Etoposide (vp-16) 50mg Capsules

Etoposide is a topoisomerase II inhibitor. It forms a ternary complex with topoisomerase II and DNA, preventing the re-ligation of DNA strands after DNA cleavage. This leads to an accumulation of DNA strand breaks, which ultimately triggers apoptosis and inhibits cell proliferation. It primarily acts in the late S and G2 phases of the cell cycle.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Shortness of breath
Rapid heartbeat
Flushing
Excessive sweating
Blue or gray skin discoloration
Back pain
Seizures

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor:

Hair loss
Fatigue or weakness
Mouth irritation or sores
Diarrhea
Nausea or vomiting
Upset stomach
* Decreased appetite
Note: These side effects are common with this medication. If you experience any of these, discuss ways to minimize them with your doctor. If they worsen, persist, or are severe, seek medical attention.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a low platelet count (thrombocytopenia) or a low white blood cell count (leukopenia).
If you have any of the following health conditions: kidney disease (renal impairment) or liver disease (hepatic impairment).
If you are breastfeeding. Note that you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and other laboratory assessments should be conducted as directed by your doctor to monitor your condition.

As this medication may increase your risk of developing infections, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.

You may experience an increased risk of bleeding while taking this medication. To minimize this risk, be cautious and avoid injuries. Additionally, use a soft toothbrush and an electric razor to reduce the risk of bleeding.

Before consuming alcohol, discuss the potential risks with your doctor. It is also important to consult with your doctor before receiving any vaccinations, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Although rare, the use of this medication may increase the risk of developing other types of cancer later in life. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks and consequences with your doctor before initiating treatment.

If you are pregnant or become pregnant while taking this medication, it may harm the unborn baby. To prevent pregnancy, you and your partner must use effective birth control methods while taking this medication and possibly for a period after the last dose. Consult with your doctor to determine the necessary duration of birth control use after stopping the medication. If you or your partner becomes pregnant, notify your doctor immediately.

• Live vaccines (due to immunosuppression)

• Myelosuppressive agents (additive myelosuppression)
• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase etoposide levels and toxicity
• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort) - may decrease etoposide levels and efficacy
• Warfarin (increased anticoagulant effect, monitor INR)
• Cyclosporine (increased etoposide exposure and toxicity)

• Phenytoin (decreased etoposide exposure)
• High-dose salicylates (may displace etoposide from protein binding)
• Protein-bound drugs (potential for displacement)

• Not available

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising
• Severe nausea, vomiting, or diarrhea
• Signs of allergic reaction (rash, hives, difficulty breathing)
• Peripheral neuropathy (numbness, tingling, weakness)
• Oral mucositis/stomatitis (mouth sores)
• Fatigue, weakness

Etoposide is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. It is embryotoxic and teratogenic in animals. Women of childbearing potential should be advised to avoid becoming pregnant during therapy and to use effective contraception.

Etoposide is contraindicated during breastfeeding. It is unknown if etoposide is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Etoposide is used in pediatric oncology for various cancers, including acute lymphoblastic leukemia (ALL), neuroblastoma, Hodgkin's lymphoma, and others. Dosing is typically based on body surface area and specific treatment protocols. Pediatric patients may be more susceptible to certain toxicities, and long-term effects (e.g., secondary malignancies) should be considered.

Geriatric patients may have reduced renal or hepatic function, which can affect etoposide clearance and increase the risk of toxicity, particularly myelosuppression. Dose adjustments may be necessary based on individual organ function and overall health status. Close monitoring for adverse effects is crucial.

• Oral etoposide bioavailability is variable (average 50%), hence oral doses are typically twice the IV dose.
• Administer oral etoposide consistently with respect to food (e.g., always with food or always without food) to minimize variability in absorption.
• Severe myelosuppression is the dose-limiting toxicity; monitor CBCs frequently, especially nadir counts (typically 7-14 days after dose).
• Etoposide can cause secondary acute myeloid leukemia (AML), particularly with cumulative doses or specific regimens.
• Capsules should not be opened, crushed, or chewed due to potential for local irritation and exposure risk.
• Patients should be educated on signs of infection and bleeding and instructed to report them immediately.

• Other topoisomerase II inhibitors (e.g., teniposide, doxorubicin)
• Other cytotoxic chemotherapy agents used in similar indications (e.g., platinum compounds, taxanes, vinca alkaloids, alkylating agents)
• Targeted therapies or immunotherapies depending on the specific cancer type and molecular profile.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.