Vepesid® (Etoposide) Capsules
SKU: 623131000956
DIN: 00616192
SIZE: 20 Capsules
INDICATIONS: Vepesid® is indicated for Small Cell Carcinoma of the Lung, Malignant Lymphoma (histiocytic type), Non-small Cell Carcinoma of the Lung and Testicular Malignancies.
DIRECTIONS: Adult dose rangle: 100-200mg/m2/day for 5 days
Product Description
ACTIONS AND CLINICAL PHARMACOLOGY
Vepesid® (etoposide) is a semi-synthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases.
In vitro, etoposide has cytostatic action, which prevents the cells from entering mitosis or destroys them in the premitotic phase. Etoposide interferes with the synthesis of DNA and has a secondary effect on arresting cells in resting (G2) phase in experiments with human lymphoblastic cell lines.
Etoposide has a marked action on human hemopoietic cells causing leukopenia and thrombocytopenia. Animal experiments have shown evidence of teratogenicity.
A plasma decay with a beta half-life of 6.8 hours was observed following oral administration of etoposide. The T1/2 for oral absorption was 0.44 hour and peak plasma concentrations were noted 0.5 to 3 hours after oral administration.
After either intravenous infusion or oral capsule administration of etoposide, the Cmax and AUC values exhibit marked intra- and inter-subject variability. The overall mean value of oral capsule bioavailability is approximately 50% (range 25-75%).
Etoposide crosses the blood brain barrier in low concentrations.
Etoposide is cleared by both renal and nonrenal processes, i.e. metabolism and biliary excretion. Biliary excretion, however, appears to be a minor route of etoposide elimination.
INDICATIONS AND CLINICAL USE
Vepesid® (etoposide)
For oral formulation
Small Cell Carcinoma of the Lung
- First-line therapy in combination with other established antineoplastic agents.
- Second-line combination or single agent therapy in patients who have not responded or relapsed on other chemotherapeutic regimens.
Malignant Lymphoma (histiocytic type)
- First-line therapy in combination with other established antineoplastic agents.
Non-small Cell Carcinoma of the Lung
- For patients considered ineligible for surgery, etoposide has been shown effective alone or in combination with PLATINOL (cisplatin).
- For patients who require chemotherapy following surgery.
Testicular Malignancies (germ cell tumors including seminomas)
- In combination with other effective chemotherapeutic agents in patients who have already received appropriate therapy.
CONTRAINDICATIONS
Vepesid® (etoposide) should not be given to individuals who have demonstrated a previous hypersensitivity to it or any component of the formulation. Also, it is contraindicated in patients having severe leukopenia, thrombocytopenia and severe hepatic and/or renal impairment.
WARNINGS
VEPESID® (ETOPOSIDE) IS A POTENT DRUG AND SHOULD BE USED ONLY BY QUALIFIED PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE PRECAUTIONS). SEVERE MYELOSUPPRESSION WITH RESULTING INFECTION OR BLEEDING MAY OCCUR. BLOOD COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION TESTS SHOULD BE TAKEN REGULARLY.
DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN.
ADVERSE REACTIONS
Very common side effects (affecting more than 1 in 10 people)
- blood disorders (this is why the patient will have having blood tests between courses of treatment)
- loss of appetite
- changes in skin colour (pigmentation)
- constipation
- temporary hair loss
- feeling weak (asthenia)
- nausea and vomiting
- generally feeling unwell (malaise)
- abdominal pain
- damage to the liver (hepatotoxicity)
Common side effects (affecting between 1 in 10 and 1 in 100 people)
- acute leukemia
- diarrhea
- irregular heartbeat (arrhythmia), or a heart attack (myocardial infarction)
- high blood pressure
- sore lips, mouth or throat ulcers
- dizziness
- skin problems such as itching or rash
DOSAGE AND ADMINISTRATION
Oral: 100 – 200 mg/m2 daily for 5 days.
The bioavailability also varies from patient to patient following any oral dose. This should be taken into consideration when prescribing this medication. In view of significant intra-patient variability, dose adjustment may be required to achieve the desired therapeutic effect. Daily doses greater than 200 mg should be given divided (BID).
