Each 1 ml contains topotecan hydrochloride equivalent to 1 mg of topotecan free base. Drug information on topotecan includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. It is supplied as a nonpyrogenic, sterile lyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg and 30 mg of thiotepa. Topotecan is used to treat ovarian cancer, small cell lung cancer, and certain types of. Because the vials contain no preservative, contents should be used. Initiate mozobil treatment after the patient has received gcsf once daily for 4 days. Hycamtin capsules topotecan dose, indications, adverse. Camptosar injection irinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase i inhibitor class. Abraxane is indicated for the firstline treatment of locally advanced or metastatic nonsmall cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Standard oncology practice for the management of neutropenia is either to administer topotecan with. Dailymed vinblastine sulfate vinblastine sulfate injection. Cervical cancer that has not gotten better with other treatment or has recurred come back. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it.
Dose based on patient weight less than or equal to 83 kg. Zanosar streptozocin dosing, indications, interactions. Ndc 0078067461 package of 1 store between 20c and 25c 68f and 77f see usp controlled room temperature in original carton. Hycamtin for injection topotecan dose, indications.
See full prescribing information for complete boxed. Cells were then plated in a control insert chamber bd biosciences for 48 h at. Teva pharmaceuticals, usa application no 022453 approval date. Refer to the package insert for dose preparation instructions. The concentration of fomepizole at which alcohol dehydrogenase is inhibited by 50% in vitro is approximately 0. Vinblastine is a cancer medication that interferes with the growth and spread of cancer cells in the body vinblastine is used to treat hodgkins disease, certain types of lymphoma, testicular cancer, breast cancer, choriocarcinoma a type of uterine cancer, kaposis sarcoma, and letterersiwe disease. Sep, 2018 what is hycamtin topotecan hydrochloride. Administer the first cycle of hycamtin for injection only topatients with a baseline neutrophil count of greater than or equal to 1,500mm3 andaplatelet count greater than or equal to 100,000mm3. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. Sep, 2018 hycamtin capsules for oral use contain topotecan hydrochloride, the content of which is expressed as topotecan free base.
Package insert thiotepa for injection, usp description thiotepa for injection is an ethyleniminetype compound. Please click here to view the full prescribing information. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. Because the vials contain no preservative, contents should be. Highlights of prescribing information these highlights do not include all the information needed to use coumadin safely and effectively. A comparison is considered statistically significant if the pvalue is jul 27, 2009 fomepizole has been shown in vitro to block alcohol dehydrogenase enzyme activity in dog, monkey, and human liver. Topotecan interferes with the function of an enzyme called topoisomerase i used by cells to repair breaks in the dna the machinery or brain that runs each cell strand. Withhold and reduce dose of hycamtin for injection based on neutrophil. Updated fda approved indication for hycamtin capsules and injection.
Dailymed pentam 300 pentamidine isethionate injection. Fecal elimination of total topotecan accounted for 17. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Reconstituted vials of hycamtin diluted for infusion are stable at approximately 20 80. Topotecan is known to be genotoxic to mammalian cells and is a probable carcinogen. Highlights of prescribing information these highlights do not include all the information needed to use pegasyssafely and effectively. Zerbaxa ceftolozane tazobactam for injection, for intravenous use. Vinp03 vinblastine sulfate for injection usp warning caution this preparation should be administered by individuals experienced in the administration of vinblastine sulfate. In addition, each kit includes a singledose sterile vial containing 2. Topotecan is not able to discriminate between good cells. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid.
The valuebased benchmark prices for a drug are defined as the. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Hycamtin topotecan capsules, for oral use initial u. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to. Oct 01, 2019 hycamtin for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder for reconstitution in 4mg free base singledose vials.
Ovarian cancer in patients whose disease has not gotten better with other chemotherapy. Withhold and reduce dose of hycamtin for injection. Vumerity diroximel fumarate delayedrelease capsules, for oral use. After reconstitution of vial, gently mix solution 4. In some cases, health care professionals may use the trade name hycamtin when referring to the generic drug name topotecan. See full prescribing information for complete boxed warning. Highlights of prescribing information these highlights do not include all the information needed to use cubicin safely and effectively.
Recommended topotecan dosage your healthcare provider will base your topotecan dose on your body surface area which is calculated using your height and weight. Hycamtin topotecan chemotherapy, side effects navigating care. Compare prices, print coupons and get savings tips for topotecan generic hycamtin and other lung cancer, ovarian cancer, and cervical cancer drugs at cvs, walgreens, and other pharmacies. Reconstituted vials of topotecan hydrochloride for injection diluted for infusion are stable at.
Topotecan is designed to slow the growth and kill lung cancer cells by stopping the production of dna in small cell lung cancer cells. Myelosuppression see full prescribing information for complete boxed warning. The reconstituted concentration of bortezomib for subcutaneous administration 2. Topotecan is approved for use in combination with cisplatin platinol to treat stage ivb cancer that has spread beyond the pelvis and pelvic lymph nodes to other places in the body, recurrent, or persistent cervical cancer that is not likely to be cured by surgery or radiation. Prozac fluoxetine hydrochloride capsules label fda. Your healthcare provider will perform a test to make sure that vizimpro is right for you. If changing patients from another insulin glargine product, 100 unitsml, to basaglar, the dose of. Thiotepa is a synthetic product with antitumor activity. Docetaxel injection, for intravenous use initial u. Tarceva is prescribed for patients with nonsmall cell lung cancer nsclc whose cancer has spread to other parts of the body and that has certain types of epidermal growth factor receptor egfr. Do not administer avastin for 28 days following major surgery and until surgical wound is fully healed.
Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether. Because the vials contain no preservative, contents should be used immediately after reconstitution. Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. Topotecan by injection topotecan toepoeteekan treats cancer of the ovary, lungs, and cervix. Highlights of prescribing information these highlights do not include all the information needed to use docetaxel safely and effectively. Mylan manufactures topotecan hydrochloride for injection hycamtin in strengths of 4 mg. Zirabev medication page for healthcare professionals to search for scientific information on pfizer medications. Administer the first cycle of topotecan only to patients with baseline neutrophil counts of 1,500 cellsmm3 or greater and platelet counts of 100,000 cellsmm3 or greater. The recommended dosage of topotecan hydrochloride for injection is 1.
The dosage amount will vary, depending on your particular chemotherapy regimen, as well as the particular type of cancer being treated. When this happens, the dna strand breaks further and cannot be repaired resulting in cell death. Hycamtin topotecan hydrochloride is a specific inhibitor of topoisomerasei enzyme. Hycamtin, premierpro rx topotecan hydrochloride there may be other brand names for this medicine. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Reduce the recommended dose to 75% in patients with creatinine clearance 15 to. One complete and 6 partial responses were seen in 60 patients, for a response rate of 12%. Highlights of prescribing information interstitial lung.
Hycamtin capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents. Istodax is supplied as a kit which includes a sterile, lyophilized powder in a 10 mg singledose vial containing 11 mg of romid epsin and 22 mg of the bulking agent, povidone, usp. Ibm micromedex it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. As with olaparib and niraparib, the fda prescribing information. Monitor blood cell counts see warnings and precautions 5. Each milliliter of solution contains 20 mg of irinotecan hydrochloride on the basis of the trihydrate salt, 45 mg of sorbitol, nf, and 0. Topotecan did not cause mutations in bacterial cells. Topotecan for injection page 5 of 27 topotecan hydrochloride has been shown to be genotoxic to mammalian cells mouse lymphoma cells and human lymphocytes in vitro, and mouse bone marrow cells in vivo, but is not mutagenic in. Pegasys peginterferon alfa2a injection, for subcutaneous use initial u.
Topotecan can cause severe bone marrow suppression, including neutropenia, thrombocytopenia, and anemia. Ibm micromedex medicines used to treat cancer are very strong and can have many side effects. Topotecan hydrochloride for injection hycamtin 4 mg. When topotecan injection is used to treat ovarian or lung cancer, it is usually given once a day for 5 days in a row every 21 days. Topotecan fda prescribing information, side effects and uses.
Torisel temsirolimus injection worldwide fact sheet. Pentam 300 pentamidine isethionate for injection, an antiprotozoal agent, is a sterile, nonpyrogenic, lyophilized product. Topotecan injection is used to treat patients with metastatic cancer a cancer that has already spread of the ovaries after other treatments have failed. Do not administer subsequent cycles of topotecan hydrochloride for injection until neutrophils recover to greater than 1,000mm 3, platelets recover to greater than 100,000mm 3, and hemoglobin levels recover to greater than or equal to 9 gdl with transfusion if necessary.
Sections or subsections omitted from the full prescribing information are not listed. Mvasi, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Vinblastine sulfate is the salt of an alkaloid extracted from vinca rosea linn. Find information about common, infrequent and rare side effects of topotecan intravenous. Topotecan injection is supplied as singleuse vial containing 4 mg4 ml as a 1 mgml solution. Enhertu famtrastuzumab deruxtecannxki for injection, for intravenous use. After reconstitution, it should be administered by intramuscular im or intravenous iv routes see dosage and administration. Before using this medicine, make sure you understand all of the risks and benefits. The excipients are gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. Previously, the generic name was vincaleukoblastine, abbreviated vlb. The product catalog provides you with a full listing of tevas brand and generic product lines. Per topotecan package insert, dilute each vial with 4 ml of sterile water for a final concentration of 1 mgml 3.
Topotecan comes as a liquid to be given intravenously into a vein over 30 minutes by a doctor or nurse in a hospital or clinic. Patients with combined abnormalities of transaminase and alkaline phosphatase should, in general, not be treated with taxotere. Updated study information from guidelines and package insert. Topotecan hydrochloride for injection hycamtin 4 mg mylan. Skyrizi risankizumabrzaa injection, for subcutaneous use. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinumresistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Topotecan hydrochloride is approved to be used alone or with other drugs to treat.
Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cellsmm 3 and platelet counts greater than or equal to 100,000 cellsmm 3. Ervebo ebola zaire vaccine, live suspension for intramuscular injection. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Camptosar is supplied as a sterile, pale yellow, clear, aqueous solution. Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of. Hycamtin fda prescribing information, side effects and uses. Learn about drug imprint, side effects, uses treating, dosage, interaction, overdose, and warnings. Store diluted product in accordance with package insert.
The nccn compendium is a derivative work of the nccn guidelines. Topotecan side effects, dosage, interactions drugs. Basaglar should be the same as the other insulin glargine. Topotecan was mutagenic to l5178y mouse lymphoma cells and clastogenic to cultured human lymphocytes with and without metabolic activation. Topotecan 4 mg injection 2 vials sterile water 8 ml directions. Xgevadenosumab injection, for subcutaneous use initial usapproval. Due to browser popup and site security settings, the prescribing information pdf did not automatically load. Read the patient information leaflet provided by your pharmacist before you start taking topotecan and each time you get a refill. Topotecan is an anticancer antineoplastic or cytotoxic chemotherapy drug. It is a water soluble analogue of camptothecin, a natural substance found in several species10s of asian tree. Nov 09, 2018 topotecan is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
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