Medication Monitor



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  • February 1, 2019

    On November 2, 2018, FDA approved lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), for patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

    This indication was approved under accelerated approval on the basis of tumor response rate and duration of response. It was the third FDA approval Pfizer received for an oncology treatment, including two lung cancer medications, within 2 months.

    Approval was based on a nonrandomized, dose-ranging and activity-estimating, multicohort, multicenter study evaluating lorlatinib for treatment of patients with ALK-positive metastatic NSCLC, who were previously treated with one or more ALK TKIs. A total of 215 patients with ALK-positive metastatic NSCLC were enrolled across various subgroups on the basis of prior treatment.

    Among these patients, overall response rate was 48%, and 57% had previous treatment with more than one ALK TKI. In the trial, 69% of patients had a history of brain metastases, and intracranial response rate was 60%.

    Among participants who received 100 mg once daily in the study, the most common adverse reactions were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. 

    The most frequent serious adverse reactions were pneumonia, dyspnea, pyrexia, mental status changes, and respiratory failure. 

  • February 1, 2019

    On November 21, 2018, FDA approved glasdegib tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

    Efficacy was studied in a randomized clinical trial in which 111 adult patients with newly diagnosed AML were treated with either glasdegib in combination with LDAC or LDAC alone. The trial measured overall survival (OS) from the date of randomization to death from any cause.

    Results demonstrated a significant improvement in OS in patients treated with glasdegib. The median OS was 8.3 months for patients treated with glasdegib plus LDAC compared with 4.3 months for patients treated with LDAC only.

    Common adverse effects were anemia, fatigue, bleeding, febrile neutropenia, muscle pain, nausea, edema, low platelet counts, shortness of breath, decreased appetite, distorted taste, pain or sores in the mouth or throat, constipation, and rash.

    The prescribing information for glasdegib includes a boxed warning to advise health professionals and patients about the risk of embryo-fetal death or severe birth defects. The agent should not be used during pregnancy or while breastfeeding. The boxed warning also advises male patients of the potential risk of drug exposure through semen and to use condoms with a pregnant partner or a female partner who could become pregnant both during treatment and for at least 30 days after the last dose.

    Patients should also be advised not to donate blood or blood products during treatment. Health care providers should also monitor patients for QT prolongation.

  • 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

    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.

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