Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • April 1, 2011

    Uses:

    Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 4 years of age and older

    A 40 mg/mL oral suspension of rufinamide has been approved by FDA. This suspension is equivalent to the already available 200 mg and 400 mg rufinamide tablets on a mg-per-mg basis. The suspension should be dosed with the supplied calibrated oral dosing syringe and adapter. Key counseling points for patients using this new formulation include shaking the medication before each use, replacing the cap securely after opening, keeping the suspension in an upright position at room temperature, and using the product within 90 days of first opening the bottle.

  • March 1, 2011

    Uses:

    Adjunctive therapy to stimulants for treatment of ADHD in children and adolescents 6–17 years of age

    Intuniv was originally approved as monotherapy for treatment of ADHD in the same age group. Approval was based on data from a 9-week, multicenter, double-blind, placebo-controlled trial involving 455 children who had a suboptimal response to stimulant therapy. Combination therapy with guanfacine and a stimulant resulted in significant improvements on the ADHD Rating Scale–IV, which includes hyperactive/impulsive and inattentive subscales, compared with stimulant monotherapy. In addition, combination therapy was associated with mild to moderate adverse events similar to those observed with either treatment alone.

  • March 1, 2011

    Uses:

    Maintenance treatment of bipolar I disorder as an adjunct to either lithium or valproate

    Approval of this agent was based on data from a 52-week maintenance trial with 337 patients with bipolar I disorder. Patients on combination therapy had fewer mood events (n = 25) compared with those on either lithium or valproate alone (n = 43). This difference was primarily attributed to a reduction in manic episodes (7 vs. 19), not depressive episodes (14 vs. 18). Tremor occurred more frequently with combination therapy (6% vs. 2.4%).

  • February 1, 2011

    Uses:

    Maintenance treatment of advanced follicular lymphoma in patients who responded to initial treatment with this agent plus chemotherapy (induction treatment)

    Approval was based on data from the PRIMA (Primary Rituxan and Maintenance) study (n = 1,217), which showed that continuing rituximab therapy every 2 months for 2 years in patients who responded to initial treatment with rituximab plus chemotherapy nearly doubled progression-free survival compared with patients who stopped therapy (hazard ratio 0.54 [95% CI 0.42–0.70], P = 0.0001). Rituximab is also indicated for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia and, in combination with methotrexate, to reduce structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

  • February 1, 2011

    Uses:

    Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in children 2 to 10 years of age

    Approval was based on Phase III trial data involving 5,297 children 2 to 10 years of age proving the safety and immunogenicity of Menveo compared with the other currently U.S.-licensed ACW-135Y meningococcal conjugate vaccine. The vaccine was initially approved in 2010 for active immunization in adolescents and adults 11 to 55 years of age.

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