Medication Monitor

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Generic Name (Trade Name—Company)
  • July 26, 2018

    FDA approved ivosidenib tablets, the first drug in its class—isocitrate dehydrogenase-1 inhibitor—to treat relapsed or refractory acute myeloid leukemia (AML) in adults with a specific mutation in the IDH1 gene. The agency also approved the RealTime IDH1 Assay, a companion diagnostic used to detect IDH1 gene mutations.

    The agent works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), leading to differentiation of malignant cells. If the IDH1 mutation is detected in blood or bone marrow samples using the RealTime IDH1 Assay, the patient may be eligible for treatment with ivosidenib.

    Ivosidenib's efficacy was studied in a single-arm trial of 174 adult patients with relapsed or refractory AML with an IDH1 mutation. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission, or CR), as well as patients with no evidence of disease and partial recovery of blood counts after treatment (complete remission with partial hematologic recovery, or CRh).

    With a median follow-up of 8.3 months, 32.8% of patients experienced a CR orCRh that lasted a median 8.2 months. Of the 110 patients who required transfusions of blood or platelets due to AML at the start of the study, 37% went at least 56 days without requiring a transfusion after treatment with ivosidenib.

    Common adverse effects are fatigue, increase in white blood cells, joint pain, diarrhea, shortness of breath, swelling in the arms or legs, nausea, pain or sores in the mouth or throat, irregular heartbeat (QT prolongation), rash, fever, cough, and constipation. Women who are breastfeeding should not take ivosidenib because it may cause harm to a newborn baby.

    A boxed warning cautions that an adverse reaction known as differentiation syndrome can occur and can be fatal if not treated.

    Signs and symptoms of differentiation syndrome may include fever, difficulty breathing (dyspnea), acute respiratory distress, inflammation in the lungs (radiographic pulmonary infiltrates), fluid around the lungs or heart (pleural or pericardial effusions), rapid weight gain, swelling (peripheral edema) or liver (hepatic), kidney (renal) or multi-organ dysfunction.

    At first suspicion of symptoms, health care providers should treat patients with corticosteroids and monitor patients closely until symptoms go away.

    Other serious warnings include QT prolongation, which can be life threatening. Electrical activity of the heart should be tested with an electrocardiogram during treatment. Guillain-Barré syndrome also has occurred with treatment, so patients should be monitored for nervous system problems.

    Ivosidenib must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

  • July 17, 2018

    FDA has approved tecovirimat, the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.

    Prior to its eradication in 1980, variola virus, the virus that causes smallpox, was mainly spread by direct contact between people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache, and backache. A rash initially consisting of small, pink bumps progressed to pus-filled sores before finally crusting over and scarring. Complications of smallpox could include encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye) and blindness.

    Tecovirimat's effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox and was based on measuring survival at the end of the studies. More animals treated with tecovirimat lived compared with the animals treated with placebo.

    It was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.

    Safety of the agents was evaluated in 359 healthy human volunteers without a smallpox infection. The most frequently reported adverse effects were headache, nausea, and abdominal pain.

  • July 9, 2018

    Dermira announced FDA approval of glycopyrronium cloth, an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients aged 9 years and older.

    Commonly known as excessive underarm sweating, primary axillary hyperhidrosis is a chronic medical skin condition that results in sweating beyond what is needed for normal body temperature regulation. The exact cause is unknown, but it affects nearly 10 million people in the United States, with both men and women having similar prevalence. Approved under the trade name Qbrexza (pronounced kew brex’ zah), it is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation.

    Approval was based on results from two Phase III clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis. Both trials assessed the absolute change from baseline in sweat production (the weight or amount of sweat a patient produced) following treatment with Qbrexza and the proportion of patients who achieved at least a four-point improvement from baseline in their sweating severity, as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument. 

    The most common adverse effects observed following topical application of Qbrexza to the underarms were dry mouth, dilated pupil, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin, and constipation. The most common local skin reactions were erythema, burning/stinging, and pruritus.  

    Qbrexza is expected to be available nationwide in pharmacies beginning in October 2018. For more information, visit

  • June 27, 2018

    Achaogen announced FDA approval of plazomicin, an I.V. infusion administered once daily, for adults aged 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis, caused by Enterobacteriaceae bacteria (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae). The drug is for patients who have limited or no alternative treatment options.

    Plazomicin was engineered to overcome aminoglycoside-modifying enzymes, the most common aminoglycoside-resistance mechanism in Enterobacteriaceae, and has in vitro activity against extended-spectrum beta-lactamase (ESBL)–producing, aminoglycoside-resistant, and carbapenem-resistant isolates.

    CDC has characterized ESBL-producing Enterobacteriaceae as a "serious threat" and CRE as "nightmare bacteria"—immediate public health threats that require urgent and aggressive action.

    Approval was supported in part by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, the first randomized controlled study of once-daily aminoglycoside therapy for treatment of cUTI, including pyelonephritis. 

    As only limited clinical safety and efficacy data for plazomicin are currently available, plazomicin is reserved for use in cUTI patients who have limited or no alternative treatment options.

    To reduce the development of drug-resistant bacteria and maintain effectiveness of plazomicin and other antibacterial drugs, plazomicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible microorganisms.

    On the potential indication for plazomicin to treat bloodstream infection (BSI), FDA issued a Complete Response Letter (CRL) stating that the CARE study does not provide substantial evidence of effectiveness of plazomicin for this indication. The company intends to meet with FDA to determine whether there is a feasible resolution to address the CRL.

    Achaogen will work with hospitals, providers, and insurers to ensure patients are able to receive this treatment. Patients, physicians, pharmacists, or other health professionals with questions about plazomicin should contact 1-833-252-6400 or visit

  • June 25, 2018

    FDA has approved cannabidiol (CBD) oral solution under the trade name Epidiolex to treat seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients aged 2 years and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for to treat patients with Dravet syndrome.

    CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).

    It is THC (and not CBD) that is the primary psychoactive component of marijuana.

    Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures. Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). In addition, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity, and difficulty relating to others.

    Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

    Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.

    The most common adverse effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.

    Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

    Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD.

    FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.