Avastin package insert pdf

Erbitux can cause serious and fatal infusion reactions. Avastin is a cancer medicine used to treat adults with the following types of cancer, in combination with other cancer medicines. Check the labels on the lucentis carton, syringe tray and prefilled syringe to make sure you have the correct dose strength. Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma mrcc. Avastin will be administered in combination with erlotinib. Hycamtin for injection,in combination with cisplatin,is indicated for the treatment of patients with stage ivb, recurrent, or persistent cervical cancernot amenable to curative treatment. Inject slowly until rubber stopper reaches the bottom of the syringe to deliver the volume of 0. Avastin is used to treat wet agerelated macular decline amd or macular edema.

Avastin bevacizumab medicare advantage policy guideline. The recommended dose of avastin is 10 mgkg of body weight given once every 2 weeks as an intravenous infusion. 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. Lucentis prefilled syringes are available in 2 dose strengths. Avastin is not indicated for adjuvant treatment of colon cancer. Genentech has revised the product information for avastin to include this information. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Length of authorization coverage will be provided for six months and may be renewed. Full prescribing information 1 indications and usage zinplavais indicated to reduce recurrence of clostridium difficile infectioncdi in patients 18 years of age or older who are receiving antibacterial drug treatment of cdi and are at a high risk for cdi recurrence. Avastin reference guide indications 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. This is due to a disease such as diabetic retinopathy or retinal vein occlusion.

Discontinue avastin for gastrointestinal perforation. Avastin reference guide indications 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. Camptosar injection must be diluted prior to infusion. Avastin is a recombinant humanized monoclonal igg1 antibody that binds to vascular endothelial growth factor vegf and inhibits the proliferation of endothelial cells and the formation of new blood vessels. Medwatch safety alerts are distributed by the fda and published by drugs. Full prescribing information 1 indications and usage zaltrap, in combination with. Reversible posterior leukoencephalopathy syndrome rpls see package insert warnings and precautions. The appropriate interval between termination of avastin and subsequent elective surgery required to reduce the risks of impaired wound healingwound dehiscence has not been determined. Bevacizumab package insert pdf px hemorrhage, and vaginal bleeding are increased in bevacizumabtreated patients. The maintenance treatment of adults with ovarian cancer, fallopian tube, primary peritoneal cancer whose cancer has come back and who are in response complete or partial response to a platinumbased chemotherapy.

After injection, do not recap the needle or detach it from the syringe. Since tumors rely on blood vessels to get the nutrients they need. See full prescribing information for complete boxed warning. The authors make no claims of the accuracy of the information contained herein. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Avastin, in combination with carboplatin and paclitaxel, is indicated for the firstline treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous nonsmall cell lung cancer nsclc. Highlights of prescribing information myopic choroidal. Genentech, a member of the roche group, would like to inform you of important new safety information in women receiving avastin bevacizumab. Cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. Avastin, in combination with fluoropyrimidineirinotecan or fluoropyrimidineoxaliplatinbased chemotherapy, is indicated for the secondline treatment of patients with metastatic colorectal cancer who have progressed on a firstline avastin containing regimen. Highlights of prescribing information platinumresistant. Amd is the leading cause of blindness in people over the. Discontinue at least 28 days prior to elective surgery.

Avastin, in combination with intravenous 5fluorouracilbased chemotherapy, is indicated for the first or secondline treatment of patients with metastatic colorectal cancer. Highlights of prescribing information reduce the dose of. Nephrotic syndrome see package insert warnings and precautions. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Do not administer bevacizumab to patients with serious hemorrhage or recent hemoptysis. Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0. Refer to everolimus prescribing information for recommended everolimus dosing information. Bevacizumab avastin is a humanized monoclonal antibody moab targeting vegf. Doxorubicin hydrochloride for injection, usp patient. Hepatotoxicity and embryofetal toxicity 1 indications and usage 2 dosage and administration 3 dosage forms and strengths 4 contraindications 5 warnings and precautions 5. Highlights of prescribing information diabetic macular edema. Vaccination schedule for infants and toddlers dose a,bdose 1 cdose 2 b dose 3 b.

