Patient Medication Information: uses, side effects, how to take - Etoposide Injection (Teva Canada)
Serious warnings and precautions box
ETOPOSIDE INJECTION can cause serious side effects, including:
- Myelosuppression (a large decrease in the production of blood cells and platelets by the bone marrow), which may result in infection, bleeding or even death.
- Tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment) when taken with other anticancer medicines. This condition can also lead to death. Your healthcare professional will closely monitor you during your treatment for early signs, especially if you are at risk. They may also put in place preventive measures to reduce the risk.
See the Serious side effects and what to do about them table for more information on this and other serious side effects
You will regularly have blood tests during your treatment with ETOPOSIDE INJECTION, and after you stop taking it. These tests will check:
- The amount of blood cells in your body.
- That your liver or kidneys are working properly.
Depending on your blood test results, your healthcare professional may adjust your dose, stop or discontinue your treatment with ETOPOSIDE INJECTION.
What ETOPOSIDE INJECTION is used for:
ETOPOSIDE INJECTION is used in adults to treat:
a type of lung cancer known as small cell carcinoma of the lung:
- as a first-line treatment in combination with other anticancer medicines.
- as a second-line treatment alone or in combination with other anticancer medicines in patients who have not responded well or relapsed on other anticancer medicines.
another type of lung cancer known as non-small cell carcinoma of the lung:
- in patients considered ineligible for surgery. ETOPOSIDE INJECTION can be taken alone or with cisplatin in these patients.
- in patients who require chemotherapy following surgery.
a type of cancer of the lymphatic system known as malignant lymphoma (histiocytic type):
- as a first-line treatment in combination with other anticancer medicines.
cancer of the testicles:
- as a first-line treatment in combination with chemotherapy and surgery and/or radiation therapy.
- in combination with other anticancer medicines in patients who have already received appropriate therapy.
How ETOPOSIDE INJECTION works:
Etoposide, the active ingredient in ETOPOSIDE INJECTION, destroys quickly dividing cells such as cancer cells. It works by blocking the action of an enzyme called topoisomerase. This enzyme helps with cell division and tumour growth by keeping the genetic material (DNA) in the proper shape when cells are dividing. Blocking this enzyme damages the cells’ DNA, which prevents them from dividing and results in cell death. This helps to treat cancer.
The ingredients in ETOPOSIDE INJECTION are:
Medicinal ingredients: etoposide
Non-medicinal ingredients: absolute ethanol, citric acid (anhydrous), polyethylene glycol 300 and polysorbate 80
ETOPOSIDE INJECTION comes in the following dosage form:
Solution for intravenous injection: 20mg / mL.
Do not use ETOPOSIDE INJECTION if:
- you are allergic to etoposide or to any of the other ingredients in ETOPOSIDE INJECTION.
you have the severe form of the following conditions:
- leukopenia (low levels of white blood cells in your blood);
- thrombocytopenia (low levels of platelets in your blood); or
- liver or kidney problems.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you are given ETOPOSIDE INJECTION. Talk about any health conditions or problems you may have, including if you:
have been told that you have:
- low albumin levels in your blood.
- low levels of white blood cells in your blood.
- low levels of platelets in your blood.
- risk factors for developing leukemia (cancer of the blood) such as a blood disorder or a genetic abnormality.
- have liver or kidney problems.
- have an infection.
- have recently received, or are planning to receive, a live vaccine.
- have a large tumour that responds to treatment (also known as a bulky treatment- sensitive tumour).
- are pregnant, think you are pregnant, plan to become pregnant or could become pregnant.
- plan to father a child.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
Your healthcare professional will weigh the benefits of ETOPOSIDE INJECTION against the possible side effects of the medicine. Most of them are reversible if they are detected early. If you experience a side effect during your treatment with ETOPOSIDE INJECTION:
- you should tell your healthcare professional right away.
- your healthcare professional may reduce your dose or stop your treatment with ETOPOSIDE INJECTION and treat your side effect first. They will then decide if you should continue your treatment with ETOPOSIDE INJECTION.
