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

    Aquestive Therapeutics announced FDA approval of riluzole oral film for treatment of amyotrophic lateral sclerosis (ALS). It can be administered without water to patients with ALS who have trouble swallowing. According to Aquestive, studies have demonstrated riluzole's pharmacokinetic bioequivalence to the reference listed drug, Rilutek.

    The recommended dosage is 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal. 

    Common adverse reactions are oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain. 

  • November 26, 2019

    As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA approved a new indication for acalabrutinib to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as an initial or subsequent therapy.

    The supplemental approval of acalabrutinib for patients with CLL or SLL was based on two randomized clinical trials that compared acalabrutinib to other standard treatments. The first clinical trial involved 535 patients with previously untreated CLL. Patients receiving acalabrutinib had a longer progression-free survival compared with patients receiving other standard treatments. The second clinical trial included 310 patients with previously treated CLL. Patients receiving acalabrutinib also had a longer progression-free survival than patients receiving other standard treatments.

    The most common adverse effects were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. Patients may experience atrial fibrillation and flutter and should be monitored for symptoms of arrhythmias. Patients may experience serious infections and should be monitored and treated promptly. Patients should also be monitored for bleeding and managed appropriately. Patients may also experience low blood counts and should have blood work monitored regularly. Patients should be advised to use sun protection as other malignancies, such as skin cancers and other solid tumors, have occurred in patients taking the drug.

    FDA advises health professionals to tell females of reproductive age to use effective contraception during treatment. Women who are pregnant or breastfeeding should not take acalabrutinib because it may cause harm to a developing fetus or newborn baby or cause delivery complications.

  • November 26, 2019

    On November 18, 2019, Pfizer announced FDA approval of adalimumab-afzb, a tumor necrosis factor (TNF) blocker and biosimilar to adalimumab (Humira), to treat certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.

    FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of adalimumab-afzb to the reference product. This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety, and immunogenicity of adalimumab-afzb and found no clinically meaningful differences compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.3

    The labeling carries a boxed warning that patients treated with adalimumab 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 should be discontinued if a patient develops a serious infection or sepsis.

    The most common adverse reactions in clinical trials were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

  • 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.

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