Medication Monitor

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Generic Name (Trade Name—Company)
  • October 30, 2019

    On October 8, Novartis announced FDA approval of brolucizumab injection to treat wet age-related macular degeneration (AMD). According to Novartis, it is the first FDA-approved anti–vascular endothelial growth factor to offer greater fluid resolution than aflibercept and the ability to maintain patients with AMD on a 3-month dosing interval immediately after a 3-month loading phase, with uncompromised efficacy.

    Approval was based on findings from the Phase III HAWK and HARRIER clinical trials, in which brolucizumab demonstrated noninferiority to aflibercept in mean change in best-corrected visual acuity at year one (week 48).

    In both clinical trials, approximately 30% of patients gained at least 15 letters at year one. In HAWK and HARRIER, patients receiving brolucizumab showed greater reduction in central subfield thickness as early as week 16, and at year one, fewer patients had intra-retinal and/or subretinal fluid. Retinal fluid is a key marker of disease activity.

    The most common adverse events are blurred vision, cataract, conjunctival hemorrhage, vitreous floaters, and eye pain.

  • October 30, 2019

    On October 11, FDA approved lasmiditan tablets for acute (active but short-term) treatment of migraine with or without aura in adults. The drug is not indicated for preventive treatment of migraine.

    Lasmiditan's effectiveness for acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved 2 hours after treatment were significantly greater among patients receiving lasmiditan at all doses compared with those receiving placebo. Although patients were allowed to take a rescue medication 2 hours after taking lasmiditan, opioids, barbiturates, triptans and ergots were not allowed within 24 hours of the study drug’s administration. Twenty-two percent of patients were taking a preventive medication for migraine.

    There is a risk of driving impairment while taking lasmiditan. Patients are advised not to drive or operate machinery for at least 8 hours after taking the medication, even if they feel well enough to do so. Patients who cannot follow this advice are advised not to take the drug. Lasmiditan causes central nervous system (CNS) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants.

    Common adverse effects are dizziness, fatigue, paresthesia, and sedation. 

  • October 22, 2019

    FDA has approved elexacaftor, ivacaftor, and tezacaftor, the first triple-combination therapy to treat patients ages 12 years and older with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population.

    Currently available therapies that target the defective protein are treatment options for some patients with cystic fibrosis, but many patients have mutations that are ineligible for treatment.

    In clinical trials, serious adverse drug reactions that occurred more frequently in patients receiving the three-drug combination compared with placebo were rash and influenza.

    The most common adverse drug reactions included headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, increased liver enzymes, nasal congestion, increased blood creatine phosphokinase, rhinorrhea, rhinitis, influenza, sinusitis, and increased blood bilirubin.

    The prescribing information includes warnings related to elevated liver function tests (transaminases and bilirubin), use at the same time with other products that are inducers or inhibitors of CYP3A, and the risk of cataracts. Patients and their caregivers should speak with a health care professional about these risks and any medication they take before starting treatment.

    Clinicians should confirm the presence of at least one F508del mutation with use of an FDA-cleared genotyping assay before beginning treatment.

    The agent's safety and effectiveness in patients with cystic fibrosis younger than 12 years have not been established.

  • September 25, 2019

    FDA has approved Jynneos, a live, nonreplicating smallpox and monkeypox vaccine that prevents smallpox and monkeypox disease in adults ages 18 years and older who are at high risk for smallpox or monkeypox infection. It is the only currently FDA-approved vaccine for prevention of monkeypox disease.

    Jynneos is made from a vaccinia virus, which is closely related to but less harmful than variola or monkeypox viruses and can protect against both of these diseases. Jynneos contains a modified form of the vaccinia virus that does not cause disease in humans and is nonreplicating.

    Its effectiveness for prevention of smallpox was determined in a clinical study comparing the immune responses in study participants who received either Jynneos or ACAM2000, an FDA-approved vaccine for prevention of smallpox. The study included approximately 400 healthy adults ages 18 through 42 years who had never been vaccinated for smallpox. Half of the study participants received two doses of Jynneos administered 28 days apart, and half received one dose of ACAM2000.

    The group vaccinated with Jynneos had an immune response that was not inferior to immune responses to ACAM2000. Vaccine effectiveness for prevention of smallpox was also inferred from supportive animal studies, which showed that prior vaccination with Jynneos protected nonhuman primates who were exposed to viruses related to the smallpox virus.

    Effectiveness of Jynneos for prevention of monkeypox disease is inferred from the antibody responses in the smallpox clinical study participants and from studies in nonhuman primates that showed protection of animals vaccinated with Jynneos who were exposed to the monkeypox virus.

    Safety was assessed in more than 7,800 individuals who received at least one dose of the vaccine. The most commonly reported adverse effects were pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue. No safety concerns that would require a Medication Guide have been identified.

    Jynneos is administered in two doses given 4 weeks apart.

    The vaccine is part of the Strategic National Stockpile (SNS), the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency that is severe enough to cause local supplies to be depleted. The availability of this vaccine in the SNS will help ensure that the vaccine is accessible in the United States if needed.

  • September 20, 2019

    FDA approved tenapanor, a 50-mg, twice-daily oral agent for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.  

    The drug is a minimally absorbed small molecule that acts locally in the GI tract to inhibit the sodium–hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain.

    The recommended dosage in adults is 50 mg orally twice daily, to be taken immediately before breakfast or the first meal of the day and immediately before dinner.  

    The prescribing information includes a boxed warning for the risk of serious dehydration in pediatric patients. It is contraindicated in patients younger than 6 years and should be avoided in children ages 6 years to 12 years, as well as in patients with known or suspected mechanical GI obstruction.

    The most common adverse reactions (≥2%) are diarrhea, abdominal distension, flatulence, and dizziness.