Medication Monitor



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  • 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.

  • November 30, 2018

    On November 16, FDA approved brentuximab vedotin injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

    PTCLs are rare, fast-growing non–Hodgkin's lymphomas that develop from T-cells. The T-cells often spread quickly throughout the body and are hard to treat.

    Brentuximab vedotinis a monoclonal antibody that binds to a CD30 protein found on some cancer cells. 

    The drug was previously approved to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic ALCL after failure of other treatment, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment.

    The new approval was based on a clinical trial of 452 patients with certain PTCLs who received either brentuximab vedotin plus chemotherapy or a standard chemotherapy (CHOP) as first-line treatment.

    The most common adverse effects of brentuximab vedotin plus chemotherapy included nerve damage (peripheral neuropathy), nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever, and anemia.

    Health care providers are advised to monitor patients for infusion reactions, life-threatening allergic reactions, neuropathy, fever, GI complications and infections. Patients should also be monitored for tumor lysis syndrome, serious skin reactions, lung adverse effects, and liver damage.

    Women who are pregnant or breastfeeding should not take brentuximab vedotin because it may cause harm to a developing fetus or newborn baby.

    The prescribing information includes a boxed warning to advise health professionals and patients about the risk of a fatal or life-threatening infection of the brain (progressive multifocal leukoencephalopathy) in patients receiving the drug.

  • November 30, 2018

    FDA approved a new indication for pembrolizumab, an anti-PD-1 therapy, for treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. HCC is the most common type of liver cancer in adults.

    The recommended dosage for HCC is 200 mg every 3 weeks until disease progression or unacceptable toxicity.

    The humanized monoclonal antibody works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

    Approval was based on data from a single-arm, open-label, multicenter trial evaluating pembrolizumab in 104 patients with HCC who had disease progression on or after sorafenib or who were intolerant to sorafenib.

    Immune-mediated adverse reactions, which may be severe or fatal, can occur with use, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

    Depending on the severity of the adverse reaction, the drug should be withheld or discontinued and corticosteroids administered if appropriate.

    Pembrolizumab can also cause severe or life-threatening infusion-related reactions, as well as fetal harm when administered to a pregnant woman.

    Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials, stated Merck in a news release.


     

  • November 29, 2018

    On November 2, Coherus BioSciences announced FDA approval of pegfilgrastim-cbqv, the first biosimilar of pegfilgrastim (Neulasta) approved by both FDA and the European Commission (EC) for patients with cancer who are receiving myelosuppressive chemotherapy.

    The biosimilar is a pegylated growth colony–stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

    In clinical trials, the most common adverse reactions (≥5% incidence) are bone pain and pain in extremity.

    Full prescribing information is available at www.UDENYCA.com.

  • November 28, 2018

    Novartis announced that FDA has expanded the approval of eltrombopag for first-line treatment of adults and pediatric patients aged 2 years and older with severe aplastic anemia (SAA) when the drug is taken in combination with standard immunosuppressive therapy. 

    SAA is a rare, life-threatening, acquired blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells, and platelets. As a result, people living with this serious disease may experience debilitating symptoms and complications, such as fatigue, trouble breathing, recurring infections, and abnormal bruising or bleeding that can limit their daily activities.

    Peltrombopag is an oral thrombopoietin receptor agonist that is already approved for SAA in patients who have had an insufficient response to IST. It is also approved for adults and children with chronic immune thrombocytopenia (ITP) who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection.

    In the clinical study upon which approval was based, the most common adverse reactions reported (incidence ≥5%) were abnormal liver function tests, rash, and skin discoloration, including hyperpigmentation.

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