Etoposide 20mg/ml Inj, 25ml

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 DNA strand breaks, accumulation of DNA damage, and ultimately, inhibition of DNA synthesis and cell cycle arrest in the late S and G2 phases, leading to apoptosis.

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 immediate medical attention:

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
Rarely, 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
+ Coffee ground-like vomit
+ 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 near-fainting
+ Changes in vision
Shortness of breath
Rapid heartbeat
Flushing
Excessive sweating
Blue or gray skin discoloration
Back pain
Seizures

If you experience any of these symptoms, notify your healthcare provider immediately.

Additional Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor for guidance:

Hair loss
Fatigue or weakness
Mouth irritation or sores
Diarrhea
Nausea or vomiting
Upset stomach
Decreased appetite

These side effects are common with this medication. If they occur, talk to your doctor about ways to minimize them. If they persist, worsen, or bother you, 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.

Important Note

If you notice any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site, inform your nurse immediately, as this medication can cause tissue damage if it leaks from the vein.

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 work and laboratory tests, as directed by your doctor, are crucial to monitor your health.

As this medication may increase your risk of developing infections, it is vital 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, so it is crucial to be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor for shaving.

Before consuming alcohol, discuss the potential risks with your doctor. Additionally, consult 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.

There is a rare possibility 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 with your doctor before starting treatment.

Taking this medication during pregnancy can harm the unborn baby. If you or your partner may become pregnant, it is essential to use birth control while taking this medication and possibly for a period after the last dose. Consult your doctor to determine the necessary duration of birth control. If pregnancy occurs, notify your doctor immediately.

• Live vaccines (increased risk of infection)
• Immunosuppressants (additive immunosuppression)
• Warfarin (increased INR/bleeding risk)
• Phenytoin (decreased etoposide levels)
• Cyclosporine (increased etoposide levels and toxicity)

• Other myelosuppressive agents (additive myelosuppression)
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital - decreased etoposide levels)
• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice - increased etoposide levels)
• P-glycoprotein inhibitors (e.g., verapamil, quinidine - increased etoposide levels)
• P-glycoprotein inducers (e.g., St. John's Wort - decreased etoposide levels)

• Not available

• Fever (sign of infection/neutropenic fever)
• Unusual bleeding or bruising (thrombocytopenia)
• Fatigue, weakness, pallor (anemia)
• Nausea, vomiting, diarrhea
• Oral sores or mucositis
• Hair loss (alopecia)
• Peripheral neuropathy (numbness, tingling)
• Signs of hypersensitivity reaction (rash, urticaria, chills, fever, tachycardia, bronchospasm, hypotension)
• Signs of extravasation (pain, swelling, redness at infusion site)

Etoposide can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Women of childbearing potential should be advised to avoid becoming pregnant during therapy. If the drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

It is not known whether etoposide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from etoposide, 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. Breastfeeding is generally contraindicated.

Etoposide has been used in pediatric oncology for various cancers (e.g., acute myeloid leukemia, neuroblastoma, lymphomas). Dosing is typically based on body surface area (mg/m²). Children may experience similar toxicities to adults, with myelosuppression being dose-limiting. Long-term effects, including secondary malignancies (e.g., AML), should be considered.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustments for renal or hepatic impairment may be more frequently required in elderly patients due to age-related decline in organ function. Monitor closely for myelosuppression and other toxicities.

• Etoposide infusion should be administered slowly over at least 30-60 minutes to minimize the risk of hypotension and hypersensitivity reactions.
• Hypotension is a common side effect, especially with rapid infusion. Monitor blood pressure during and after administration.
• Myelosuppression is the dose-limiting toxicity, with nadir typically occurring 7-14 days after administration. Close monitoring of CBC is crucial.
• Hypersensitivity reactions can occur, ranging from mild to severe. Have emergency equipment and medications readily available.
• Etoposide is a vesicant/irritant; extravasation can cause local irritation or tissue damage. Administer via a central line if possible, or ensure good peripheral venous access.
• Oral etoposide (VePesid capsules) is available but has variable bioavailability; IV and oral forms are not interchangeable on a mg-to-mg basis (oral dose is typically double the IV dose for equivalent exposure).
• Secondary acute myeloid leukemia (AML) has been reported in patients treated with etoposide, particularly with higher cumulative doses or certain schedules.

• Other topoisomerase II inhibitors (e.g., Doxorubicin, Daunorubicin, Mitoxantrone)
• Other cytotoxic agents used in similar indications (e.g., Paclitaxel, Docetaxel, Irinotecan, Topotecan, Cyclophosphamide, Ifosfamide, Carboplatin, Cisplatin)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the best disposal method, consult your pharmacist, as they may be aware of local drug take-back programs. Additionally, some medications may have a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion to ensure prompt and effective treatment.