Medication Monitor



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  • December 27, 2018

    FDA approved calaspargase pegol-mknl, an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years. This new product provides for a longer interval between doses compared with other available pegaspargase products.

    Approval was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL when using calaspargase pegol-mknl, 2,500 U/m2 intravenously, every 3 weeks. The pharmacokinetics of calaspargase pegol-mknl were studied when administered in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL.

    The most common adverse reactions were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. In a randomized trial, the safety profile of calaspargase pegol-mknl administered every 3 weeks was similar to that of pegaspargase administered every 2 weeks.

    The recommended calaspargase pegol-mknl dose is 2,500 units/m2 intravenously, administered at a minimum dosing interval of every 21 days.

  • December 20, 2018

    Shire announced FDA approval of prucalopride, a once-daily, oral treatment option for adults with chronic idiopathic constipation.

    The drug, a selective serotonin-4 (5-HT4) receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility.  

    Efficacy of once-daily treatment with prucalopride was evaluated in six double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks (studies 1–5) or 24 weeks (study 6).

    Of the 2,484 patients, most were female (76%) and Caucasian (76%), with an average age of 47 (+/- 16 y).

    Most common adverse reactions are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

    The drug is expected to launch in 2019 in the United States, where an estimated 35 million adults are living with CIC.

  • 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.

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