Medication Monitor

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  • December 11, 2018

    Fresenius Kabi announced that fish oil triglycerides injectable emulsion, approved under the trade name Omegaven, is now commercially available in the United States. This novel lipid had previously been available only for compassionate use in the United States.

    Omegaven is an I.V. lipid emulsion that provides calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis, or PNAC. It is the first and only FDA-approved fish oil lipid emulsion for this condition.

    The product is available as a 5 g/50 mL and 10 g/100 mL (0.1 g/mL) injectable emulsion in a single-dose bottle.  

    Cholestasis is a condition in which bile is not released from the liver. PNAC may occur following long-term parenteral nutrition administration in pediatric patients with temporary or permanent intestinal failure. Development of PNAC is associated with increased morbidity and mortality and can progress to liver fibrosis, hepatic failure, and death.

    In clinical trials, the most common adverse drug reactions (>15%) were vomiting, agitation, bradycardia, apnea, and viral infection.

  • November 30, 2018

    FDA approved amifampridine tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.

    Efficacy of amifampridine was studied in two clinical trials that together included 64 adult patients who received amifampridine or placebo. The studies measured the Quantitative Myasthenia Gravis score (a 13-item physician-rated categorical scale assessing muscle weakness) and the Subject Global Impression (a 7-point scale on which patients rated their overall impression of the effects of the study treatment on their physical well-being).

    For both measures, the patients receiving amifampridine experienced a greater benefit than those on placebo.  

    The most common adverse effects in the clinical trials were burning or prickling sensation, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms. Seizures have been observed in patients without a history of seizures.

    Patients should inform their health care provider immediately if they have signs of hypersensitivity reactions, such as rash, hives, itching, fever, swelling, or trouble breathing.

  • November 30, 2018

    FDA approved gilteritinib tablets to treat relapsed or refractory acute myeloid leukemia (AML) in adult patients with an FLT3 mutation as detected by an FDA-approved test, the LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies).

    Efficacy of gilteritinib was studied in a clinical trial of 138 patients with relapsed or refractory AML having a confirmed FLT3 mutation. Twenty-one percent of patients achieved complete remission (no evidence of disease and full recovery of blood counts) or complete remission with partial hematologic recovery (no evidence of disease and partial recovery of blood counts) with treatment.

    Of the 106 patients who required red blood cell or platelet transfusions at the start of treatment, 31% became transfusion-free for at least 56 days.

    Common adverse effects reported in clinical trials were muscle and joint pain, fatigue, and elevated liver enzymes.

    Health care providers are advised to monitor patients for posterior reversible encephalopathy syndrome, which is characterized by headache, confusion, seizures, and visual loss; prolonged QT interval; and pancreatitis.

    Rare cases of differentiation syndrome (symptoms of which may include fever, cough, trouble breathing, fluid around the lungs or heart, rapid weight gain, swelling, and renal or hepatic dysfunction) have been seen in patients taking the drug.

    Women who are pregnant or breastfeeding should not take gilteritinib because it may cause harm to a developing fetus or newborn baby.

  • 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.