Medication Monitor

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  • August 9, 2019

    On August 2, FDA approved pexidartinib capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. 

    TGCT is a rare tumor that affects the synovium (thin layer of tissue that covers the surfaces of the joint spaces) and tendon sheaths. The tumor is rarely malignant but causes the synovium and tendon sheaths to thicken and overgrow, resulting in damage to surrounding tissue. Pexidartinib is the first FDA-approved therapy to treat this rare disease.

    Approval of pexidartinib was based on the results of a multicenter international clinical trial of 120 patients, 59 of whom received placebo. The primary efficacy endpoint was the overall response rate (ORR) analyzed after 25 weeks of treatment. The clinical trial demonstrated a statistically significant improvement in ORR in patients who received pexidartinib, with an ORR of 38% compared with no responses in patients who received placebo. The complete response rate was 15%, and the partial response rate was 23%. Twenty-two of 23 responders who had been followed for a minimum of 6 months after the initial response maintained their response for 6 or more months, and 13 out of 13 responders who had been followed for a minimum of 12 months after the initial response maintained their response for 12 or more months.

    The prescribing information for pexidartinib includes a boxed warning to advise health professionals and patients about the risk of serious and potentially fatal liver injury. Health professionals should monitor liver tests before beginning treatment and at specified intervals during treatment. If liver tests become abnormal, pexidartinib may need to be withheld or the dose reduced or permanently discontinued, depending on the severity of the liver injury.

    Pexidartinib is available only through a Risk Evaluation and Mitigation Strategy (REMS) Program.

    Common side effects for patients taking pexidartinib were increased lactate dehydrogenase, increased aspartate aminotransferase, loss of hair color, increased alanine aminotransferase, and increased cholesterol. Additional adverse effects included neutropenia, increased alkaline phosphatase, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate.

    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 pexidartinib because it may cause harm to a developing fetus or newborn baby.

  • August 9, 2019

    On July 30, FDA approved darolutamide for nonmetastatic, castration-resistant prostate cancer.

    Approval was based on ARAMIS, a multicenter, double-blind, placebo-controlled clinical trial in 1,509 patients with nonmetastatic, castration-resistant prostate cancer. Patients were randomized (2:1) to receive either 600 mg darolutamide orally twice daily (n = 955) or matching placebo (n = 554). All patients received a gonadotropin-releasing hormone (GnRH) analog concurrently or had a previous bilateral orchiectomy. Twelve patients with previous seizure histories were treated in the darolutamide arm.

    The primary endpoint was metastasis free survival (MFS), defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. The median MFS was 40.4 months (95% CI 34.3–not reached) for patients treated with darolutamide compared with 18.4 months (95% CI 15.5–22.3) for those receiving placebo (hazard ratio 0.41 [95% CI 0.34–0.50; P < 0.0001). Overall survival data were not mature.

    The most common adverse reactions (≥2%) in patients who received darolutamide were fatigue, pain in extremity, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common in the darolutamide arm. The seizure incidence was similar in the two arms (0.2%).

    The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a GnRH analog concurrently or should have had bilateral orchiectomy.

  • July 17, 2019

    FDA has approved imipenem, cilastatin, and relebactam, an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

    The three-drug combination injection contains imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.

    The determination of efficacy was supported in part by the findings of the efficacy and safety of imipenem-cilastatin for treatment of cUTI and cIAI. The contribution of relebactam was assessed on the basis of data from in vitro studies and animal models of infection. Safety was studied in two trials, one each for cUTI and cIAI. The cUTI trial included 298 adult patients, with 99 treated with the proposed dose of the combination drug. The cIAI trial included 347 patients with 117 treated with the proposed dose.

    The most common adverse reactions observed in patients included nausea, diarrhea, headache, fever and increased liver enzymes.

    The agent should not be used in patients taking ganciclovir unless the benefits outweigh the risks, as generalized seizures have been reported. Patients should also avoid using the drug when taking valproic acid or divalproex sodium, drugs used to manage seizures, as a reduction in valproic acid level may lead to seizures.

  • July 16, 2019

    FDA has approved Grifol's 20% immunoglobulin for S.C. injection to treat primary humoral immunodeficiency in patients ages 2 years and older. It can also be used to treat rare neurological conditions, such as chronic inflammatory demyelinating polyneuropathy.

    The product has a boxed warning on the risk of thrombosis. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, clinicians should administer at the minimum dose and infusion rate practicable, and ensure adequate hydration before administration. Clinicians should also monitor for signs and symptoms of thrombosis, and assess blood viscosity in patients at risk for hyperviscosity.

    Common adverse reactions are infusion site erythema, pain, swelling, bruising, nodule, pruritus, induration, scab, and edema; as well as systemic reactions such as cough and diarrhea.

    Grifols plans to launch the product in the United States in the last quarter of 2019.


  • July 8, 2019

    FDA granted accelerated approval to selinexor tablets in combination with the corticosteroid dexamethasone for treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

    Efficacy was evaluated in 83 patients with RRMM who were treated with selinexor in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%. The median time to first response was 4 weeks, with a range of 1 to 10 weeks. The median duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.

    Common adverse effects of patients taking selinexor in combination with dexamethasone included leukopenia, neutropenia, thrombocytopenia, and anemia. Patients also reported vomiting, nausea, fatigue, diarrhea, fever, decreased appetite and weight, constipation, upper respiratory tract infections, and low blood sodium levels.

    Health professionals are advised to monitor patients for low blood counts, platelets, and sodium levels. Patients should avoid taking selinexor with other medications that may cause dizziness or confusion and avoid situations where dizziness may be a problem. Health professionals also are advised to optimize the patient’s hydration status, blood counts, and other medications to avoid dizziness or confusion.

    Females of reproductive age and males with a female partner of reproductive potential should use effective contraception during treatment. Women who are pregnant or breastfeeding should not take selinexor because it may cause harm to a developing fetus or newborn baby. Selinexor must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.