Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9)
Actavis Pharma, Inc.
ORAL
PRESCRIPTION DRUG
Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. This indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels [see Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. Deferasirox tablets are contraindicated in patients with: - Estimated GFR
Deferasirox Tablets are supplied as follows: 90 mg – Gray, film-coated, oval shaped tablet debossed with “A090” on one side and plain on the other side. Tablets are supplied in bottles of 30 (NDC 0591-3847-30) and 500 (NDC 0591-3847-05). 180 mg – Orange, film-coated, oval shaped tablet debossed with “A180” on one side and plain on the other side. Tablets are supplied in bottles of 30 (NDC 0591-3853-30) and 500 (NDC 0591-3853-05). 360 mg – Pink, film-coated, oval shaped tablet debossed with “A361” on one side and plain on the other side. Tablets are supplied in bottles of 30 (NDC 0591-3861-30) and 500 (NDC 0591-3861-05). Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
Actavis Pharma, Inc. ---------- MEDICATION GUIDE Deferasirox (dee fer′ a sir ox) Tablets What is the most important information I should know about deferasirox tablets? Deferasirox tablets can cause serious side effects, including: Kidney problems: Deferasirox tablets can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have happened mostly in people who also have other health problems and had a blood disorder that was in an advanced stage. Adults and children who already have kidney problems and are taking certain medicines with deferasirox tablets may also have an increased risk of sudden kidney problems. Be sure to tell your healthcare provider about all the medicines you take during treatment with deferasirox tablets. Your healthcare provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with deferasirox tablets. Call your healthcare provider right away if: • your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with deferasirox tablets. Your child may be dehydrated. Your healthcare provider may need to temporarily stop treatment with deferasirox tablets and treat your child for dehydration to help prevent kidney problems. Your healthcare provider may monitor your child’s kidney function more closely. • you notice that you or your child are passing less urine than usual during treatment with deferasirox tablets. Liver problems. Deferasirox tablets can cause liver problems, including liver failure that can sometimes cause death. Liver problems with deferasirox tablets may be more common in people who are over 55 years of age but can also happen in children. Liver failure has happened more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also happened along with kidney problems in certain children who become dehydrated. See “Kidney problems” above. Your healthca Przeczytaj cały dokument
DEFERASIROX- DEFERASIROX TABLET, FILM COATED ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEFERASIROX TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEFERASIROX TABLETS. DEFERASIROX TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2005 WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ DEFERASIROX MAY CAUSE SERIOUS AND FATAL: ACUTE KIDNEY INJURY, INCLUDING ACUTE RENAL FAILURE REQUIRING DIALYSIS AND RENAL TUBULAR TOXICITY INCLUDING FANCONI SYNDROME (5.1) HEPATIC TOXICITY, INCLUDING FAILURE (5.2) GASTROINTESTINAL HEMORRHAGE (5.3) DEFERASIROX THERAPY REQUIRES CLOSE PATIENT MONITORING, INCLUDING LABORATORY TESTS OF RENAL AND HEPATIC FUNCTION. (5) RECENT MAJOR CHANGES Indications and Usage, Limitations of Use (1.3) 7/2019 INDICATIONS AND USAGE Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1) Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non- transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. This indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels_._ Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.2) Limitations of Use: The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3) DOSAGE AND ADMINISTRATION Transfusional Iron Overload: Initial dose for patients with estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m is 1 Przeczytaj cały dokument