Medication Monitor



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  • October 25, 2018

    Genentech announced an update to the rituximab label to include information on follow-up treatment of adult patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) who have achieved disease control with induction treatment.

    GPA and MPA are two types of antineutrophil cytoplasmic antibody–associated vasculitis, or inflammation of the blood vessels, that largely affects the small blood vessels of the kidneys, lungs, and a variety of other organs.

    The label update was based on data from a Roche-supported study by the French Vasculitis Study Group showing that treatment with the rituximab regimen (rituximab and glucocorticoids) resulted in fewer major relapses by month 28 compared with treatment with azathioprine. The observed safety profile was consistent with that previously observed in this patient population. 

    In combination with glucocorticoids, rituximab was approved by FDA in 2011 for adult patients with GPA and MPA with the precaution that limited data were available on the safety and efficacy of subsequent courses of rituximab in patients with GPA and MPA, and that the safety and efficacy of retreatment with rituximab had not been established. As part of this label update, the precaution has been removed from the rituximab prescribing information.

  • October 19, 2018

    FDA approved emicizumab-kxwh injection to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII (FVIII) inhibitors.

    The agent was first approved in 2017 for patients with hemophilia A with FVIII inhibitors.

    The current approval was based on two clinical trials: HAVEN 3 (NCT02847637) and HAVEN 4 (NCT03020160). This approval expanded the indication for patients with hemophilia A without FVIII inhibitors and provided for new dosing regimens for patients with and without FVIII inhibitors.

    The prescribing information includes a warning that thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of greater than 100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving prophylaxis with emicizumab-kxwh. Patients should be monitored for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. aPCC should be discontinued and emicizumab-kxwh dosing should be suspended if there is evidence of thrombotic microangiopathy or an acute thrombotic event.

    The most common adverse reactions reported (incidence ≥10%) were injection-site reactions, headache, and arthralgia.

    The recommended loading dose is 3 mg/kg by S.C. injection once weekly for the first 4 weeks for all approved prophylactic dosing regimens. In addition to the already approved weekly dose of 1.5 mg/kg, the new maintenance dosing regimens include 3 mg/kg by S.C. injection once every 2 weeks and 6 mg/kg by S.C. injection every 4 weeks.

  • October 9, 2018

    FDA approved a supplemental application for human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9), expanding the approved use to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

    Gardasil, a vaccine approved by FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the United States. In 2014, FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

    Effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women aged 27 through 45 who were followed for an average of 3.5 years, Gardasil was 88% effective in preventing a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.

    FDA’s approval of Gardasil 9 in women aged 27 through 45 is based on these results and new data on long-term follow-up from this study.

    Effectiveness of Gardasil 9 in men aged 27 through 45 is inferred from the data described above in women aged 27 through 45, as well as efficacy data from Gardasil in younger men (aged 16–26 y) and immunogenicity data from a clinical trial in which 150 men, aged 27 through 45, received a three-dose regimen of Gardasil over 6 months.

    Safety of Gardasil 9 was evaluated in approximately 13,000 males and females. The most commonly reported adverse reactions were injection-site pain, swelling, redness, and headaches.

    FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition. 
     

  • 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.

  • September 27, 2018

    Sun Pharma announced FDA approval of latanoprost ophthalmic emulsion 0.005% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

    It is the first and only form of latanoprost that is not formulated with benzalkonium chloride, a preservative commonly used in topical ocular preparations.

    Recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3 to 4 hours after administration, and the maximum effect is reached after 8 to 12 hours. 

    In clinical trials, the most frequently reported adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness).  

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