Vepesid (Oral)

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

Etoposide is part of a group of medicines called antineoplastic agents. The exact way etoposide works against cancer is not known. However, it appears to disrupt the growth of cancer cells, which are eventually destroyed. Since etoposide can also affect the growth of normal body cells, there may be additional effects. Some of these effects can be serious and should be reported to your doctor. Other effects, such as hair loss, may not be serious but can be concerning. Some effects may not appear until months or years after using the medicine.

Before starting treatment with etoposide, you and your doctor should discuss the benefits of this medicine as well as the risks associated with it.

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

It is very important for your doctor to check your progress at regular visits to make sure that this medicine is working properly. You may need blood tests 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 prevent getting pregnant. If you think you may be pregnant while using the medicine, tell your doctor right away.

This medicine may cause a serious 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 breathing while you are using this medicine.

Etoposide can temporarily lower the number of white blood cells in your blood, increasing your risk of 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 your urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your 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 like 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.

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. Here are some important considerations for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies you have, including allergies to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There haven't been appropriate studies on how etoposide affects children. Its safety and effectiveness for this age group have not been established.

Geriatric

Studies so far have not shown specific problems in older adults that would limit the use of etoposide. However, older patients are more likely to experience unwanted side effects (like infection, nausea and vomiting, hair loss) and may have age-related kidney issues, which could require careful management and dosage adjustments when using etoposide.

Breast Feeding

There are no adequate studies to determine the risks to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a risk of interaction. In these cases, your doctor might adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are noteworthy but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or adjust other medicines you are taking.

• 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 it may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or frequency for 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 increase the risk of certain side effects, but using both may be necessary for your treatment. If both are prescribed together, your doctor may adjust the dose or frequency for one or both.

• Rolapitant

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific foods due to possible interactions. Alcohol or tobacco use with certain medicines may also lead to interactions. The following interactions are significant but do not cover all possibilities.

Using this medicine with any of the following may increase the risk of certain side effects, but it may be unavoidable in some cases. If used together, your doctor might adjust the dose or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Be sure to tell your doctor if you have any other medical problems, especially:

• Infection—This may lower your body's ability to fight infections.

• Kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from your body.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, 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.

In the U.S.

• Vepesid

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

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.

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