Medication Monitor



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Generic Name (Trade Name—Company)
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  • October 19, 2018

    Rare Disease Therapeutics announced FDA approval of Crotalidae Immune F(ab’ )2 (Equine), an equine-derived antivenin, to manage adult and pediatric patients with North American rattlesnake envenomation.

    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 5/y). However, coagulopathies (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 (delayed) coagulopathy. Because this new antivenom lasts longer in the body, it eliminates the need for scheduled maintenance doses. 

    The antivenom was specifically engineered with 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. Patients with known allergies to horse protein are particularly at risk for an anaphylactic reaction. 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.

    The product is made from equine plasma and may therefore carry a risk of transmitting infectious agents (e.g., viruses).

    Reactions to Cresol Localized reactions and generalized myalgias have been reported with use of cresol as an injectable excipient.

  • 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 is the first and only RNA-targeting therapeutic that reduces the production of TTR protein through a once-weekly S.C. injection. In hATTR amyloidosis, transthyretin (TTR) protein misfolds and accumulates as amyloid deposits throughout the body. TEGSEDI targets the disease at its source by reducing the production of TTR protein.

    In the NEURO-TTR study, treatment with inotersen produced up to a 79% mean decrease from baseline in serum TTR protein in patients regardless of TTR mutation, sex, age, or race.

    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 (Norfolk QoL-DN) and modified Neuropathy Impairment Score +7 (mNIS+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 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.

     

  • October 3, 2018

    Amirall announced FDA approval of sarecycline, an innovative first-in-class tetracycline-derived oral antibiotic for treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older. 

    Sarecycline is an oral tablet that is taken once daily with or without food. It has proven to significantly reduce inflammatory lesions as early as 3 weeks after start of treatment and is generally safe and well tolerated. 

    Safety of the product was established in two 12-week multicenter, randomized, double-blind, placebo-controlled studies. Efficacy was assessed in 2,002 participants aged 9 years and older. Efficacy of sarecycline beyond 12 weeks and safety beyond 12 months have not been established.

    Sarecycline has not been evaluated for treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, patients should use sarecycline only as indicated. The product is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

    Use during tooth development may cause permanent discoloration of the teeth. If Clostridium difficileassociated diarrhea (antibiotic-associated colitis) or intracranial hypertension occurs, use should be discontinued. Central nervous system adverse effects, including light-headedness, dizziness, or vertigo, have been reported with tetracycline use. The most common adverse reaction is nausea.

    Sarecycline is expected to be launched in January 2019.

  • October 2, 2018

    Antares Pharma announced FDA approval of testosterone enanthate, the first testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone in adult males.

    The product is self-administered subcutaneously once weekly at home with an easy-to-use, single-dose, disposable QuickShot auto injector. It comes in three dosage strengths: 50 mg, 75 mg, and 100 mg.

    In Phase III clinical trials, the product was shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio. According to the principal investigator, the S.C. dosing removes transfer concerns commonly associated with gels and potentially reduces the need for in-office injection procedures that may require more frequent patient visits. 

    The product can cause blood pressure elevations that can increase the risk for major adverse cardiovascular events (MACE), including nonfatal myocardial infarction, nonfatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.

    The most commonly reported adverse reactions in clinical trials were hematocrit increases, hypertension, prostate-specific antigen increases, injection-site bruising, and headache.

    Recommended dosage is 100–400 mg every 4 weeks.

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