Medication Monitor



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  • April 30, 2019

    Bausch Health announced FDA approval of halobetasol propionate and tazarotene lotion 0.01%/0.045% for topical treatment of plaque psoriasis in adults. It is the first and only topical lotion that combines halobetasol propionate and tazarotene in one formulation.

    In a year-long safety study, patients used the lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.

    When used separately to treat plaque psoriasis, duration of use of halobetasol propionate is limited by FDA labeling constraints, and use of tazarotene can be limited due to tolerability concerns. 

    Safety and efficacy of once-daily use for treatment of plaque psoriasis were assessed in two Phase III prospective, multicenter, randomized, double-blind clinical trials in participants aged 18 years and older with moderate to severe plaque psoriasis.

    The majority of responders maintained treatment success over the 4-week posttreatment period. The most common adverse events were redness, itching, swelling, burning, stinging, application-site pain, inflamed hair follicles, thinning of the skin, peeling, and rash.

    A third Phase III multicenter, open-label study assessed the drug's long-term safety over a year in participants with plaque psoriasis. Treatment-related adverse events were application-site reactions such as itching, pain, irritation, and inflamed hair follicles.

  • April 30, 2019

    FDA approved belimumab as an I.V. infusion for treatment of children with systemic lupus erythematosus (SLE). This is the first FDA approval of a treatment for pediatric patients with SLE. Belimumab has been approved for use in adult patients since 2011.

    While childhood-onset SLE is rare, when diagnosed, it is generally more active in children and adolescents than adult patients, particularly in how it affects organs such as the kidneys and central nervous system. As a result of the disease starting early in life, pediatric patients with SLE are at a higher risk for developing increased organ damage and complications from the disease as well as adverse events from the life-long treatments usually required.

    Efficacy belimumab I.V. for treatment of SLE in pediatric patients was studied over 52 weeks in 93 pediatric patients with SLE. The proportion of pediatric patients achieving the composite primary endpoint, the SLE response index (SRI-4), was higher in pediatric patients receiving belimumab I.V. plus standard therapy compared with placebo plus standard therapy. Pediatric patients who received belimumab I.V. plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare (160 d vs. 82 d). The drug’s safety and pharmacokinetic profiles in pediatric patients were consistent with those in adults with SLE.

    Belimumab I.V.’s doctor and patient information includes a warning for mortality, serious infections, hypersensitivity, and depression, based on data from the clinical studies in adults with SLE. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with the drug.

    The most common adverse effects include nausea, diarrhea, and fever. Patients also commonly experienced infusion reactions, so health professionals are advised to pretreat patients with an antihistamine.

  • April 25, 2019

    FDA has granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an OTC naloxone product.

    Though the approval is the first generic naloxone nasal spray for use in a community setting by individuals without medical training, generic injectable naloxone products have been available for years for use in a health care setting. FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.

    In a press announcement, FDA said that while business and other considerations may affect how quickly this product becomes available, the approval is an important step for the agency as it works toward expanding access to this live-saving drug. FDA also held a two-day advisory committee meeting in December to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community.

    Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This product can be used for adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

    Use of naloxone nasal spray in patients who are opioid-dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

  • April 24, 2019

    FDA approved two new indications for pembrolizumab:

    –First-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation for metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥ 1%), as determined by an FDA-approved test.

    –With axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC).

    Approval for stage III or IV NSCLC was based on KEYNOTE‑042, a randomized, multicenter, open-label, active-controlled trial conducted in 1,274 patients with stage III or IV NSCLC who had not received prior systemic treatment for metastatic NSCLC and whose tumors expressed PD-L1 (TPS ≥ 1%). The trial demonstrated statistically significant OS improvements for those randomized to pembrolizumab compared with chemotherapy in all three populations.

    The recommended dosage for NSCLC is 200 mg as an I.V. infusion over 30 minutes every 3 weeks. The most common adverse reactions are fatigue, decreased appetite, dyspnea, cough, rash, constipation, diarrhea, nausea, hypothyroidism, pneumonia, pyrexia, and weight loss.

    Approval for RCC was based on KEYNOTE‑426, a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced RCC. Patients were enrolled regardless of PD-L1 tumor expression status and were randomly allocated to receive either pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally twice daily, or sunitinib 50 mg orally once daily for 4 weeks and then off treatment for 2 weeks.

    Treatment continued until confirmed disease progression or unacceptable toxicity. Pembrolizumab was received for maximum of 24 months.

    The recommended dosage for this indication is pembrolizumab 200 mg every 3 weeks with axitinib 5 mg orally twice daily.

    The most common adverse reactions for pembrolizumab plus axitinib are diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.  

     

  • April 10, 2019

    FDA is extending the indication of palbociclib capsules in combination with specific endocrine therapies for hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer in male patients.

    Palbociclib was initially approved in 2015 in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with fulvestrant in patients whose disease progressed following hormonal therapy.

    The most common adverse effects are infections, leukopenia  fatigue, nausea, stomatitis, anemia  hair loss, diarrhea, and thrombocytopenia. Other common adverse effects are rash, vomiting, decreased appetite, asthenia, and fever.

    Health care providers are advised to monitor a patient’s blood count for neutropenia. Patients should have their blood count checked before starting palbociclib and at the beginning of each cycle, as well as on day 15 of the first two cycles and as clinically indicated.

    Because of the potential for genotoxicity, health care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose. Women who are pregnant or breastfeeding should not take palbociclib because it may cause harm to a developing fetus or newborn baby.

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