drug-monograph

teniposide

Other Names

Vumon®

Appearance

clear, pale yellow solution mixed into larger bags of fluids

A - Drug Name

teniposide

SYNONYM(S): PTG; VM-26

COMMON TRADE NAME(S): Vumon® (Bristol-Myers Squibb)

B - Mechanism of Action and Pharmacokinetics

Teniposide is a semisynthetic podophyllotoxin derived from the root of Podophyllum peltatum (the May apple or mandrake) and is structurally and pharmacologically related to etoposide. It is known to cause single or double-strand breaks in DNA and DNA-protein cross links, through inhibition of the enzyme topoisomerase II. Teniposide is cell cycle phase-specific with predominant activity occurring in late S₂ and G₂, thus preventing cells from entering mitosis.

Absorption

Not studied

Distribution

Mostly distributed to liver, kidneys, large intestines, thyroid and adrenals. Pharmacokinetics are linear with no evidence of accumulation with multiple doses

Cross blood brain barrier?

Low

PPB

> 99%

Metabolism

Primary route of elimination is by hepatic metabolism (86%)

Active metabolites

Yes

Inactive metabolites

Yes

Elimination

Urine

44%; 4-12% unchanged

Feces

<10% within 72 hours

Half-life

6-20 hours; 5 hours (pediatrics)

C - Indications and Status

Health Canada Approvals:

Acute lymphocytic leukemia (second-line combination with cytarabine)
Neuroblastoma (second-line single agent or in combination)
Non-Hodgkin’s lymphoma (second-line single agent or in combination)

D - Adverse Effects

Emetogenic Potential:

Low

Extravasation Potential: Irritant

The percentage incidences below were reported in pediatric patients.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Arrhythmia (rare)	I E
	Hypertension (rare)	E
	Hypotension (2%) (with rapid IV infusion, or high doses)	I
Dermatological	Alopecia (9%)	E
	Rash (3%)	E
Gastrointestinal	Abdominal pain	E
	Anorexia	E
	Diarrhea (33%)	E
	Mucositis (76%)	E
	Nausea, vomiting (29%)	I
General	Fatigue	E
Hematological	Myelosuppression ± infection, bleeding (90%) (may be severe)	E
Hepatobiliary	↑ LFTs (<1%)	E
Hypersensitivity	Hypersensitivity (5%)	I
Immune	Other (Immune mediated hemolysis - rare)	E
Injection site	Phlebitis (chemical)	I
Metabolic / Endocrine	Other (metabolic disturbances < 1%; acidosis)	E
Neoplastic	Leukemia (secondary) (acute myelogenous leukemia)	D
Nervous System	Headache (rare)	E
	Neuropathy (with vincas)	E
	Neurotoxicity (<1%, cognitive disturbance)	E
Renal	Nephrotoxicity (<1%)	E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.
Dose-limiting side effects are underlined.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

Myelosuppression is dose-limiting. Leukopenia is more frequent and more severe than thrombocytopenia.

Hypersensitivity reactions may be severe and there appears to be an increased risk in patients with brain tumours or neuroblastoma. Hypersensitivity may be related to repeated exposure and cumulative dose, but has also been observed on the first dose. If it occurs, teniposide should be discontinued and patients managed with fluids, steroids, antihistamines and vasopressors as necessary.

Hypotension has also been reported during the infusion and may be severe. Use a slower administration rate and monitor the patient closely if the infusion is restarted.

E - Dosing

Refer to protocol by which patient is being treated. Numerous dosing schedules exist and depend on disease, response and concomitant therapy; in general the total dose per cycle is 300mg/m² given over 3-5 days, repeated every 3 weeks for monotherapy. Guidelines for dosing also include consideration of white blood cell count. Dosage may be reduced and/or delayed in patients with bone marrow depression due to cytotoxic/radiation therapy. Higher doses are used in leukemia regimens.

