Medication Monitor

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  • October 2, 2019

    Janssen announced that FDA has approved a new indication for canagliflozin to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease.

    The recommended starting dose is 100 mg once daily, taken before the first meal of the day. The dose can be increased to 300 mg once daily in patients tolerating 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control

    The drug includes a boxed warning for patients with type 2 diabetes who have established cardiovascular disease (CVD) or who are at risk for CVD. Canagliflozin has been associated with lower limb amputations in these patients, most frequently of the toe and midfoot; some also involved the leg.

    The most common adverse effects of canagliflozin include vaginal yeast infections and yeast infections of the penis; as well as changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

  • October 2, 2019

    FDA approved rituximab injection in combination with glucocorticoids to treat granulomatosis with polyangiitis and microscopic polyangiitis in children ages 2 years and older.

    It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them. This can cause serious problems and damage to organs, most notably the lungs and kidneys. It also can impact the sinuses and skin.

    Rituximab's most common adverse effects are infections, infusion-related reactions, lymphopenia, and anemia. Health professionals are advised to monitor patients for tumor lysis syndrome, cardiac adverse reactions, renal toxicity, and bowel obstruction and perforation.

    The prescribing information includes a boxed warning of fatal infusion reactions; potentially fatal severe skin and mouth reactions; hepatitis B virus reactivation, which may cause serious liver problems, including liver failure and death; and progressive multifocal leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death.

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

    The agent was approved to treat adult patients with GPA and MPA in 2011. It is also approved to treat four additional diseases, first gaining approval to treat non-Hodgkin's lymphoma in 1997.

  • October 2, 2019

    FDA expanded the approval of glecaprevir/pibrentasvir tablets for 8-week treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis and have not been previously treated for HCV.

    Glecaprevir/pibrentasvir is now the first 8-week treatment approved for all treatment-naive adult and certain pediatric patients with HCV genotypes 1–6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.

    The most common adverse reactions in patients taking glecaprevir/pibrentasvir are headache and fatigue. The agent is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C) or in those with any history of liver decompensation. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

  • October 1, 2019

    On September 26, FDA approved daratumumab in combination with bortezomib, thalidomide, and dexamethasone for adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

    In clinical trials, the most frequent (≥20%) adverse reactions were infusion reactions, peripheral sensory neuropathy, constipation, asthenia, nausea, peripheral edema, neutropenia, thrombocytopenia, pyrexia, and paresthesia. 

    The recommended dosage for this indication is 16 mg/kg actual body weight.

    For more informtion, view full prescribing information.

  • September 26, 2019

    FDA approved Pifeltro (doravirine 100 mg) in combination with other antiretroviral agents and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) as a complete regimen for treatment of adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the drugs' individual components.

    Pifeltro is a nonnucleoside reverse transcriptase inhibitor that is administered with other antiretroviral agents.

    Delstrigo is a once-daily, fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg). The agent has a boxed warning for the risk of posttreatment acute exacerbation of hepatitis B virus infection.

    The agents are contraindicated when coadministered with drugs that are strong cytochrome CYP3A enzyme inducers, as significant decreases in doravirine plasma concentrations may occur and decrease the drugs' effectiveness. Delstrigo is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

    The most common adverse reactions with Pifeltro are nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and abnormal dreams. The most common adverse reactions with Delstrigo are dizziness, nausea, and abnormal dreams.