Secondary acute leukemia (new cancer of the blood): It was rarely reported in patients taking ETOPOSIDE INJECTION with other anticancer medicines. It occurred in patients with or without risk factors for leukemia. The condition can develop rapidly after the start of treatment (i.e., average median time of 32 months approximately).
Infection: If you have an infection, tell your healthcare professional. It should be treated before you start your treatment. Taking ETOPOSIDE INJECTION while you have an infection may increase your risk of sepsis. It is a serious condition that happens when your body’s immune system has an extreme response to an infection.
Driving and using machines: ETOPOSIDE INJECTION may cause drowsiness, nausea, vomiting, lack of energy, loss of vision or allergic reactions with a drop in blood pressure. Do not drive, use machinery, or do activities that require you to be alert until you know how ETOPOSIDE INJECTION affects you.
Vaccinations: Etoposide decreases a patient’s ability to fight infections. Therefore, you should avoid receiving live vaccines while taking ETOPOSIDE INJECTION as it may result in severe infection.
Fertility: ETOPOSIDE INJECTION may affect your ability to become pregnant or father a child. Talk to your healthcare professional if you wish to have children in the future.
Pregnancy and birth control:
- Male and female patients: Use a highly effective birth control method during your treatment with ETOPOSIDE INJECTION and for at least 6 months after your last dose.
- ETOPOSIDE INJECTION can harm an unborn baby.
- If you become pregnant during your treatment or it is recommended that you take ETOPOSIDE INJECTION during pregnancy, your healthcare professional will discuss the potential risks with you.
- You should avoid becoming pregnant while taking ETOPOSIDE INJECTION. Tell your healthcare professional right away if you discover that you are pregnant during your treatment.
Breastfeeding: Etoposide can pass into breastmilk and could harm a breastfed baby. Do not breastfeed while you are taking ETOPOSIDE INJECTION. Talk to your healthcare professional about the best way to feed your baby during your treatment.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions:
The following may also interact with ETOPOSIDE INJECTION:
- certain medicines used to treat cancer (e.g., vincristine, cisplatin and anthracyclines)
- medicines used to treat seizures (e.g., phenytoin)
- cyclosporine, used to prevent the rejection of organ transplants
- warfarin, used to treat and prevent blood clots
How ETOPOSIDE INJECTION is given:
ETOPOSIDE INJECTION will be given to you by:
- a healthcare professional in a healthcare setting;
- slow injection into a vein (usually for 30 to 60 minutes).
Your healthcare professional will decide on:
- the site of injection;
- your dose; and
- the number of injections you will receive.
- Your healthcare professional will give you the lowest possible dose for the shortest amount of time.
Usual dose:
Receiving live vaccines during your treatment with ETOPOSIDE INJECTION is not recommended. It may increase your risk of severe infection and can even lead to death.
- Your healthcare professional will determine the right dose for you based on your body surface area. It is the external surface area of your body given in square meters (i.e., m2). It takes into account both your weight and height.
- Usual adult dose: 50 – 100 mg per m2 (body surface area) per day for 5 days.
Overdose:
If you think you, or a person you are caring for, have been given too much ETOPOSIDE INJECTION, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you miss an appointment, contact your healthcare professional right away to let them know you missed your injection. Your healthcare professional will advise you when to come next for your scheduled appointment.
Possible side effects from using ETOPOSIDE INJECTION:
These are not all the possible side effects you may have when taking ETOPOSIDE INJECTION. If you experience any side effects not listed here, tell your healthcare professional.
