Toposar (Etoposide) 50mg Capsule & 100mg/5mL Injection

What Is Toposar (Etoposide)?

Toposar is a brand name for etoposide. Drug International Ltd. makes it in Bangladesh. The factory holds WHO-GMP certification, a manufacturing standard set by the World Health Organization.

Etoposide is a chemotherapy drug. Doctors have used it for more than 40 years. It is most often used for small cell lung cancer and testicular cancer, usually together with other chemotherapy drugs.

Toposar comes in two forms. One is a 50mg capsule you swallow. The other is a 100mg/5mL liquid given through a vein (IV) in a hospital or clinic. Your oncologist chooses the form and dose that fit your treatment plan.

“Etoposide has a decades-long track record in small cell lung cancer and testicular cancer, so we know how to use it and manage its risks well. What’s changed more recently is access: patients in many countries now reach WHO-GMP-manufactured versions like this one through Named Patient Programs, which matters when the originally available product isn’t sold or affordable where they live.”

— Salma Mamdouh Elreedy, Clinical Oncologist, Sphinx Cure Oncology Center

Important: Two Different “Toposar” Products Exist

The brand name Toposar is also used in the United States. There, it names an etoposide injection made by Teva Parenteral Medicines, under FDA application number ANDA074529.

This is a different manufacturer’s product. It is made in a different country, under different regulatory oversight, from the Toposar described on this page. Both products share the same active ingredient: etoposide. But they are not the same manufactured product. Everything on this page describes Drug International’s Bangladesh-manufactured Toposar.

Clinical Uses and Safety Management

Approved Uses

Etoposide is approved for these uses:

• Small cell lung cancer (SCLC): Given with a platinum drug, either cisplatin or carboplatin. Used as a first treatment. Sometimes used again if the cancer returns.
• Testicular cancer: Used as a first treatment. Also used if earlier chemotherapy did not work. Covers both seminoma and non-seminoma types.
• AIDS-related Kaposi’s sarcoma: Used as a second treatment option to ease symptoms.

Doctors also prescribe etoposide for other cancers, based on cancer treatment guidelines rather than a specific approval for that cancer. This is normal practice for an older chemotherapy drug: etoposide has been a standard part of many treatment combinations for decades, and guidelines reflect that accumulated experience even where a formal approval was never filed for every use. These guideline-supported, off-label uses include Hodgkin and non-Hodgkin lymphoma, acute myeloid leukemia, acute lymphoblastic leukemia, neuroblastoma, Wilms’ tumor, and ovarian germ cell tumors. If your doctor prescribes Toposar for one of these, ask them to explain why. This is normal practice, but you should understand your specific treatment goal.

Use in Children

Some of the guideline-supported uses above, including neuroblastoma and Wilms’ tumor, are cancers that occur in children. However, the safety and effectiveness of etoposide have not been systematically studied in children, and clinical experience in childhood cancers is limited compared with adult use. If a child is prescribed Toposar, this should happen only under the direct care of a pediatric oncologist, who can weigh the limited pediatric data against your child’s specific situation.

How Etoposide Works

Etoposide blocks an enzyme called topoisomerase II. Cells use this enzyme to unwind and repair their own DNA. They need it right before they divide into two new cells.

Without this enzyme working properly, DNA strands break apart. The breaks do not repair correctly. Cancer cells cannot finish dividing, so they die.

Etoposide mainly affects cells in two specific phases of their life cycle: late S phase and G2 phase. These are the stages just before a cell splits in two.

How the Body Processes Etoposide (Pharmacokinetics)

Dosing and Managing Side Effects

The ranges below are typical starting points, not a fixed rule. Your oncologist sets your exact dose. This depends on your body size, blood counts, kidney function, and overall treatment plan.

• Small cell lung cancer: 35 mg/m² per day for 4 days. Or 50 mg/m² per day for 5 days. Repeated every 3 to 4 weeks.
• Testicular cancer: 50 to 100 mg/m² per day on days 1 through 5. Or 100 mg/m² per day on days 1, 3, and 5. Repeated every 3 to 4 weeks.
• Switching from IV to capsules: The oral dose is about twice the IV dose, rounded to the nearest 50mg. This is because the body absorbs less of the oral dose.
• Reduced kidney function: If creatinine clearance is 15 to 50 mL/min, the dose is usually cut to 75%. Your doctor may lower it further if kidney function is worse.

If you miss a capsule dose: call your oncology team the same day for instructions. Do not double up on your next dose to make up for a missed one unless your doctor tells you to. Because your treatment schedule is planned around specific days, a missed dose can affect your whole cycle, so your care team needs to know right away, not at your next visit.

