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Journal Cover The Medical Letter
  [SJR: 0.142]   [H-I: 16]   [5 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0025-732X - ISSN (Online) 1523-2859
   Published by The Medical Letter, Inc Homepage  [1 journal]
  • In Brief: Jadenu - A New Formulation of Deferasirox for Iron Overload
           (online only)
    • Authors: admin
      Abstract: Date:  April 25, 2016 Issue #:  1493 Summary:  The FDA has approved an oral tablet formulation of deferasirox (Jadenu [ jade' new] – Novartis) for once-daily treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients ≥2 years old or chronic iron overload in patients ≥10 years old with non-transfusion-dependent thalassemia syndromes. A once-daily, oral tablet for suspension formulation of deferasirox (Exjade) was approved in 2005 for the same indications.1 Jadenu and Exjade are the only once-daily oral formulations for iron chelation available in the US.

      No new clinical trials were required for approval of Jadenu, which was based on earlier clinical trials with Exjade. The most common adverse effects reported with use of deferasirox in clinical trials were diarrhea, vomiting, nausea, abdominal pain, rash, neutropenia, and increases in serum creatinine. Severe skin reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported rarely. Hearing loss and ocular disturbances, including cataracts, have been reported with deferasirox; patients taking the drug should have annual auditory and ophthalmic exams. Gastrointestinal ulceration and hemorrhage and renal and hepatic toxicity have also occurred.


      Deferasirox (Exjade): a new iron chelator. Med Lett Drugs Ther 2006; 48:35.

      Download complete U.S. English article


      PubDate: Mon, 18 Apr 2016 15:55:38 +000
       
  • In Brief: Cholic Acid (Cholbam) for Bile Acid Synthesis Disorders
    • Authors: admin
      Abstract: Date:  April 25, 2016 Issue #:  1493 Summary:  The FDA has approved oral cholic acid (Cholbam – Retrophin) for treatment of children and adults with bile acid synthesis disorders caused by single enzyme defects and for adjunctive treatment of peroxisomal disorders such as Zellweger spectrum disorders in patients who have liver disease, steatorrhea, or complications from fat-soluble vitamin malabsorption. Patients with these rare inborn errors of bile acid metabolism cannot synthesize primary bile acids such as cholic acid, resulting in reduced bile flow, decreased absorption of fat and fat-soluble vitamins, and development of liver disease, which can be fatal. Cholbam is the first drug to be approved in the US for these indications.

      FDA approval was based on a long-term, single-arm clinical trial, an extension of that trial, and case reports in a total of 77 patients with bile acid synthesis disorders and 34 patients with peroxisomal disorders. Administration of cholic acid appeared to decrease hepatic injury and increase height and weight; 67% of patients with bile acid synthesis disorders and 42% of those with peroxisomal disorders treated in the clinical trials survived for more than 3 years.1 Some of these survivors have been treated successfully for more than 20 years. Diarrhea has been the most common adverse effect.

      Cholbam is available in 50- and 250-mg capsules. The usual dosage is 10-15 mg/kg taken once daily or in two divided doses. The cost of 30 days' treatment for a 50-kg patient at a daily dose of 10 mg/kg is about $50,000.2


      FDA. Medical review: cholic acid (Cholbam). Available at: www.accessdata.fda.gov. Accessed April 14, 2016.
      Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. April 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.

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      PubDate: Mon, 18 Apr 2016 14:13:49 +000
       
  • In Brief: New Recommendations for Use of Metformin in Renal Impairment
    • Authors: admin
      Abstract: Date:  April 25, 2016 Issue #:  1493 Summary:  The FDA has required labeling changes that replace serum creatinine (SCr) with estimated glomerular filtration rate (eGFR) as the parameter used to determine the appropriateness of treatment with the biguanide metformin (Glucophage, and others) in patients with renal impairment. These changes will allow more patients with mild to moderate renal impairment to receive metformin, which is generally the first drug prescribed for treatment of type 2 diabetes.

      Metformin was previously contraindicated in women with a SCr level ≥1.4 mg/dL and in men with a SCr level ≥1.5 mg/dL, but use of SCr as a surrogate indicator tends to underestimate renal function in certain populations (e.g., younger patients, men, black patients, patients with greater muscle mass). The calculation of eGFR takes into account age, race, and sex, as well as SCr level, providing a more accurate assessment of kidney function. A literature review summarized in an FDA Drug Safety Communication concluded that, based on eGFR, metformin is safe to use in patients with mild renal impairment and in some patients with moderate renal impairment.1

      The eGFR should be calculated before patients begin treatment with metformin and at least annually thereafter. Metformin is now contraindicated in patients with an eGFR <30 mL/min/1.73 m2, and starting treatment with the drug in patients with an eGFR between 30 and 45 mL/min/1.73 m2 is not recommended. If the eGFR falls below 45 mL/min/1.73 m2 in a patient already taking metformin, the benefits and risks of continuing treatment should be assessed. Metformin should be not be administered for 48 hours after an iodinated contrast imaging procedure in patients with an eGFR <60 mL/min/1.73 m2 or a history of liver disease, alcoholism, or heart failure, or in those receiving intra-arterial contrast, and the eGFR should be re-evaluated before treatment is restarted.


      FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. Available at: www.fda.gov. Accessed April 14, 2016.

      Download complete U.S. English article


      PubDate: Fri, 15 Apr 2016 17:56:18 +000
       
  • Maestro Rechargeable System for Weight Loss
    • Authors: admin
      Abstract: Date:  April 25, 2016 Issue #:  1493 Summary:  The FDA has approved the Maestro Rechargeable System (EnteroMedics), a subcutaneously implanted device, for use in adults who have not been able to lose weight with a weight loss program within the past 5 years and who have a body mass index (BMI) of 40 to 45, or a BMI ≥35 and at least one obesity-related comorbidity.
      PubDate: Wed, 06 Apr 2016 11:44:21 +000
       
  • Mifepristone (Mifeprex) Label Changes
    • Authors: admin
      Abstract: Date:  April 25, 2016 Issue #:  1493 Summary:  The FDA has approved several significant changes in the labeling of mifepristone (Mifeprex – Danco), an oral antiprogestin that has been used in the US for more than 15 years for termination of intrauterine pregnancy. It has generally been used with the prostaglandin analog misoprostol (Cytotec, and generics).
      PubDate: Wed, 23 Mar 2016 11:57:28 +000
       
  • Cariprazine (Vraylar) for Schizophrenia and Bipolar I Disorder
    • Authors: admin
      Abstract: Date:  April 25, 2016 Issue #:  1493 Summary:  The FDA has approved cariprazine (Vraylar – Actavis), an oral, once-daily, second-generation antipsychotic, for treatment of schizophrenia and for acute treatment of manic or mixed episodes associated with bipolar I disorder.
      PubDate: Wed, 23 Mar 2016 11:56:55 +000
       
 
 
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