Medication Monitor



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Generic Name (Trade Name—Company)
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  • October 4, 2018

    Paratek announced FDA approval of omadacycline 100 mg for injection/150 mg tablets for treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI) in adults.

    Omadacycline, a modernized tetracycline, is a once-daily I.V. and oral antibiotic that targets a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug-resistant strains.

    Approval was supported by multiple clinical trials involving nearly 2,000 adult patients.

    Warnings and precautions include the following:

    Use during tooth development (last half of pregnancy, infancy, and childhood to age 8) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    Use during the second and third trimester of pregnancy, infancy and childhood up to age 8 years may cause reversible inhibition of bone growth.

    Omadacycline is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs.

    Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. 

    The most common adverse reactions (incidence ≥2%) in clinical trials were nausea, vomiting, infusion-site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

    The drug is expected to become available in the first quarter of 2019.

     

  • 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 2, 2018

    Antares Pharma announced FDA approval of testosterone enanthate, the first testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone in adult males.

    The product is self-administered subcutaneously once weekly at home with an easy-to-use, single-dose, disposable QuickShot auto injector. It comes in three dosage strengths: 50 mg, 75 mg, and 100 mg.

    In Phase III clinical trials, the product was shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio. According to the principal investigator, the S.C. dosing removes transfer concerns commonly associated with gels and potentially reduces the need for in-office injection procedures that may require more frequent patient visits. 

    The product can cause blood pressure elevations that can increase the risk for major adverse cardiovascular events (MACE), including nonfatal myocardial infarction, nonfatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.

    The most commonly reported adverse reactions in clinical trials were hematocrit increases, hypertension, prostate-specific antigen increases, injection-site bruising, and headache.

    Recommended dosage is 100–400 mg every 4 weeks.

  • 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.

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