Loose stools or diarrhea may occur within 3 days after the drug is given. Toposar etoposide injection, usp also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. Dosage should be modified to take into account the myelosuppressive effects of. Vimpat lacosamide injection, for intravenous use, cv. Page 2 of 21 full prescribing information 1 indications and usage 1. At decreased creatinine clearance of 15 to 50 mlmin a dose reduction by 25% is recommended. Please read carefully and keep this information for future use. Manufacturing cmc label is not available on this site.
Apr 16, 2020 a dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. Hepatotoxicity see full prescribing information for complete boxed warning. Dosage may be reduced, delayed or discontinued in patients with bone. This package insert is intended for the eyecare practitioner, but should be made available to the patient upon requrest. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Highlights of prescribing information these highlights. Full text full text is available as a scanned copy of the original print version. Federal law restricts this device to sale by or on the order of a licensed practitioner important. Pdf importance of package insert information in the. Vepesid etoposide is indicated for use in the treatment of. Lift the package away from the adapter and discard the package. Public assessment report scientific discussion etoposide fresenius. Individuals using assistive technology may not be able to. Package insert for the extreme h 2 o 54% hioxifilcon d soft contact lens for daily wear caution.
All cases of hypoglycemia resolved with appropriate therapy and if needed. Deplin tablets folic acid, when administered in daily doses above 800 mcg, may increase the amount of unmetabolized folic description less likely than folic acid to accelerate the growth of existing neoplasms. Videx didanosine, usp pediatric powder for oral solution initial u. These highlights do not include all the information needed to use cuvitru safely and effectively. Actemra can be used alone following discontinuation of glucocorticoids. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Injectafer ferric carboxymaltose injection is an iron replacement product indicated for the treatment of iron deficiency anemia ida in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and in adult patients with nondialysis dependent chronic kidney disease. Information for the patient vepesid 50 mg and 100 mg capsules, soft etoposide read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Daunorubicin hydrochloride injection must be given into a rapidly. Nov 21, 2019 vepesid etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
The components of the kit are stable up to the expiration date printed on the kit. Vepesid for injection is available in 100 mg 5 ml, 150 mg 7. Vimpat lacosamide film coated tablet, for oral use, cv. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Each capsule contains etoposide 50 mg or 100 mg as the active ingredient. General in all instances where the use of vepesid is considered for chemotherapy, the physician must.
Etoposide package insert pdf chemotherapy organic compounds. Highlights of prescribing information platinumresistant. Highlights of prescribing information these highlights do not include all the information needed to use amyvid safely and effectively. This package insert is intended for the eyecare practitioner, but should be made available to the patient upon request. Guidelines for dosing also include consideration of white blood cell count. Daunorubicin hydrochloride injection rx only warnings 1. Sep 18, 2008 vepesid etoposide has been shown to cause metaphase arrest in chick fibroblasts. If you have any further questions, ask your doctor or pharmacist. Follow applicable special handling and disposal procedures. Each liquidfilled, soft gelatin capsule contains 50 mg of etoposide in a vehicle consisting of citric. Highlights of prescribing information these highlights do. This package insert is intended for the eye care practitioner, but should be made available to the patient upon request.
Patients being treated with vepesid must be frequently observed for myelosuppression both during and after therapy. Its main effect, however, appears to be at the g 2 portion of the cell cycle in mammalian cells. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. Bacterial infection must be brought under control before the administration of vepesid therapy because of. What may also help in your search is a website that has most, but not all package inserts. Vepesid fda prescribing information, side effects and uses. Pancreatitis, lactic acidosis and hepatomegaly with steatosis.
These highlights do not include all the information needed to use vimpat safely and effectively. Keep the febridx test card in the sealed foil pouch until just before use. The ph of the clear, nearly colorless to yellow liquid is 3 to 4. Changes to the summary of product characteristics, labeling or package leaflet also known as. Tb 50 are single use items and should be used immediately once opened and not reused. Myelosuppression resulting in death has been reported. The usual dose of vepesid is 100 to 200 mg per m2of body surface area for 5 days in a row or 200 mgm2day on days 1, 3 and 5 every 3 to 4 weeks. Severe local tissue necrosis will occur if there is extravasation during administration. If a serious infection develops, interrupt xeljanzxeljanz xr until the infection is controlled. It must never be given by the intramuscular or subcutaneous route.
Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. Emtricitabinetenofovir disoproxil fumarate truvada package insert truvada is a combination of emtriva and viread, both nucleoside analog hiv1 reverse transcriptase inhibitors. The eye care practitioner should provide the patient with the wearers guide that pertains to the patients prescribed lens. See full prescribing information for complete boxed warning. Use standard precautions for collecting and handling a blood sample. Highlights of prescribing information patients at risk of. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for lasix furosemide. Amyvid florbetapir f 18 injectionfor intravenous use initial u. Vepesid pharmacokinetics on intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution halflife of about 1.
Highlights of prescribing information these highlights do not. Tarceva is not recommended for use in combination with platinumbased chemotherapy see clinical studies 14. Importance of package insert information in the european union. Dosage may be reduced andor delayed in patients with bone marrow depression due. This module reflects the scientific discussion for the approval of etoposide. Get a printable copy pdf file of the complete article 7k, or click on a page image below to browse page by page. Individuals using assistive technology may not be able to fully access the information contained in this file. Elimination halflife of the drug in 10 of 14 patients was approximately 2. Etoposide is a semisynthetic derivative of the podophyllotoxins.
Etopophos etoposide phosphate for injection, for intravenous use. Questions and answers on vepesid and associated names. Etopophos solutions may be administered at infusion rates up to 3. The eyecare practitioner should provide the patient with the wearers guide that pertains to the patients prescribed lens. Vepesid capsules should be taken on an empty stomach. Medicinal and pharmaceutical experts questioning results.
Severe myelosuppression with resulting infection or bleeding may occur. The dose of vepesid capsules is based on the recommended dose with. Vepesid is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Vepesid may be administered either intravenously or orally. It is very soluble in methanol and chloroform, slightly.
Vepesid etoposide also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin. Etoposide package insert pdf free download as pdf file. Do not use the febridx test card or the buffer solution past the expiration date. Actemra subcutaneous formulation is not intended for intravenous administration. Vepesid etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Highlights of prescribing information these highlights do not include all the information needed to use videx safely and effectively. It is 4demethylepipodophyllotoxin 94,60rethylidene. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it. Truvada is indicated in combination with other antiretroviral agents for the treatment of hiv1 infection in adults and pediatric patients weighing at least 17 kg.
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