Medication Monitor



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  • November 18, 2019

    FDA granted accelerated approval to zanubrutinib to treat adult patients with mantle cell lymphoma who have received at least one prior therapy.

    A single-arm clinical trial of zanubrutinib included 86 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 84% of patients had tumor shrinkage with a median duration of response (time between the initial response to therapy and subsequent disease progression or relapse) of 19.5 months. This trial was supported by an additional single-arm trial that included 32 patients, in which 84% of patients had tumor shrinkage with a median duration of response of 18.5 months.

    Common adverse effects for patients taking zanubrutinib were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea. and cough. During treatment, patients should be monitored for hemorrhage, signs and symptoms of infection, cytopenias, and cardiac arrhythmias. Patients are advised to use sun protection if taking this therapy because there is a risk of other malignancies, including skin cancers.

    FDA advises health professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment. Women who are pregnant or breastfeeding should not take zanubrutinib because it may cause harm to a developing fetus or newborn baby.

  • November 18, 2019

    Today, FDA approved crizanlizumab-tmca, a treatment for patients ages 16 years and older to reduce the frequency of vaso-occlusive crisis, a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells.

    Approval was based on the results of a randomized clinical trial enrolling 198 patients with sickle cell disease with a history of vaso-occlusive crisis. Patients received either crizanlizumab-tmca or a placebo. The patients treated with crizanlizumab-tmca experienced fewer health care visits for vaso-occlusive crisis annually (median annual rate of 1.63 visits), compared with patients who received a placebo (median annual rate of 2.98 visits). In addition, 36% of patients who received crizanlizumab-tmca did not experience vaso-occlusive crisis during the study, and it delayed the time that patients first experienced vaso-occlusive crisis after starting treatment from 1.4 months to 4.1 months.

    Common adverse effects for patients taking crizanlizumab-tmca were back pain, nausea, fever, and arthralgia. Health professionals are advised to monitor patients for infusion-related reactions and to discontinue crizanlizumab-tmca for severe reactions. Patients who receive crizanlizumab-tmca should be monitored for interference with automated platelet counts or platelet clumping (platelet counts reported may be much lower than the actual count in the blood). Health professionals are advised to run tests as soon as possible or use citrate tubes.

  • November 8, 2019

    FDA has approved luspatercept–aamt to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.

    Beta thalassemia, also called “Cooley’s anemia,” is an inherited blood disorder that reduces the production of hemoglobin. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue, and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots.

    Approval of the new drug was based on results of a clinical trial of 336 patients with beta thalassemia who required red blood cell transfusions, of which 112 received a placebo. Twenty-one percent of the patients who received luspatercept–aamt achieved at least a 33% reduction in transfusions, compared with 4.5% of the patients who received a placebo. The transfusion reduction meant that the patient needed fewer transfusions over 12 consecutive weeks while taking luspatercept–aamt.

    Common adverse effects were headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea, and dizziness. Patients may experience hypertension while using luspatercept–aamt. Health professionals are advised to monitor a patient’s blood pressure during treatment and to initiate antihypertensive treatment if necessary. Patients who receive the drug should be monitored for thrombosis.

    FDA advises health professionals to tell females of reproductive age to use effective contraception during treatment. Women who are pregnant or breastfeeding should not take luspatercept–aamt because it may cause harm to a developing fetus or newborn baby.

  • November 6, 2019

    RedHill BioPharma announced FDA approval of omeprazole magnesium, amoxicillin, and rifabutin delayed-release capsules for treatment of Helicobacter pylori infection in adults. The product is a combination of omeprazole, a proton pump inhibitor; amoxicillin, a penicillin-class antibacterial; and rifabutin, a rifamycin antibacterial­­.

    The new agent is the only rifabutin-based therapy approved for the treatment of H. pylori infection. It is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.  

    The recommended dosage is four capsules every 8 hours with food for 14 days. The capsules should be swallowed whole and not crushed or chewed. The drug should not be taken with alcohol.  

    Common adverse reactions are diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.  

    Warnings and precautions are hypersensitivity reactions, including serious and occasionally fatal reactions (e.g., anaphylaxis); Clostridioides difficilesssociated diarrhea; reduction in the efficacy of hormonal contraceptives; acute interstitial nephritis; and cutaneous and systemic lupus erythematosus.

    RedHill expects to launch the drug in the first quarter of 2020.

  • October 30, 2019

    On October 7, Galderma announced FDA approval of trifarotene cream, 0.005%, for topical treatment of acne in patients ages 9 years and older. It is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin, and is the first new retinoid to receive FDA approval for treatment of acne in more than 20 years. It will be provided in a 45-g pump. 

    The most common adverse reactions are application site irritation, application site pruritus, and sunburn.

    The medication is expected to be available in the United States in November 2019. Galderma is working closely with payers, providers, and pharmacy benefit managers to ensure broad and rapid access. The company will also offer a patient savings card program, Galderma CareConnect.

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