Xulane norelgestromin and ethinyl estradiol transdermal system initial u. Jadenu fda prescribing information, side effects and uses. For patients with ntdt, measure lic by liver biopsy or by using an fdacleared or approved method for monitoring patients receiving deferasirox therapy every 6. Dose of deferasirox exjade will not exceed 20 mgkg, dose of jadenu will not exceed 14 mgkg. Jadenu is a new oral formulation of exjade tablets for oral suspension. Treatment for chronic iron overload jadenu deferasirox.
Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer 188, and povidone k30. For patients already taking exjade deferasirox tablets for oral suspension, start jadenu deferasirox tablets or jadenu sprinkle deferasirox granules at the nearest equivalent dose eg, exjade 30 mgkgday jadenu 21 mgkgday 1 in patients not adequately controlled with jadenu 21 mgkgday, up to 28 mgkgday may be. Abuse or misuse of illicit ghb is associated with cns adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death 5. Monitor patients and discontinue rituxan infusion for severe reactions 5. Exjade or jadenu will be approved based on the following criterion. The efficacy and safety of deferasirox have been established in a comprehensive clinical development program involving patients with various. Highlights of prescribing information exjade initial. Administration is by intravenous or intramuscular injection. Advate is used to prevent and control bleeding in adults and children 016 years with hemophilia a. If you must administer exjade with 1 of these agents, consider increasing the initial dose of exjade by 50%, and monitor serum ferritin levels and clinical responses for further dose modification see dosage and administration 2. Highlights of prescribing information patients with high. Now you can find the tools you need to help manage your patients, all in one place. Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with nontransfusiondependent thalassemia ntdt syndromes and with a liver iron fe concentration lic of at least 5 mg fe per gram of dry. Highlights of prescribing information these highlights do not include all the information needed to use enbrel safely and effectively.
Your doctor will do regular tests before and during treatment to check the levels of fluid and electrolytes in your blood, platelet counts, and an electrocardiogram ecg. Severe mucocutaneous reactions, some with fatal outcomes 5. Your doctor has decided that you need this medicine to helptreat your condition. Exjade can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over. Desferrioxamine is the chelator that has been in use for the longest time, but its poor oral bioavailability and short halflife require administration by continuous parenteral infusion. Exjade is not recommended for children aged under 2 years. Xermelo is a prescription pill, used along with somatostatin analog ssa therapy, for carcinoid syndrome diarrhea in adults who are not adequately controlled by ssa therapy. Take exjade on an empty stomach at least 30 minutes before eating. Calculate doses mgkg per day to the nearest whole tablet. See full prescribing information for complete boxed warning. This medicinal product is subject to additional monitoring. Dose of deferasiroxexjade will not exceed 20 mgkg, dose of jadenu will not exceed 14 mgkg. Highlights of prescribing information these highlights do not include all the information needed to use jadenu safely and effectively.
You may take jadenu on an empty stomach or with a small lowfat meal. Find information about common, infrequent and rare side effects of exjade oral. When tamiflu for oral suspension is not available from wholesaler or the manufacturer, tamiflu capsules may be opened and mixed with sweetened liquids such as regular or sugarfree chocolate syrup, corn syrup, caramel topping, or light brown sugar. Exjade can cause hepatic injury including hepatic failure and death. Highlights of prescribing information these highlights. Jadenu deferasirox tablets, for oral use jadenu sprinkledeferasirox granules, for oral use initial u. Exjade deferasirox prior authorizationnotification.
Exjade deferasirox tablets for oral suspension initial u. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. See important safety information including boxed warning. This is an international website for exjade deferasirox filmcoated tablets and is intended for healthcare professionals outside the united states. Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
Treatment of chronic iron overload due to blood transfusions transfusional iron overload jadenu deferasirox tablets for oral use and jadenu sprinkle deferasirox granules are indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions transfusional hemosiderosis in patients 2 years of age and older. Highlights of prescribing information these highlights do not include all the information needed to use exjade safely and effectively. Description cortrosyn cosyntropin for injection is a sterile iyophilized powder in vials containing 0. Crinone 4% and crinone 8% progesterone gel physician information for vaginal use only rx only content updated. In order to avoid a large tablet for swallowing due to a relatively high amount of drug substance per dosage unit, dispersible tablets were developed.
Information for the user exjade 90 mg filmcoated tablets exjade 180 mg filmcoated tablets exjade 360 mg filmcoated tablets deferasirox this medicine is subject to additional monitoring. Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter. Pdf evaluation of a new tablet formulation of deferasirox to reduce. Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Safety and efficacy of deferasirox in the management of. Fewer drugrelated adverse events were reported in extension than core study. Find patient medical information for exjade oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Exjade therapy should only be considered when a patient has evidence of chronic transfusional iron overload.
