How to add and organize pages in a pdf adobe acrobat dc tutorials. Nucala mepolizumab for injection nucala mepolizumab injection. Grapefruit may also increase plasma concentrations of lapatinib and should be avoided. Patients who receive anthracyclines after stopping herceptin may. These highlights do not include all the information needed to use sustol safely and effectively. Highlights of prescribing information these highlights do not include allthe information needed to use boniva injectionsafely and effectively. Highlights of prescribing information childpugh class b. Contraception should be used while receiving herceptin and for 7 months after your last dose of herceptin. Please click here for full prescribing information for lantus or scan qr code. Highlights of prescribing information these highlights do not. Do not substitute enhertu for or with trastuzumab or ado trastuzumab emtansine. Highlights of prescribing information adjuvant treatment. Insert pdf file in latex document tex latex stack exchange. For use as adjunctive therapy in the treatment of irritable bowel syndrome irritable colon, spastic colon, mucous colitis and acute enterocolitis.
Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder. Mar 23, 2020 mononine is not indicated in the treatment or prophylaxis of hemophilia a patients with inhibitors to factor viii. Highlights of prescribing information consideration of the. Fda approves pfizers oncology biosimilar trazimera. Herceptin fda prescribing information, side effects and uses. Nerlynx as a single agent is indicated for the extended adjuvant treatment of adult patients with earlystage human epidermal growth factor receptor 2 her2positive breast cancer, to follow adjuvant trastuzumab based. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion.
Trastuzumab is produced by recombinant dna technology in a mammalian cell chinese hamster ovary culture which may contain the antibiotic gentamicin. Highlights of prescribing information initial dose of 4. Prescribing information kogenate fs, antihemophilic factor. Mononine fda prescribing information, side effects and uses. If you are or become pregnant while receiving herceptin or within 7 months after your last dose of herceptin, you should immediately report herceptin exposure to. Mar 05, 2018 for the prevention and control of bleeding in patients with factor ix deficiency due to hemophilia b. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for zyloprim allopurinol.
Dm1, the cytotoxic component of kadcyla, may cause serious adverse reactions in breastfed infants based on its mechanism of. The efficacy of natazia in women with a body mass index bmi of 30 kgm2 has not been evaluated. Permanently discontinue herceptin for a persistent 8 weeks lvef decline or for suspension of herceptin dosing on more than 3 occasions for cardiomyopathy. Administer perjeta, trastuzumab, and docetaxel by intravenous infusion every 3 weeks. Learn about rates of recurrence and how nerlynx may help. Physicians package insert ortho tricyclen tablets orthocyclen tablets norgestimateethinyl estradiol patients should be counseled that this product does not protect against hiv infection aids and other sexually transmitted diseases. Product monograph lantus insulin glargine injection. If the next scheduled boniva day is only 1 to 7 days away, wait until the subsequent months scheduled boniva day to take their tablet. Mesnex injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight ww at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. Perjeta, trastuzumab or trastuzumab hyaluronidaseoysk, and taxane should be administered sequentially. See full prescribing information for complete boxed warning coadministration of norvir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious andor lifethreatening adverse events due to possible effects of norvir on the hepatic metabolism of certain drugs. If you are looking for information about pfizer studies currently recruiting new patients in your area, you can begin your search on our website. The pathvysion her2 dna probe kit is one of the first examples of what is recognized as genomic disease management, or personalized medicine. Youll need to have adobe acrobat or abode reader installed to see or read pdf files.
If patients must be coadministered, a strong cyp3a4 inhibitor, based on pharmacokinetic studies, a dose reduction to 500 mgday of lapatinib is predicted to adjust the lapatinib auc to the range. Pfizer today announced that it received a complete response letter crl from the united states food and drug administration fda in response to the biologics license application for the companys proposed trastuzumab biosimilar. Directions for proper use of pharmacy bulk package. Patients preferred herceptin hylecta administration over iv trastuzumab 1. Policy document for herceptin trastuzumab the overall objective of this policy is to support the appropriate and cost effective use of the medication. Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with earlystage her2overexpressedamplified breast cancer, to follow adjuvant trastuzumab based therapy. Naropin ropivacaine hcl injection a fresenius kabi site. Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery.
