Medication Monitor

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  • September 20, 2019

    On September 10, Xeris Pharmaceuticals announced FDA approval of glucagon injection for treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and older.

    It is the first glucagon product approved that can be administered via a prefilled syringe or auto-injector. It will be available in two doses: a 0.5-mg/0.1-mL dose for pediatric patients and a 1-mg/0.2-mL dose for adolescent and adult patients. 

    The product is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients.

    The most common adverse reactions are nausea, vomiting, and hypoglycemia.

  • September 20, 2019

    FDA approved nintedanib, a kinase inhibitor, to slow the rate of decline in pulmonary function in adults with interstitial lung disease (ILD) associated with systemic sclerosis or scleroderma (SSc-ILD). It is the first FDA-approved treatment for this rare lung condition.

    Scleroderma causes tissue throughout the body, including the lungs and other organs, to thicken and scar. ILD affects the interstitium and is one of the most common disease manifestations of sclerderma. SSc-ILD is a progressive lung disease in which lung function declines over time, and it can be debilitating and life-threatening. ILD is the leading cause of death among people with scleroderma, typically resulting from a loss of pulmonary function that occurs when the lungs cannot supply enough oxygen to the heart. 

    The prescribing information includes warnings for patients with moderate or severe liver impairment, those with elevated liver enzymes and drug-induced liver injury, and those with GI disorders. The drug may also cause embryo-fetal toxicity that can result in fetal harm, arterial thromboembolic events, bleeding, and GI perforation. P-gp and CYP3A4 inhibitors may increase nintedanib exposure, and patients taking these inhibitors should be closely monitored for tolerability.

    The recommended dosage is 150 mg twice daily approximately 12 hours apart, taken with food.

    Common adverse effects include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss, and hypertension.

    The agent was originally approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung condition.

  • September 20, 2019

    FDA approved rimabotulinumtoxinB, an acetylcholine release inhibitor, to treat chronic sialorrhea (drooling) in adults, which is a common and often problematic symptom of many neurological disorders (e.g., Parkinson’s disease, amyotrophic lateral sclerosis, cerebral palsy, stroke, and other condition).

    It is the only approved botulinum toxin for chronic sialorrhea that provides significant results in as early as 1 week, stated the manufacturer in a news release, and one treatment significantly decreases symptoms of sialorrhea for up to 3 months.

    The recommended dosage is 1,500 units to 3,500 units; 500 units to 1,500 units per parotid gland and 250 units per submandibular gland, no more frequently than every 12 weeks. The botulinum toxin injection must be administered by a licensed health care provider and requires no reconstitution.

    Common adverse effects include dry mouth and dysphagia.

    The drug is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, or in those with infection at the proposed injection site(s).

    A boxed warning cites the risk of spreading from the injection area to produce symptoms consistent with botulinum toxin effects hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk is greatest in children treated for spasticity, but symptoms can also occur in adults, particularly in patients with a predisposing underlying condition.



  • September 20, 2019

    On August 26, FDA approved ixekizumab injection 80 mg/mL to treat adults with active ankylosing spondylitis, also known as radiographic axial spondyloarthritis.

    This is the third indication for ixekizumab, which was first approved in March 2016 for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It was then approved by FDA in December 2017 to treat adults with active psoriatic arthritis.

    The drug is a humanized interleukin-17A antagonist. The recommended dosage is 160 mg by S.C. injection (two 80-mg injections), followed by 80 mg every 4 weeks.

    Adverse effects include injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

    The prescribing info includes warnings and precautions not to use in patients with a previous serious hypersensitivity, such as anaphylaxis, to ixekizumab or any of the excipients. The drug may increase the risk of infection.

    Patients should be evaluated for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations before treatment initiation.

  • August 9, 2019

    On July 30, FDA approved a new indication for pembrolizumab for treatment of patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

    FDA also approved a new use for the PD-L1 IHC 22C3 pharmDx kit as a companion diagnostic device for selecting patients for the above indication.

    Efficacy was investigated in two clinical trials, KEYNOTE‑181 and KEYNOTE‑180. KEYNOTE-181 was a randomized, open-label, active-controlled trial that enrolled 628 patients with recurrent locally advanced or metastatic esophageal cancer who progressed on or after one prior line of systemic treatment for advanced or metastatic disease. KEYNOTE‑180 was a single arm, open-label trial that enrolled 121 patients with locally advanced or metastatic esophageal cancer who progressed on or after at least two prior systemic treatments for advanced disease. 

    Adverse reactions in patients with esophageal cancer were similar to those in 2,799 patients with melanoma or non–small cell lung cancer treated with single-agent pembrolizumab in clinical trials. Common adverse reactions reported in at least 20% of patients receiving pembrolizumab included fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

    The recommended pembrolizumab dose for esophageal cancer is 200 mg every 3 weeks.