Medication Monitor

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Generic Name (Trade Name—Company)
  • September 5, 2018

    Merck announced FDA approval of two new HIV-1 medications for adult patients with no prior antiretroviral treatment experience: a once-daily fixed-dose combination tablet of doravirine 100 mg, lamivudine (3TC) 300 mg, and tenofovir disoproxil fumarate (TDF) 300 mg, approved under the trade name Delstrigo; and doravirine 100 mg, a new nonnucleoside reverse transcriptase inhibitor that is administered in combination with other antiretroviral medicines and was approved under the trade name Pifeltro. 

    Both drugs are administered orally once daily with or without food.

    Approval was based on findings from two pivotal, randomized, multicenter, double-blind, active controlled Phase III trials, DRIVE-AHEAD and DRIVE-FORWARD.

    Delstrigo is contraindicated in patients with a previous hypersensitivity reaction to 3TC. 

    Delstrigo and Pifeltro are contraindicated when coadministered with drugs that are strong CYP450 3A enzyme inducers because significant decreases in doravirine plasma concentrations may occur and lessen their effectiveness.

    Immune reconstitution syndrome can occur, including autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

    Renal impairment, including acute renal failure and Fanconi syndrome, has been reported with use of TDF. Delstrigo should be avoided with concurrent or recent use of a nephrotoxic agent, as cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

    Common adverse reactions in clinical trials included dizziness (7%), nausea (5%) and abnormal dreams (5%). 

    Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.

  • August 28, 2018

    Tetraphase Pharmaceuticals announced FDA approval of eravacycline for the treatment of complicated intra-abdominal infections (cIAI) in patients aged 18 years and older.

    In clinical trials, eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical noninferiority to two widely used comparators—ertapenem and meropenem.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of eravacycline and other antibacterial drugs, eravacycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Eravacycline is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity reactions have been reported with use of the drug.

    The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion-site reactions, nausea, and vomiting. 

  • August 28, 2018

    FDA approved lanadelumab, the first monoclonal antibody approved in the United States to treat patients aged 12 years and older with types I and II hereditary angioedema (HAE).

    HAE is a rare and serious genetic disease that affects an estimated 1 in 50,000 men and women with low levels of and poorly functioning C1-INH proteins. This results in recurrent, unpredictable episodes of severe swelling in different areas of the body, including the stomach, limbs, face, and throat.

    Type I is the most common and accounts for 85% of cases. Symptoms of HAE typically begin in childhood and worsen following puberty. Some patients may have many attacks each month, while others will go months without an attack.

    FDA based its approval on data from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 125 patients with HAE. Patients who received lanadelumab had clinically meaningful and statistically significant reductions in the rate of investigator-confirmed HAE attacks compared with placebo over a 6-month treatment period.

    The most common adverse reactions in clinical trials were injection-site reactions, upper respiratory infections, headache, rash, muscle pain, dizziness, and diarrhea.

  • August 28, 2018

    FDA has approved cenegermin, the first drug for treatment of neurotrophic keratitis, a rare disease affecting the cornea.

    Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation. The loss of corneal sensation impairs corneal health, causing progressive damage to the top layer of the cornea, including corneal thinning, ulceration, and perforation in severe cases. Prevalence of neurotrophic keratitis has been estimated to be fewer than 5 in 10,000 individuals.

    Safety and efficacy were studied in 151 patients with neurotrophic keratitis in two randomized, controlled, multicenter, double-masked studies lasting 2 weeks.

    Across both studies, complete corneal healing in 8 weeks was demonstrated in 70% of patients treated with cenegermin compared with 28% of patients treated without cenegermin.

    The most common adverse reactions in patients taking cenegermin are eye pain, ocular hyperemia (enlarged blood vessels in the white of the eyes), eye inflammation, and increased lacrimation (watery eyes).

  • August 20, 2018

    Sun Pharma announced FDA approval of cyclosporine ophthalmic solution 0.09% to increase tear production in patients with keratoconjunctivitis sicca (dry eye).     

    Approval was based on a Phase III trail showing that after 12 weeks of treatment, cyclosporine ophthalmic solution 0.09% showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production), compared with vehicle. Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment.

    The solution is dosed twice daily and will be available as a single-use vial.