Restricted access do not disseminate or copy without approval. Page 1 highlights of prescribing information these highlights do not include all the information needed to use xgeva safely and effectively. In clinical studies, nplate was discontinued in four of the 271 patients because of bone marrow reticulin deposition. Medication guide nplate nplat romiplostim worsening. Highlights of prescribing information do not shake during. Winrho sdf for the treatment of immune thrombocytopenic. This includes some forms of blood clots that spread to the lungs or that cause strokes or heart attacks. Holder see section 6 of the package leaflet for antibody testing. With the vial sitting on a flat surface, insert the tip of the syringe into the adapter. The prescribing information carries a blackbox warning for hepato toxicity, and unlike the pack age insert for romiplostim, the literature for eltrombopag warns of. The prescribed nplate dose may consist of a very small volume eg, 0.
If nplate romiplostim is stopped, have your blood work checked for at least 2 weeks after stopping it. Immune thrombocytopenia itp treatment nplate romiplostim. The benefits and risks of repeat injections have not been demonstrated. Nplate should be used only in patients with itp whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Vincristine sulfate vincristine sulfate this product information is intended only for residents of the united states. Highlights of prescribing information these highlights do not include all the information needed to use vraylar safely and effectively. Pentam 300 pentamidine isethionate for injection, an antiprotozoal agent, is a sterile, nonpyrogenic, lyophilized product.
Each ml of the sterile solution contains 20 mg of plerixafor. Dailymed pentam 300 pentamidine isethionate injection. And patient has previously failed one of the following treatments for itp. Bleeding risk see full prescribing information for complete boxed warning. The initial nplate dose is 1 mcgkg once weekly as a sc. Successful treatment of cyclic thrombocytopenia with. Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0. Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether. Nplate romiplostim prior auth criteria proprietary information. Nplates active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune idiopathic thrombocytopenic purpura called. Initial dose the initial dose for nplate is 1 mcgkg based on actual body weight. See full prescribing information including boxed warning on serious infections. Use the lowest dose of nplate to achieve and maintain a platelet count.
Zoladex can cause fetal harm when administered to a pregnant woman. Highlights of prescribing information these highlights do. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Zilretta is an extendedrelease corticosteroid approved to manage osteoarthritis knee pain. Nplate is a prescription medicine used to treat low blood platelet counts thrombocytopenia in adults with immune thrombocytopenia itp when certain medicines or surgery to remove your spleen have not worked well enough. Page 3 of 44 full prescribing information 1 indications and usage 1.
Zilretta is not for people allergic to corticosteroids, triamcinolone acetonide or any other component of the product. Defend against platelet destruction discover a different way to manage chronic immune thrombocytopenia citp. Highlights of prescribing information these highlights do not include all the information needed to use effientsafely and effectively. 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. Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab based treatment. Nplate administration increases the risk for development or progression of reticulin fiber deposition within the bone marrow. In addition, each kit includes a singledose sterile vial containing 2.
Zoladex is contraindicated in patients with a known hypersensitivity to gnrh, gnrh agonist analogues, or any of the components in zoladex. Highlights of prescribing information do not shake. After reconstitution, it should be administered by intramuscular im or intravenous iv routes see dosage and administration. Nplate 125 micrograms powder for solution for injection. Please see full prescribing information and medication guide. Mulpleta is a thrombopoietin tpo receptor agonist, and tpo receptor agonists have been associated with thrombotic and thromboembolic complications in. Administer nplate only with a syringe that contains 0. Please see indication and important safety information. Select patients for therapy based on an fdaapproved companion diagnostic for kadcyla see dosage and.
Please refer to table 1 in the prescribing information for instructions on dilution. Tavalisse is a prescription medication used to treat adults with low platelet counts due to chronic itp when a prior treatment for itp has not worked well enough. Nplate romiplostim for injection, for subcutaneous use. Highlights of prescribing information discontinuation of. Zoladex is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. Learn more about nplate as a possible treatment option for adults and children with itp. Nplate should only be utilized in patients with itp whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate 2 approvals may be subject to dosing limits in accordance with fdaapproved labeling, accepted compendia, andor evidencebased practice guidelines. Appendix examples of risk factors for bleeding not all inclusive5,6 undergoing a medical or dental procedure where blood loss is anticipated.
Nplate product monograph page 6 of 67 of the 630 adult patients who received nplate in itp clinical studies, the study duration adjusted thromboticthromboembolic rate in subjects with age 65 years and over was 10 per 100. Do not remove the vial adapter from the package or touch the inside of the package of the adapter. Nplate is a manmade protein medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia itp, when certain other medicines, or surgery to remove your spleen. January 1, 2020 page 2 of 3 immune thrombocytopenia itp pediatric patient aged 1 year or older with itp for at least 6 months. 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. Dosage and administration approvals may be subject to dosing limits in accordance with fdaapproved labeling, accepted compendia, andor evidencebased practice guidelines. The prescribed nplate dose may consist of a very small volume e.
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