Medication Monitor



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  • December 27, 2018

    Teva announced FDA approval of albuterol sulfate 117 mcg digital inhaler for treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm in patients aged 4 years and older.

    The inhaler combines a breath-activated, multidose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app. The built-in sensors detect when the inhaler is used and measure inspiratory flow, then send data to the companion mobile app so patients can review their data over time and, if desired, share it with their health professionals.

    The inhaler will be available in 2019 through a small number of “Early Experience” Programs, which will be conducted in partnership with health care systems and in limited geographies in order to gather real-world experience. A national launch is planned for 2020. For more information, visit www.ProAirDigihaler.com.

  • December 27, 2018

    FDA granted accelerated approval to pembrolizumab for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

    Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017, a multicenter, nonrandomized, open-label trial that enrolled 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease. Patients received pembrolizumab 2 mg/kg every 3 weeks.

    The major efficacy outcome measures were overall response rate (ORR) and response duration assessed by blinded independent central review per RECIST 1.1. The ORR was 56% (95% CI 41–70) with a complete response rate of 24%. The median response duration was not reached. Among the 28 patients with responses, 96% had response durations of greater than 6 months, and 54% had response durations of greater than 12 months.

    The most common adverse reactions, reported in at least 20% of patients who received pembrolizumab as a single agent, were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

    The recommended dose for MCC is 200 mg administered as a 30-minute I.V. infusion every 3 weeks for adults; 2 mg/kg (to a maximum of 200 mg) administered as a 30-minute I.V. infusion every 3 weeks for patients younger than 18 years (pediatric patients).

  • December 27, 2018

    AstraZeneca and Merck announced FDA approval of olaparib for maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test.

    This is the first regulatory approval for a poly (ADP-ribose) polymerase (PARP) inhibitor in the first-line maintenance setting for BRCAm advanced ovarian cancer.

    Approval was based on positive results from the pivotal Phase III SOLO-1 trial in which olaparib reduced the risk of disease progression or death by 70% in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23–0.41], P < 0.0001) compared with placebo following platinum-based chemotherapy.

    The safety profile of olaparib was consistent with that of previous trials.

  • December 27, 2018

    FDA approved romiplostim for pediatric patients aged 1 year and older who have had immune thrombocytopenia (ITP) for at least 6 months and have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

    Approval was based on two double-blind, placebo-controlled clinical trials in pediatric patients aged 1 year and older with ITP for at least 6 months' duration. In one study (NCT01444417), patients whose disease was refractory or relapsed after at least one prior ITP therapy were randomized (2:1) to receive romiplostim (n = 42) or placebo (n = 20). Durable platelet response (at least 6 weekly platelet counts ≥ 50 × 109/L during weeks 18 through 25 of treatment) was achieved in 22 patients (52%) who received romiplostim and 2 (10%) in the placebo arm.

    Overall platelet response, defined as a durable or a transient platelet response, was achieved in 30 (71%) and 4 (20%) patients, respectively. Patients who received romiplostim had platelet counts ≥ 50 x 109/L for a median of 12 weeks, compared with 1 week in patients who received placebo. The results for all three endpoints were statistically significant, with P values all less than 0.05.

    In the other study (NCT00515203), patients diagnosed with ITP at least 6 months prior to enrollment were randomized (3:1) to receive romiplostim (n = 17) or placebo (n = 5). Fifteen patients who received romiplostim achieved a platelet count ≥ 50 x 109/L for 2 consecutive weeks and an increase in platelet count of ≥ 20 × 109/L above baseline for 2 consecutive weeks during the treatment period (88%, 95% CI 64–99). No patient receiving placebo achieved either endpoint.

    In pediatric patients, the most common adverse reactions (≥25%) included contusion, upper respiratory tract infection, and oropharyngeal pain.

    The recommended initial romiplostim dose for pediatric patients is 1 mcg/kg on the basis of actual body weight and administered as a weekly S.C. injection. Dose should be adjusted in increments of 1 mcg/kg until the patient achieves a platelet count of ≥ 50 x 109/L. Reassessment of body weight is recommended every 12 weeks.

  • December 14, 2018

    Mayne Pharma announced FDA approval of SUBA-itraconazole 65 mg capsules, a new formulation of itraconazole that targets certain systemic fungal infections in adult patients.

    The agent is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy).

    These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.

    The product will launch in January 2019, according to the manufacturer.

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