Pronunciation:

e-TOE-poe-side

Brand Names:

• Vepesid

Dosage Forms:

• Capsule, Liquid Filled

Warnings:

Severe myelosuppression with resulting infection or bleeding may occur with etoposide .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

Etoposide (also known as VP-16) is used in combination with other cancer medicines to treat small cell lung cancer.

Etoposide belongs to the group of medicines known as antineoplastic agents. The exact way that etoposide acts against cancer is not known. However, it seems to interfere with the growth of the cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by etoposide, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with etoposide, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of etoposide in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etoposide in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., infection, nausea and vomiting, hair loss), and have age-related kidney problems, which may require caution and an adjustment in the dose for elderly patients receiving etoposide.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Aprepitant
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Echinacea
• Fosaprepitant
• Glucosamine
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• St John's Wort
• Typhoid Vaccine, Live
• Valspodar
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Rolapitant

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your body's ability to fight infection.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Low serum albumin (protein in the blood)—Use with caution. May increase risk for more serious side effects.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Etoposide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to remember to take your medicines at the right times.

Etoposide often causes nausea, vomiting, and loss of appetite, which may be severe. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Always wear impervious gloves when handling the blisterpacks containing the capsules. This would prevent exposure to the medicine.

If you vomit shortly after taking a dose of this medicine, check with your doctor. You will be told whether to take the dose again or to wait until the next dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For small cell lung cancer:
    • Adults—Dose is based on body size and must be determined by your doctor. The dose is usually two times the IV dose rounded to the nearest 50 milligrams (e.g., two times 35 mg per square meter (m(2)) per day for 4 days to 50 mg/m(2)/day for 5 days).
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chills; fever; lightheadedness, dizziness, or fainting; fast, pounding heartbeat; swelling of the face, tongue, and throat; or trouble with breathing while you are using this medicine.

Etoposide can temporarily lower the number of white blood cells in your blood, increasing the chance of your getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause leukemia (cancer of the blood or bone marrow) in rare cases. Talk with your doctor about any concerns you have about this.

Talk with your doctor before getting flu shots or other vaccines while you are receiving this medicine because there are certain vaccines that you should not receive.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

chest pain

chills

cough

fever

painful or difficult urination

pale skin

pinpoint red spots on the skin

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Blurred vision

confusion

cough

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast heartbeat

feeling of warmth

headache

hives

itching

nervousness

numbness or tingling in the fingers or toes

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

skin rash

slow or fast heartbeat

sweating

tightness in the chest

wheezing

Rare

Bone pain

Incidence not known

Abdominal or stomach pain, severe

blistering, peeling, or loosening of the skin

cough or hoarseness

dark urine

diarrhea

difficult breathing

drowsiness

joint or muscle pain

loss of appetite

lower back or side pain

muscle tremors

nausea or vomiting

rapid, deep breathing

red, irritated eyes

red skin lesions, often with a purple center

restlessness

seizures

stomach cramps

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Hair loss or thinning of the hair

swelling or inflammation of the mouth

weight loss

Incidence not known

Bad, unusual, or unpleasant (after) taste

change in taste

constipation

cracked lips

general feeling of discomfort or illness

heartburn

lack or loss of strength

pain or burning in the throat

sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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