Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9)
Teva Pharmaceuticals USA, 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. 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 less than 40 mL/min/1.73 m2 [see Dosage and Administration (2.5), Warnings and Precautions (5.1)] ; - Poor performance status [see Warnings and Precautions (5.1, 5.3)] ; - High-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy) ; - Advanced malign
Deferasirox 90 mg tablets are light blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D22” on the other side. Tablets are available in bottles of 30 (NDC 0093-3517-56). Deferasirox 180 mg tablets are medium blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D17” on the other side. Tablets are available in bottles of 30 (NDC 0093-3516-56). Deferasirox 360 mg tablets are dark blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D21” on the other side. Tablets are available in bottles of 30 (NDC 0093-3515-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
Teva Pharmaceuticals USA, 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. You Baca dokumen lengkapnya
DEFERASIROX- DEFERASIROX TABLET, FILM COATED TEVA PHARMACEUTICALS USA, 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) 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. (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 14 mg per kg (calculated to nearest whole tablet) once daily. (2.1) NTDT Syndromes: Initial dose for patients with eGFR greater than 60 mL/min/1.73 m is 7 mg per kg (calculated to nearest whole tablet) once daily. (2.2) See full prescribing information for information regarding monitoring, administration, and dose-reductions for organ impairment. (2.1, 2.2, 2.3, Baca dokumen lengkapnya