Medication Monitor

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  • April 10, 2019

    US WorldMeds announced that its subsidiary, Sloan Pharma, has received FDA approval to reintroduce tegaserod, a twice-daily oral treatment for irritable bowel syndrome with constipation (IBS-C) in women younger than 65.

    Tegaserod was originally approved by FDA in 2002 for treatment of IBS-C in women. It was voluntarily withdrawn from the U.S. market in 2007 because of safety concerns. The drug has remained consistently available in the United States through an expanded access program authorized by FDA and is used by patients with IBS-C in several other countries.

    Approval to reintroduce the agent came after a complete safety review by FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on evaluation of clinical data from 29 placebo-controlled trials and newly available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported its reintroduction for appropriate patients with IBS-C.

    Tegaserod is the only selective serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. The drug targets the 5-HT4 receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the GI tract to induce contraction and relaxation and decrease pain signaling.

    In clinical trials, patients taking tegaserod saw improvement in some of the most bothersome IBS-C symptoms. In the first 4 weeks, significantly more patients treated with tegaserod than placebo-treated patients reported an improvement in their abdominal pain/discomfort and bloating. Frequency of bowel movements also increased from a median number of 3.8 per week at baseline to 6.3 per week at month one.

  • April 9, 2019

    Circassia Pharmaceuticals announced FDA approval of aclidinium bromide/formoterol fumarate for maintenance treatment of chronic obstructive pulmonary disease (COPD) under the trade name Duaklir. 

    The agent is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) and long-acting beta-agonist (LABA) formoterol fumarate (12 mcg). It is  administered twice daily via the breath-actuated inhaler Pressair. 

    Approval was based on a broad clinical database, including data from three Phase III studies, ACLIFORM, AUGMENT, and AMPLIFY. The label also includes clinical data from the Phase IV ASCENT study, which shows aclidinium therapy is effective at reducing COPD exacerbations.  As a result, Duaklir is the only twice-daily LAMA/LABA in the United States with COPD exacerbation data included in its prescribing information.

    Circassia plans to launch Duaklir in the United States in the second half of 2019.

  • April 9, 2019

    FDA has approved multiple generics for ambrisentan tablets. With the approval of these first generics and their associated risk evaluation and mitigation strategy (REMS) programs, patients will now have access to additional products (brand-name and generic) and additional types of pharmacies (retail or specialty) to fill their prescriptions, according to FDA.

    The agency also approved two shared-system REMS programs for ambrisentan. The first, the Ambrisentan REMS (formerly the Letairis REMS), comprises the reference listed drug or brand sponsor (Letairis), as well as three abbreviated new drug applications (ANDAs, or generics).

    The second program, the PS-Ambrisentan REMS, currently consists of one ANDA sponsor. The PS signifies “parallel system” to assist in differentiating the programs within the market.

    For more information, including action items prescribers, patients, and pharmacists should complete to access these additional options, see the First Generic Drug Approvals section of FDA's website.

  • April 9, 2019

    FDA approved cladribine tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease.

    Cladribine is not recommended for patients with MS who have clinically isolated syndrome. Because of its safety profile, its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for treatment of MS.

    The drug's efficacy was shown in a clinical trial in 1,326 patients with relapsing forms of MS who had least one relapse in the previous 12 months. Compared with placebo, cladribine significantly decreased the number of relapses and also reduced progression of disability.

    Cladribine must be dispensed with a patient Medication Guide and has a boxed warning for an increased risk of malignancy and fetal harm. It should not to be used in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, health professionals should evaluate its benefits and risks on an individual patient basis. They should also follow standard cancer screening guidelines in patients treated with cladribine.

    The drug should not be used in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during treatment and for 6 months after drug therapy because of the potential for fetal harm. The drug must be stopped if the patient becomes pregnant.

    Other warnings include the risk of decreased lymphocyte counts, hematologic toxicity, and bone marrow suppression. Health professionals should measure a patient’s complete blood counts and lymphocyte counts before, during, and after treatment. The drug may increase the risk of infections, so health professionals should screen patients for infections and delay treatment with cladribine if necessary. 

    The drug has been associated with graft-versus-host-disease following blood transfusions with nonirradiated blood. It may cause liver injury, and treatment should be interrupted or discontinued, as appropriate, if clinically significant liver injury is suspected.

    The most common adverse reactions reported in the clinical trials included upper respiratory tract infections, headache, and decreased lymphocyte counts.

  • April 9, 2019

    FDA approved certolizumab pegol injection for treatment of adults with nonradiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first time FDA has approved a treatment for nr-axSpA.

    Nr-axSpA is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms. There is no visible damage seen on x-rays, so it is referred to as nonradiographic.

    The drug was originally approved in 2008 and is also indicated for adult patients with Crohn’s disease, moderate to severe rheumatoid arthritis, active ankylosing spondylitis, and moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

    Its efficacy for treatment of nr-axSpA was studied in a randomized clinical trial in 317 adult patients with nr-axSpA with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis on MRI. 

    The trial measured the improvement response on the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity including patient-reported outcomes and CRP levels. Responses were greater for patients treated with certolizumab pegol compared with patients treated with placebo. The overall safety profile observed in the certolizumab pegol treatment group was consistent with the known safety profile of the drug.

    The prescribing information includes a boxed warning about the increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis, an infection that affects the lungs), and other infections.

    Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis. Health care providers are advised to perform testing for latent TB and, if positive, to start treatment for TB prior to starting certolizumab pegol. All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.

    The boxed warning also advises that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers such as certolizumab pegol. The agent is not indicated for use in pediatric patients. 

    Certolizumab pegol must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.