Some patients may need every 4 week 52019 dosage and administration 2 82019 indications and usage eylea is a vascular endothelial growth factor vegf inhibitor indicated for. Gastrointestinal perforations, surgery and wound healing complications, and hemorrhage. The primary efficacy endpoint of the trial was overall survival. Myopic choroidal neovascularization mcnv for ranibizumab lucentis only. Local coverage article for drugs and biologicals bevacizumab avastin l34303. Learn about avastin bevacizumab solution for iv infusion, including benefits, risks, possible side effects, patient support, and options for financial help. Eloxatin oxaliplatin injection for intravenous use. 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. Avastin, in combination with fluoropyrimidineirinotecan or fluoropyrimidineoxaliplatinbased. Highlights of prescribing information recurrent or. Follow applicable special handling and disposal procedures.

Product information for auspar avastin bevacizumab roche products pty ltd pm20120271634 final 31 march 2014. Avastin is an injectable cancer medication that works by blocking a protein that is important for the formation of blood vessels. Avastin is also used for the treatment of adult patients with advanced nonsmall cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor egfr. The administration of oxaliplatin injection does not require prehydration. Prevnar is to be administered as a fourdose series at 2, 4, 6, and 1215 months of age. Avastin is indicated for the treatment of recurrent glioblastoma gbm in adults. A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema bolt study 12month data. This product information was approved at the time this auspar was published. Added intracanaliculardextenza insert to section h with criteria. Highlights of prescribing information these highlights do not include all the information needed to use beovu safely and effectively. Discontinue avastin in patients with wound dehiscence. In a second phase 1 study, oxaliplatin was administered to 26 pediatric patients as a 2hour intravenous infusion on day 1 every 3 weeks 1 cycle at 5 dose levels starting at 100 mgm 2 with escalation to 160 mgm 2, for a maximum of 6 cycles.

Highlights of prescribing information these highlights do. Patients should be monitored following the injection to permit early treatment, should an infection occur. Premedication with antiemetics, including 5ht3 blockers with or without dexamethasone, is recommended. 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. Mvasi bevacizumabawwb is biosimilar to avastin bevacizumab warning. Highlights of prescribing information wounds have adequately. Avastin is administered in combination with one of the following agents paclitaxel, topotecan given weekly or pegylated liposomal doxorubicin. Avastin bevacizumab, mvasi bevacizumabawwb, zirabev bevacizumabbvzr this medication is included in this policy but is not available in the market as of yet. Use only the supplied adjuvant suspension component liquid for reconstitution.

At least 4 weeks prior to elective surgery see package insert. Intravitreal injections, including those with lucentis, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. General information the fda revoked the approval of the breast cancer indication for avastin bevacizumab on november 18, 2011. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Eylea aflibercept injection, for intravitreal use initial u. Camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded. Bolded medications are the preferred products bevacizumab fep clinical rationale rationale for inclusion in pa program background. Adding bevacizumab to a variety of firstline regimens used for metastatic. When avastin is administered in combination with topotecan given on days 1 5. It is the salt of an alkaloid obtained from a common flowering herb, the periwinkle plant vinca rosealinn. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Avastin is the preferred agent for medicare members. Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to. Eylea 2mg via intravitreal injection every 4 weeks iii.

Avastin is administered in addition to platinumbased chemotherapy for up to 6 cycles of treatment followed by avastin as a single agent until disease progression. Highlights of prescribing information these highlights do not. Added j3490 injection, dexamethasone, intracanalicular insert, 0. At least 4 weeks prior to elective surgery see package insert warnings and precautions. Q5107 injection, bevacizumabawwb, biosimilar, mvasi, 10mg vii. Proper aseptic injection technique should always be utilized when administering lucentis. Download, view or print all the forms and documents you need to get started with avastin access solutions, including enrollment forms, tips and checklists.

Avastin, in combination with carboplatin and paclitaxel, followed by avastin as a single agent, is indicated for the treatment of patients with stage iii or iv epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. Avastin will be administered together with a chemotherapy regimen containing platinum. Package insert vincristine sulfate injection, usp preservative free solution description vincristine sulfate injection, usp is vincaleukoblastine, 22oxo, sulfate 1. Carboplatin carboplatin this product information is intended only for residents of the united states.

In a separate cohort, oxaliplatin 85 mgm 2 was administered on day 1 every 2 weeks, for a maximum of. Do not initiate avastin for at least 28 days after surgery and until the surgical wound is fully healed. Avastin singleuse vial, 100 mg4 ml solution for injection. Doxorubicin hydrochloride for injection, usp for intravenous use only rx only warnings 1. The fda alerts below may be specifically about avastin or relate to a group or class of drugs which include avastin bevacizumab.

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