Medication Monitor

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  • November 30, 2018

    FDA approved a new indication for pembrolizumab, an anti-PD-1 therapy, for treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. HCC is the most common type of liver cancer in adults.

    The recommended dosage for HCC is 200 mg every 3 weeks until disease progression or unacceptable toxicity.

    The humanized monoclonal antibody works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

    Approval was based on data from a single-arm, open-label, multicenter trial evaluating pembrolizumab in 104 patients with HCC who had disease progression on or after sorafenib or who were intolerant to sorafenib.

    Immune-mediated adverse reactions, which may be severe or fatal, can occur with use, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

    Depending on the severity of the adverse reaction, the drug should be withheld or discontinued and corticosteroids administered if appropriate.

    Pembrolizumab can also cause severe or life-threatening infusion-related reactions, as well as fetal harm when administered to a pregnant woman.

    Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials, stated Merck in a news release.


  • 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 29, 2018

    On November 2, Coherus BioSciences announced FDA approval of pegfilgrastim-cbqv, the first biosimilar of pegfilgrastim (Neulasta) approved by both FDA and the European Commission (EC) for patients with cancer who are receiving myelosuppressive chemotherapy.

    The biosimilar is a pegylated growth colony–stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

    In clinical trials, the most common adverse reactions (≥5% incidence) are bone pain and pain in extremity.

    Full prescribing information is available at

  • November 28, 2018

    Novartis announced that FDA has expanded the approval of eltrombopag for first-line treatment of adults and pediatric patients aged 2 years and older with severe aplastic anemia (SAA) when the drug is taken in combination with standard immunosuppressive therapy. 

    SAA is a rare, life-threatening, acquired blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells, and platelets. As a result, people living with this serious disease may experience debilitating symptoms and complications, such as fatigue, trouble breathing, recurring infections, and abnormal bruising or bleeding that can limit their daily activities.

    Peltrombopag is an oral thrombopoietin receptor agonist that is already approved for SAA in patients who have had an insufficient response to IST. It is also approved for adults and children with chronic immune thrombocytopenia (ITP) who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection.

    In the clinical study upon which approval was based, the most common adverse reactions reported (incidence ≥5%) were abnormal liver function tests, rash, and skin discoloration, including hyperpigmentation.