Dosage should be modified to consider the myelosuppressive effects of other drugs in the combination or the effects of prior X-ray therapy or chemotherapy which may have compromised bone marrow reserve.
Capsules should be taken on an empty stomach.
ABOUT THE DISEASE
Small Cell Carcinoma of the Lung
Small-cell carcinoma is a type of highly malignant cancer that most commonly arises within the lung, although it can occasionally arise in other body sites, such as the cervix, prostate, and gastrointestinal tract. Compared to non-small cell carcinoma, small cell carcinoma has a shorter doubling time, higher growth fraction, and earlier development of metastases.
Treatments for SCLC can include:
Chemotherapy, Immunotherapy, Radiation Therapy, Surgery or Palliative Procedures.
Malignant Lymphoma (histiocytic type)
A rare, very aggressive (fast-growing) type of non-Hodgkin lymphoma (cancer that begins in the cells of the immune system). It is marked by large abnormal lymphoid cells that do not look like T cells or B cells.
Non-small Cell Carcinoma of the Lung
Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitive to chemotherapy, compared to small cell carcinoma.
There are different types of treatment for patients with non-small cell lung cancer. These include Surgery, Radiation therapy, Chemotherapy, Targeted therapy, Immunotherapy, Laser therapy, Photodynamic therapy (PDT), Cryosurgery and Electrocautery
Testicular Malignancies (germ cell tumors including seminomas)
A Seminoma is a germ cell tumor of the testicle or, more rarely, the mediastinum or other extra-gonadal locations. It is a malignant neoplasm and is one of the most treatable and curable cancers, with a survival rate above 95% if discovered in early stages.
Testicular seminoma originates in the germinal epithelium of the seminiferous tubules. About half of germ cell tumors of the testicles are seminomas.
The preferred treatment for most forms of stage 1 seminoma is active surveillance. Stage 1 seminoma is characterized by the absence of clinical evidence of metastasis. Active surveillance consists of periodic history and physical examinations, tumor marker analysis, and radiographic imaging. Around 85-95% of these cases will require no further treatment. Modern radiotherapy techniques as well as one or two cycles of single-agent carboplatin have been shown to reduce the risk of relapse but carry the potential of causing delayed side effects. Regardless of treatment strategy, stage 1 seminoma has nearly a 100% cure rate.
Stage 2 seminoma is indicated by the presence of retroperitoneal metastasis. Cases require radiotherapy or, in advanced cases, combination chemotherapy. Large residual masses found after chemotherapy may require surgical resection. Second-line treatment is the same as for nonseminomas.
Stage 3 seminoma is characterized by the presence of metastasis outside the retroperitoneum—the lungs in “good risk” cases or elsewhere in “intermediate risk” cases. This is treated with combination chemotherapy. Second-line treatment follows nonseminoma protocols
CLINICAL TRIALS
Please check back later
RESOURCES
Click here to download Prescribing Information
FREQUENTLY ASKED QUESTIONS
Get emergency medical help if you have signs of an allergic reaction: fever, chills, sweating, fast heartbeats, fainting; hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- sudden chest pain or discomfort, wheezing, dry cough or hack;
- easy bruising, unusual bleeding, purple or red pinpoint spots under your skin;
- vision problems;
- seizure (convulsions);
- liver problems–nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- low red blood cells (anemia)–pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
- low white blood cell counts–fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or
- severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
- nausea, vomiting; or
- temporary hair loss.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
- You should not use etoposide if you are allergic to it.
- To make sure you can safely take etoposide, tell your doctor if you have kidney disease.
- Using etoposide may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.
- Do not use etoposide if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
- It is not known whether etoposide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using etoposide.
- Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
- Take this medicine with a full glass of water.
- Do not break or open the etoposide capsule. Do not use a pill that has been accidentally broken.
- The medicine from a broken capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Wear disposable rubber gloves when you handle an etoposide capsule. Throw the gloves away after one use.
- Etoposide can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
- Store etoposide capsules in the refrigerator, do not freeze.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
Do not receive a “live” vaccine while using etoposide. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Other drugs may interact with etoposide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all the medicines you use now and any medicine you start or stop using.
Your doctor or pharmacist can provide more information about etoposide