Medication Monitor



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  • January 3, 2019

    FDA has approved diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine for use as a three-dose series in children aged 6 weeks through 4 years (prior to the 5th birthday).

    The vaccine, approved under the trade name Vaxelis, prevents diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. The three-dose immunization series consists of a 0.5-mL I.M. injection administered at 2, 4, and 6 months of age.

    The series does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.

    Vaxelis is contraindicated in children with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of Vaxelis, any of its ingredients, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine. Adverse reactions are irritability; crying; injection-site pain, erythema, or swelling; somnolence, decreased appetite, fever, and vomiting.

    In a news release, Sanofi said the vaccine will be commercially available in 2020.

  • December 27, 2018

    Acorda Therapeutics announced FDA approval of levodopa inhalation powder for intermittent treatment of "off" episodes in people with Parkinson’s disease treated with carbidopa/levodopa.

    Off episodes, also known as off periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.

    Approval was based on a clinical program that included approximately 900 people with Parkinson’s on a carbidopa/levodopa regimen experiencing off periods.

    The agent should not be used by patients who take or have taken a nonselective monoamine oxidase inhibitor, such as phenelzine or tranylcypromine, within the last 2 weeks.

    Approval was based on SPAN-PD, a Phase III pivotal efficacy trial, a 12-week, randomized, placebo-controlled, double-blind study evaluating the effectiveness of levodopa inhalation powder in patients with mild to moderate Parkinson’s experiencing off periods.

    The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score for levodopa inhalation powder 84 mg (n = 114) compared with placebo (n = 112) at 30 minutes postdose (–9.83 points and –5.91 points respectively; P = 0.009). Onset of action was seen as early as 10 minutes.

    The most common adverse reactions were cough, upper respiratory tract infection, nausea, and discolored sputum.

    The agent was also studied in a Phase III long-term, active-controlled, randomized, open-label study (N = 398) assessing safety and tolerability over 1 year. This study showed the average reduction in FEV1 (forced expiratory volume in 1 second) from baseline was the same (–0.1 L) for the levodopa inhalation powder and observational cohorts.

    Patients with COPD, asthma, or other chronic respiratory disease within the last 5 years were excluded from this study.

    Levodopa inhalation powder is expected to be commercially available by prescription in the United States in the first quarter of 2019 and will be distributed through a network of specialty pharmacies.

  • December 27, 2018

    FDA approved ravulizumab injection to adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. Ravulizumab is a long-acting complement inhibitor that prevents hemolysis.

    According to FDA, prior to this approval, the only approved therapy for PNH required treatment every 2 weeks, which can be burdensome for patients and their families. Ravulizumab uses a novel formulation so patients need treatment only every 8 weeks, without compromising efficacy.

    Patients with PNH are missing a certain protein that normally protects red blood cells from being destroyed by the patient’s immune system. Patients with PNH have sudden, recurring episodes in which red blood cells are prematurely destroyed. Episodes may be triggered by stresses on the body, such as infections or physical exertion. During these episodes, the following symptoms may occur: severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark colored urine, kidney disease, or recurrent pain. PNH can occur at any age, although it is most often diagnosed in young adulthood.

    Efficacy of ravulizumab was studied in a clinical trial of 246 patients who previously had not been treated for PNH. The patients were randomized to be treated with ravulizumab or eculizumab, the current standard of care for PNH. The results demonstrated that ravulizumab had similar results to eculizumab (noninferior): patients did not receive a transfusion and had similar incidence of hemolysis, as measured by the normalization of lactate dehydrogenase levels in patients’ blood.

    In addition, ravulizumab was studied in a second clinical trial of 195 patients with PNH who were clinically stable after having been treated with eculizumab for at least the previous 6 months. These patients were randomly selected to be treated with ravulizumab or to continue eculizumab.

    Ravulizumab again demonstrated similar effects to eculizumab (noninferior) on the basis of several clinical measures, including hemolysis and avoidance of transfusion.

    Common adverse effects were headache and upper respiratory infection. Health care providers are advised to use caution when administering ravulizumab to patients with any other systemic infection.

    The prescribing information includes a boxed warning to advise health professionals and patients about the risk of life-threatening meningococcal infections and sepsis.  Health care providers are advised to comply with the most current Advisory Committee on Immunization Practices recommendations for meningococcal vaccination in patients with complement deficiencies. Patients should be immunized with meningococcal vaccines at least 2 weeks prior to administering the first dose of ravulizumab, unless the risks of delaying treatment outweigh the risks of developing a meningococcal infection.

    Patients and health care providers are advised that vaccination reduces, but does not eliminate, the risk of meningococcal infection. Patients should be monitored for early signs of meningococcal infections and evaluated immediately if infection is suspected.

    Ravulizumab is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. It must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.  

  • December 27, 2018

    FDA approved tagraxofusp-erzs infusion for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older.

    According to FDA, prior to this approval, there had been no FDA-approved therapies for BPDCN. The standard of care had been intensive chemotherapy followed by bone marrow transplantation.

    BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin. It often presents as leukemia or evolves into acute leukemia. The disease is more common in men than women and in patients aged 60 and older.

    Efficacy of tagraxofusp-erzs was studied in two cohorts of patients in a single-arm clinical trial. The first trial cohort enrolled 13 patients with untreated BPDCN, and 7 patients (54%) achieved complete remission (CR) or CR with a skin abnormality not indicative of active disease (CRc). The second cohort included 15 patients with relapsed or refractory BPDCN. One patient achieved CR, and one patient achieved CRc.

    Common adverse effects reported by patients in clinical trials were capillary leak syndrome, nausea, fatigue, peripheral edema, fever, chills, and weight increase. Most common laboratory abnormalities were decreases in lymphocytes, albumin, platelets, hemoglobin, and calcium, and increases in glucose and liver enzymes (ALT and AST). Health care providers are advised to monitor liver enzyme levels and for signs of intolerance to the infusion.

    Women who are pregnant or breastfeeding should not take tagraxofusp-erzs 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 the increased risk of capillary leak syndrome, which may be life-threatening or fatal.

  • 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.

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