Etoposide 20mg/ml Inj, 50ml

Etoposide is a semisynthetic derivative of podophyllotoxin that inhibits topoisomerase II. It forms a ternary complex with topoisomerase II and DNA, leading to DNA strand breaks (single and double-strand breaks). This prevents DNA synthesis and repair, ultimately leading to cell cycle arrest in the late S or early G2 phase and induction of apoptosis in rapidly proliferating cells.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: 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 hoarsiness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or unhealing wounds.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained or enlarging bruises, or uncontrollable bleeding.
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or 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. Additionally, if the medication leaks from the vein during administration, it can cause tissue damage. Inform your nurse if you notice any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, consult your doctor:

Hair loss.
Fatigue or weakness.
Mouth irritation or sores.
Diarrhea, vomiting, stomach upset, and decreased appetite are common side effects. If you experience these, discuss ways to manage them with your doctor. If they persist, worsen, or are severe, seek medical attention.

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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. Be sure to describe the allergic reaction and its symptoms.
If you have a low platelet count (thrombocytopenia) or a low white blood cell count (leukopenia).
If you have a history of 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 condition.

As this medication may increase your risk of developing an infection, 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 initiating treatment.

Taking this medication during pregnancy may 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 after stopping the medication. If you or your partner becomes pregnant, notify your doctor immediately.

• Live vaccines (risk of severe infection)
• Other myelosuppressive agents (additive myelosuppression)
• CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir, grapefruit juice - may increase etoposide exposure and toxicity)
• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort - may decrease etoposide exposure and efficacy)
• Warfarin (increased INR and bleeding risk)

• Cyclosporine (may increase etoposide exposure)
• High-dose cisplatin (may reduce etoposide clearance)
• Phenytoin (may increase etoposide clearance)

• Fever (sign of infection/neutropenic fever)
• Unusual bleeding or bruising (thrombocytopenia)
• Severe fatigue or weakness (anemia)
• Sore throat, mouth sores (mucositis)
• Nausea, vomiting, diarrhea
• Peripheral neuropathy (numbness, tingling)
• Allergic reactions (rash, itching, shortness of breath, facial swelling, hypotension)
• Hair loss (alopecia)

Etoposide is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. It is teratogenic and embryotoxic in animals. Women of childbearing potential should be advised to avoid becoming pregnant during therapy and to use effective contraception during and for at least 6 months after treatment. Men with female partners of childbearing potential should use effective contraception during and for at least 4 months after treatment.

Etoposide is contraindicated during breastfeeding. It is unknown whether etoposide is excreted in human milk, but due to the potential for serious adverse reactions in breastfed infants, 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 malignancies (e.g., acute lymphoblastic leukemia, Hodgkin's and non-Hodgkin's lymphoma, neuroblastoma, germ cell tumors). Dosing is typically based on body surface area (mg/m²) and varies significantly by specific protocol and indication. Pediatric patients may be more susceptible to certain toxicities, and close monitoring is essential.

Clinical studies of etoposide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may have reduced renal or hepatic function, which could lead to increased exposure and toxicity. Close monitoring for myelosuppression and other adverse effects is recommended, and dose adjustments may be necessary based on renal function and overall tolerance.

• 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.
• Hypersensitivity reactions (chills, fever, tachycardia, bronchospasm, dyspnea, hypotension) can occur, typically during or shortly after infusion. Have resuscitation equipment and medications readily available.
• Etoposide is an irritant, not a vesicant, but extravasation can cause local irritation and inflammation. Administer via a central line if possible, especially for prolonged infusions.
• Myelosuppression is dose-limiting and typically occurs 7-14 days after administration. Nadir for neutrophils is usually 10-14 days, and for platelets 9-16 days. Recovery usually occurs by day 21.
• Oral etoposide has variable bioavailability (~50%) and should not be used interchangeably with IV etoposide without appropriate dose adjustment.
• Etoposide can cause secondary malignancies, particularly acute myeloid leukemia (AML), which is a rare but serious long-term complication.

• Other topoisomerase II inhibitors: Doxorubicin, Daunorubicin, Idarubicin, Mitoxantrone.
• Other antineoplastic agents used in similar indications: Paclitaxel, Docetaxel, Irinotecan, Topotecan, Cyclophosphamide, Ifosfamide, Cisplatin, Carboplatin, Vincristine, Dactinomycin, Bleomycin.

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for proper treatment.