Medication Monitor



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  • May 29, 2019

    FDA approved ruxolitinib (Jakafi—Incyte Corporation) for steroid-refractory acute graft versus host disease (GVHD) in adult and pediatric patients aged 12 years and older.

    In acute GVHD, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia. The most common nonhematologic adverse reactions (incidence > 50%) are infections and edema.

    The recommended starting dose of ruxolitinib for GVHD is 5 mg given orally twice daily.

    Approval was based on Study INCB 18424-271 (NCT02953678), an open-label, single-arm, multicenter study of ruxolitinib that enrolled 49 patients with steroid-refractory acute GVHD Grades 2 to 4 (Mount Sinai Acute GVHD International Consortium criteria) occurring after allogeneic hematopoietic stem cell transplantation. Ruxolitinib was administered at 5 mg twice daily, and the dose could be increased to 10 mg twice daily after 3 days in the absence of toxicity. 

     

  • May 29, 2019

    FDA has approved calcipotriene foam, 0.005%, for treating plaque psoriasis of the scalp and body in patients aged 12 years and older. Plaque psoriasis is the most common form of psoriasis, affecting roughly 80% of people who have the condition.

    FDA approved calcipotriene in 2010 on the basis of evidence from two 8-week placebo-controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo-controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data were obtained in a follow-on open label study in patients aged 12 to 17 years with psoriasis. Calcipotriene is a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

  • 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. 

     

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