Medication Monitor

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Generic Name (Trade Name—Company)
  • August 20, 2018

    Vertex Pharmaceuticals announced FDA approval of lumacaftor/ivacaftor to include use in children aged 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medication approved to treat the underlying cause of CF in this population. 

    The oral granules are available in two dosage strengths—lumacaftor 100mg/ivacaftor 125mg and lumacaftor 150mg/ivacaftor 188mg—for weight-based dosing.

    FDA approval for this indication was based on a Phase III open-label safety study in 60 patients that showed treatment with lumacaftor/ivacaftor was generally safe and well tolerated for 24 weeks, with a safety profile similar to that in patients aged 6 years and older. Improvements in sweat chloride, a secondary endpoint, were observed at week 24. Researchers also saw changes in key growth parameters, which were also secondary endpoints in the study.

    The most common adverse event (≥30%) was cough (63%); most adverse events were mild or moderate in severity. Four patients experienced serious adverse events (two pulmonary exacerbations, one gastroenteritis, one constipation), and three patients discontinued treatment due to treatment-emergent adverse events or elevated liver function tests. 

    The agent was originally approved for treatment of CF in patients aged 6 years and older who have two copies of the F508del-CFTR mutation.

  • August 17, 2018

    FDA has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening, in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals gained approval to market its generic epinephrine auto-injector in 0.3-mg and 0.15-mg strengths.

    The EpiPen is intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick, and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names.

    An authorized generic is made under the brand name’s existing new drug application using the same formulation, process, and manufacturing facilities used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.

    This epinephrine injection (auto-injector) is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.

    The most common adverse effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. Rare cases of serious skin and soft tissue infections have been reported following use of the drug. In patients with heart disease, use of epinephrine injection may cause chest pain or abnormal heart beats. Following use of epinephrine injection, patients should seek immediate medical or hospital care.

    Epinephrine should not be injected into the vein, buttock, fingers, hands, or feet. To minimize risk of injection-site injury, movement of the leg should be limited during injection.

  • July 31, 2018

    Indivior PLC announced FDA approval of the first once-monthly, long-acting injectable (LAI) containing risperidone to treat schizophrenia in adults. Clinically relevant levels were reached after the first injection without use of a loading dose or any supplemental oral risperidone.

    The extended-release delivery system forms an S.C. depot that provides sustained levels of risperidone over 1 month. Initial peak risperidone plasma levels occur within 4 to 6 hours of dosing and are due to an initial release of the drug during the depot formation process.  

    Efficacy of the new formulation was evaluated in a pivotal Phase III randomized, double-blind, placebo-controlled, 8-week study of 354 patients. The study demonstrated an improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale (PANSS) total score at day 57. The improvement in Clinical Global Impression Severity of Illness (CGI-S) was also statistically significant at day 57. Clinical trials were designed for the product to be initiated with neither a loading dose nor any supplemental risperidone.

    Safety was evaluated in 814 adults with schizophrenia who received at least one dose during clinical trials. A total of 322 patients were treated with the injectable agent for at least 6 months, with 234 of those treated for at least 12 months. The systemic safety profile was consistent with the known safety profile of oral risperidone.

    The most common systemic adverse reactions were increased weight, sedation/somnolence, and musculoskeletal pain. The most common injection-site reactions were injection-site pain and reddening of the skin.

    The labeling comes with a boxed warning cautioning that older adult patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. The agent is not approved for use in patients with dementia-related psychosis. 

  • July 31, 2018

    Astellas Pharma and Pfizer announced FDA approval of enzalutamide for treatment of men with nonmetastatic castration-resistant prostate cancer (CRPC). It is the first and only oral medication FDA approved for both nonmetastatic and metastatic CRPC.

    Enzalutamide was first approved by FDA in 2012 to treat patients with metastatic CRPC who had previously received docetaxel, and in 2014, it was granted approval for chemotherapy-naive men with metastatic CRPC.

    The updated label is based on results from the Phase III PROSPER trial, which demonstrated that use of enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastasis or death compared with ADT alone in men with nonmetastatic CRPC.

    The most common adverse reactions in the clinical trial were asthenic conditions, hot flush, hypertension, dizziness, nausea, and fall.

  • July 19, 2018

    Janssen announced FDA approval of darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg under the trade name Symtuza—the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of HIV-1 in treatment-naive and certain virologically suppressed adults. 

    Symtuza combines the high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of an STR.

    Approval was based on data from two 48-week, noninferiority, pivotal Phase III studies that assessed the safety and efficacy of Symtuza versus a control regimen in adults with no prior antiretroviral history (AMBER) and in virologically suppressed adults (EMERALD).

    Results from both trials demonstrated that Symtuza was effective and well tolerated, with up to 95% achieving or maintaining virologic suppression (HIV-1 RNA < 50 c/mL).

    The recommended dosage of Symtuza is one tablet taken once daily with food. Symtuza is not recommended in patients with creatinine clearance below 30 mL per minute or those with severe hepatic impairment.

    According to the prescribing information, prior to or when initiating treatment with Symtuza, patients should be tested for hepatitis B virus (HBV) infection and renal function, and renal function should be monitored as clinically appropriate during therapy. The agent comes with a boxed warning on the risk of posttreatment acute exacerbation of hepatitis B.