Medication Monitor

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  • September 5, 2019

    FDA approved istradefylline as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes. An off episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms such as tremor and difficulty walking.The new agent is an adenosine receptor antagonist.

    Istradefylline's effectiveness in treating off episodes in patients with PD who are already being treated with levodopa/carbidopa was shown in four 12-week, placebo-controlled clinical studies with 1,143 participants. In all four studies, patients treated with istradefylline experienced a statistically significant decrease from baseline in daily “off” time compared with patients receiving a placebo.

    The recommended dosage is 20 mg orally once daily, with or without food, and may be increased to a maximum of 40 mg once daily. For patients with moderate hepatic impairment, the maximum-recommended dosage is 20 mg once daily; use in patients with severe hepatic impairment should be avoided. For patients who smoke 20 or more cigarettes per day (or the equivalent of another tobacco product), the recommended dosage is 40 mg once daily.  

    The most common adverse reactions are involuntary muscle movement, dizziness, constipation, nausea, hallucination, and insomnia. Patients should be monitored for development of dyskinesia or exacerbation of existing dyskinesia. If hallucinations, psychotic behavior, or impulsive/compulsive behavior occurs, a dosage reduction or stoppage of istradefylline should be considered. Use during pregnancy is not recommended. Women of childbearing potential should be advised to use contraception during treatment.

  • August 21, 2019

    On August 15, Harmony Biosciences announced FDA approval of pitolisant for treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. It is the first treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by DEA.

    WAKIX, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. The drug is administered orally once daily in the morning upon wakening.

    Efficacy was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies, HARMONY 1 and HARMONY 1bis. These studies included a total of 261 patients who were randomized to receive pitolisant, placebo, or active control; these patients had a median age of 37 (HARMONY 1) and 40 (HARMONY 1bis). Treatment duration was 8 weeks, with a 3-week dose titration phase followed by a 5-week stable dose phase; 75% to 80% of the patients in these studies had a history of cataplexy.

    In both studies, pitolisant demonstrated a statistically significant improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) score. In the placebo-controlled trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (occurring in ≥5% of patients and at twice the rate of placebo) were insomnia, nausea, and anxiety.

  • August 21, 2019

    On August 16, AbbVie announced FDA approval of upadacitinib, a 15-mg, once-daily oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).

    Approval was supported by data from the SELECT program, one of the largest registrational Phase III programs in RA, with approximately 4,400 patients evaluated across all treatment arms in five studies. The studies include assessments of efficacy, safety, and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying antirheumatic drugs and who were naive or inadequate responders to methotrexate. Upadacitinib is not indicated for methotrexate-naive patients.

    Across the SELECT Phase III studies, upadacitinib met all primary and ranked secondary endpoints.

    The recommended dosage is 15 mg taken once a day with or without food.

    The most common adverse effects include upper respiratory tract infections (common cold, sinus infections), nausea, cough, and pyrexia. Patients treated with the drug are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include tuberculosis and invasive fungal, bacterial, viral, and other infections caused by opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. 

    Lymphoma and other malignancies have been observed in patients treated with upadacitinib. Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. Patients treated also may be at risk for other serious adverse reactions, including GI perforations, neutropenia, lymphopenia, anemia, lipid elevations, liver enzyme elevations, and embryo-fetal toxicity. 

  • August 21, 2019

    On August 19, FDA approved lefamulin to treat adults with community-acquired bacterial pneumonia. According to CDC data, each year in the United States about 1 million people are hospitalized with community-acquired pneumonia, and 50,000 people die from the disease.

    Lefamulin's safety and efficacy, taken either orally or intravenously, was evaluated in two clinical trials with 1,289 patients who had CABP. Treatment with lefamulin was compared with treatment using another antibiotic, moxifloxacin, with or without linezolid. The trials showed that patients treated with lefamulin had similar rates of clinical success as those treated with moxifloxacin with or without linezolid. 

    The most common adverse reactions reported in patients taking lefamulin included diarrhea, nausea, injection-site reactions, elevated liver enzymes, and vomiting.

    Lefamulin may cause prolonged QT interval. Patients with prolonged QT interval, certain arrhythmias, receiving antiarrhythmic agents for certain irregular heart rhythms, or receiving other drugs that prolong the QT interval should avoid lefamulin. In addition, patients should not use the drug if they have a known hypersensitivity to lefamulin (or any of its components) or to any other members of the pleuromutilin antibiotic class.

    Pregnant women and women who could become pregnant should be advised of the potential risks to a fetus. Women who could become pregnant should be advised to use effective contraception during treatment and for 2 days after the final dose.

  • August 21, 2019

    On August 16, FDA approved fedratinib capsules to treat adult patients with certain types of myelofibrosis.

    Approval of fedratinib for intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis was based on the results of a clinical trial in which 289 patients with myelofibrosis were randomized to receive two different doses (400 mg/d or 500 mg/d orally) of fedratinib or placebo.

    Thirty-five of 96 patients treated with the fedratinib 400-mg daily dose (the dose recommended in the approved label) experienced a significant therapeutic effect, measured by greater than or equal to a 35% reduction from baseline in spleen volume at the end of cycle 6 (week 24) as measured by an MRI or CT scan with a follow-up scan 4 weeks later.

    As a result of treatment, 36 patients experienced 50% or greater reduction in myelofibrosis-related symptoms, such as night sweats, itching, abdominal discomfort, feeling full sooner than normal, pain under ribs on left side, and bone or muscle pain.

    The fedratinib prescribing information includes a boxed warning about the risk of serious and fatal encephalopathy, including Wernicke’s, a neurologic emergency related to a thiamine deficiency. Health professionals are advised to assess thiamine levels in all patients before starting fedratinib, during treatment, and as clinically indicated. If encephalopathy is suspected, fedratinib should be immediately discontinued.

    Common adverse effects are diarrhea, nausea, vomiting, fatigue, and muscle spasms. Health professionals are cautioned that patients may experience severe anemia and thrombocytopenia. Patients should be monitored for GI toxicity and for hepatic toxicity. The dose should be reduced or stopped if a patient develops severe diarrhea, nausea, or vomiting, and treatment with antidiarrhea medications may be recommended.

    Patients may develop high levels of amylase and lipase in their blood and should be managed by dose reduction or stopping the medication.

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