Medication Monitor



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  • June 12, 2019

    Merz Americas announced FDA approval of a new indication for incobotulinumtoxinA as first-line treatment of blepharospasm (involuntary blinking) in adult patients.

    Blepharospasm causes muscles around the eyes to contract involuntarily. Patients can experience symptoms including excessive blinking, light sensitivity, dry eyes, and eye irritation and watering eyes, and symptoms may worsen over time.

    Approval for this indication was based on a Phase III, randomized, double-blind, placebo-controlled, multicenter trial in 61 treatment-naive patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale (JRS) Severity subscore of 2 or higher. JRS is the most commonly used clinical scale to measure severity and frequency of blepharospasm. Patients were defined as treatment-naive if at least 12 months had passed since their last toxin treatment.

    The primary efficacy endpoint was the change from baseline in JRS Severity subscore determined at week 6 after the injection. The 50-unit treatment group demonstrated statistically significant improvement compared with placebo. The safety findings were similar to previous studies and in line with the product's known safety profile.

    IncobotulinumtoxinA was first approved by FDA in 2010 for treatment of blepharospasm (previously treated with onabotulinumtoxinA) and cervical dystonia in adult patients and later in 2015 for upper limb spasticity in adult patients. Most recently, the agent gained a new approval in July 2018 to treat chronic sialorrhea (excessive drooling) in adult patients.

  • June 12, 2019

    UCB announced FDA approval of midazolam nasal spray, a benzodiazepine indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy who are aged 12 years and older.    

    The agent is a Schedule IV Controlled Substance that can be administered by a non–health care professional in patients actively seizing when and where a seizure cluster occurs. The nasal spray is designed as a single-use treatment that can be carried with a patient. 

    Concomitant use of benzodiazepines (including midazolam) and opioids may result in profound sedation, respiratory depression, coma, and death. See the prescribing information for more information.

  • June 12, 2019

    FDA approved dalteparin sodium injection for S.C. use to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged 1 month and older. VTE can include deep-vein thrombosis and pulmonary embolism, which can lead to death.

    VTE usually develops as a secondary complication of underlying clinical conditions such as a venous catheter, cancer, infection, congenital heart disease, and trauma or surgery. Pediatric VTE is associated with an increased risk of in-hospital mortality, recurrent VTE, and postthrombotic syndrome.

    The product was initially FDA approved in 1994 for adults and is a type of heparin, which works as an anticoagulant.

    Its efficacy in children was based on a single trial with 38 pediatric patients with symptomatic deep-vein thrombosis and/or pulmonary embolism. Patients were treated with the agent for up to 3 months, with starting doses by age and weight.

    At study completion, 21 patients achieved resolution of the qualifying VTE, 7 patients showed regression, 2 patients showed no change, 0 patients experienced progression of the VTE, and 1 patient experienced recurrence of VTE.

    Common adverse effects are bleeding, including hemorrhage, thrombocytopenia, hematoma, or pain at the injection site and transient elevated liver enzymes.

    Health professionals should use caution in conditions with increased risk of hemorrhage and closely monitor thrombocytopenia of any degree. They should not use benzyl alcohol preservative multiple-dose formulations in infants, as they contain benzyl alcohol.

    The label contains a boxed warning to alert health professionals and patients that epidural or spinal hematomas may occur in patients who are anticoagulated because they take low molecular weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.

    Health professionals should monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

  • June 12, 2019

    FDA approved venetoclax for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

    Approval was based on CLL14, a randomized (1:1), multicenter, open-label, actively controlled trial of venetoclax in combination with obinutuzumab (VEN+G) versus obinutuzumab in combination with chlorambucil (GClb) in 432 patients with previously untreated CLL with coexisting medical conditions.

    The trial demonstrated a statistically significant improvement in progression-free survival (PFS) for patients who received VEN+G compared with those who received GClb. The overall response rate was 85% in the VEN+G arm compared with 71% in the GClb arm.

    The trial also demonstrated statistically significant improvements in rates of minimal residual disease negativity (< 1 CLL cell per 104 leukocytes) in bone marrow and peripheral blood. Overall survival data were not mature at this analysis.

    In CLL/SLL, the most common adverse reactions (≥20%) for venetoclax when administered with obinutuzumab, rituximab, or as monotherapy were neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema.

    View full prescribing information for recommended starting and ramp-up dosages.

  • June 12, 2019

    EMD Serono and Pfizer announced FDA approval of avelumab in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.

    Approval for this indication was based on positive results from the Phase III JAVELIN Renal 101 study, in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than 5 months in the intent-to-treat (ITT) patient population. The ITT population included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups (favorable 21%, intermediate 62%, and poor 16%)

    Common adverse reactions include diarrhea (62% vs. 48%), fatigue (53% vs. 54%), hypertension (50% vs. 36%), musculoskeletal pain (40% vs. 33%), and nausea (34% vs. 39%). 

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