Medication Monitor



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Generic Name (Trade Name—Company)
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  • November 27, 2018

    FDA approved emapalumab-lzsg for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent, or progressive disease or intolerance to conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

    HLH is a condition in which the body’s immune cells do not work properly and start to damage the body’s own organs, including the liver, brain, and bone marrow. It can be inherited, which is known as primary or “familial” HLH. It can also have noninherited causes. People with primary HLH usually develop symptoms within the first months or years of life. Symptoms may include fever, enlarged liver or spleen, and decreased number of blood cells.

    Emapalumab-lzsg efficacy was studied in a clinical trial of 27 pediatric patients with suspected or confirmed primary HLH with either refractory, recurrent, or progressive disease during conventional HLH therapy or who were intolerant of conventional HLH therapy. The median age of the patients in the trial was 1 year old.

    The study showed that 63% of patients experienced a response, and 70% were able to proceed to stem cell transplant.

    Common adverse effects in clinical trials included infections, hypertension, infusion-related reactions, low potassium, and fever.

    Patients receiving the agent should not receive any live vaccines and should be tested for latent tuberculosis. Patients should be closely monitored and treated promptly for infections while receiving emapalumab-lzsg.

  • November 26, 2018

    FDA has approved glasdegib tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy.

    Efficacy of glasdegib was studied in a randomized clinical trial in which 111 adult patients with newly diagnosed AML were treated with either glasdegib in combination with LDAC or LDAC alone. The trial measured overall survival (OS) from the date of randomization to death from any cause. Results demonstrated a significant improvement in OS in patients treated with glasdegib. The median OS was 8.3 months for patients treated with glasdegib plus LDAC compared with 4.3 months for patients treated with LDAC only.

    Common adverse effects in clinical trials were anemia, fatigue, hemorrhage, febrile neutropenia, muscle pain, nausea, edema, low platelet counts, shortness of breath, decreased appetite, distorted taste, pain or sores in the mouth or throat, constipation and rash.

    The prescribing information includes a boxed warning about the risk of embryo-fetal death or severe birth defects. Glasdegib should not be used during pregnancy or while breastfeeding. Pregnancy testing should be conducted in females of reproductive age before treatment initiation, and effective contraception should be used during treatment and for at least 30 days after the last dose.

    The boxed warning also advises male patients of the potential risk of drug exposure through semen and to use condoms with a pregnant partner or a female partner who could become pregnant both during treatment and for at least 30 days after the last dose.

    Glasdegib must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Patients should also be advised not to donate blood or blood products during treatment. Health care providers should also monitor patients for QT prolongation.

  • November 14, 2018

    FDA approved revefenacin inhalation solution for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist, a class of medicines that improve lung function in patients with COPD. The agent is administered once daily via a standard jet nebulizer.  

    As with other inhaled medicines, revefenacin can cause paradoxical bronchospasm (wheezing). If paradoxical bronchospasm occurs, patients should discontinue use. Patients should also be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual changes). Patients should consult a health professional immediately if any of these signs or symptoms develop.

    The most common adverse reactions include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Health professionals should avoid administering revefenacin with other anticholinergic-containing drugs. The agency does not recommend administering revefenacin at the same time as OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.), as it may lead to an increase in exposure of the active metabolite.

  • November 14, 2018

    Pfizer announced FDA approval of a new indication for lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

    Accelerated approval was based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

    While many ALK-positive metastatic NSCLC patients respond to initial TKI therapy, they typically experience tumor progression, stated Pfizer in a news release. In addition, options for patients who progress after treatment with second-generation ALK TKIs, alectinib, brigatinib and ceritinib, are limited. Approval of this indication represents a new option for patients who have progressed on a second-generation ALK TKI, providing an opportunity to remain on oral therapy.

    In clinical trials, the most common (≥20%) adverse reactions were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. 
    increased alkaline phosphatase.

    The most frequent serious adverse reactions reported were pneumonia, dyspnea, pyrexia, mental status changes, and respiratory failure.

    Fatal adverse reactions occurred in 2.7% percent of patients and included pneumonia, myocardial infarction, acute pulmonary edema, embolism, peripheral artery occlusion, and respiratory distress.

  • November 14, 2018

    FDA is alerting patients, caregivers, and health professionals that the labels attached to some EpiPen 0.3 mg and EpiPen Jr 0.15 mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.

    In a letter to health professionals from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.

    The auto-injector device and the epinephrine it delivers are not affected by this issue and can be used as prescribed. It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product.

    The letter also describes how to inspect potentially affected products and explains that patients should contact Mylan Customer Relations at 800-796-9526 if an auto-injector does not slide out easily from the carrier tube OR the label is not fully adhered to the auto-injector. Pharmacists should inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product that does not slide easily out of its carrier tube.    

    FDA is not aware of any adverse event reports associated with improperly applied EpiPen or EpiPen Jr auto-injectors, or their authorized generics label. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.

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