Side effects with ETOPOSIDE INJECTION may include:
- nausea or vomiting
- feeling weak, dizzy or sleepy
- lack of energy
- bad aftertaste
- change in the way things taste
- difficulty swallowing
- loss of appetite
- hair loss
- abnormal nail or skin pigmentation
- itching, rash
- constipation, diarrhea
- general feeling of discomfort
- swelling at the site of injection
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very Common | |||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | ✓ | ||
| Leukopenia (low white blood cells): aches, fatigue, fever, infections, mouth ulcers, pains and flu-like symptoms, sweating | ✓ | ||
| Myelosuppression (a large decrease in the production of blood cells and platelets by the bone marrow): bleeding, bruising, chills, fatigue, fever, infections, weakness, shortness of breath or other signs of infection | ✓ | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | ✓ | ||
| Common | |||
| Mucositis (inflammation and ulceration of the mucous membranes lining the digestive tract): painful, red, shiny or swollen gums, tongue, mouth or throat sores, blood in the mouth, difficult or painful swallowing or talking, dry mouth, mild burning, or pain when eating food | ✓ | ||
| Uncommon | |||
| Sepsis: confusion, fever, low body temperature, rapid breathing, rapid heart rate, swelling | ✓ | ||
| Infections: chills, fatigue, feeling unwell, fever, sore throat | ✓ | ||
| Peripheral neuropathy (problem with the nerves in your limbs): gradual weakness, numbness, pain or other sensations in the hands and feet, lack of coordination, falling, inability to move | ✓ | ||
| Hyperuricemia (increased levels of uric acid in the blood): swelling, redness in the joints, sudden and intense attacks of joint pain (gout attack) | ✓ | ||
| Rare | |||
| Allergic Reaction / Angioedema: chills, fever, fast heartbeat, difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, flushing, swelling of the face, lips, tongue or throat | ✓ | ||
| Hepatotoxicity (damage to your liver): jaundice (yellowing of the skin or whites of eyes), urine turns dark, light-colored stool, loss of appetite for several days or longer, nausea, lower stomach pain | ✓ | ||
| Bronchospasm (when there is a sudden narrowing of the airway): difficulty breathing with wheezing or coughing | ✓ | ||
| Pneumonia (infection in the lungs): chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking chills, nausea, vomiting or diarrhea, shortness of breath | ✓ | ||
| Seizures (fits): uncontrollable shaking with or without loss of consciousness | ✓ | ||
| Stevens-Johnson syndrome / toxic epidermal necrolysis (severe skin reactions): rash, red skin, red or purple skin patches possibly with blister or crust in the center, pus-filled rash, peeling skin, blisters on the lips, eyes, skin or in the mouth, itching, burning, flu-like feeling, fever | ✓ | ||
| Optic neuritis (eye pain or changes in vision) | ✓ | ||
| Radiation recall dermatitis (skin reaction at site of radiation): skin rash, flaking and/or itchy skin, swelling, blistering, peeling or discolouration of the skin | ✓ | ||
| Interstitial lung disease/ pulmonary fibrosis (diseases that inflame or scar lung tissue): shortness of breath when rest that gets worse with exertion, dry painful cough | ✓ | ||
| Unknown | |||
| Secondary acute leukemia (new cancer of the blood): feeling tired, pale skin, trouble breathing, bruising or | ✓ | ||
| bleeding easily (e.g., nosebleeds or bleeding gums), fever, chills, excessive sweating or other signs of infection | |||
Tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment): nausea, shortness of breath, irregular heartbeat, heart rhythm disturbances, lack of urination, clouding of urine, muscle spasms or twitching, tiredness and/or joint pain, severe muscle weakness, and seizures. Metabolic disorders (kidney failure, abnormal heartbeat) and abnormal blood tests due to rapid breakdown of cancer cells | ✓ | ||
| Posterior Reversible Encephalopathy Syndrome (PRES) (a nervous system disorder): change in mental state, coma, confusion, numbness and tingling, headache, seizures, vision changes | ✓ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain in the chest, jaw, left arm, between the shoulder blades or upper abdomen, shortness of breath, dizziness, fatigue, light- headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | ✓ | ||
| Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat | ✓ | ||
| Bleeding problems: coughing up blood, blood in the urine, black tarry stools, pinpoint red spots on skin, extensive bruising | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Storage:
ETOPOSIDE INJECTION will be stored by your healthcare professional as follows:
- at room temperature (15°C - 30°C), protected from light.
Keep out of reach and sight of children.
If you want more information about ETOPOSIDE INJECTION:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or by emailing druginfo@tevacanada.com.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Date of Authorization: 2025-07-21