Adults:

Consider a lower starting dose for patients with Down syndrome (see section G)

Single agent (IV):

30 mg/m² daily x 5 to 10 days
q1w: 130-180 mg/m²
q1w: 50-100 mg/m²

Combination (IV):

q21d: 60-100 mg/m²
q1w: 60-70 mg/m²

Dosage with Toxicity:

Worst grade of toxicity in previous cycle	*Dose modification as percentage of previous dose**
Febrile neutropenia, thrombocytopenic bleeding, grade 4 platelets, or grade 4 neutrophils ≥ 7 days	75%
Grade 3 non-hematologic/organ	75%
Grade 4 non-hematologic/organ	Discontinue
Hypersensitivity	Treat appropriately and discontinue
*Hold until recovery to platelets ≥ 100 x 10⁹/L, AGC ≥ 1.5 x 10⁹/L and other toxicity ≤ grade 1, then restart with dose modification indicated.

Dosage with Hepatic Impairment:

There appears to be an association between an ↑ in LFTs and a ↓ in teniposide clearance. Exercise caution and consider dose reduction. No specific recommendations found.

Dosage with Renal Impairment:

No dose adjustment required. Exercise caution in renal impairment.

Children:

See specific protocols for dose and dose modification recommendations.

Children are at increased risk for neurotoxicity.

F - Administration Guidelines

Must be diluted before administration. Do not administer as a bolus injection or rapid infusion.
Dilute in Normal Saline or 5% Dextrose to give a final concentration of 0.1 to 0.4 mg/mL. Solutions at 1 mg/mL are less stable, with a higher potential for precipitation.
Infuse IV over at least 30 minutes to 1 hour (adjust infusion time for blood pressure response).
Precipitation may occur at the recommended concentration, especially with prolonged infusions (24 hours). Avoid agitation of the diluted solution and minimize storage time before administration. Do not use preparations with any evidence of precipitation.
Store diluted solution at room temperature only.
Use non-DEHP container and administration sets to avoid leaching of DEHP. Do not use ABS containers since it may be decomposed by one of the solvents in teniposide.
Care should be taken to ensure that teniposide infusions are given i.v. with indwelling catheter in proper position prior to infusion, as extravasation, necrosis and/or thrombophlebitis may result with improper administration.
Incompatible with heparin. Do not mix teniposide with other drugs.

G - Special Precautions

Other:

Teniposide is contraindicated in patients who have a history of severe hypersensitivity reactions to teniposide, Cremophor EL (polyoxyethylated castor oil), or other components in the formulation, in patients with severe myelosuppression, active infection, or severe hepatic and/or renal impairment.

Patients with Down syndrome may be more sensitive to treatment; consider 50% reduction for cycle 1 and then titration based on tolerance. Gasping syndrome may occur in newborns and CNS depression in older patients as teniposide contains benzyl alcohol.

Teniposide is carcinogenic, mutagenic, fetotoxic, embryotoxic, teratogenic and should not be used in pregnancy. Adequate contraception must be used by both sexes, during teniposide treatment and for at least 6 months after the last dose. Infertility can occur. Breast feeding is not recommended due to the potential secretion into breast milk.

H - Interactions

Teniposide is a substrate of CYP3A4 and p-glycoprotein . Exercise caution and monitor patient as inducers and inhibitors of these enzyme pathways may increase or decrease metabolism of teniposide.

AGENT	EFFECT	MECHANISM	MANAGEMENT
Vincristine	↑ neurotoxicity	Unknown	Caution
Phenytoin, phenobarbital and other inducers of p450 enzymes	↓ antineoplastic effect	Induction of hepatic microsomal enzyme oxidation system	Higher doses of teniposide may be required
Highly protein bound drugs	↑ teniposide toxicity	Displacement or teniposide from plasma proteins	Caution
CNS depressants, alcohol	↑ CNS depression	Alcohol content in teniposide	Caution

I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
CBC	Baseline and regular
Monitor patient and vital signs for at least 1 hour after the start of the infusion.
Liver and renal function tests	Baseline and regular
Clinical toxicity assessment of neurotoxicity, hypersensitivity, infection, bleeding, cardiac and GI toxicity

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

K - References

Product monograph: Vumon® (teniposide). Bristol-Myers Squibb, May 27, 2011.

Prescribing information: Vumon® (teniposide). Bristol-Myers Squibb (US), October 2011.

The Merck Manual: Teniposide monograph. Lexi-comp, April 2012. Available from http://www.merckmanuals.com

Teniposide: AHFS Drug Information. June 2012. Available from http://www.ahfsdruginformation.com

Teniposide: NCI Drug Library. Accessed October 5, 2012.

_{^{October 2012: Entire document revision}}

L - Disclaimer

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Last Updated: July 27, 2026

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