Medication Monitor



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Generic Name (Trade Name—Company)
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  • November 14, 2018

    FDA approved revefenacin inhalation solution for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist, a class of medicines that improve lung function in patients with COPD. The agent is administered once daily via a standard jet nebulizer.  

    As with other inhaled medicines, revefenacin can cause paradoxical bronchospasm (wheezing). If paradoxical bronchospasm occurs, patients should discontinue use. Patients should also be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual changes). Patients should consult a health professional immediately if any of these signs or symptoms develop.

    The most common adverse reactions include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Health professionals should avoid administering revefenacin with other anticholinergic-containing drugs. The agency does not recommend administering revefenacin at the same time as OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.), as it may lead to an increase in exposure of the active metabolite.

  • November 1, 2018

    Sandoz announced FDA approval of adalimumab-adaz (Hyrimoz), a biosimilar to adalimumab (Humira), for treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. 

    The drug, a tumor necrosis factor inhibitor administered subcutaneously by injection, is the third FDA-approved biosimilar to adalimumab.

    Approval was based on a randomized, double-blind, three-arm, parallel biosimilarity study that confirmed the pharmacokinetics, immunogenicity, and safety of adalimumab-adaz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters.

    A confirmatory efficacy and safety biosimilarity study demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic.

    The most common adverse reactions (incidence > 10%) were infections (e.g., upper respiratory, sinusitis), injection-site reactions, headache, and rash.

  • October 30, 2018

    FDA approved Bijuva (TherapeuticsMD), the first bioidentical oral hormone combination of estradiol and progesterone (1-mg/100-mg capsule) to treat moderate to severe hot flashes in women with a uterus.

    Approval was based on the Phase III Replenish Trial, in which Bijuva demonstrated a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared with placebo, while reducing the risks to the endometrium.

    The most common adverse reactions (≥3%) were breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain. No clinically significant changes were found in lipid, coagulation, or glucose parameters compared with placebo, and no unexpected safety signals were noted.

    The recommended dosage is one tablet orally each evening with food.

    Bijuva comes with a boxed warning; see the prescribing information for more information.

    The drug will be available in the United States in the second quarter of 2019.

  • October 29, 2018

    FDA approved talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2–negative locally advanced or metastatic breast cancer. Patients must be selected for therapy on the basis of an FDA-approved companion diagnostic, the BRACAnalysis CDx test (Myriad Genetic Laboratories).

    Approval was based on an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

    The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo–fetal toxicity. Most common (≥20%) adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite.

    The recommended talazoparib dose is 1 mg taken as a single-oral daily dose, with or without food.

  • October 24, 2018

    FDA has approved a new antiviral drug, baloxavir marboxil, to treat acute uncomplicated influenza (flu) in patients aged 12 years and older who have been symptomatic for no more than 48 hours.

    According to FDA Commissioner Scott Gottlieb, MD, the polymerase acidic (PA) endonuclease inhibitor is the first new antiviral flu treatment with a novel mechanism of action approved by FDA in nearly 20 years.

    Safety and efficacy of baloxavir marboxil taken as a single oral dose was demonstrated in two randomized controlled clinical trials of 1,832 patients in which participants were assigned to receive either baloxavir marboxil, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.

    In both trials, patients treated with baloxavir marboxil had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between participants who received baloxavir marboxil and those who received the other flu treatment.

    Within 48 hours of symptom onset, patients weighing 40 kg to less than 80 kg take a single oral dose of 40 mg, and patients weighing at least 80 kg take a single oral dose of 80 mg, with or without food. Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).

    Common adverse reactions in clinical trials were diarrhea and bronchitis.

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