Medication Monitor

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Generic Name (Trade Name—Company)
  • October 3, 2018

    Amirall announced FDA approval of sarecycline, an innovative first-in-class tetracycline-derived oral antibiotic for treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older. 

    Sarecycline is an oral tablet that is taken once daily with or without food. It has proven to significantly reduce inflammatory lesions as early as 3 weeks after start of treatment and is generally safe and well tolerated. 

    Safety of the product was established in two 12-week multicenter, randomized, double-blind, placebo-controlled studies. Efficacy was assessed in 2,002 participants aged 9 years and older. Efficacy of sarecycline beyond 12 weeks and safety beyond 12 months have not been established.

    Sarecycline has not been evaluated for treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, patients should use sarecycline only as indicated. The product is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

    Use during tooth development may cause permanent discoloration of the teeth. If Clostridium difficileassociated diarrhea (antibiotic-associated colitis) or intracranial hypertension occurs, use should be discontinued. Central nervous system adverse effects, including light-headedness, dizziness, or vertigo, have been reported with tetracycline use. The most common adverse reaction is nausea.

    Sarecycline is expected to be launched in January 2019.

  • October 1, 2018

    FDA has approved galcanezumab-gnlm, a calcitonin gene-related peptide (CGRP) antagonist, as a once-monthly, self-administered, S.C. 120-mg injection for preventive treatment of migraine in adults. 

    Efficacy and safety of galcanezumab-gnlm were demonstrated in two Phase III clinical trials (EVOLVE-1 and EVOLVE-2) in patients with episodic migraine and one Phase III clinical trial (REGAIN) in patients with chronic migraine.

    Safety was evaluated in three clinical trials that included more than 2,500 patients. Hypersensitivity reactions (e.g., rash, urticaria and dyspnea) have been reported in clinical studies, can occur days after administration, and may be prolonged. The most common adverse effects were injection-site reactions.

    The recommended dose for galcanezumab-gnlm is 240 mg (two consecutive S.C. injections of 120 mg each), once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.

    Galcanezumab-gnlm is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

    Patients with commercial insurance are candidates to receive galcanezumab-gnlm for up to 12 months free as part of Lilly's patient support program.

  • October 1, 2018

    FDA has approved dacomitinib, a kinase inhibitor for first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

    Safety and efficacy of dacomitinib were demonstrated in ARCHER 1050, a randomized, multicenter, multinational, open-label study in which 452 patients were randomized 1:1 to treatment with dacomitinib or with gefitinib. A statistically significant improvement was demonstrated in patients receiving dacomitinib compared with gefitinib.

    The most common adverse reactions were diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

    The most common serious adverse reactions reported were diarrhea and interstitial lung disease. The full prescribing information can be found here.

  • October 1, 2018

    FDA approved amikacin liposome inhalation suspension to treat lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC), in a limited population of patients with the disease who do not respond to conventional treatment. The drug is an inhaled treatment taken through a nebulizer.

    MAC is a type of nontuberculous mycobacteria (NTM) commonly found in water and soil. Symptoms of disease in patients with MAC include persistent cough, fatigue, weight loss, night sweats, and occasionally, shortness of breath and coughing up of blood.

    It is the first drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, established by Congress under the 21st Century Cures Act to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need. Approval under the LPAD pathway may be supported by a streamlined clinical development program. These programs may involve smaller, shorter, or fewer clinical trials. As required for drugs approved under the LPAD pathway, the labeling includes certain statements to convey that the drug has been shown to be safe and effective only for use in a limited population.

    Approval was based on achieving three consecutive negative monthly sputum cultures by month six of treatment. FDA requires the sponsor to conduct an additional postmarketing study to describe the drug's clinical benefits.

    Safety and efficacy were demonstrated in a randomized, controlled clinical trial in which patients were assigned to one of two treatment groups: one group receiving amikacin plus a background multidrug antibacterial regimen, and the other group receiving a background multidrug antibacterial regimen alone.

    By the sixth month of treatment, 29% percent of patients treated with amikacin had no growth of mycobacteria in their sputum cultures for three consecutive months, compared with 9% of patients who were not treated with amikacin.

    The prescribing information includes a boxed warning about the increased risk of respiratory conditions. Other common adverse effects are difficulty speaking, cough, damaged hearing, upper airway irritation, musculoskeletal pain, fatigue, diarrhea, and nausea.

  • October 1, 2018

    FDA approved cemiplimab-rwlc injection for I.V. use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

    By blocking the PD-1 pathway, cemiplimab-rwlc may help the body’s immune system fight the cancer cells.

    Safety and efficacy of cemiplimab-rwlc was studied in two open-label clinical trials. Results showed that 47.2% percent of all patients treated with the agent had their tumors shrink or disappear. The majority of these patients had ongoing responses at the time of data analysis.

    Common adverse effects of cemiplimab-rwlc include fatigue, rash, and diarrhea. The agent must be dispensed with a patient Medication Guide that describes uses of the drug and its serious warnings.

    Serious adverse reactions include the risk of immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, and dermatologic and kidney problems. Patients should also be monitored for infusion-related reactions.  

    Because the agent can cause harm to a developing fetus, women should be advised of the potential risk to the fetus and to use effective contraception.