Medication Monitor



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Generic Name (Trade Name—Company)
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  • May 1, 2019

    FDA approved glecaprevir and pibrentasvir tablets to treat all six genotypes of hepatitis C virus (HCV) in children aged 12 to 17. The combination drug was previously approved to treat HCV in adults in 2017.

    With this approval, dosing information is provided for treatment of adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of six identified HCV genotypes either without cirrhosis or with compensated cirrhosis.

    Safety and efficacy of glecaprevir/pibrentasvir for use with pediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis. Results demonstrated that 100% of patients who received the drug for 8 or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.

    In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or genotype 5 or 6 HCV infection, safety and efficacy are supported by previous studies observed in glecaprevir and pibrentasvir in adults. The adverse reactions observed were consistent with those observed in clinical studies in adults.

    Treatment duration differs depending on treatment history, viral genotype, and cirrhosis status.

    The most common adverse reactions are headache and fatigue. The agent is not recommended for treatment of patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

    Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV-coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with glecaprevir/pibrentasvir.

  • May 1, 2019

    Regeneron and Sanofi announced FDA approval of alirocumab to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.

    Approval for the expanded indication was based on data from the ODYSSEY OUTCOMES trial, which assessed the effect of adding alirocumab to maximally tolerated statins on CV outcomes in 18,924 patients who had an acute coronary syndrome within a year of enrolling in the trial. 

    FDA also approved alirocumab as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.

    Alirocumab was the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved by FDA and is the only PCSK9 inhibitor available in two doses with two levels of efficacy as a single 1-mL injection (75 mg and 150 mg) once every 2 weeks. It can also be administered as 300 mg once every 4 weeks (monthly), enabling physicians to tailor treatment based on an individual patient's LDL-C-lowering needs. 

    Alirocumab can cause serious adverse effects, including allergic reactions that can be severe and require treatment in a hospital, such as a severe rash, redness, severe itching, a swollen face, or trouble breathing.

    The most common adverse effects are redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms.

  • May 1, 2019

    Samsung Bioepis announced FDA approval of etanercept-ykro, a biosimilar of etanercept (Enbrel). The drug is a tumor necrosis factor blocker indicated for treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. 

    Approval was based on a 52-week Phase III clinical study that randomized 596 patients with rheumatoid arthritis across 70 sites in 10 countries. The biosimilar demonstrated comparable safety and efficacy to the etanercept reference product, Enbrel.

    The labeling includes a warning that patients treated with etanercept products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. The drug's risks and benefits should be carefully considered before initiating therapy in patients with chronic or recurrent infection.

    Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection before therapy initiation. Etanercept-ykro should be discontinued if a patient develops a serious infection or sepsis. 

     

  • April 30, 2019

    Bausch Health announced FDA approval of halobetasol propionate and tazarotene lotion 0.01%/0.045% for topical treatment of plaque psoriasis in adults. It is the first and only topical lotion that combines halobetasol propionate and tazarotene in one formulation.

    In a year-long safety study, patients used the lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.

    When used separately to treat plaque psoriasis, duration of use of halobetasol propionate is limited by FDA labeling constraints, and use of tazarotene can be limited due to tolerability concerns. 

    Safety and efficacy of once-daily use for treatment of plaque psoriasis were assessed in two Phase III prospective, multicenter, randomized, double-blind clinical trials in participants aged 18 years and older with moderate to severe plaque psoriasis.

    The majority of responders maintained treatment success over the 4-week posttreatment period. The most common adverse events were redness, itching, swelling, burning, stinging, application-site pain, inflamed hair follicles, thinning of the skin, peeling, and rash.

    A third Phase III multicenter, open-label study assessed the drug's long-term safety over a year in participants with plaque psoriasis. Treatment-related adverse events were application-site reactions such as itching, pain, irritation, and inflamed hair follicles.

  • April 30, 2019

    FDA approved belimumab as an I.V. infusion for treatment of children with systemic lupus erythematosus (SLE). This is the first FDA approval of a treatment for pediatric patients with SLE. Belimumab has been approved for use in adult patients since 2011.

    While childhood-onset SLE is rare, when diagnosed, it is generally more active in children and adolescents than adult patients, particularly in how it affects organs such as the kidneys and central nervous system. As a result of the disease starting early in life, pediatric patients with SLE are at a higher risk for developing increased organ damage and complications from the disease as well as adverse events from the life-long treatments usually required.

    Efficacy belimumab I.V. for treatment of SLE in pediatric patients was studied over 52 weeks in 93 pediatric patients with SLE. The proportion of pediatric patients achieving the composite primary endpoint, the SLE response index (SRI-4), was higher in pediatric patients receiving belimumab I.V. plus standard therapy compared with placebo plus standard therapy. Pediatric patients who received belimumab I.V. plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare (160 d vs. 82 d). The drug’s safety and pharmacokinetic profiles in pediatric patients were consistent with those in adults with SLE.

    Belimumab I.V.’s doctor and patient information includes a warning for mortality, serious infections, hypersensitivity, and depression, based on data from the clinical studies in adults with SLE. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with the drug.

    The most common adverse effects include nausea, diarrhea, and fever. Patients also commonly experienced infusion reactions, so health professionals are advised to pretreat patients with an antihistamine.

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