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AHFS Drug Information/Essentials Update – July 2016

The July update to the AHFS Drug Information/Essentials database was published today. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • Daclatasvir (Daklinza®)
    • Daclatasvir dihydrochloride is used in conjunction with sofosbuvir (with or without ribavirin) for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in adults who are treatment-naive (previously untreated) or previously treated, including those with cirrhosis (compensated or decompensated), liver transplant recipients, and those with human immunodeficiency virus (HIV) coinfection
  • Ombitasvir, paritaprevir, and ritonavir (Technivie®)
    • The fixed combination of ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/ritonavir) is used in conjunction with ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 4 infection in treatment-naive (previously untreated) or previously treated adults without cirrhosis

FDA MedWatch Alerts

  • Canagliflozin & Dapagliflozin
    • FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
  • Aspirin
    • The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach
  • Sumatriptan
    • Sumatriptan iontophoretic transdermal system patch (Zecuity) manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the sumatriptan iontophoretic transdermal system patch
  • Loperamide
    • FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death

Epclusa (sofosbuvir/velpatasvir) Approved

FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6. According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.

The safety and efficacy of Epclusa for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95–99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.

The most common side effects of Epclusa include headache and fatigue. Epclusa and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.

Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of Epclusa.

Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

AHFS Patient Medication Information Update – June 2016

The June update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

New PMI Monographs:

  • Cobicistat (Tybost®)
    • Cobicistat is used to increase the amounts of atazanavir (Reyataz®) or darunavir (Prezista®) in your blood when these medications are used to treat human immunodeficiency virus (HIV) in adults.
  • Venetoclax (Venclexta®)
    • Venetoclax is used to treat certain patients with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) who have already been treated with at least one other chemotherapy medication.
  • Brivaracetam & Brivaracetam Injection (Briviact®)
    • Brivaracetam is used is used along with other medications to control partial onset seizures (seizures that involve only one part of the brain) in people who are 16 years of age or older.
  • Ixekizumab Injection (Taltz®)
    • Ixekizumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in people whose psoriasis is too severe to be treated by topical medications alone.
  • Defibrotide Injection (Defitelio®)
    • Defibrotide injection is used to treat adults and children with hepatic veno-occlusive disease (VOD; blocked blood vessels inside the liver, also known as sinusoidal obstruction syndrome), who have kidney or lung problems after receiving a hematopoietic stem-cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body).

FDA MedWatch Alerts – Monograph Revisions

  • Aspirin
    • The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach.
  • Loperamide
    • FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death.
  • Ketoconazole
    •  FDA is warning healthcare professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections.
  • Canagliflozin & Dapagliflozin
    • FDA has strengthened the existing warning about the risk of acute kidney injury.
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