Medication Monitor

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  • November 14, 2018

    Pfizer announced FDA approval of a new indication for lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

    Accelerated approval was based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

    While many ALK-positive metastatic NSCLC patients respond to initial TKI therapy, they typically experience tumor progression, stated Pfizer in a news release. In addition, options for patients who progress after treatment with second-generation ALK TKIs, alectinib, brigatinib and ceritinib, are limited. Approval of this indication represents a new option for patients who have progressed on a second-generation ALK TKI, providing an opportunity to remain on oral therapy.

    In clinical trials, the most common (≥20%) adverse reactions were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. 
    increased alkaline phosphatase.

    The most frequent serious adverse reactions reported were pneumonia, dyspnea, pyrexia, mental status changes, and respiratory failure.

    Fatal adverse reactions occurred in 2.7% percent of patients and included pneumonia, myocardial infarction, acute pulmonary edema, embolism, peripheral artery occlusion, and respiratory distress.

  • November 1, 2018

    FDA approved a new indication for pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non–small cell lung cancer (NSCLC).

    Approval was based on a randomized, multicenter, double-blind, placebo-controlled trial in 559 patients with metastatic squamous NSCLC, regardless of PD-L1 tumor expression status, who had not previously received systemic therapy for metastatic disease.

    Patients were randomized (1:1) to pembrolizumab 200 mg or placebo in combination with carboplatin, along with either paclitaxel every 3 weeks or nab-paclitaxel weekly on a 3-week cycle for four cycles, followed by pembrolizumab or placebo. Patients continued pembrolizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 24 months.

    The trial demonstrated statistically significant improvements in patients receiving pembrolizumab plus chemotherapy compared with those randomized to placebo plus chemotherapy. 

    The most common adverse reactions in at least 20% of patients who received pembrolizumab were fatigue/asthenia, nausea, constipation, diarrhea, vomiting, pyrexia, decreased appetite, rash, cough, dyspnea, alopecia, and peripheral neuropathy.

    The recommended pembrolizumab dose for metastatic squamous NSCLC is 200 mg intravenously every 3 weeks, prior to chemotherapy when given on the same day, until disease progression, unacceptable toxicity, or 24 months after initiation.

  • October 29, 2018

    FDA approved sodium oxybate for treatment of cataplexy and excessive daytime sleepiness in pediatric patients (aged 7–17 y) with narcolepsy.

    Sodium oxybate is a central nervous system (CNS) depressant approved in 2002 for treatment of cataplexy in adult patients with narcolepsy. Cataplexy is a sudden and transient episode of muscle weakness accompanied by full conscious awareness, typically triggered by emotions such as laughing, crying, or terror.

    Sodium oxybate either alone or in combination with other CNS depressants may be associated with adverse reactions that include seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Rapid onset of sedation, coupled with amnesia, particularly when combined with alcohol, has posed risks for voluntary and involuntary users (e.g., assault victims).

    The agent is contraindicated in patients being treated with sedative hypnotic agents and in patients with succinic semialdehyde dehydrogenase deficiency. In addition, patients should not drink alcohol when using Sodium oxybate. Succinic semialdehyde deficiency is a rare inborn error of metabolism variably characterized by mental retardation, hypotonia, and ataxia.

    The most common adverse reactions in pediatric patients were bed-wetting, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness. 

    The following adverse reactions have been identified during postapproval use of sodium oxybate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: joint pain, decreased appetite, fall, fluid retention, hangover, headache, hypersensitivity, hypertension, memory impairment, nocturia, panic attack, vision blurred and weight decreased.

    Because of the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion, sodium oxybate is only available through a risk evaluation mitigation strategy (REMS) programs



  • October 25, 2018

    FDA has approved a new indication for rivaroxaban to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in patients with chronic coronary or peripheral artery disease (CAD/PAD). It is now the first and only factor Xa inhibitor approved for patients with these conditions.

    Approval was based on results from the COMPASS trial, which showed a significant 24% reduction in the risk of major CV events in patients with chronic CAD and/or PAD with the rivaroxaban 2.5-mg vascular dose twice daily plus aspirin 100 mg once daily, compared with aspirin alone.

    This finding was driven by a 42% reduction in stroke, 22% reduction in CV death, and 14% reduction in heart attack. The risk of major bleeding was significantly higher in patients taking the rivaroxaban/aspirin regimen compared with aspirin alone, with no significant increase in fatal or intracranial bleeds.

  • October 25, 2018

    Dupilumab gained FDA approval as add-on maintenance therapy for patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

    Dupilumab inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the type 2 inflammation that may underlie moderate to severe asthma. This effect is associated with the reduction of inflammatory biomarkers, including fractional exhaled nitric oxide, immunoglobulin E, and eotaxin-3.

    For people with asthma, dupilumab comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose.

    Approval for the indication was based on a pivotal trial program that evaluated 2,888 adult and adolescent patients with moderate to severe asthma in three randomized, placebo-controlled, multicenter trials for 6 months to 1 year (24 to 52 weeks).

    The agent comes in a pre-filled syringe and is intended for subcutaneous injection under the guidance of a health care provider. It can be given in a clinic or, for convenience, at home by self-administration after training by a health professional.

    Dupilumab was previously approved for treatment of adults with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.