Medication Monitor

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  • August 9, 2019

    On July 30, FDA approved a new indication for pembrolizumab for treatment of patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

    FDA also approved a new use for the PD-L1 IHC 22C3 pharmDx kit as a companion diagnostic device for selecting patients for the above indication.

    Efficacy was investigated in two clinical trials, KEYNOTE‑181 and KEYNOTE‑180. KEYNOTE-181 was a randomized, open-label, active-controlled trial that enrolled 628 patients with recurrent locally advanced or metastatic esophageal cancer who progressed on or after one prior line of systemic treatment for advanced or metastatic disease. KEYNOTE‑180 was a single arm, open-label trial that enrolled 121 patients with locally advanced or metastatic esophageal cancer who progressed on or after at least two prior systemic treatments for advanced disease. 

    Adverse reactions in patients with esophageal cancer were similar to those in 2,799 patients with melanoma or non–small cell lung cancer treated with single-agent pembrolizumab in clinical trials. Common adverse reactions reported in at least 20% of patients receiving pembrolizumab included fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

    The recommended pembrolizumab dose for esophageal cancer is 200 mg every 3 weeks.

  • July 30, 2019

    FDA approved Baqsimi nasal powder, the first glucagon therapy that can be administered without an injection for emergency treatment of severe hypoglycemia. It is indicated for patients with diabetes aged 4 years and older. The agent will come in a single-use dispenser.

    Injectable glucagon has been approved for use in the United States for several decades. Efficacy and safety of Baqsimi nasal powder to treat severe hypoglycemia was evaluated in two studies of 83 and 70 adults with diabetes, comparing a single dose of Baqsimi to a single dose of glucagon injection in causing a blood glucose response to insulin-induced hypoglycemia. Baqsimi adequately increased blood glucose levels. Similar results were observed in a pediatric study of 48 patients with type 1 diabetes who were older than 4 years.

    Baqsimi should not be taken by patients with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients who have insulinoma, a tumor of the pancreas. The agent should not be taken by patients with a known hypersensitivity to glucagon or the inactive ingredients found in Baqsimi, as allergic reactions may occur. Baqsimi also carries a warning that it should be used with caution by those who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia, because these conditions result in low levels of releasable glucose in the liver.

    The most common adverse reactions associated with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. Adverse effects of Baqsimi are similar to those of injectable glucagon, with the addition of nasal and eye-related symptoms (e.g., watery eyes and nasal congestion) because of the way the drug is administered.

  • July 24, 2019

    Samsung Bioepis announced FDA approval of adalimumab-bwwd, a biosimilar of adalimumab (Humira), for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. 

    FDA approval was based on data derived from a randomized, double-blind, 52-week Phase III study in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy were randomized to receive either adalimumab-bwwd or the adalimumab reference product (ADL).

    At week 24, the ACR20 response rate was 72.4% in the adalimumab-bwwd group versus 72.2% in the ADL group. The safety profile of adalimumab-bwwd was comparable to ADL up to week 24. At week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transition to adalimumab-bwwd, and 254 patients receiving adalimumab-bwwd continued to receive adalimumab-bwwd.

    Up to week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment-emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.

    Patients treated with adalimumab products, including adalimumab-bwwd, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to other opportunistic pathogens. 

    Adalimumab-bwwd should be discontinued if a patient develops a serious infection or sepsis. Patients also should be tested for latent tuberculosis before use and during therapy, and treated initiated for latent tuberculosis before use.

    Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers, including adalimumab products.

    Warnings include serious infections, malignancies, hypersensitivity reactions including anaphylaxis and angioneurotic edema, Hepatitis B virus reactivation, neurologic and hematological reactions, use with Anakinra, heart failure, autoimmunity, immunizations, and use with Abatacept.

    Adalimumab-bwwd is expected to launch in the United States after June 30, 2023.

  • July 24, 2019

    Pfizer announced FDA approval of rituximab-pvvr, a biosimilar to rituximab (Rituxan) for treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

    Approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of rituximab-pvvr to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety, and immunogenicity, pharmacokinetics, and pharmacodynamics of rituximab-pvvr. The study found no clinically meaningful differences in safety or efficacy compared with the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.

    Boxed warnings include fatal infusion-related reactions, severe mucocutaneous reactions, and hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.

    The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion-related reactions. In addition, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials.

  • July 24, 2019

    On July 19, FDA approved multiple applications for first generics of Lyrica (pregabalin) for management of neuropathic pain associated with diabetic peripheral neuropathy, for management of postherpetic neuralgia, for management of fibromyalgia, for management of neuropathic pain associated with spinal cord injury, and as an adjunctive therapy for treatment of partial-onset seizures in patients ages 17 years and older. 

    Pregabalin must be dispensed with a patient Medication Guide that contains important information about its uses and risks. Warnings include the risk of angioedema, which may be associated with life-threatening respiratory compromise requiring emergency treatment.

    Hypersensitivity reactions such as hives, difficulty breathing, and wheezing can occur. Increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. In addition, pregabalin may cause peripheral edema, so caution should be exercised when coadministering it with thiazolidinedione antidiabetic agents.

    Pregabalin also may cause dizziness and drowsiness and impair ability to drive or operate machinery.

    The most common adverse effects in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking (primarily difficulty with concentration and attention).

    FDA granted approvals for the generic versions of Lyrica to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.