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Etopophos

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Etopophos

Etopophos Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Etopophos (etoposide phosphate) is used alone or in combination with other chemotherapies to treat cancer of the lung or testicles. It is also commonly known as VP-16. It is a cancer (antineoplastic) medication. Common side effects include nausea and vomiting (may be severe), diarrhea, muscle aches, tiredness, loss of appetite, and pain/redness at the injection site.

Dosage of Etopophos is determined by a physician and it is administered intravenously. Etopophos may interact with cyclosporine. Tell your doctor all medications and supplements you use. Etopophos is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment; consult your doctor. It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Breastfeeding while using this medication is not recommended.

Our Etopophos (etoposide phosphate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Etopophos in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • pain, burning, irritation, or skin changes where the injection was given;
  • feeling like you might pass out; or
  • severe nausea and vomiting.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain, loss of appetite;
  • constipation, diarrhea;
  • dizziness, feeling tired or weak;
  • temporary hair loss; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Etopophos (Etoposide Phosphate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Etopophos Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, muscle aches, tiredness, loss of appetite, and pain/redness at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication may have serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. To lower your risk of serious side effects, your doctor will follow your condition closely and order lab tests.

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling of hands/feet, bloody/black/tarry stool, coughing up blood, fast/irregular heartbeat, severe abdominal pain, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever/chills.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Etopophos (Etoposide Phosphate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Etopophos FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

ETOPOPHOS (etoposide phosphate) 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 (etoposide phosphate) 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.

Summary of Adverse Events Reported With Single-Agent ETOPOPHOS (etoposide phosphate) Following Course 1 at Total Five Day Doses of ≥ 450 mg/m²

    Percent of Patients
Hematologic toxicity  
  Leukopenia < 4000/mm³ 91
  < 1000/mm³ 17
  Neutropenia < 2000/mm³ 88
  < 500/mm³ 37
  Thrombocytopenia < 100,000/mm³ 23
  < 50,000/mm³ 9
  Anemia < 11 g/dL 72
  < 8 g/dL 19
Gastrointestinal toxicity  
  Nausea and/or vomiting   37
  Anorexia   16
  Mucositis   11
  Constipation   8
  Abdominal Pain   7
  Diarrhea   6
  Taste Alteration   6
Asthenia/Malaise   39
Alopecia   33
Chills and/or Fever   24
Dizziness   5
Extravasation/Phlebitis   5

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

Hematologic Toxicity

Myelosuppression after ETOPOPHOS (etoposide phosphate) 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 to 19 after initiation of drug therapy, and platelet nadirs occurring from day 10 to 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 (etoposide phosphate) with infusion times ranging from 30 minutes to 3.5 hours. Sixty-three patients received ETOPOPHOS (etoposide phosphate) 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 (etoposide phosphate) , 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 (etoposide phosphate) . Facial flushing was reported in 2% and skin rashes in 3% of patients receiving ETOPOPHOS (etoposide phosphate) . 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 (see WARNINGS). 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.

Rash, urticaria, and/or pruritus have 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 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 radiation recall dermatitis. Hepatic toxicity may be seen.

Local soft tissue toxicity has been reported following extravasation of ETOPOPHOS (etoposide phosphate) . Infiltration of ETOPOPHOS (etoposide phosphate) may result in swelling, pain, cellulitis, and necrosis including skin necrosis.

The incidences of adverse reactions in the table that follows are derived from multiple databases from studies in 2081 patients when VePesid was used either orally or by injection as a single agent.

Adverse Drug Effects Observed With Single-Agent VePesid Percent Range of Reported Incidence
Hematologic toxicity
  Leukopenia ( < 1000/mm³) 3-17
  Leukopenia ( < 4000/mm³) 60-91
  Thrombocytopenia ( < 50,000/mm³) 1-20
  Thrombocytopenia ( < 100,000/mm³) 22-41
  Anemia 0-33
Gastrointestinal toxicity
  Nausea and vomiting 31-43
  Abdominal pain 0-2
  Anorexia 10-13
  Diarrhea 1-13
  Stomatitis 1-6
  Hepatic 0-3
Alopecia 8-66
Peripheral neurotoxicity 1-2
Hypotension 1-2
Allergic Reaction 1-2

Read the entire FDA prescribing information for Etopophos (Etoposide Phosphate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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