Medication Monitor

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Generic Name (Trade Name—Company)
  • November 27, 2018

    FDA approved emapalumab-lzsg for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent, or progressive disease or intolerance to conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

    HLH is a condition in which the body’s immune cells do not work properly and start to damage the body’s own organs, including the liver, brain, and bone marrow. It can be inherited, which is known as primary or “familial” HLH. It can also have noninherited causes. People with primary HLH usually develop symptoms within the first months or years of life. Symptoms may include fever, enlarged liver or spleen, and decreased number of blood cells.

    Emapalumab-lzsg efficacy was studied in a clinical trial of 27 pediatric patients with suspected or confirmed primary HLH with either refractory, recurrent, or progressive disease during conventional HLH therapy or who were intolerant of conventional HLH therapy. The median age of the patients in the trial was 1 year old.

    The study showed that 63% of patients experienced a response, and 70% were able to proceed to stem cell transplant.

    Common adverse effects in clinical trials included infections, hypertension, infusion-related reactions, low potassium, and fever.

    Patients receiving the agent should not receive any live vaccines and should be tested for latent tuberculosis. Patients should be closely monitored and treated promptly for infections while receiving emapalumab-lzsg.

  • November 26, 2018

    FDA has 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 that may preclude the use of intensive chemotherapy.

    Efficacy of glasdegib 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 in clinical trials were anemia, fatigue, hemorrhage, 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 includes a boxed warning about the risk of embryo-fetal death or severe birth defects. Glasdegib should not be used during pregnancy or while breastfeeding. Pregnancy testing should be conducted in females of reproductive age before treatment initiation, and effective contraception should be used during treatment and for at least 30 days after the last dose.

    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.

    Glasdegib must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Patients should also be advised not to donate blood or blood products during treatment. Health care providers should also monitor patients for QT prolongation.

  • November 14, 2018

    FDA approved revefenacin inhalation solution for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist, a class of medicines that improve lung function in patients with COPD. The agent is administered once daily via a standard jet nebulizer.  

    As with other inhaled medicines, revefenacin can cause paradoxical bronchospasm (wheezing). If paradoxical bronchospasm occurs, patients should discontinue use. Patients should also be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual changes). Patients should consult a health professional immediately if any of these signs or symptoms develop.

    The most common adverse reactions include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Health professionals should avoid administering revefenacin with other anticholinergic-containing drugs. The agency does not recommend administering revefenacin at the same time as OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.), as it may lead to an increase in exposure of the active metabolite.

  • November 1, 2018

    Sandoz announced FDA approval of adalimumab-adaz (Hyrimoz), a biosimilar to adalimumab (Humira), for treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. 

    The drug, a tumor necrosis factor inhibitor administered subcutaneously by injection, is the third FDA-approved biosimilar to adalimumab.

    Approval was based on a randomized, double-blind, three-arm, parallel biosimilarity study that confirmed the pharmacokinetics, immunogenicity, and safety of adalimumab-adaz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters.

    A confirmatory efficacy and safety biosimilarity study demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic.

    The most common adverse reactions (incidence > 10%) were infections (e.g., upper respiratory, sinusitis), injection-site reactions, headache, and rash.

  • October 30, 2018

    FDA approved Bijuva (TherapeuticsMD), the first bioidentical oral hormone combination of estradiol and progesterone (1-mg/100-mg capsule) to treat moderate to severe hot flashes in women with a uterus.

    Approval was based on the Phase III Replenish Trial, in which Bijuva demonstrated a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared with placebo, while reducing the risks to the endometrium.

    The most common adverse reactions (≥3%) were breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain. No clinically significant changes were found in lipid, coagulation, or glucose parameters compared with placebo, and no unexpected safety signals were noted.

    The recommended dosage is one tablet orally each evening with food.

    Bijuva comes with a boxed warning; see the prescribing information for more information.

    The drug will be available in the United States in the second quarter of 2019.