This indication is based on reduction in serum ferritin and liver iron concentration lic. Advate is a medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a also called classic hemophilia. Highlights of prescribing information patients with. The food and drug administration fda has approved jadenu deferasirox for the treatment of chronic iron overload, a condition that can affect patients with myelodysplastic syndromes mds, sickle cell disease and thalassemia. This will allow quick identification of new safety information. Swallow the jadenu tablet whole with a full glass of water. Once the iron is bound the body is able to get rid of it. In april 2007, novartis updated the warnings section of the exjade package insert to add warnings concerning renal failures and cytopenias. Exjade jadenu sgm p2017 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. It has become the most common iron chelator used in north america and many parts of the world because of its onceperday oral dosage. The use of deferasirox is contraindicated in adults and pediatric. Exjade deferasirox is an ironchelating agent, which binds to iron and removes it from the blood stream, used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.
In december 2007, novartis further updated the warnings and postmarketing experience sections of the exjade package insert to add information concerning hepatic failures. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Exjade deferasirox has black box warnings for renal toxicityfailure, hepatic toxicityfailure, and gastrointestinal hemorrhage. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. For instance, a patient who is receiving exjade at. Take exjade once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Exjade is a tablet for oral suspension while jadenu is an oral tablet.
Desferal vials 500 mg and 2 g desferrioxamine mesilate patient information leaflet. June 2017 description crinone progesterone gel is a bioadhesive vaginal gel containing micronized progesterone in an emulsion. If she does not get her period within a week after taking the last active pill or removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant. For more information about xermelo, talk to your doctor or see full prescribing information. Farydak can cause serious side effects in some people. Highlights of prescribing information these highlights do not include all the information needed to use rasuvo saf ely an d effectively. These highlights do not include all the information needed to use tamiflu safely and effectively. It is an iron chelator which is a medicine used to remove the excess iron from the body also called iron. When converting a patient from exjade to jadenu, the dosage should be decreased by. Highlights of prescribing information exjade initial u.
Treatment for chronic iron overload exjade deferasirox. Exjade contains an active substance called deferasirox. Enbrel etanerceptinjection, for subcutaneous use enbrel etanercept for injection, for subcutaneous use initial u. The recommended initial daily dose of exjade is 20 mgkg body weight. Jul 01, 2019 jadenu tablets contain 90 mg, 180 mg, or 360 mg deferasirox. As the patient grows the doctor will adjust the dose. Inlyta axitinib tablets 2ndline mrcc treatment safety. Renal failure, hepatic failure,and gastrointestinal hemorrhage see full prescribing information for complete boxed warning. Jadenu sprinkle granules contain 90 mg, 180 mg, or 360 mg deferasirox. The evidence should include the transfusion of at least 100 mlkg of packed red blood cells e. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
Do not take exjade with aluminumcontaining antacid products. Iron chelators are agents that promote negative iron balance by binding and allowing excretion of iron in a nontoxic form. Desferal vials 500 mg and 2 g desferrioxamine mesilate. Youll have access to the site in a moment, or click continue to close this message and advance directly to the site. It is not known if gattex is safe and effective in children under 1 year of age. Aug 07, 2019 exjade can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Talk to your healthcare provider if this is a concern for you. If you are a us resident, please click on the us residents link at the top of this page. Fe per gram of dry weight prior to initiation of treatment with exjade or jadenu1,3and 3 patient has serum ferritin levels consistently 300 mcgl prior to initiation of treatment with exjade or jadenu1,3 authorization will be issued for 12 months. Hereditary hemochromatosis authorization of 6 months may be granted for treatment of hereditary hemochromatosis when both of the following criteria are met. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. Learn more about exjade deferasirox tablets for oral suspension including copay assistance and patient assistance now oncology, and another treatment option for chronic iron overload.
Highlights of prescribing information these highlights do not. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling. Exjade and jadenu are used for the treatment of patients who have. Indication tykerb lapatinib tablets is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 her2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. Your healthcare provider hcp may give you advate when you have. You can help by reporting any side effects you may get. For patients who cannot swallow capsules, tamiflu for oral suspension is the preferred formulation. Evaluate baseline renal function prior to starting or increasing exjade dosing in all patients. Highlights of prescribing information these highlights do not include all the information needed to use xulane safely and effectively. Exjade jadenu deferasirox exjade jadenu fep clinical rationale rationale for inclusion in pa program background exjade and jadenu are an oral medication that binds to iron in the blood. Serious side effects associated with farydak include diarrhea, heart problems, and bleeding.