Medication Monitor

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  • January 4, 2016

    FDA approved lesinurad to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI).

    Lesinurad works by helping the kidney excrete uric acid. It does this by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

    Safety and efficacy for lesinurad were evaluated in three randomized, placebo-controlled studies in combination with a XOI involving 1,537 participants for up to 12 months. Participants treated with lesinurad in combination with a XOI experienced reduced serum uric acid levels compared with those on placebo.

    The most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.

    Lesinurad has a boxed warning that provides important safety information for health professionals, including the risk for acute kidney failure, which is more common when used without an XOI and with higher than approved doses of lesinurad.

    FDA is also requiring a postmarketing study to further evaluate the renal and cardiovascular safety of lesinurad.

  • 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.

  • October 22, 2015

    Patiromer for oral suspension has received FDA approval for treatment of hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.

    Hyperkalemia typically occurs in patients with acute or chronic kidney disease or heart failure, particularly in those who are taking drugs that inhibit the renin-angiotensin-aldosterone system, which regulates blood pressure and fluid balance in the body.

    Patiromer for oral suspension, a powdered medication that patients mix with water and take by mouth, works by binding potassium in the gastrointestinal tract, decreasing its absorption. In clinical trials, patiromer was effective in lowering potassium levels in hyperkalemic participants with chronic kidney disease on at least one drug that inhibited the renin–angiotensin–aldosterone system.

    In clinical trials, the most common adverse reactions reported by participants taking patiromer were constipation, decreased magnesium levels in the blood, diarrhea, nausea, abdominal discomfort, and flatulence. Use of the agent is not appropriate for rapid correction of severe hyperkalemia because lowering of serum potassium may take hours to days.

    Patiromer has a boxed warning because it binds many other orally administered drugs, which could decrease their absorption and reduce their effects. The warning recommends taking it and any other orally administered medication at least 6 hours apart.

    The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.