Medication Monitor



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Generic Name (Trade Name—Company)
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  • February 6, 2019

    Exelixis announced FDA approval of a new indication for cabozantinib in patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

    Approval was based on results from the CELESTIAL Phase III pivotal trial that enrolled patients with advanced HCC who received prior sorafenib. Cabozantinib demonstrated a statistically significant and clinically meaningful improvement in overall survival versus placebo. 

    The tablets come in 20-, 40-, and 60-mg dosage strengths. The recommended dose is 60 mg orally, once daily. The drug should be administered at least 1 hour before or at least 2 hours after eating. Tablets should not be substituted with cabozantinib capsules.

    The most common adverse events are palmar-plantar erythrodysesthesia, hypertension, increased aspartate aminotransferase, fatigue, and diarrhea. Serious adverse effects include hemorrhage, perforation of the stomach or intestinal or fistula; and blood clots, stroke, heart attack, and chest pain.

  • February 1, 2019

    FDA has approved the first generic of GlaxoSmithKline’s Advair Diskus—fluticasone propionate and salmeterol inhalation powder—for twice-daily treatment of asthma in patients aged 4 years and older and for maintenance treatment of airflow obstruction and reduction of exacerbations in patients with COPD.

    The generic inhaler comes in three strengths: fluticasone propionate 100 mcg/salmeterol 50 mcg, fluticasone propionate 250 mcg/salmeterol 50 mcg, and fluticasone propionate 500 mcg/salmeterol 50 mcg.

    The most common adverse effects of the inhaler for treatment of asthma are upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea, and vomiting.

    For treatment of COPD, the most common adverse effects are pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, and musculoskeletal pain.

  • January 31, 2019

    Duchesnay announced FDA approval of ospemifene, an oral, nonhormonal treatment for moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA) due to menopause. Ospemifene helps improve specific vaginal tissues by increasing superficial cells, decreasing parabasal cells, and reducing vaginal pH. 

    Prior to this approval, ospemifene was indicated only for treatment of moderate to severe dyspareunia, also a symptom of VVA due to menopause.

    Approval was based on a Phase III, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of ospemifene in patients with moderate to severe vaginal dryness. 

    Dosage is one 6-mg tablet taken orally once daily with food.

    Common adverse effects include hot flushes or flashes, vaginal discharge, muscle spasms, headache, excessive sweating, heavy vaginal bleeding, and night sweats.

    Serious but less common adverse effects can include stroke, blood clots, and endometrial cancer.

  • January 31, 2019

    FDA has approved an expanded use of ibrutinib in combination with obinutuzumab for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Ibrutinib is a once-daily, first-in-class Bruton's tyrosine kinase inhibitor that is administered orally. It was previously approved as a single agent or in combination with bendamustine and rituximab (BR) for adult patients with CLL/SLL.

    FDA also updated the ibrutinib label to include additional long-term efficacy follow-up supporting its use as a single agent in CLL/SLL from two Phase III international studies.

    The recommended dose for CLL/SLL is 420 mg orally once daily until disease progression or unacceptable toxicity as a single agent or in combination with obinutuzumab or with bendamustine and rituximab.

    Warnings and precautions include hemorrhage, infections, cytopenias, cardiac arrhythmias, hypertension, second primary malignancies, tumor lysis syndrome, and embryo-fetal toxicity.

    The most common adverse reactions in patients treated with ibrutinib plus obinutuzumab were neutropenia, thrombocytopenia, rash, diarrhea, musculoskeletal pain, bruising, cough, infusion-related reaction, hemorrhage, and arthralgia.

  • January 31, 2019

    FDA has approved Tosymra, a new dosage formulation of sumatriptan 10 mg as a single-dose nasal spray for acute treatment of migraine with or without aura in adults. 

    The spray is formulated using a proprietary novel excipient known as Intravail to achieve blood levels similar to a 4-mg sumatriptan S.C. injection, resulting in rapid onset of action.

    The recommended dose is 10 mg given as a single spray in one nostril. The maximum cumulative dose that may be given in a 24-hour period is 30 mg, with doses separated by at least 1 hour. The agent may also be given at least 1 hour following a dose of another sumatriptan product.

    The most common adverse effects are tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

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