Medication Monitor

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  • April 25, 2019

    FDA has approved a plasma-derived, polyclonal, intravenous immune globulin (IVIG) for treatment of primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents aged 12 to 17 years.  

    Approval was based on a pivotal Phase III clinical study that enrolled 59 patients with PI at nine sites across the United States. Patients received regular infusions of the drug over 1 year. The trial’s primary endpoint evaluated the rate of serious bacterial infections (SBI) in patients treated with the agent. Secondary endpoints included time to first SBI and to first serious infection, days on antibiotics, days off school or work due to infections, all confirmed infections of any kind, and hospitalizations due to infection. No SBIs occurred during the 12-month study period.

    The approved labeling will include a boxed warning about potential thrombosis and renal dysfunction or failure. Common adverse events are headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

  • April 25, 2019

    FDA approved risankizumab-rzaa, an interleukin-23 (IL-23) inhibitor, to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 

    In clinical trials, risankizumab produced high rates of durable skin clearance, with most participants (82% and 81%) achieving a 90% skin clearance (PASI 90) at 1 year, and the majority (56% and 60%) achieving complete skin clearance (PASI 100).

    The recommended dose is 150 mg administered by two S.C. injections every 12 weeks following two initiation doses at weeks 0 and 4. The drug can be administered in the office or by self-injection after training.

    The most common adverse events associated with risankizumab are upper respiratory infections, headache, fatigue, injection-site reactions, and tinea infections. The drug requires an initial evaluation for tuberculosis (TB) prior to starting treatment, and patients are instructed to report signs and symptoms of infection.

  • April 25, 2019

    FDA granted accelerated approval to erdafitinib for treatment of adult patients with locally advanced or metastatic bladder cancer that has a FGFR3 or FGFR2 genetic alteration, and that has progressed during or following prior platinum-containing chemotherapy. An FDA-approved companion diagnostic device must be used to select patients for treatment.

    Bladder cancer is the sixth most common cancer in the United States. Transitional cell carcinoma, also called urothelial carcinoma, is the most common type. Bladder cancers are associated with genetic mutations that are present in the patient's bladder or entire urothelium. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer.

    Efficacy of erdafitinib was studied in a clinical trial that included 87 patients with locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, that had progressed following treatment with chemotherapy. The overall response rate in these patients was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. The response lasted for an average of approximately 5.5 months.

    About a quarter of patients in the study were previously treated with anti PD-L1/PD-1 therapy, which is a standard treatment for patients with locally advanced or metastatic bladder cancer. Responses to erdafitinib were seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.

    Common adverse effects are increased phosphate level, mouth sores, fatigue, change in kidney function, diarrhea, dry mouth, nails separating from the bed or poor formation of the nail, change in liver function, low sodium levels, decreased appetite, change in sense of taste, anemia, dry skin, dry eyes, and hair loss.

    Other adverse effects are redness, swelling, peeling or tenderness on the hands or feet, constipation, stomach pain, nausea, and muscle pain.

    Erdafitinib may cause serious eye problems, including inflamed eyes, inflamed cornea, and disorders of the retina. Patients are advised to have eye examinations intermittently and to tell their health professional right away if they develop blurred vision, loss of vision, or other visual changes. Health professionals are advised to check patients’ blood phosphate level between 14 and 21 days after starting treatment and monthly, and to increase the dose of erdafitinib in patients whose serum phosphate is below the target level.

    Male patients with female partners of reproductive potential should be advised to use effective contraception during treatment and for 1 month after the last dose. Pregnancy testing is recommended for females of reproductive potential before initiating treatment. Women who are pregnant or breastfeeding should not take erdafitinib because it may cause harm to a developing fetus or newborn baby.

  • April 10, 2019

    FDA approved romosozumab-aqqg to treat osteoporosis in postmenopausal women at high risk of fracture. Women at high risk have a history of osteoporotic fracture or multiple risk factors for fracture, or have experienced treatment failure or intolerance to other osteoporosis therapies.

    Romosozumab-aqqg is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation. One dose consists of two injections, one immediately following the other, given once a month by a health professional. The bone-forming effect wanes after 12 doses, so more than 12 doses should not be used. If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown.

    Safety and efficacy of the agent were demonstrated in two clinical trials involving a total of more than 11,000 women with postmenopausal osteoporosis. In the first trial, one year of treatment with romosozumab-aqqg lowered the risk of a new vertebral fracture by 73% compared with placebo. This benefit was maintained over the second year of the trial, when the agent was followed by 1 year of denosumab (another osteoporosis therapy) compared with placebo followed by denosumab.

    In the second trial, one year of treatment followed by 1 year of alendronate (another osteoporosis therapy) reduced the risk of a new vertebral fracture by 50% compared with 2 years of alendronate alone. Romosozumab-aqqg followed by alendronate also reduced the risk of fractures in nonvertebral fractures compared with alendronate alone.

    The agent increased the risk of cardiovascular death, heart attack, and stroke in the alendronate trial but not in the placebo trial. Therefore, romosozumab-aqqg contains a boxed warning stating that it may increase the risk of heart attack, stroke, and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year.

    Health professionals should also consider whether the benefits of romosozumab-aqqg outweigh its risks in those with other risk factors for heart disease. The drug should be discontinued in any patient who experiences a heart attack or stroke during treatment.

    In clinical trials, common adverse effects included joint pain, headache, and injection-site reactions.

  • April 10, 2019

    FDA has approved dolutegravir and lamivudine as a complete regimen for treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of the new agent. This is the first two-drug, fixed-dose, complete regimen approved for adults with HIV-1 who have never received treatment.

    The labeling includes a boxed warning cautioning that patients infected with both HIV and hepatitis B should receive additional treatment for their hepatitis B or consider a different drug regimen.

    Patients with both HIV and hepatitis B who take products containing lamivudine, an ingredient in the new combination drug, have developed hepatitis B variants associated with resistance to lamivudine. These patients may have severe liver problems, including liver failure, when they stop taking drugs containing lamivudine. Patients with both HIV and hepatitis B virus who stop using the drug should be closely monitored by their health care provider.

    Efficacy and safety of one tablet of dolutegravir and lamivudine taken daily were demonstrated in two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history. Results were similar to a drug regimen that included dolutegravir, emtricitabine, and tenofovir in reducing the amount of HIV in the blood. Treatment was considered successful if the patient maintained low levels (<50 copies/mL) of HIV RNA in their blood for at least 48 weeks.  

    The most common adverse reactions were headache, diarrhea, nausea, insomnia, and fatigue.

    As there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid use of the new drug at the time of conception through the first trimester of pregnancy. In May 2018, FDA released a Drug Safety Communication about reported neural tube birth defects in babies born to women treated with dolutegravir.