Drug Interactions

Clinical Evidence Behind These Uses

Etoposide plus a platinum drug (cisplatin or carboplatin) has been a standard first treatment for extensive-stage small cell lung cancer for decades, backed by a large body of clinical trial data. Current treatment guidelines now prefer adding an immunotherapy drug (atezolizumab or durvalumab) to platinum-etoposide as the first choice for this cancer. Platinum-etoposide alone remains a recommended option, including for patients who cannot receive immunotherapy.

In testicular cancer, etoposide is a core part of the BEP regimen. BEP stands for bleomycin, etoposide, and cisplatin. This regimen replaced an earlier combination that used vinblastine instead of etoposide, after research (with Dr. Lawrence Einhorn among the investigators) found it worked as well with fewer nerve-related side effects. Cisplatin-based combination chemotherapy, which Einhorn pioneered in the 1970s, changed testicular cancer from a disease that often killed patients into one of the most curable solid tumors in oncology. Under the IGCCCG risk classification, patients in the “good-risk” group now have cure rates above 90%.

Boxed Warning

Secondary Cancer Risk (Long-Term)

Etoposide belongs to a class of drugs that can rarely cause a second cancer years after treatment, most often a form of acute leukemia. This has been reported in patients treated with etoposide together with other chemotherapy drugs, at a median of around 32 months after treatment. This risk is well documented but not fully predictable. It does not mean this will happen to you, and it is not a reason to avoid necessary chemotherapy on its own. Your oncologist weighs this small long-term risk against the risk of not treating your cancer, and can answer questions specific to your situation.

Administration and Handling

• IV infusion: Given slowly through a vein, over 30 to 60 minutes. Always given in a hospital or cancer clinic, under medical supervision. The IV form of Toposar is never meant for self-injection at home. Infusing it too quickly can cause a sudden drop in blood pressure (see the side effects table above), which is why the slow infusion rate matters.
• Extravasation: If the IV solution leaks into the skin around the vein, it can cause swelling. Rarely, it can cause tissue damage. Tell your nurse right away if you feel burning, stinging, or swelling at the injection site.
• Capsules: Taken by mouth, usually once a day. Take them with or without food, as your doctor directs. Swallow capsules whole. Do not open or crush them.
• Handling at home: Etoposide is a hazardous drug. Caregivers should wash their hands after contact with the patient’s body fluids. Follow your care team’s instructions for safe handling.

Storage

• Capsules: Store in a refrigerator, between 2°C and 8°C (36°F to 46°F). Do not freeze.
• IV vials (unopened): Store at room temperature, 20°C to 25°C (68°F to 77°F). Do not freeze.

Pregnancy, Breastfeeding, and Fertility

• Etoposide can harm an unborn baby. Animal studies have shown birth defects with this drug.
• Effective contraception is needed for both male and female patients during treatment and for 6 months after the last dose.
• Do not breastfeed while taking this medicine.
• Chemotherapy can affect fertility in both men and women. Talk to your oncologist about fertility preservation before you start treatment.

Kidney and Liver Function

Your doctor checks your kidney function before and during treatment. The dose is reduced if kidney function is reduced (see the dosing section above).

For liver function, available data suggests the body clears etoposide at a similar rate even when liver function is reduced, so no separate dose reduction formula exists for liver impairment. Your doctor still checks your liver function regularly during treatment and will stop treatment if it becomes abnormal.

Manufacturing and Quality

Drug International Ltd. makes Toposar at a WHO-GMP certified facility in Bangladesh. WHO-GMP certification means the factory follows World Health Organization manufacturing standards.

This is different from FDA approval. FDA approval is a US regulatory decision about one specific product. Drug International’s Toposar does not carry FDA approval. It is manufactured to WHO-GMP standards, for markets that recognize that certification.

Drug International has not yet supplied comparative dissolution or bioequivalence data for this product. We will add a bioequivalence statement once that data is available. Until then, we are stating plainly that this data has not been provided, rather than assuming it.

Global Access Through a Named Patient Program (NPP)

Toposar may not be sold or affordable where you live. If so, you may be able to access it through a Named Patient Program. This is a legal pathway. It lets one named patient import a medicine prescribed by their own doctor, even if that exact product isn’t sold in their country.

You will typically need:

1. A valid prescription from your treating oncologist
2. A Letter of Medical Necessity (LMN)
3. Patient identification
4. An import license or no-objection certificate (NOC), if your country requires one

The capsule and IV forms are not equally simple to import. The capsule ships and clears customs like most oral medicines. The IV form is a hazardous injectable drug, so some countries add extra requirements for it, such as cold-chain shipping or a licensed facility to receive it. Our team will tell you upfront which requirements apply to your country and the form you need.

Frequently Asked Questions