Medication Monitor



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  • February 1, 2017

    Teva announced FDA approval of two BX-rated generic products for adolescent and adult patients with asthma: fluticasone propionate and salmeterol inhalation powder (AirDuo RespiClick) and fluticasone propionate inhalation powder (ArmonAir RespiClick).

    AirDuo RespiClick, a fixed-dose combination product containing the same active ingredients as Advair, is a corticosteroid and long-acting beta2-adrenergic agonist indicated for treatment of asthma in patients aged 12 years and older. 

    ArmonAir RespiClick, an inhaled corticosteroid containing the same active ingredient as Flovent, is indicated for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.

    These BX generics cannot be substituted for Advair without permission of the prescriber.

    The medications are delivered via Teva’s RespiClick breath-activated, multidose dry powder inhaler.

    Both products, approved in three strengths each, are expected to become available to patients later in 2017. Approved strengths of AirDuo RespiClick are 55/14 mcg, 113/14 mcg, and 232/14 mcg administered as one inhalation twice daily. Approved strengths of ArmonAir RespiClick are 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily.

    Approval was based on data from three Phase III trials evaluating the efficacy and safety of the treatments in adolescent and adult patients with asthma.  

    In the two double-blind studies, both therapies showed clinically relevant and greater benefit compared with placebo in improvement of lung function after 12 weeks of treatment as measured by forced expiratory volume in one second (FEV1).

  • November 20, 2015

    FDA has approved naloxone hydrochloride as a nasal spray under the trade name Narcan. It is the first FDA-approved nasal spray version of naloxone, a life-saving medication that can stop or reverse the effects of an opioid overdose.

    Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver and eliminates the risk of a contaminated needle stick. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.

    Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This prescription product can be used on adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

    However, it is important to note that it is not a substitute for immediate medical care, and the person administering Narcan nasal spray should seek further immediate medical attention on the patient’s behalf.

    The FDA granted fast-track designation and priority review for Narcan nasal spray. Narcan is being approved in less than 4 months, significantly ahead of the product’s prescription drug user fee goal date of January 20, 2016.

    In clinical trials conducted to support the approval of Narcan nasal spray, administering the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.

    The National Institute on Drug Abuse (NIDA) played a critical role in the development of Narcan nasal spray as well, forming a public–private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. NIDA then worked with its private sector partners to obtain FDA approval.

    Use of Narcan nasal spray in patients who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

  • November 25, 2015

    FDA expanded the indication of nivolumab to treat patients with metastatic renal cell carcinoma, the most common form of kidney cancer, and have received prior anti-angiogenic therapy.

    Nivolumab was previously approved for melanoma and non–small cell lung cancer.

    The agent works by targeting the cellular pathway known as PD-1/PD-L1. By blocking this pathway, nivolumab may help the body’s immune system fight cancer cells.

    Safety and efficacy of nivolumab for this use were demonstrated in an open-label, randomized study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent.

    Patients were treated with nivolumab or another type of kidney cancer treatment called everolimus (Afinitor—Novartis). Those treated with nivolumab lived an average of 25 months after starting treatment compared with 19.6 months in those treated with everolimus. This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors. In addition, 21.5% of those treated with nivolumab experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared with 3.9% of those taking everolimus, lasting an average of 13.7 months.

    The most common adverse effects of nivolumab for this use are conditions relating to abnormal weakness or lack of energy, cough, nausea, rash, difficulty breathing, diarrhea, constipation, decreased appetite, back pain, and joint pain.

    The agent may also cause serious adverse effects that result from its immune system effect. These severe immune-mediated adverse effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands, and the brain.  

    FDA granted the nivolumab application a breakthrough therapy designationfast track designation, and priority review status.

  • November 6, 2015

    FDA approved a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide under the trade name Genvoya for use in adults and children ages 12 years and older who are infected with HIV-1, weigh at least 35 kg (77 pounds), and have never taken HIV therapy (treatment-naive) and in adults whose HIV-1 virus is currently suppressed.

    While Genvoya is not recommended for patients with severe renal impairment, those with moderate renal impairment can take the drug.

    Genvoya’s safety and efficacy in adults were evaluated in 3,171 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA-approved HIV treatment. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens.

    Genvoya contains a new form of tenofovir that has not been previously approved. This new form of tenofovir provides lower levels of drug in the bloodstream but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug adverse effects.

    Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir-containing regimens, based on laboratory measures. Patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies.

    Genvoya carries a boxed warning alerting patients and health care providers that the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal. The boxed warning also states that Genvoya is not approved to treat chronic hepatitis B virus infection.

    The most common adverse effect associated with Genvoya is nausea. Serious adverse effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution, and changes in the immune system. Health care providers are advised to monitor patients for kidney and bone adverse effects. Genvoya should not be given with other antiretroviral products and may have drug interactions with a number of other commonly used medications.

  • October 30, 2015

    FDA approved an expanded use of ipilimumab for adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.   

    Approval was based on improvement in recurrence-free survival (RFS) in a randomized (1:1), double-blind, placebo-controlled trial in 951 patients with resected Stage IIIA (lymph node > 1 mm), IIIB, and IIIC (with no in-transit metastases) histologically confirmed cutaneous melanoma.    

    The primary efficacy endpoint was RFS determined by an independent review committee. The median RFS was 26 and 17 months in the ipilimumab (n = 475) and placebo (n = 476) arms, respectively (hazard ratio [HR] 0.75 [95% CI 0.64–0.90], P <0.002, stratified log-rank test).    Safety data were evaluated in 945 patients (median age 51 y; 62% male), who received ipilimumab 10 mg/kg (n = 471) or placebo (n = 474) administered as an I.V. infusion for four doses every 3 weeks, followed by 10 mg/kg every 12 weeks beginning at week 24 up to a maximum of 3 years. Ipilimumab-treated patients received a median of four doses (range: 1–16), and 36% of patients received ipilimumab for longer than 6 months. Ipilimumab was discontinued for adverse reactions in 52% of patients.  

    The most common adverse reactions included rash, pruritus, diarrhea, nausea, colitis, vomiting, weight loss, fatigue, pyrexia, headache, decreased appetite, and insomnia.    

    Grades 3–5 immune-mediated adverse reactions, occurring in 41% of ipilimumab-treated patients, included enterocolitis (16%), hepatitis (11%), endocrinopathy (8%), dermatitis (4%), and neuropathy (1.7%). The five treatment-related deaths were due to immune-mediated adverse reactions of enterocolitis (3), Guillain-Barré syndrome (1), and myocarditis (1).  

    Patients should be assessed for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries, including liver function tests, adrenocorticotropic hormone level, and thyroid function tests, at baseline and before each dose.  

    The recommended dose and schedule for ipilimumab for adjuvant treatment of melanoma is 10 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years. If toxicity occurs, doses are omitted, not delayed.

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