Medication Monitor

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  • June 26, 2018

    FDA has expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes.

    FDA originally approved this device in September 2017 for use in patients aged 14 years and older with type 1 diabetes. The device works by measuring glucose levels every 5 minutes and automatically adjusting insulin delivery by either administering or withholding insulin.

    The system includes a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump strapped to the body, and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime.

    Approval was based on data from a clinical trial that included 105 individuals aged 7 to 11 years. Study participants wore the device for approximately 3.5 months and participated in three phases of the study to evaluate both at-home use as well as remote use. That study found no serious adverse events associated with use of the MiniMed 670G and that the device is safe for use in people aged 7 to 13 years with type 1 diabetes.

    Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch.

    As part of this approval, FDA is requiring a postmarketing study to evaluate device performance in real-world settings in children between the ages of 7 and 13. This device is not approved for use in children aged 6 years or younger or in individuals who require less than eight units of insulin per day.

  • June 26, 2018

    Amphastar announced FDA approval of isoproterenol hydrochloride injection, USP 0.2 mg/mL, 1mL and 0.2 mg/mL, 5-mL single-dose vial, for multiple uses including mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.

    The product was determined by FDA to be therapeutically equivalent to Isuprel, which is sold in the United States by Valeant Pharmaceuticals.

    Amphastar anticipates launching the product in the third quarter of 2018.


  • June 19, 2018

    Merck announced FDA approval of pembrolizumab to treat adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) or relapsed PMBCL after two or more prior lines of therapy. With this indication, pembrolizumab becomes the first anti-PD-1 therapy to be approved for  treatment of PMBCL, a type of non-Hodgkin lymphoma. It is the second indication for the agent for treatment of a hematologic malignancy.

    This indication was approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. 

    The agent is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. 

    Immune-mediated adverse reactions include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions and solid organ transplant rejection. Because of the severity of the adverse reaction, pembrolizumab should be withheld or discontinued and corticosteroids administered if appropriate. Immune-mediated complications, including fatal events, occurred in patients with classical Hodgkin lymphoma who underwent allogeneic hematopoietic stem cell transplantation after treatment with pembrolizumab.

  • June 15, 2018

    FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence.

    Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse.

    At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their OUD cut their risk of death from all causes in half.

    One of the ways FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products. Generic drugs approved by FDA have, among other things, the same quality as brand-name drugs. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.

    Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema (accumulation of fluid causing swelling in lower limbs). These products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.

    Mylan Technologies and Dr. Reddy's Laboratories received approval to market buprenorphine and naloxone sublingual film in multiple strengths. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

  • June 14, 2018

    FDA approved bevacizumab for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for Stage III or IV disease after initial surgical resection.

    Approval was based on a multicenter, randomized, double-blind, placebo-controlled, three-arm study evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

    A total of 1,873 patients were randomized to carboplatin plus paclitaxel without bevacizumab, carboplatin plus paclitaxel with bevacizumab for up to six cycles, or carboplatin plus paclitaxel with bevacizumab for six cycles followed by single-agent bevacizumab for up to 16 additional doses. Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. On this trial, 1,215 patients received at least one bevacizumab dose.

    The primary efficacy outcome was investigator-assessed progression-free survival (PFS); overall survival (OS) was a secondary outcome. The estimated median PFS was 18.2 months for patients receiving bevacizumab with chemotherapy followed by single-agent bevacizumab (hazard ratio [HR] 0.62 [95% CI 0.52–0.75]; P < 0.0001). For those receiving bevacizumab with chemotherapy without single-agent bevacizumab, the estimated median PFS was 12.8 months (HR 0.83 [95% CI 0.70–0.98]; not significant).

    For patients receiving chemotherapy without bevacizumab, the estimated median PFS was 12.0 months. Estimated median OS was 43.8 months in the bevacizumab with chemotherapy followed by bevacizumab, compared with 40.6 months in the chemotherapy alone arm (HR 0.89 [95% CI 0.76–1.05]). 

    Adverse reactions occurring at higher incidence (at least 5%) of patients receiving bevacizumab were diarrhea, nausea, stomatitis, fatigue, arthralgia, muscular weakness, pain in extremity, dysarthria, headache, dyspnea, epistaxis, nasal mucosal disorder, and hypertension.

    Grade 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the bevacizumab arms versus the control arm were fatigue, hypertension, decreased platelet count, and decreased white blood cell count.

    The recommended bevacizumab dose for Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to six cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles.