Medication Monitor

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Generic Name (Trade Name—Company)
  • November 7, 2019

    Sandoz announced FDA approval of pegfilgrastim-bmez, its biosimilar to pegfilgrastim (Neulasta), to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

    Pegfilgrastim is a long-acting form of filgrastim, which is very similar to a natural protein, granulocyte-colony stimulating factor, produced by a person's own body.

    The recommended dosage for patients with cancer receiving myelosuppressive chemotherapy is 6 mg administered subcutaneously once per chemotherapy cycle. The agent should not be administered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Weight-based dosing should be used for pediatric patients weighing less than 45 kg; see the prescribing information for instructions.

    Warnings and precautions include fatal splenic rupture; acute respiratory distress syndrome; serious allergic reactions, including anaphylaxis; fatal sickle cell crises; and glomerulonephritis.

    The drug's most common adverse reactions are bone pain and pain in extremity.

  • October 31, 2019

    On October 24, FDA approved a new indication for delafloxacin, a fluoroquinolone antibacterial, to treat adult patients with community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

    Delafloxacin was FDA approved in 2017 to treat adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.

    Delafloxacin has a boxed warning cautioning that fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together. These include tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Patients who experience any of these serious adverse reactions should discontinue use immediately. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis; patients with a known history of myasthenia gravis should avoid use.

    The recommended dosage of delafloxacin is 300 mg by I.V. infusion over 60 minutes every 12 hours or a 450-mg tablet orally every 12 hours for 5 to 14 days.

    Common adverse reactions are nausea, diarrhea, headache, transaminase elevations, and vomiting.

  • 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.