Severe myelosuppression with resulting infection or bleeding may occur. If you have any further questions, ask your doctor or nurse. Abraxane is indicated for the firstline treatment of patients with metastatic adenocarcinoma of the pancreas, in. Like cisplatin, it contains a platinum atom surrounded in a plane by two ammonia groups and two other. Carboplatin is a crystalline powder with the molecular formula of c6h12n2o4pt and a molecular weight of 371. Package insert template for carboplatin solution for injection brand or product name product name solution for injection 10mgml name and strength of active substances carboplatin 10mgml product description visual description of the appearance of the product eg colour etc eg clear colourless liquid pharmacodynamics. Gemcitabine fda prescribing information, side effects and uses. Information for the user carboplatin 10mgml concentrate for solution for infusion carboplatin read all of this leaflet carefully before you start using this medicine because it contains important information. Tecentriq atezolizumab injection, for intravenous use initial u. Randomized phase ii study of pemetrexed, carboplatin, and. Highlights of prescribing information adequately rehydrate.
Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you. Mylan manufactures carboplatin injection carboplatin in strengths of 50 mg5 ml 10 mgml150 mg15 ml 10 mgml450 mg45 ml 10 mgml600 mg60 ml 10 mgml. Docetaxel was not mutagenic in the ames test or the chohgprt gene mutation assays. Package insert of accord healthcares cisplatin injection, 1. Please refer to the full prescribing information for pembrolizumab and for. Each 50 ml or 100 ml amber vial of infusion concentrate contains.
Highlights of prescribing information these highlights do not include all the information needed to use gemcitabine for injection safely and effectively. During and following paclitaxel, docetaxel, or docetaxel carboplatin. Paclitaxel fda prescribing information, side effects and uses. Etopophos is indicated, in combination with cisplatin, for firstline treatment of patients with small cell lung cancer. Highlights of prescribing information when administering. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Carboplatin 10 mgml intravenous infusion carboplatin. Paclitaxel injection, usp is available in 30 mg 5 ml, 100 mg 16. Jevtana is a prescription medicine used with the steroid medicine prednisone to treat men with prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has worsened after treatment with other medicines, including docetaxel. Each vial also contains anhydrous citric acid and mannitol. Package insert of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml. Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively.
Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. Paraplatin carboplatin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. Dbl carboplatin injection is a solution for injection medsafe. Initial dose of 4 mgkg as an intravenous infusion over 90 minutes then at 2 mgkg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks paclitaxel or docetaxel or 18 weeks docetaxel carboplatin. Camptosar injection must be diluted prior to infusion.
Pfizer hospital us has the broadest portfolio of sterile injectable medications in the us and a diverse selection of surgical products. Highlights of prescribing information these highlights do not include all the information needed to use taxotere safely and effectively. Carboplatin has a carboxycyclobutane moiety replacing the chloride atoms on cisplatin. Recommended dosageof abraxane is 260 mgm2 intravenously over 30 minutes every 3 weeks. Camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded. Paraplatin carboplatin aqueous solution injection warning. T ab l e1 i st dv rc onw h f5% g, cu sl ity, fr o mhe nd s1 p gfa lodex5 0 intramuscularly once a month with faslodex 250 mg intramuscularly once a month. Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 2025 c 68t o 77 f. This solution is readytouse and may be administered directly to the patient without further preparation. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available. Description etopophos etoposide phosphate for injection is an antineoplastic agent which is. The chemical name for carboplatin is platinum, diammine1,1cyclobutanedicarboxylato2o,o.
Learn about avastin bevacizumab solution for iv infusion, including benefits, risks, possible side effects, patient support, and options for financial help. The product catalog provides you with a full listing of tevas brand and generic product lines. Aug 01, 2019 alimta and carboplatin carbo is approved by the fda to be used with an the fda in combination with carboplatin another chemotherapy drug and. Paraplatin may also be used for purposes not listed in this medication guide. Dose modifications recommended gemzar dose modifications for myelosuppression are described table 1 and table 2 see warnings and precautions 5. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by avastin as a single agent, is indicated for the treatment of patients with platinumsensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Gemzar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinumbased therapy.
Paraplatin carboplatin injection is supplied as a sterile, pyrogenfree, 10 mgml aqueous solution of carboplatin. Unopened vials of carboplatin injection are stable to the date indicated on the. For directions regarding the use and administration of cyclophosphamide please refer to its package insert. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Patients should have an absolute granulocyte count. However, platinum from carboplatin becomes irreversibly bound to plasma proteins and. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Cisplatin injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it. Carboplatin carboplatin injection accord healthcare, inc.
Carboplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Highlights of prescribing information urothelial carcinoma. Carboplatin injection 300 mgm 2 iv on day 1 every four weeks for six cycles alternatively see formula dosing. Dailymed dacarbazine injection, powder, for solution.
Docetaxel fda prescribing information, side effects and uses. Etopophos solutions may be administered at infusion rates up to 3. As a single agent, cisplatin should be administered at a dose of 100 mgm2 iv per cycle once every 4 weeks. Carboplatin injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25c following multiple needle entries. Etopophos etoposide phosphate for injection is an antineoplastic agent which is available for intravenous infusion as a sterile lyophile in singledose vials containing etoposide phosphate equivalent to 100 mg etoposide, 32. The following table contains adverse effects reported with single agent carboplatin in the product monograph. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion.
