Medication Monitor

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  • October 22, 2015

    FDA approved coagulation Factor X (human) for hereditary Factor X (10) deficiency under the trade name Coagadex. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.

    In healthy individuals, the Factor X protein activates enzymes to help with normal blood clotting in the body. Factor X deficiency is an inherited disorder, affecting men and women equally, in which the blood does not clot as it should. Patients with the disorder are usually treated with fresh-frozen plasma or plasma-derived prothrombin complex concentrates (plasma products containing a combination of vitamin K–dependent proteins) to stop or prevent bleeding. The availability of a purified Factor X concentrate increases treatment options for patients with this rare bleeding disorder.

    Coagadex, which is derived from human plasma, is indicated for individuals aged 12 and older with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary Factor X deficiency.

    Safety and efficacy of the product were evaluated in a multicenter, nonrandomized study involving 16 participants (208 bleeding episodes) for treatment of spontaneous, traumatic, and heavy menstrual bleeding episodes. Coagadex was demonstrated to be effective in controlling bleeding episodes in participants with moderate to severe hereditary Factor X deficiency.

    Coagadex was also evaluated in five participants with mild to severe Factor X deficiency who were undergoing surgery. The five individuals received Coagadex for perioperative management of seven surgical procedures. Coagadex was demonstrated to be effective in controlling blood loss during and after surgery in participants with mild deficiency. No individuals with moderate or severe Factor X deficiency received Coagadex for perioperative management of major surgery, and no safety concerns were identified in either study.

    Coagadex was also granted fast track designation and priority review.

  • October 23, 2015

    FDA approved irinotecan liposome injection, administered in combination with fluorouracil (5FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy. Irinotecan liposome is not approved for use as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.  

    Approval was based on the demonstration of improved overall survival (OS) in a multicenter, randomized, open-label, active-controlled, three-arm trial enrolling 417 patients with metastatic pancreatic adenocarcinoma with documented disease progression after gemcitabine-based therapy. Patients were randomly allocated (1:1:1) to receive irinotecan liposome in combination with 5FU and LV (n = 117), irinotecan liposome (n = 151), or 5FU and LV (n = 149) until disease progression or unacceptable toxicity. Patients homozygous for the UGT1A1*28 allele initiated treatment with irinotecan liposome at a reduced dose in the two irinotecan liposome–containing arms.  

    The primary study endpoint was OS, with comparisons of each of the two irinotecan liposome–containing arms with the 5FU/LV control arm; progression-free survival (PFS) and overall response rate (ORR) were secondary endpoints. The trial showed a statistically significant improvement in OS for patients randomized to receive irinotecan liposome in combination with 5FU and LV compared with those randomized to receive 5FU/LV; the median OS was 6.1 and 4.2 months, respectively. 

    PFS was also significantly longer in patients randomized to receive irinotecan liposome plus 5FU/ LV compared with those randomized to receive 5FU/LV, with median PFS of 3.1 and 1.5 months, respectively. The ORR was low in both arms (7.7% vs. 0.8%). There was no improvement in OS for patients randomized to receive irinotecan liposome alone compared with those randomized to receive 5FU/LV.  

    Serious risks of irinotecan liposome injection include neutropenic fever or sepsis, severe diarrhea, and interstitial lung disease. Severe hypersensitivity reactions have occurred with irinotecan hydrochloride; irinotecan liposome injection is contraindicated in patients with severe allergic reactions to irinotecan liposome or irinotecan hydrochloride. 

    The most common adverse drug reactions were diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis, and pyrexia. The most common severe (Grade 3–-4) laboratory abnormalities were lymphopenia and neutropenia. The most frequent adverse reactions resulting in discontinuationof irinotecan liposome were diarrhea, vomiting, and sepsis.

    The most frequent adverse reactions leading to dose reductions or delays were neutropenia, diarrhea, nausea/vomiting, anemia, fatigue, and thrombocytopenia.  

    The recommended dose and schedule of irinotecan liposome is 70 mg/m2 administered by I.V. infusion over 90 minutes, prior to leucovorin and fluorouracil, every 2 weeks. For patients homozygous for the UGT1A1*28 allele, the recommended starting dose of irinotecan liposome is 50 mg/m2 every 2 weeks.

  • December 16, 2015

    FDA approved sugammadex injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

    Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle and are used to paralyze the vocal cords when patients require tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator. 

    Safety and efficacy of sugammadex injection were evaluated in three Phase 3 clinical trials involving 456 participants. The return to recovery time was faster overall for the sugammadex treatment groups compared with the comparator groups, with most participants recovering within 5 minutes of routine use of sugammadex.

    Because of concerns about the nature and frequency of anaphylaxis (severe, potentially life-threatening allergic reaction) and hypersensitivity reactions reported in the clinical trials, sugammadex injection was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with sugammadex injection, one person had an anaphylactic reaction. Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate.

    Cases of marked bradycardia (abnormally slow heart action), some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex injection. Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.

    The most common adverse reactions reported in clinical trials included vomiting, low blood pressure, pain, headache and nausea. Doctors should also advise women using hormonal contraceptives that sugammadex injection may temporarily reduce the contraceptive effect, so they must use an alternate method of birth control for a period of time.

  • December 22, 2015

    FDA approved selexipag tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.

    Selexipag belongs to a class of drugs called oral IP prostacyclin receptor agonists. The drug acts by relaxing muscles in the walls of blood vessels to dilate blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs.

    Safety and efficacyof the drug were established in a long-term clinical trial of 1,156 participants with PAH. Selexipag was shown to be effective in reducing hospitalization for PAH and reducing the risks of disease progression compared with placebo. Participants were exposed to selexipag in this trial for a median duration of 1.4 years.  

    Common adverse effects observed in those treated with selexipag in the trial include headache, diarrhea, jaw pain, nausea, muscle pain, vomiting, pain in an extremity, and flushing.

    Selexipag was granted orphan drug designation, which provides incentives such as tax credits, user fee waivers, and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.

  • November 18, 2016

    FDA approved prasterone to treat women experiencing moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy due to menopause. It is the first FDA-approved product containing the active ingredient dehydroepiandrosterone (DHEA).

    Efficacy of prasterone, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, aged 40 to 80 years, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA.

    Women were randomly assigned to receive prasterone or a placebo vaginal insert. When compared twith placebo, prasterone was shown to reduce severity of pain experienced during sexual intercourse.

    Its safety was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

    Although DHEA is included in some dietary supplements, efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating, or preventing any disease.