Medication Monitor

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  • 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.

  • October 19, 2018

    Rare Disease Therapeutics announced FDA approval of Crotalidae Immune F(ab’ )2 (Equine), an equine-derived antivenin for treatment of North American rattlesnake bites in adult and pediatric patients.

    CDC has estimated that the U.S. incidence of venomous snake bites is 7,000 to 8,000 per year. Because people seek—and receive—rapid medical intervention, the number of deaths from snake bites is low: about five per year. However, blood clotting disorders can be major complications of a venomous rattlesnake bite, and one of the goals of treatment is to limit the potential incidence of latent coagulopathy. Because this new antivenom lasts longer in the body, it eliminates the need for scheduled maintenance doses. 

    The antivenom has a long half-life to minimize the likelihood of reemergent venom effects (such as a drop in platelets, prolonged bleeding times, and other abnormal blood clotting tests) that commonly require additional doses of a shorter-acting antivenom.  

    The most common adverse reactions (>2%) in clinical studies were pruritus, nausea, rash, arthralgia, peripheral edema, myalgias, headache, pain in extremity, vomiting, and erythema.

    Warnings and precautions include allergic reactions, especially in patients with known allergies to horse protein. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately, and institute appropriate treatment.

    Monitor patients with follow-up visits for signs and symptoms of delayed allergic reactions or serum sickness (rash, fever, myalgia, arthralgia, pruritus, urticarial rash), and treat appropriately if necessary.

    Because the product is made from equine plasma, it may carry a risk of transmitting infectious agents (e.g., viruses).

  • October 19, 2018

    Akcea Therapeutics and Ionis Pharma announced FDA approval of inotersen for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. It reduces the production of transthyretin (TTR) protein through a once-weekly S.C. injection. In hATTR amyloidosis, TTR protein misfolds and accumulates as amyloid deposits throughout the body.

    FDA’s approval of inotersen was based on results from the Phase III NEURO-TTR study in patients with hATTR amyloidosis with symptoms of polyneuropathy.

    Results demonstrated that patients treated with inotersen experienced significant benefit compared with patients treated with placebo across both coprimary endpoints: the Norfolk Quality of Life Questionnaire–Diabetic Neuropathy and modified Neuropathy Impairment Score +7, a measure of neuropathic disease progression.

    Inotersen is associated with risk of thrombocytopenia and glomerulonephritis. Enhanced monitoring is required to support early detection and management of these identified risks. For full prescribing information, including a boxed warning, please visit Inotersen is being marketed with a Risk Evaluation and Mitigation Strategy (REMS).

    The most common adverse effects include injection-site reactions (such as redness or pain at the injection site), nausea, headache, tiredness, low platelet counts, and fever.

  • 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.