Medication Monitor

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Generic Name (Trade Name—Company)
  • September 26, 2019

    FDA approved Pifeltro (doravirine 100 mg) in combination with other antiretroviral agents and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) as a complete regimen for treatment of adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the drugs' individual components.

    Pifeltro is a nonnucleoside reverse transcriptase inhibitor that is administered with other antiretroviral agents.

    Delstrigo is a once-daily, fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg). The agent has a boxed warning for the risk of posttreatment acute exacerbation of hepatitis B virus infection.

    The agents are contraindicated when coadministered with drugs that are strong cytochrome CYP3A enzyme inducers, as significant decreases in doravirine plasma concentrations may occur and decrease the drugs' effectiveness. Delstrigo is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

    The most common adverse reactions with Pifeltro are nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and abnormal dreams. The most common adverse reactions with Delstrigo are dizziness, nausea, and abnormal dreams. 

  • September 25, 2019

    FDA approved apalutamide for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved in 2018 for patients with nonmetastatic castration-resistant prostate cancer.

    Common adverse reactions are fatigue, arthralgia, rash, decreased appetite, fall, weight loss, hypertension, hot flush, diarrhea, and fracture.

    The recommended dose of apalutamide is 240 mg (four 60-mg tablets) orally once daily, with or without food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.

  • September 25, 2019

    FDA granted accelerated approval to lenvatinib in combination with pembrolizumab for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

    The approval is part of Project Orbis, an initiative of FDA's Oncology Center of Excellence, in conjunction with decisions by Australian Therapeutic Goods Administration (TGA) and Health Canada. Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, FDA, TGA, and Health Canada collaboratively reviewed applications for the two oncology drugs, allowing for simultaneous decisions in all three countries.

    Lenvatinib was initially approved by FDA in 2015, and pembrolizumab was initially approved in 2014.

    Approval of lenvatinib combined with pembrolizumab was based on the results of a clinical trial of 94 patients with endometrial carcinoma tumors that were not MSI-H or dMMR. Of the 94 patients, 10 patients (10.6% of responders) had a complete response, or disappearance of all lesions on imaging, and 26 patients (27.7% of responders) had a partial response, or shrinkage of lesions by at least 30%, leading to an objective response rate of 38.3%. Of these, 25 patients (69% of responders) have a duration of response of greater than 6 months. 

    Common adverse effects included fatigue, high blood pressure, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, and sore mouth.

    Additional adverse effects included vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.

    Health professionals should inform females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with the combination. Women who are pregnant or breastfeeding should not take this combination because it may cause harm to a developing fetus or newborn baby.

  • September 25, 2019

    FDA approval semaglutide tablets to improve control of blood glucose levels in adult patients with type 2 diabetes, along with diet and exercise. The agent is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. 

    The prescribing information includes a boxed warning about the potential increased risk of thyroid c-cell tumors, and that semaglutide oral tablets are not recommended as the first choice of medication for treating diabetes. Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had MTC are advised not to use the medication. In addition, patients who have ever had multiple endocrine neoplasia syndrome type 2 are advised not to use it. The drug is not for use in patients with type 1 diabetes or diabetic ketoacidosis.

    The prescribing information also has warnings about pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions. 

    The medication should be taken at least 30 minutes before the first food, beverage, or other oral medication of the day, with no more than 4 oz. of plain water. Because the medication slows digestion, patients should discuss other medications they are taking with their health care provider before starting it.

    The most common adverse effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

  • September 21, 2019

    FDA has approved mepolizumab for use in children as young as 6 years old who have severe eosinophilic asthma. It is the only targeted biologic to be approved for the condition in the 6- to 11-year-old age group in the United States. 

    First approved in 2015 for severe eosinophilic asthma, mepolizumab is a first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding reduces blood eosinophils without completely depleting them.

    For severe asthma in patients aged 6 to 11 years, the recommended dosage is 40 mg administered subcutaneously once every 4 weeks.

    The most common adverse reactions include headache, injection site reaction, back pain, and fatigue.