Medication Monitor



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  • February 7, 2019

    FDA approved caplacizumab-yhdp injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.

    Patients with aTTP develop extensive blood clots in the small blood vessels throughout the body. These clots can cut off oxygen and blood supply to the major organs and cause strokes and heart attacks that may lead to brain damage or death. Patients can develop aTTP because of conditions such as cancer, HIV, pregnancy, lupus or infections or after having surgery, bone marrow transplantation, or chemotherapy.

    Common adverse effects reported by patients in clinical trials were bleeding of the nose or gums and headache. The prescribing information for caplacizumab-yhdp includes a warning to advise health care providers and patients about the risk of severe bleeding.

    Health care providers are advised to monitor patients closely for bleeding when administering the drug to patients who currently take anticoagulants.

  • February 6, 2019

    Evolus announced FDA approval of prabotulinumtoxinA-xvfs, an acetylcholine release inhibitor and a neuromuscular blocking agent that temporarily improves the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) associated with corrugator and/or procerus muscle activity in adults.

    Approval was supported by clinical data from two Phase III randomized, multicenter, double-blind, placebo-controlled clinical trials. Both trials met the primary endpoint and demonstrated efficacy compared with placebo in the reduction of severity of glabellar lines, defined as a 2-point composite improvement agreed upon by physician and patient, at day 30.

    Dosage is 0.1 mL (four units) by I.M. injection into each of five sites, for a total dose of 20 units.

    The product may cause rare but serious adverse effects that can be life-threatening, including problems swallowing, speaking, or breathing due to weakening of associated muscles and spread of toxin effects.

    The most common adverse effects include headache, eyelid drooping, upper respiratory tract infection, and increased white blood cell count.

    The product is expected to be available in spring 2019.

     

  • 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.

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