Medication Monitor



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Generic Name (Trade Name—Company)
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  • 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 7, 2019

    Sandoz announced FDA approval of pegfilgrastim-bmez, its biosimilar to pegfilgrastim (Neulasta), to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

    Pegfilgrastim is a long-acting form of filgrastim, which is very similar to a natural protein, granulocyte-colony stimulating factor, produced by a person's own body.

    The recommended dosage for patients with cancer receiving myelosuppressive chemotherapy is 6 mg administered subcutaneously once per chemotherapy cycle. The agent should not be administered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Weight-based dosing should be used for pediatric patients weighing less than 45 kg; see the prescribing information for instructions.

    Warnings and precautions include fatal splenic rupture; acute respiratory distress syndrome; serious allergic reactions, including anaphylaxis; fatal sickle cell crises; and glomerulonephritis.

    The drug's most common adverse reactions are bone pain and pain in extremity.

  • October 31, 2019

    On October 24, FDA approved a new indication for delafloxacin, a fluoroquinolone antibacterial, to treat adult patients with community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

    Delafloxacin was FDA approved in 2017 to treat adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.

    Delafloxacin has a boxed warning cautioning that fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together. These include tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Patients who experience any of these serious adverse reactions should discontinue use immediately. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis; patients with a known history of myasthenia gravis should avoid use.

    The recommended dosage of delafloxacin is 300 mg by I.V. infusion over 60 minutes every 12 hours or a 450-mg tablet orally every 12 hours for 5 to 14 days.

    Common adverse reactions are nausea, diarrhea, headache, transaminase elevations, and vomiting.

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