Medication Monitor



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  • October 31, 2019

    FDA approved an expanded indication for niraparib, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy.

    Patient selection is based on an FDA-approved companion diagnostic.

    This represents the first time a PARP inhibitor has been approved for use in patients beyond those with a BRCA-positive mutation as monotherapy in the late-line treatment setting. Now women with late line, HRD-positive disease are eligible to be treated with a PARP inhibitor.

    Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other cancer medications have developed bone marrow problems, called myelodysplastic syndrome (MDS), or acute myeloid leukemia (AML), during treatment with niraparib. MDS or AML may lead to death.

    The recommended dosage is 300 mg taken once daily, with or without food. Treatment should be continued until disease progression or unacceptable adverse reaction. 

    Niraparib may cause serious adverse effects; see the prescribing information for complete details.

    Common adverse effects are nausea, fatigue, thrombocytopenia, anemia, vomiting, constipation, abdominal pain, musculoskeletal pain, decreased appetite, neutropenia, insomnia, headache, dyspnea, diarrhea, hypertension, cough, dizziness, hypomagnesemia, urinary tract infection, acute kidney injury, and decreases in white blood cell counts.

  • October 31, 2019

    On October 21, Janssen announced FDA approval of ustekinumab to treat adult patients with moderately to severely active ulcerative colitis (UC).

    Approval for this new indication was based on the pivotal Phase III UNIFI clinical trial, which demonstrated that treatment with ustekinumab induced and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active UC compared with placebo.

    Ystekinumab is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines, which have been shown to play an important role in inflammatory and immune responses.

    The recommended dosage for UC starts with a weight-based, one-time I.V. infusion induction dose, followed by a maintenance dosing schedule of a 90-mg S.C. maintenance injection every 8 weeks.

    Common adverse effects include nasal congestion, sore throat, and runny nose; upper respiratory infections; fever; headache; tiredness; itching; nausea and vomiting; redness at the injection site; vaginal yeast infections; urinary tract infections; sinus infection; stomach pain; diarrhea; and joint pain.

  • October 31, 2019

    Alexion announced FDA approval of ravulizumab-cwvz for treatment of adults and pediatric patients ages 1 month and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). Atypical HUS is an ultrarare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots. Atypical HUS can cause sudden organ failure or a slow loss of function over time—potentially resulting in the need for a transplant, and in some cases, death.

    Atypical HUS affects both adults and children and many patients present in critical condition, often requiring supportive care, including dialysis, in an intensive care unit. The prognosis of aHUS can be poor in many cases, so a timely and accurate diagnosis—in addition to treatment—is critical to improving patient outcomes.

    Ravulizumab-cwvz is the first and only long-acting C5 complement inhibitor.

    Common adverse reactions of ravulizumab-cwvz are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension, and pyrexia. Serious meningococcal infections have occurred in patients treated with ravulizumab-cwvz. To minimize the risk for patients, specific risk-mitigation plans, including a REMS, have been established.

    It is administered intravenously every 8 weeks or every 4 weeks for pediatric patients less than 20 kg, following a loading dose.

  • October 31, 2019

    On October 18, FDA approved minocycline topical foam, 4%, a tetracycline-class drug that targets inflammatory lesions of nonnodular moderate to severe acne vulgaris in adults and pediatric patients ages 9 years and older. It is the first topical minocycline to be approved by FDA for any condition.

    Minocycline is a broad-spectrum antibiotic known for its efficacy in treating moderate to severe acne, but its use is limited in some patients because of systemic adverse effects when taken orally. Until now, minocycline has not been available as a topical treatment because of its instability in traditional topical formulations.

    The recommended dosage is to apply to affected areas once daily. The foam should be gently rubbed into the skin.

    Minocycline topical foam is expected to be available for prescribing in January 2020.

    Headache was the most common adverse reaction reported during clinical trials.

  • October 31, 2019

    On October 17, Genentech announced FDA approval of baloxavir marboxil for the treatment of acute, uncomplicated influenza in people ages 12 years and older who have been symptomatic for no more than 48 hours and are at high risk of developing flu-related complications. This first-in-class, one-dose oral medication has a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.

    This expanded indication was approved on the basis of results from the Phase III CAPSTONE-2 study of a single dose of baloxavir marboxil 40 mg or 80 mg compared with oseltamivir 75 mg twice daily for 5 days or placebo in people aged 12 years of age or older who met CDC criteria for being at high risk of complications from the flu.

    Baloxavir marboxil significantly reduced the time to improvement of flu symptoms compared with placebo, including in people infected with flu type B virus.

    Adverse events, reported in at least 1% of adult and adolescent participants treated with baloxavir marboxil, included diarrhea, bronchitis, nausea, sinusitis, and headache.

    Baloxavir marboxil is currently approved in several countries for treatment of flu types A and B. In October 2018, the medication was first approved for treatment of acute, uncomplicated flu in otherwise healthy people ages 12 years and older who have been symptomatic for no more than 48 hours, representing the first new antiviral to treat the flu in the United States in 20 years.

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