Medication Monitor

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Generic Name (Trade Name—Company)
  • November 30, 2018

    FDA approved rituximab-abbs as the first biosimilar to rituximab (Rituxan) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Rituximab-abbs is the first biosimiliar to be approved in the United States for the treatment of NHL. It has been approved as a biosimilar, not as an interchangeable product.

    Approval was based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrate the drug is biosimilar to Rituxan.  

    The most common adverse effects are infusion reactions, fever, abnormally low level of lymphocytes in the blood, chills, infection, and weakness. Health care providers are advised to monitor patients for tumor lysis syndrome, cardiac adverse reactions, damage to kidneys, and bowel obstruction and perforation.

    Patients should not receive vaccinations while in treatment. Women who are pregnant or breastfeeding should not take the drug because it may cause harm to a developing fetus or newborn baby.

    The labeling contains a boxed warning to alert health professionals and patients about increased risks of the following: fatal infusion reactions, severe skin and mouth reactions, some with fatal outcomes; Hepatitis B virus reactivation, which may cause serious liver problems including liver failure and death; and progressive multifocal leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death.

    The new biosimilar must be dispensed with a patient Medication Guide that provides important information about the drug’s uses and risks.

  • November 30, 2018

    On November 16, FDA approved rifamycin, an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli, not complicated by fever or blood in the stool.

    Travelers' diarrhea is the most common travel-related illness, affecting an estimated 10% to 40% percent of travelers worldwide each year. Travelers' diarrhea is defined by having three or more unformed stools in 24 hours, in a person who is traveling. It is caused by a variety of pathogens, but most commonly bacteria found in food and water. The highest-risk destinations are in most of Asia as well as the Middle East, Africa, Mexico, and Central and South America.

    Efficacy of rifamycin was demonstrated in a randomized, placebo-controlled clinical trial in 264 adults with travelers’ diarrhea in Guatemala and Mexico. It showed that rifamycin significantly reduced symptoms of travelers’ diarrhea compared with placebo. 

    Its safety, taken orally over 3 or 4 days, was evaluated in 619 adults with travelers’ diarrhea in two controlled clinical trials. The most common adverse reactions were headache and constipation. 

    Rifamycin was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea caused by pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients.

    It also should not be used in patients with a known hypersensitivity to rifamycin, any of the other rifamycin-class antimicrobial agents (e.g. rifaximin), or any of the drug's components.

    FDA granted rifamycin a Qualified Infectious Disease Product (QIDP) designation, which is given to antibacterial and antifungal drug products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

  • 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.