The incidence and severity was highest in patients receiving trastuzumab with anthracyclinecontaining chemotherapy regimens. Highlights of prescribing information these highlights do not include all the information needed to use harvoni safely and effectively. Highlights of prescribing information initial dose of. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration see warnings and precautions 5. For questions about a pfizer clinical trial, call 800 7181021 or email email protected. Basaglar should be the same as the other insulin glargine. Dailymed levora levonorgestrel and ethinyl estradiol kit. Full prescribing information for kogenate fs antihemophilic factor recombinant with vial adapter is available in a downloadable pdf file. Insert the syringe needle into the vial through the center of the stopper and direct the stream of sterile water for injection to the glass wall of the vial to avoid excessive foaming. When using in combination with perjeta pertuzumab and docetaxel, consult product monographs for perjeta and docetaxel for further information on these drugs. For a list of all side effects that have been reported, ask your doctor or pharmacist for the geodon professional package insert. Herceptin trastuzumab is a recombinant dnaderived humanized monoclonal antibody that selectively binds with high affinity in a cellbased assay kd 5 nm to the extracellular domain of the human epidermal growth factor receptor 2 protein, her2.
Click select to convert the file into pdf format and insert it into the document. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Dosageand administration for intravenous iv infusion only. Herceptin may result in the death of an unborn baby or birth defects. Trastuzumab products administration can result in subclinical and clinical cardiac failure. The apparent volume of distribution at steady state ranged from 43 to 90 l. Do not substitute enhertu for or with trastuzumab or adotrastuzumab emtansine. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively.
Zerbaxa ceftolozane tazobactam for injection, for intravenous use. Clinical criteria policy information specific to the clinical appropriateness for the medication. Using a sterile syringe, slowly inject 5 ml of sterile water for injection into the 100 mg kadcyla vial, or 8 ml of sterile water for injection into the 160 mg kadcyla vial to yield a solution containing 20 mgml. Highlights of prescribing information these highlights do not include all the information needed to use entereg safely and effectively. Each vial of nucala should be used for a single patient, and any remainder of the contents.
Page 3 of 44 full prescribing information 1 indications and usage 1. Patient package insert procysbi procisbee cysteamine. Thirty patients were randomized to receive aredia and 35 to receive etidronate disodium. This document provides specific information to each section of the overall policy. Highlights of prescribing information coadministration with.
To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Xgevadenosumab injection, for subcutaneous use initial usapproval. If changing patients from another insulin glargine product, 100 unitsml, to basaglar, the dose of. Fda approves ogivri as a biosimilar to herceptin fda. Capitals indicate lifethreatening, underlines indicate most frequent. In case of an overdose, call your doctor or poison control center right away or go to the nearest emergency room. Aliqopa copanlisib for injection, for intravenous use. This means that the test helps enable the accurate assessment of a patients her2 status at the dna level with a high degree of accuracy and helps guide doctors to make the most appropriate therapy. There is no information regarding the presence of ado trastuzumab emtansine in human milk, the effects on the breastfed infant, or the effects on milk production. These highlights do not include all the information needed to use halaven safely and effectively. Received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. One week after the last weekly dose of herceptin, administer 6 mgkg as an iv infusion over 30. Highlights of prescribing information these highlights.
Herceptin treatment was permanently discontinued in patients who developed congestive heart failure, or persistentrecurrent lvef decline see dosage and administration. See full prescribing information for boniva injection. Information for the user herceptin 150 mg powder for concentrate for solution for infusion trastuzumab read all of this leaflet carefully before you start using this medicine because it contains important information for you. Calan sr verapamil sustained release oral caplets description. The pdfpages package makes it easy to insert pages of external pdf documents. For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one boniva 150 mg tablet every month on their previous chosen day. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults.
