Medication Monitor



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  • December 2, 2019

    FDA granted accelerated approval to voxelotor, a hemoglobin S polymerization inhibitor for adults and children ages 12 years and older with sickle cell disease.

    Efficacy was evaluated in 274 patients with sickle cell disease in HOPE, a randomized, double-blind, placebo-controlled, multicenter trial. The primary efficacy outcome measure was hemoglobin (Hb) response rate, defined as an Hb increase of > 1 g/dL from baseline to week 24. The response rate for voxelotor was 51.1% (46/90) compared with 6.5% (6/92) in the placebo group (P < 0.0001). 

    The most common adverse reactions to voxelotor are headache, diarrhea, abdominal pain, nausea, rash, fatigue, and pyrexia. Product information includes a warning for hypersensitivity and potential laboratory interference. Voxelotor may interfere with measurement of Hb subtypes (HbA, HbS, and HbF) by high-performance liquid chromatography.

    The recommended voxelotor dose is 1,500 mg orally once daily with or without food. Recommended dosage for patients with severe hepatic impairment (Child Pugh C) is 1,000 mg orally once daily.  

  • November 26, 2019

    FDA approved cenobamate tablets to treat partial-onset seizures in adults.

    Cenobamate's safety and efficacy to treat partial-onset seizures were established in two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. Participants had partial-onset seizures with or without secondary generalization for an average of approximately 24 years and median seizure frequency of 8.5 seizures per 28 days during an 8-week baseline period. Doses of 100 mg, 200 mg, and 400 mg daily of cenobamate reduced the percentage of seizures per 28 days compared with the placebo group.

    The recommended maintenance dose of cenobamate, following a titration period, is 200 mg daily; however, some patients may need an additional titration to 400 mg daily, the maximum recommended dose, based on their clinical response and tolerability.

    Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported among patients taking cenobamate. In the clinical trials, some patients experienced DRESS, and one patient died, when cenobamate was titrated rapidly (weekly or faster titration). No cases of cenobamate were reported in an open-label safety study of 1,339 patients with epilepsy when cenobamate was started at 12.5 mg per day and adjusted every 2 weeks; however, this finding does not show that the risk of DRESS is prevented by a slower titration.

    A higher percentage of patients who took cenobamate also had a shortening of the QT interval of greater than 20 ms compared with placebo. The drug should not be used in patients with hypersensitivity to cenobamate or any of the inactive ingredients or Familial Short QT syndrome. QT shortening can be associated with ventricular fibrillation.

    Antiepileptic drugs (AEDs), including cenobamate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients taking an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Cenobamate may cause neurological adverse reactions, including sleepiness and fatigue, dizziness, trouble with walking and coordination, trouble with thinking, and visual changes. Patients should also be advised not to drive or operate machinery until the effect of the drug is known.

    Common adverse effects are sleepiness, dizziness, fatigue, double vision, and headaches.

  • November 26, 2019

    FDA approved cefiderocol, a cephalosporin antibacterial for treatment of patients ages 18 years or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.

    Cefiderocol's safety and effectiveness were demonstrated in a study of 448 patients with cUTIs. Of the patients who were administered the drug, 72.6% had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 54.6% of patients who received an alternative antibiotic. The clinical response rates were similar between the two treatment groups.

    The recommended dosage is 2 g administered by injection every 8 hours by IV infusion over 3 hours in patients with creatinine clearance (CLcr) 60 to 119 mL/min. Dose adjustments are required for patients with CLcr less than 60 mL/min and for patients with CLcr 120 mL/min or greater.

    The labeling includes a warning about the higher all-cause mortality rate observed in patients receiving cefiderocol compared with those treated with other antibiotics in a trial in critically ill patients with multidrug-resistant Gram-negative bacterial infections. The cause of the increase in mortality has not been established. Some of the deaths were a result of worsening or complications of infection or of underlying comorbidities. The higher all-cause mortality rate was observed in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e.nosocomial pneumonia), bloodstream infections, or sepsis. The drug's efficacy has not been established for treatment of these types of infections.

    The most common adverse reactions included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion site reactions, candidiasis, cough, headache, and hypokalemia. Cefiderocol should not be used in individuals with a known history of severe hypersensitivity to beta-lactam antibacterial drugs.

  • November 25, 2019

    FDA approved givosiran for adults with acute hepatic porphyria (AHP).

    Efficacy was evaluated in ENVISION, a randomized, double‑blind, placebo‑controlled, multinational trial enrolling 94 patients with AHP. Patients were randomized (1:1) to receive once-monthly S.C. injections of givosiran 2.5 mg/kg or placebo during a 6‑month double‑blind period.

    The primary efficacy outcome measure was the rate of porphyria attacks requiring hospitalizations, urgent health care visit, or I.V. hemin administration at home. The mean rates of attacks over a 6-month time period were 1.9 (95% CI1.3–2.8) for patients receiving givosiran and 6.5 (95% CI 4.5–9.3) for those on placebo. On average, patients with AHP on givosiran experienced 70% (95% CI 60%, 80%) fewer porphyria attacks compared with placebo.

    The most common adverse reactions included nausea and injection site reactions. The label contains warnings for anaphylactic reactions, hepatic and renal toxicities, and injection site reactions. Hepatic toxicity was mostly transaminase elevation. Renal toxicity was mostly serum creatinine elevation and decreases in estimated glomerular filtration rate.

    The recommended givosiran dose is 2.5 mg/kg once monthly by S.C. injection.

  • November 18, 2019

    FDA granted accelerated approval to zanubrutinib to treat adult patients with mantle cell lymphoma who have received at least one prior therapy.

    A single-arm clinical trial of zanubrutinib included 86 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 84% of patients had tumor shrinkage with a median duration of response (time between the initial response to therapy and subsequent disease progression or relapse) of 19.5 months. This trial was supported by an additional single-arm trial that included 32 patients, in which 84% of patients had tumor shrinkage with a median duration of response of 18.5 months.

    Common adverse effects for patients taking zanubrutinib were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea. and cough. During treatment, patients should be monitored for hemorrhage, signs and symptoms of infection, cytopenias, and cardiac arrhythmias. Patients are advised to use sun protection if taking this therapy because there is a risk of other malignancies, including skin cancers.

    FDA advises health professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment. Women who are pregnant or breastfeeding should not take zanubrutinib because it may cause harm to a developing fetus or newborn baby.

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