Medication Monitor

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Generic Name (Trade Name—Company)
  • June 15, 2019

    FDA approved galcanezumab-gnlm solution for self-injection to treat episodic cluster headache in adults. The agent was first approved in September 2018 for prevention of migraine in adults.  

    Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. The headaches are accompanied by symptoms that may include bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion and facial sweating. Some people experience restlessness and agitation. Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and 3 hours.   

    Hypersensitivity reactions with use of galcanezumab-gnlm could occur days after administration and may be prolonged. Treatment should be discontinued if this occurs. The most common adverse effect is injection site reactions.

  • June 13, 2019

    FDA approved a new indication for ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. FDA initially approved ceftolozane/tazobactam in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.

    HABP/VABP occur in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. According to CDC data, HABP and VABP are currently the second most common type of hospital-acquired infection in the United States and are a significant issue in patients in the intensive care unit (ICU).

    Safety and efficacy of ceftolozane/tazobactam for treatment of HABP/VABP, administered via injection, was demonstrated in a multinational, double-blind study that compared ceftolozane/tazobactam to another antibacterial drug in 726 adult patients hospitalized with HABP/VABP. The study showed that mortality and cure rates were similar between ceftolozane/tazobactam and the comparator treatment.

    In the clinical trials, the most common adverse reactions were elevated liver enzyme levels, renal impairment or failure, and diarrhea.

    Ceftolozane/tazobactam should not be used in patients with known serious hypersensitivity to its components, as well as hypersensitivity to piperacillin/tazobactam or other members of the beta-lactam class of antibacterial drugs.

    The FDA granted the approval of Zerbaxa for the treatment of HABP/VABP to Merck & Co., Inc.

  • June 13, 2019

    On May 28, 2019, FDA approved lenalidomide in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

    Approval was based on two clinical trials: AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, 358 patients with relapsed or refractory FL or MZL were randomized (1:1) to receive lenalidomide and rituximab or rituximab and placebo. In the single-arm component of MAGNIFY, 232 patients with relapsed or refractory FL, MZL, or mantle cell lymphoma received 12 induction cycles of lenalidomide and rituximab.

    The most common adverse reactions were neutropenia, fatigue, diarrhea, constipation, nausea, and cough.

    The prescribing information includes a boxed warning alerting health professionals and patients about the risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, which may be life-threatening or fatal.

    The recommended lenalidomide dose for FL or MZL is 20 mg once daily orally on days 1 to 21 of repeated 28-day cycles for up to 12 cycles.

  • June 13, 2019

    Allergan and Gedeon Richter announced FDA approval of cariprazine, an oral, once-daily, atypical antipsychotic, for expanded use to treat depressive episodes associated with bipolar I disorder  in adults (1.5 or 3 mg/day). Cariprazine is also approved in the United States to treat manic or mixed episodes associated with bipolar I disorder in adults (3–6 mg/d). 

    Approval for the expanded indication was based on three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to week six on the Montgomery Asberg Depression Rating scale total score. In all three studies, the cariprazine 1.5-mg dose demonstrated statistical significance over placebo. In addition, in RGH-MD-54, the cariprazine 3-mg dose demonstrated statistical significance over placebo.

    Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms.

  • June 12, 2019

    Merz Americas announced FDA approval of a new indication for incobotulinumtoxinA as first-line treatment of blepharospasm (involuntary blinking) in adult patients.

    Blepharospasm causes muscles around the eyes to contract involuntarily. Patients can experience symptoms including excessive blinking, light sensitivity, dry eyes, and eye irritation and watering eyes, and symptoms may worsen over time.

    Approval for this indication was based on a Phase III, randomized, double-blind, placebo-controlled, multicenter trial in 61 treatment-naive patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale (JRS) Severity subscore of 2 or higher. JRS is the most commonly used clinical scale to measure severity and frequency of blepharospasm. Patients were defined as treatment-naive if at least 12 months had passed since their last toxin treatment.

    The primary efficacy endpoint was the change from baseline in JRS Severity subscore determined at week 6 after the injection. The 50-unit treatment group demonstrated statistically significant improvement compared with placebo. The safety findings were similar to previous studies and in line with the product's known safety profile.

    IncobotulinumtoxinA was first approved by FDA in 2010 for treatment of blepharospasm (previously treated with onabotulinumtoxinA) and cervical dystonia in adult patients and later in 2015 for upper limb spasticity in adult patients. Most recently, the agent gained a new approval in July 2018 to treat chronic sialorrhea (excessive drooling) in adult patients.