Highlights of prescribing information the recommended. Mesnex fda prescribing information, side effects and uses. Natazia is indicated for use by women to prevent pregnancy. Pfizer provides update on proposed trastuzumab biosimilar. Do not substitute herceptin hylecta for or with ado trastuzumab emtansine. Vectibix is not indicated for the treatment of patients with colorectal cancer that harbor somatic ras mutations in exon 2 codons 12 and, exon 3 codons 59 and 61, and exon 4 codons 117 and 146 of either kras or nras and hereafter is referred to as. Herceptin trastuzumab is contraindicated in patients with known hypersensitivity to trastuzumab, chinese hamster ovary cho cell proteins, or any component of this product.
On december 1, 2017, the food and drug administration approved ogivri trastuzumab dkst, mylan as a biosimilar to herceptin trastuzumab, genentech, inc. Each vial contains 10 mg of pentostatin and 50 mg of mannitol, usp. Trastuzumab may persist in the circulation for up to 7 mont hs after stopping herceptin treatment based on population pharmacokinetic analysis of all available data see section 5. Boniva ibandronateinjection, for intravenous use initial u. Herceptin is available as a singledose vial containing 60 mg or 150 mg of trastuzumab with the following excipients. Package insert profilnine sd pdf 280kb supporting documents. Nipent pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in singledose vials for intravenous administration. Lamictal starter kits and lamictal odt patient titration kits provide lamictal at doses consistent with the recommended titration schedule for the first 5 weeks of treatment, based upon concomitant medications, for patients with epilepsy older than 12 years and bipolar i disorder adults and are intended to help reduce the potential for rash. Dec 01, 2019 mesnex may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.
Description each of the following products is a combination oral contraceptive containing the. You can resize the object, but you cant edit it after you insert it. Trastuzumab is a humanized igg1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, her2. Select patients for therapy based on an fdaapproved companion diagnostic. Mononine contains nondetectable levels of factors ii, vii and x package insert, drug facts, dosage and administration, and adverse effects for afrin oxymetazoline.
Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. Herceptin is indicated, in combination with cisplatin and capecitabine or 5fluorouracil, for the treatment of patients with her2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease. Unasyn sterile powder for intravenous use may be reconstituted with any of the compatible diluents described in this insert. Evaluate left ventricular function in all patients prior to and during treatment with. The mean baselinecorrected serum calcium for the aredia 60mg and etidronate disodium groups were. Highlights of prescribing information these highlights do not include all the information needed to use afrezza safely and effectively. Sustol granisetron extendedrelease injection, for subcutaneous use initial u. See full prescribing information for complete boxed warning. Highlights of prescribing information these highlights do.
Insert pdf file content into a powerpoint presentation powerpoint. This solution is readytouse and may be administered directly to the patient without further preparation. The recommended dose of herceptin hylecta is 600 mg10,000 units 600 mg trastuzumab and 10,000 units hyaluronidase administered subcutaneously over approximately 25 minutes once every three weeks. The ph of the final product is maintained between 7. Naropin may be associated with adverse reactions which are characteristic of those associated with other amidetype local anesthetics. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. Prozac fluoxetine hydrochloride capsules label fda. Jevtana is indicated in combination with prednisone for the treatment of patients with metastatic castrationresistant prostate cancer previously treated with a docetaxelcontaining treatment regimen. Herceptin was administered at 4 mgkg on the day of initiation of paclitaxel and then at a dose of 2 mgkg weekly for a total of 52 weeks. Serious pneumocystis jiroveci pneumonia pjp occurred in 0. Herceptin is a sterile, white to pale yellow, preservativefree lyophilized powder for intravenous iv infusion. Insert pdf content into your presentation either as a picture that shows on your slide, or as a document that you can open during your slide show.
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