Medication Monitor

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  • November 30, 2018

    On November 8, FDA approved a new version of epinephrine inhalation aerosol bronchodilator suspension—known as Primatene Mist. The OTC metered-dose inhaler was reapproved to provide temporary relief for symptoms of mild, intermittent asthma in those who have been diagnosed with asthma by a health care provider. 

    The former OTC Primatene Mist was taken off the market in 2011 because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer. This new version contains hydrofluoroalkane (HFAs) propellants, which are permitted under current international and U.S. law. Prescription-only inhalers that use different medications, such as albuterol and levalbuterol, also use HFAs as propellants.

    In an FDA news release discussing concerns about the reapproval, FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, stated that as the OTC product is being reintroduced, the agency has taken steps to make sure consumers understand how to safety and effectively use the new product.

    "Health professionals can ensure that patients understand and correctly apply the instructions for use. ... Patients with more severe asthma should not rely on it. Instead, they should be working with their health care provider to ensure an appropriate treatment plan for their condition," they said. "You’ll see that this risk is addressed in the instructions on how to use the product safely and a warning to seek medical care if the patient is using it regularly as overuse of the product is a risk."

    They also noted that "for the right patient, our analysis of the data, including new information that was developed since this product was previously on the market, shows that there are no serious safety concerns when Primatene Mist is used as directed." But they pointed out that severe exacerbations can still occur even in individuals with mild asthma and that "any patient who experiences severe exacerbations should go to the emergency department right away." 

    It’s also important to note that the new product looks different from the old version, with updated instructions for use that patients need to follow for the inhaler to work properly, they added.

  • November 30, 2018

    On November 2, AcelRx announced FDA approval of sufentanil for management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised health care settings, such as hospitals, surgical centers, and emergency departments.

    It is the first and only sufentanil sublingual tablet approved for acute pain in health care settings and will not be available in retail pharmacies or for outpatient use, according to AcelRx in a news release. Health care settings must be certified in a sufentanil Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the health care setting will comply with appropriate dispensing and use restrictions.

    As part of the REMS program, AcelRx will monitor distribution and audit wholesalers' data, evaluate proper use within the health care settings, and monitor for any diversion and abuse. In addition, AcelRx will decertify health care settings that are noncompliant with the REMS program.

    The 30-mcg sufentanil tablet comes in a single-dose, prefilled applicator for sublingual administration.

    Approval was based on a randomized, double-blind, placebo-controlled clinical study demonstrating a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study compared with placebo. The pain intensity difference from baseline was superior to that of the placebo group within 15 minutes, and median meaningful pain relief occurred following a single dose.

    The single-strength tablet and single-unit packaging are designed to mitigate the possibility of dosing errors, misuse, and diversion. The sublingual administration makes the opioid an option for patients with nothing-by-mouth status and patients with difficult I.V. access (e.g., obese, older adults, burn, needle-phobic).

  • November 28, 2018

    FDA granted accelerated approval to larotrectinib, a treatment for adult and pediatric patients whose cancers have a specific genetic biomarker.

    This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic,” said FDA in a news release. It follows the policies that the FDA developed in a guidance document released earlier this year.

    Larotrectinib is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

    Research has shown that the NTRK genes, which encode for TRK proteins, can become fused to other genes abnormally, resulting in growth signals that support the growth of tumors. NTRK fusions are rare but occur in cancers arising in many sites of the body. Prior to today’s approval, there had been no treatment for cancers that frequently express this mutation, like mammary analogue secretory carcinoma, cellular or mixed congenital mesoblastic nephroma, and infantile fibrosarcoma.

    Efficacy of larotrectinib was studied in three clinical trials that included 55 pediatric and adult patients with solid tumors that had an identified NTRK gene fusion without a resistance mutation and were metastatic or where surgical resection was likely to result in severe morbidity. These patients had no satisfactory alternative treatments or had cancer that progressed following treatment.

    Larotrectinib demonstrated a 75% overall response rate across different types of solid tumors. These responses were durable, with 73% of responses lasting at least 6 months, and 39% lasting 1 year or more at the time results were analyzed. Examples of tumor types with an NTRK fusion that responded to larotrectinib include soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer.

    Larotrectinib received an accelerated approval, which enables FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm the agent's clinical benefit. The sponsor is conducting or plans to conduct these studies.

    Common adverse effects in clinical trials included fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and increased AST and ALT enzyme blood levels in the liver. Health care providers are advised to monitor patient ALT and AST liver tests every 2 weeks during the first month of treatment, then monthly and as clinically indicated. Women who are pregnant or breastfeeding should not take larotrectinib because it may cause harm to a developing fetus or newborn baby. Patients should report signs of neurologic reactions such as dizziness.

  • 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.