Teniposide

• Store the unopened ampules of teniposide under refrigeration 2° to 8°C (36° to 46°F).
• Retain in original package to protect from light.
• Keep this and all other medications out of the reach of children.

Call your doctor for instructions if you miss an appointment for your teniposide injection.

Tell your doctor about all other medicines you use, especially drugs that weaken the immune system, such as:

• cancer medicine;

• steroids; or

• medicines to prevent rejection of a transplanted organ.

This list is not complete and other drugs may interact with teniposide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Storage

Parenteral

2–8°C; protect from light.1

Store diluted solutions at room temperature; do not refrigerate.1 Diluted solutions at concentrations of 0.1, 0.2, or 0.4 mg/mL are stable for up to 24 hours at room temperature.1 Diluted solutions at concentration of 1 mg/mL should be administered within 4 hours to reduce potential for precipitation.1 Stability and use times are identical for solutions prepared in glass or plastic containers.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Possible precipitation of diluted solutions.1 Precipitation reported during 24-hour infusions of teniposide diluted to concentrations of 0.1–0.2 mg/mL, resulting in occlusion of central venous access catheters.1 17 (See IV Administration under Dosage and Administration.) To minimize precipitation, avoid agitation, decrease storage time prior to administration, and avoid contact with other drugs or fluids.1

• It is used to treat a type of leukemia.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take teniposide. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• Talk with your doctor before you drink alcohol.
• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. Talk with the doctor.
• This medicine may lower sperm counts in men. This may affect being able to father a child. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking teniposide.
• If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

Use teniposide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Teniposide does not inhibit microtubular assembly; it has been shown to delay transit of cells through the S phase and arrest cells in late S or early G2 phase, preventing cells from entering mitosis. Teniposide is a topoisomerase II inhibitor, and appears to cause DNA strand breaks by inhibition of strand-passing and DNA ligase action.

Distribution

Vdss: Children: 3 to 11 L/m2; Adults: 8 to 44 L/m2; mainly into liver, kidneys, small intestine, and adrenals; limited distribution into CSF <1%

Metabolism

Extensively hepatic

Excretion

Urine (44%, 4% to 12% as unchanged drug); feces (≤10%)

Clearance: Renal: 10% of total body clearance

Half-Life Elimination

Children: 5 hours

Protein Binding

>99%; primarily albumin

Concerns related to adverse effects:

• Bone marrow suppression: [US Boxed Warning]: Severe myelosuppression resulting in infection or bleeding may occur; may be dose-limiting; monitor blood counts during and after treatment.

• Extravasation: Teniposide is considered an irritant (Pérez Fidalgo, 2012). For IV use only; ensure proper catheter/needle position prior to infusion; monitor infusion site; may cause local tissue necrosis and/or thrombophlebitis if extravasation occurs.

• Hypersensitivity reactions: [US Boxed Warning]: Hypersensitivity reactions, including anaphylaxis-like reactions, have been reported; may occur with initial dosing or with repeated exposure to teniposide. Epinephrine, with or without corticosteroids and antihistamines, has been employed to alleviate hypersensitivity reaction symptoms. Hypersensitivity reactions may include bronchospasm, dyspnea, hypertension, hypotension, tachycardia, flushing, chills, fever, or urticaria. Monitor closely during infusion (observe continuously for first 60 minutes, frequently thereafter). Stop infusion for signs of anaphylaxis; immediate treatment for anaphylactic reaction should be available during administration (may require treatment with epinephrine, corticosteroids, antihistamines, pressors, or volume expanders). Patients experiencing prior hypersensitivity are at risk for recurrence; re-treat only if the potential benefit outweighs the risk of hypersensitivity; premedication (with corticosteroids and antihistamines) is recommended for re-treatment.

• Hypotension: Hypotension may occur with rapid infusion; infuse slowly over at least 30 to 60 minutes; discontinue for clinically significant hypotension. If infusion is restarted after being withheld for hypotension, reinitiate at a slower infusion rate.

• Toxicity with high doses: Acute CNS depression, hypotension and metabolic acidosis have been reported; these events occurred in patients who received high-dose teniposide (investigation protocol) and were premedicated with antiemetics, which along with the alcohol content of teniposide, may have contributed to the CNS depression.

Disease-related concerns:

• Hepatic impairment: Use with caution; may require dosage reduction in patients with significant impairment.

• Renal impairment: Use with caution; may require dosage reduction in patients with significant impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Down syndrome: Patients with Down syndrome and leukemia may be more sensitive to the myelosuppressive effects; reduced initial doses are recommended.

• Hypoalbuminemia: Since teniposide is highly bound to plasma proteins, carefully monitor patients with hypoalbuminemia.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Dehydrated alcohol: Product contains about 43% alcohol.

• Dimethylacetamide (DMA): Teniposide contains N,N-dimethylacetamide, which is incompatible with many closed system transfer devices (CSTDs); the plastic components of CSTDs may dissolve and result in subsequent leakage and potential infusion of dissolved plastic into the patient (ISMP [Smetzer 2015]).

• Polyoxyl 35/polyoxyethylated castor oil: Contains polyoxyl 35/polyoxyethylated castor oil (Cremophor EL), which is associated with hypersensitivity reactions.

Other warnings/precautions:

• Experienced physician: [US Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available.

Adverse effects were observed in animal reproduction studies. May cause fetal harm if administered during pregnancy. Women of childbearing potential should avoid becoming pregnant during teniposide treatment.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience mouth irritation, mouth sores, nausea, vomiting, diarrhea, or hair loss. Have patient report immediately to prescriber signs of infection, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), tachycardia, abnormal heartbeat, shortness of breath, severe headache, severe dizziness, passing out, flushing, severe fatigue, severe loss of strength and energy, severe injection site redness, burning, pain, edema, or irritation, or confusion (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

There is insufficient data and there are no specific dose adjustment recommendations. However, dose adjustments may be necessary.