyl 35 castor oil.
Warnings
- Teniposide is a potent drug and should be used only by physicians experienced in the administration of cancer chemotherapeutic drugs. Blood counts, as well as renal and hepatic function tests, should be carefully monitored prior to and during therapy.
- Patients being treated with teniposide injection should be observed frequently for myelosuppression both during and after therapy. Dose-limiting bone marrow suppression is the most significant toxicity associated with teniposide therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent dose of teniposide: hemoglobin, white blood cell count and differential, and platelet count. If necessary, repeat bone marrow examination should be performed prior to the decision to continue therapy in the setting of severe myelosuppression.
Physicians should be aware of the possible occurrence of a hypersensitivity reaction variably manifested by chills, fever, urticaria, tachycardia, bronchospasm, dyspnea, hypertension, orhypotension, rash, and facial flushing. This reaction may occur with the first dose of teniposide and may be life threatening if not treated promptly with antihistamines, corticosteroids, epinephrine, intravenous fluids, and other supportive measures as clinically indicated. The exact cause of these reactions is unknown. They may be due to the polyoxyl 35 castor oil componentof the vehicle or to teniposide itself. Patients who have experienced prior hypersensitivity reactions to teniposide are at risk for recurrence of symptoms and should only be retreatedreactions has been accomplished using measures described above. To date, there is no evidence to suggest cross-sensitization between teniposide and etoposide.
One episode of sudden death, attributed to probable arrhythmia and intractable hypotension, has been reported in an elderly patient receiving teniposide combination therapy for a nonleukemicmalignancy.
- Patients receiving teniposide treatment should be under continuous observation for at least the first 60 minutes following the start ofthe infusion and at frequent intervals thereafter. If symptoms or signs of anaphylaxis occur, the infusion should be stopped immediately, followed by the administration of epinephrine, corticosteroids, antihistamines, pressor agents, or volume expanders at the discretion of the physician. An aqueous solution of epinephrine 1:1000 and a source of oxygen should beavailable at the bedside.
- For parenteral administration, teniposide should be given only by slow intravenous infusion (lasting at least 30 to 60 minutes) since hypotension has been reported as a possible side effect of rapid intravenous injection, perhaps due to a direct effect of polyoxyl 35 castor oil. If clinically significant hypotension develops, the teniposide infusion should be discontinued. The blood pressure usually normalizes within hours in response to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. If the infusion is restarted, a slower administration rate should be used and the patient should be carefully monitored.
- Acute central nervous system depression, hypotension, and metabolic acidosis have been observed in patients receiving investigational infusions of high-dose teniposide who were pretreated with antiemetic drugs. The depressant effects of the antiemetic agents and the alcohol content of the teniposide formulation may place patients receiving higher than recommended doses of teniposide a risk for central nervous system depression.
Adverse Reactions
Clinical Trials Experience
The table below presents the incidences of adverse reactions derived from an analysis of data contained within literature reports of 7 studies involving 303 pediatric patients in which teniposide was administered by injection as a single agent in a variety of doses and schedules for a variety of hematologic malignancies and solid tumors. The total number of patients evaluable for a given event was not 303 since the individual studies did not address the occurrence of each event listed. Five of these 7 studies assessed teniposide activity in hematologic malignancies, such as leukemia. Thus, many of these patients had abnormal hematologic status at start of therapy with teniposide and were expected to develop significant myelosuppression as an endpoint of treatment.
Hematologic Toxicity Teniposide, when used with other chemotherapeutic agents for the treatment of ALL, results in severe myelosuppression. Sepsis, sometimes fatal, may be a consequence of severe myelosuppression. Early onset of profound myelosuppression with delayed recovery can be expected when using the doses and schedules of teniposide necessary for treatment of refractory ALL, since bone marrow hypoplasia is a desired endpoint of therapy. The occurrence of acute non-lymphocytic leukemia (ANLL), with or without a preleukemic phase, has been reported in patients treated with teniposide in combination with other antineoplastic agents. (See PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility.)
Gastrointestinal Toxicity Nausea and vomiting are the most common gastrointestinal toxicities, having occurred in 29% of evaluable pediatric patients. The severity of this nausea and vomiting is generally mild to moderate.
Hypotension Transient hypotension following rapid intravenous administration has been reported in 2% of evaluable pediatric patients. One episode of sudden death, attributed to probable arrhythmia and intractable hypotension, has been reported in an elderly patient receiving teniposide combination therapy for a non-leukemic malignancy.
No other cardiac toxicity or electrocardiographic changes have been documented. No delayed hypotension has been noted.
Allergic Reactions Hypersensitivity reactions characterized by chills, fever, tachycardia, flushing, bronchospasm, dyspnea, rash, and blood pressure changes (hypertension or hypotension) have been reported to occur in approximately 5% of evaluable pediatric patients receiving intravenous teniposide. The incidence of hypersensitivity reactions to teniposide appears to be increased in patients with brain tumors and in patients with neuroblastoma.
Central Nervous System Neurotoxicity has been reported, including severe cases of neuropathy, in patients receiving vincristine sulfate and teniposide concomitantly.
Acute central nervous system depression and hypotension have been observed in patients receiving investigational infusions of high-dose teniposide who were pretreated with antiemetic drugs. The depressant effects of the antiemetic agents and the alcohol content of the teniposide formulation may place patients receiving higher than recommended doses of teniposide at risk for central nervous system depression.
Alopecia Alopecia, sometimes progressing to total baldness, was observed in 9% of evaluable pediatric patients who received teniposide as single-agent therapy. It was usually reversible.
Other Adverse Reactions The following adverse reactions have been reported: headache, confusion, and asthenia. Headache and confusion were associated with hypersensitivity reactions.
Postmarketing Experience
There is limited information regarding Teniposide Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Teniposide Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Teniposide in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Teniposide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Teniposide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Teniposide in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Teniposide in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Teniposide in geriatric settings.
Gender
There is no FDA guidance on the use of Teniposide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Teniposide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Teniposide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Teniposide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Teniposide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Teniposide in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Teniposide Administration in the drug label.
Monitoring
There is limited information regarding Teniposide Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Teniposide and IV administrations.
Overdosage
- Acute central nervous system depression, hypotension, and metabolic acidosis have been observed in patients who were receiving higher than recommended doses of teniposide, and who were also pretreated with antiemetic drugs.
- There is no known antidote for teniposide overdosage. The anticipated complications of overdosage are secondary to bone marrow suppression. Treatment should consist of supportive care, including blood products and antibiotics as indicated.
Pharmacology
There is limited information regarding Teniposide Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Teniposide Mechanism of Action in the drug label.
Structure
There is limited information regarding Teniposide Structure in the drug label.
Pharmacodynamics
There is limited information regarding Teniposide Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Teniposide Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Teniposide Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Teniposide Clinical Studies in the drug label.
How Supplied
There is limited information regarding Teniposide How Supplied in the drug label.
Storage
There is limited information regarding Teniposide Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Teniposide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Teniposide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Teniposide Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Teniposide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Teniposide Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Teniposide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.