The total body clearance, apparent volume of distribution and mean residence time for carboplatin, usp is 4. Patients should discontinue therapy if grade 3 or 4 neurotoxicity is experienced. Package insert of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section. Nccn chemotherapy order templates nccn templates appendix b. It is soluble in water at a rate of approximately 14 bristolmyers squibb company approved 1. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Cisplatin should be administered as a single agent at a dose of 50 to 70 mgm2 iv per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy andor prior chemotherapy. Dose adjustment for gemcitabine for injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. Gemcitabine for injection in combination with carboplatin is indicated for the treatment.
Carboplatin is a cisplatin derivative and shares the same mechanism of action. Alimta package insert pdf alimta pemetrexed for injection. Six preoperative cycles of perjeta in combination with docetaxel, carboplatin, and trastuzumab tch or trastuzumab hyaluronidaseoysk escalation of docetaxel above 75 mgm2 is not recommended as given in tryphaena. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide anhydrous.
Refer to carboplatin prescribing information for additional information. Cyclophosphamide 600 mgm 2 iv on day 1 every four weeks for six cycles. Package insert of accord healthcares cisplatin injection. Sep 23, 2019 paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution.
Highlights of prescribing information palmarplantar. Gemzar is a nucleoside metabolic inhibitor indicated. No significant quantities of proteinfree, ultrafilterable platinumcontaining species other than carboplatin are present in plasma. Etopophos etoposide phosphate for injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Therefore in patients who have abnormal renal function. Cytoxan cyclophosphamide for injection, usp cytoxan. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. Jan 01, 2020 the addition of gemcitabine to carboplatin resulted in statistically signi. Highlights of prescribing information initial dose of. Paraplatin carboplatin aqueous solution injection warning paraplatin carboplatin aqueous solution injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Alimta and carboplatin carbo is approved by the fda to be used with an the fda in combination with carboplatin another chemotherapy drug and. For carboplatin dosage adjustment, see manufacturers prescribing information. Description cisplatin injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Carboplatin auc 4 should be administered intravenously on day 1 after gemzar administration.
Carboplatin is a cisplatin analog with similar antineoplastic activity, but with a different adverse effect profile than cisplatin. Mar 01, 2019 cisplatin, the active ingredient in cisplatin for injection, usp, is a yellow to orange crystalline powder with the molecular formulacl 2 h 6 n 2 pt and a molecular weight of 300. Patients received folic acid, vitamin b 12, and dexamethasone as recommended in the pemetrexed package insert. See 17 for patient counseling information and fdaapproved patient labeling. Carboplatin injection carboplatin 50 mg5 ml 10 mgml150. Carboplatin carboplatin this product information is intended only for residents of the united states. Cytoxan cyclophosphamide for injection, usp cytoxan tablets. Follow applicable special handling and disposal procedures. Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0. Cisplatin fda prescribing information, side effects and uses.
Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Following completion of platinumbased therapy, treatment with alimta with or without pembrolizumab isadministered until disease progression or unacceptable toxicity. Nonsmall cell lung cancer the recommended dose of alimta is 500 mgm. Paraplatin is used together with other cancer medications to treat ovarian cancer.
The initial plasma halflife alpha was found to be 1. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Cytoxan cyclophosphamide for injection, usp cytoxan tablets cyclophosphamide tablets, usp description cytoxan cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Highlights of prescribing information platinumresistant. Information for the user carboplatin 10 mgml intravenous infusion carboplatin read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Paraplatin carboplatin injection should be administered under the. In the event of neurotoxicity, the recommended dose adjustments for alimta and cisplatin are described in table 3. Cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. The recommended dosage for previously untreated adults with normal renal function is 400mg. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. This product information is intended only for residents of the united states. Recommended dosage of abraxane is 100 mgm2 intravenously over 30 minutes on days 1, 8, and 15 of each 21day cycle. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Randomized, doubleblind, phase 3 study of pembrolizumab or placebo plus pemetrexed and platinum as firstline therapy for metastatic nsclc.
Alimta pemetrexed for injection healthcare provider site. Appropriate management of therapy and complications is. Approximately 75% of patients in each arm received additional chemotherapy for disease progression. Docetaxel was clastogenic in the in vitro chromosome aberration test in chok1 cells and in the in vivo micronucleus test in mice administered doses of 0. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Myelosuppression as a result of carboplatin treatment is closely related to the renal clearance of the drug. List of nationally authorised medicinal products ema7538642016 page 441 product name in authorisation country mrpdcp. Carboplatinteva 10 mgml concentrate for solution for infusion carboplatin. Imfinzi,in combination with etoposide and either carboplatin or cisplatin,is indicated for the firstline treatment of adult patients with extensivestage small cell lung cancer essclc.
583 1309 165 509 740 635 264 314 479 1619 1069 187 448 996 264 308 1466 1408 457 488 1587 754 566 311 1352 1318 1186 1545 1028 938 529 1352 1039 930 172 217 392 1276 6 1021 326 522