Medication Monitor



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Generic Name (Trade Name—Company)
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  • October 29, 2018

    FDA approved talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2–negative locally advanced or metastatic breast cancer. Patients must be selected for therapy on the basis of an FDA-approved companion diagnostic, the BRACAnalysis CDx test (Myriad Genetic Laboratories).

    Approval was based on an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

    The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo–fetal toxicity. Most common (≥20%) adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite.

    The recommended talazoparib dose is 1 mg taken as a single-oral daily dose, with or without food.

  • October 24, 2018

    FDA has approved a new antiviral drug, baloxavir marboxil, to treat acute uncomplicated influenza (flu) in patients aged 12 years and older who have been symptomatic for no more than 48 hours.

    According to FDA Commissioner Scott Gottlieb, MD, the polymerase acidic (PA) endonuclease inhibitor is the first new antiviral flu treatment with a novel mechanism of action approved by FDA in nearly 20 years.

    Safety and efficacy of baloxavir marboxil taken as a single oral dose was demonstrated in two randomized controlled clinical trials of 1,832 patients in which participants were assigned to receive either baloxavir marboxil, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.

    In both trials, patients treated with baloxavir marboxil had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between participants who received baloxavir marboxil and those who received the other flu treatment.

    Within 48 hours of symptom onset, patients weighing 40 kg to less than 80 kg take a single oral dose of 40 mg, and patients weighing at least 80 kg take a single oral dose of 80 mg, with or without food. Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).

    Common adverse reactions in clinical trials were diarrhea and bronchitis.

  • October 19, 2018

    Rare Disease Therapeutics announced FDA approval of Crotalidae Immune F(ab’ )2 (Equine), an equine-derived antivenin for treatment of North American rattlesnake bites in adult and pediatric patients.

    CDC has estimated that the U.S. incidence of venomous snake bites is 7,000 to 8,000 per year. Because people seek—and receive—rapid medical intervention, the number of deaths from snake bites is low: about five per year. However, blood clotting disorders can be major complications of a venomous rattlesnake bite, and one of the goals of treatment is to limit the potential incidence of latent coagulopathy. Because this new antivenom lasts longer in the body, it eliminates the need for scheduled maintenance doses. 

    The antivenom has a long half-life to minimize the likelihood of reemergent venom effects (such as a drop in platelets, prolonged bleeding times, and other abnormal blood clotting tests) that commonly require additional doses of a shorter-acting antivenom.  

    The most common adverse reactions (>2%) in clinical studies were pruritus, nausea, rash, arthralgia, peripheral edema, myalgias, headache, pain in extremity, vomiting, and erythema.

    Warnings and precautions include allergic reactions, especially in patients with known allergies to horse protein. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately, and institute appropriate treatment.

    Monitor patients with follow-up visits for signs and symptoms of delayed allergic reactions or serum sickness (rash, fever, myalgia, arthralgia, pruritus, urticarial rash), and treat appropriately if necessary.

    Because the product is made from equine plasma, it may carry a risk of transmitting infectious agents (e.g., viruses).

  • October 19, 2018

    Akcea Therapeutics and Ionis Pharma announced FDA approval of inotersen for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. It reduces the production of transthyretin (TTR) protein through a once-weekly S.C. injection. In hATTR amyloidosis, TTR protein misfolds and accumulates as amyloid deposits throughout the body.

    FDA’s approval of inotersen was based on results from the Phase III NEURO-TTR study in patients with hATTR amyloidosis with symptoms of polyneuropathy.

    Results demonstrated that patients treated with inotersen experienced significant benefit compared with patients treated with placebo across both coprimary endpoints: the Norfolk Quality of Life Questionnaire–Diabetic Neuropathy and modified Neuropathy Impairment Score +7, a measure of neuropathic disease progression.

    Inotersen is associated with risk of thrombocytopenia and glomerulonephritis. Enhanced monitoring is required to support early detection and management of these identified risks. For full prescribing information, including a boxed warning, please visit www.TEGSEDI.com. Inotersen is being marketed with a Risk Evaluation and Mitigation Strategy (REMS).

    The most common adverse effects include injection-site reactions (such as redness or pain at the injection site), nausea, headache, tiredness, low platelet counts, and fever.

  • October 4, 2018

    Paratek announced FDA approval of omadacycline 100 mg for injection/150 mg tablets for treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI) in adults.

    Omadacycline, a modernized tetracycline, is a once-daily I.V. and oral antibiotic that targets a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug-resistant strains.

    Approval was supported by multiple clinical trials involving nearly 2,000 adult patients.

    Warnings and precautions include the following:

    Use during tooth development (last half of pregnancy, infancy, and childhood to age 8) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    Use during the second and third trimester of pregnancy, infancy and childhood up to age 8 years may cause reversible inhibition of bone growth.

    Omadacycline is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs.

    Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. 

    The most common adverse reactions (incidence ≥2%) in clinical trials were nausea, vomiting, infusion-site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

    The drug is expected to become available in the first quarter of 2019.

     

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