Medication Monitor

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  • August 20, 2018

    FDA has approved a novel, extended-release formulation of methylphenidate for the treatment of ADHD in patients aged 6 years and older. It is taken once daily in the evening at 8:00, instead of immediately upon waking, to provide early-morning symptom control.

    Timing of administration may be adjusted between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and the efficacy the next morning and throughout the day.

    Effectiveness of methylphenidate was established in two separate Pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled studies conducted in a total of 278 pediatric patients aged 6 to 12 years with a diagnosis of ADHD per DSM-5 criteria.

    In addition to the traditional scales that assess efficacy in ADHD clinical trials, such as the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale and the ADHD Rating Scale (ADHD-RS-IV), Ironshore’s pivotal trials assessed methylphenidate's efficacy in the early morning period using the morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale and the Before School Functioning Questionnaire (BSFQ).

    Ironshore plans to make the drug available commercially in the first half of 2019.

  • August 16, 2018

    FDA has approved segesterone acetate and ethinyl estradiol vaginal system under the trade name Annovera. The combined hormonal contraceptive is the first vaginal ring contraceptive that can be used for an entire year.

    Annovera is a reusable donut-shaped (ring), nonbiodegradable, flexible vaginal system that is placed in the vagina for 3 weeks, followed by 1 week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every 4 weeks for 1 year (thirteen 28-day menstrual cycles).

    The ring is washed and stored in a compact case for the 7 days not in use. It does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30° C (86° F).

    Efficacy and safety of Annovera were studied in three open-label clinical trials that included healthy women ranging in age from 18 to 40 years. The results showed that about 2 to 4 women out of 100 may get pregnant during the first year they use Annovera.

    Annovera carries a boxed warning on cigarette smoking and serious cardiovascular events. Women older than 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

    Annovera also is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the Annovera components; and use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

    The most common adverse effects are similar to those of other combined hormonal contraceptive products, such as headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.

    FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism and the effects of CYP3A-modulating drugs and tampon use on the pharmacokinetics of Annovera.

  • August 16, 2018

    FDA approved migalastat, the first oral medication for the treatment of adults with Fabry disease, a rare and serious genetic disorder caused by mutations in the alpha-galactosidase A (GLA) gene located on the X-chromosome. The disease results from buildup of globotriaosylceramide (GL-3) in blood vessels, the kidneys, the heart, the nerves, and other organs.

    It is estimated that classic Fabry disease (the most severe type) affects approximately one in 40,000 males. The later-onset type is more frequent and in some populations may occur in one in 1,500 to 4,000 males. Patients with Fabry disease develop slowly progressive kidney disease, cardiac hypertrophy, arrhythmias, stroke, and early death.

    Efficacy was demonstrated in a 6-month, placebo-controlled clinical trial in 45 adults with Fabry disease. Patients treated with migalastat had a greater reduction in GL-3 in blood vessels of the kidneys (as measured in kidney biopsy samples) compared with patients on placebo. Migalastat's safety was studied in four clinical trials that included 139 patients with Fabry disease.

    The most common adverse drug reactions were headache, nasal and throat irritation, urinary tract infection, nausea, and fever.

  • August 16, 2018

    FDA approved patisiran infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.

    This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating, and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart, and other organs. It is also the first FDA approval of a new class of drugs called small interfering ribonucleic acids (siRNAs).

    siRNAs work by silencing a portion of RNA involved in causing the disease. More specifically, patisiran encases the siRNA into a lipid nanoparticle to deliver the drug directly into the liver, in an infusion treatment, to alter or halt the production of disease-causing proteins.

    The agent is designed to interfere with RNA production of an abnormal form of the protein transthyretin (TTR). By preventing the production of TTR, the drug can help reduce the accumulation of amyloid deposits in peripheral nerves, improving symptoms and helping patients better manage the condition.

    Efficacy was shown in a clinical trial involving 225 patients, 148 of whom were randomly assigned to receive a patisiran infusion once every three weeks for 18 months, and 77 of whom were randomly assigned to receive a placebo infusion at the same frequency. The patients who received patisiran had better outcomes on measures of polyneuropathy, including muscle strength, sensation (pain, temperature, numbness), reflexes, and autonomic symptoms (blood pressure, heart rate, digestion) compared with those receiving the placebo infusions. Patisiran-treated patients also scored better on assessments of walking, nutritional status, and the ability to perform activities of daily living.

    The most common adverse reactions reported by patients in clinical trials included flushing, back pain, nausea, abdominal pain, dyspnea, and headache. All patients who participated in the clinical trials received premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) to reduce the occurrence of infusion-related reactions.

    Patients may also experience vision problems, including dry eyes, blurred vision, and eye floaters (vitreous floaters). Use of the agent can cause a decrease in serum vitamin A levels, so patients should take a daily Vitamin A supplement at the recommended daily allowance.

  • August 16, 2018

    FDA approved mogamulizumab-kpkc injection for I.V. use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.

    The agent is a monoclonal antibody that binds to a CC chemokine receptor type 4 (CCR4) found on some cancer cells. 

    Approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either mogamulizumab-kpkc or a type of chemotherapy called vorinostat. Progression-free survival was longer for patients taking mogamulizumab-kpkc (median 7.6 mo) compared with patients taking vorinostat (median 3.1 mo).

    In clinical trials, the most common adverse effects of treatment included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.

    Serious warnings include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with the drug.