Medication Monitor



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  • April 18, 2018

    Rigel Pharmaceuticals announced FDA approval of fostamatinib disodium hexahydrate to treat thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    The agent is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of the disease by impeding platelet destruction, providing an important new treatment option for adult patients with chronic ITP. 

    FDA approval was supported by data from the FIT clinical program, which included two randomized, placebo-controlled Phase III trials and an open-label extension, as well as an initial proof of concept study. The studies included 163 patients with ITP and was supported by a safety database of more than 4,600 participants across other indications in which fostamatinib has been evaluated.

    Rigel plans to launch the new drug in the United States in late May 2018.

  • April 17, 2018

    FDA has approved burosumab, the first drug approved to treat adults and children aged 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life.

    Most children with XLH experience bowed or bent legs, short stature, bone pain, and severe dental pain. Some adults with XLH experience persistent discomfort or complications, such as joint pain, impaired mobility, tooth abscesses, and hearing loss.

    Safety and efficacy of burosumab were studied in four clinical trials. In the placebo-controlled trial, 94% of adults receiving burosumab once a month achieved normal phosphorus levels, compared with 8% of those receiving placebo. In children, 94% to 100% of patients treated with burosumab every 2 weeks achieved normal phosphorus levels. In both children and adults, X-ray findings associated with XLH improved with burosumab therapy. Comparison of the results to a natural history cohort also provided support for burosumab's effectiveness.

    The most common adverse reactions in adults taking burosumab were back pain, headache, restless leg syndrome, decreased vitamin D, dizziness, and constipation. The most common adverse reactions in children were headache, injection site reaction, vomiting, decreased vitamin D, and fever.

    Burosumab was granted breakthrough therapy and orphan drug designations, which provides incentives to assist and encourage the development of drugs for rare diseases.

  • March 7, 2018

    FDA approved ibalizumab-uiyk, a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).

    Ibalizumab-uiyki is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.

    Safety and efficacy the agent were evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs. Many of the participants had previously been treated with 10 or more antiretroviral drugs. The majority of participants experienced a significant decrease in their HIV-RNA levels one week after ibalizumab-uiyk was added to their failing antiretroviral regimens. After 24 weeks of ibalizumab-uiyk plus other antiretroviral drugs, 43% of the trial’s participants achieved HIV RNA suppression.

    The clinical trial focused on the small patient population with limited treatment options and demonstrated the benefit of ibalizumab-uiyk in achieving reduction of HIV RNA. The seriousness of the disease, the need to individualize other drugs in the treatment regimen, and safety data from other trials were considered in evaluating the ibalizumab-uiyk development program. 

    The most common adverse reactions were diarrhea, dizziness, nausea and rash. Severe adverse effects included rash and changes in the immune system.      
     

  • February 27, 2018

    FDA approved apalutamide to treat patients with prostate cancer that has not spread but that continues to grow despite treatment with hormone therapy (castration-resistant). It is the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer. 

    Approval was based on clinical trial data showing that the agent decreased the risk of distant metastasis or death by 72% and improved median metastasis-free survival by more than 2 years.  

    The major efficacy outcome was supported by statistically significant improvements for secondary endpoints, including time to metastasis, progression-free survival, and time to symptomatic progression.

    Common adverse effects (in at least 10% of patients in the clinical trial) are fatigue, high blood pressure, rash, diarrhea, nausea, weight loss, joint pain, falls, hot flush, decreased appetite, fractures, and swelling in the limb (peripheral edema). Severe adverse effects include falls, fractures, and seizures.

    The recommended apalutamide dose is 240 mg (four 60-mg tablets) administered orally once daily.

  • February 12, 2018

    Gilead Sciences announced FDA approval of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg ([BIC/FTC/TAF] Biktarvy—Gilead), a once-daily, single-tablet regimen (STR) for treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the product’s individual components.

    It combines bictegravir, a novel unboosted integrase strand transfer inhibitor (INSTI), with emtricitabine 200 mg/tenofovir alafenamide 25 mg (Descovy—Gilead), a dual nucleoside reverse transcriptase inhibitor (NRTI). It is the smallest INSTI-based triple-therapy STR available.

    No dosage adjustment of BIC/FTC/TAF is required in patients with estimated creatinine clearance greater than or equal to 30 mL/min.

    BIC/FTC/TAF does not require testing for HLA-B*5701, has no food intake requirements, and has no baseline viral load or CD4 count restrictions.

    Before or when initiating treatment, health care providers should test for hepatitis B virus (HBV) infection and renal function, as well as monitor renal function as clinically appropriate during therapy. The agent does not cure HIV infection or AIDS.

    A boxed warning cautions on the risk of acute exacerbation of HBV posttreatment.

     

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