Medication Monitor



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Generic Name (Trade Name—Company)
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  • February 1, 2011

    Uses:

    Treatment of major depressive disorder (MDD) in adults

    Vilazodone has a unique mechanism of action because it is a selective serotonin reuptake inhibitor (SSRI) and a partial agonist at the 5HT1A receptor. Although the net result of this action on serotonergic transmission is not fully understood, experts have theorized that the partial agonist activity of vilazodone may decrease the occurrence of sexual adverse effects that are commonly associated with SSRIs. FDA approved the antidepressant based on two Phase III, 8-week, placebo-controlled trials involving 869 patients with MDD age 18 to 70 years showed that treatment with vilazodone 40 mg once daily was superior to placebo in the improvement of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale total score. Some of the most common adverse events with vilazodone were diarrhea, nausea, vomiting, and insomnia

  • January 1, 2011

    Uses:

    Treatment of metastatic breast cancer

    Eribulin is a nontaxane microtubule dynamics inhibitor indicated for patients who have previously received at least two chemotherapeutic regimens for treatment of their metastatic breast cancer. The recommended dose is 1.4 mg/m2 given I.V. over 2 to 5 minutes on days 1 and 8 of a 21-day cycle. FDA approved the drug based on data from an open-label trial showed that treatment with eribulin improved overall survival compared with a control treatment regimen, resulting in a median response duration of 4.2 months. Common adverse events observed with therapy were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.

  • January 1, 2011

    Uses:

    Treatment of lipodystrophy in patients with HIV

    Tesamorelin is a synthetic analogue of growth hormone–releasing factor, administered once daily as a 2-mg subcutaneous injection, which has been shown to reduce abdominal fat in patients with HIV. Two 26-week studies with 26-week extension phases conducted in 816 patients with HIV and lipodystrophy with excess abdominal fat provided the basis for FDA approval. Patients randomized to tesamorelin had 14% to 18% reductions in visceral adipose tissue, compared with minimal changes in the placebo group. The most commonly reported adverse events included arthralgia, injection site erythema and pruritus, pain in extremity, peripheral edema, and myalgia. Other safety concerns with tesamorelin include induction of supraphysiological levels of insulin-like growth factor 1, which may affect the development of malignancies, glucose intolerance, and fluid retention.

  • January 1, 2011

    The vaccine is now approved by FDA for prevention of anal cancer caused by HPV types 16 and 18 and prevention of AIN grades 1–3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16, and 18 in males and females 9 to 26 years of age. The vaccine was previously approved for prevention of cervical, vaginal, and vulvar cancers in females. The product was also licensed for prevention of genital warts in females and males.

  • January 1, 2011

    Uses:

    Prevention of skeletal-related events in patients with bone metastases from solid tumors

    Data from three randomized, double-blind trials comparing denosumab 120 mg with zoledronic acid 4 mg (Zometa—Novartis), both given once every 4 weeks, showed that denosumab was superior to zoledronic acid in preventing skeletal-related events in patients with breast or prostate cancer and bone metastasis and was noninferior to zoledronic acid in preventing these events in patients with multiple myeloma or other solid tumors. The FDA-recommended dose is 120 mg administered as a subcutaneous injection every 4 weeks. It is important to distinguish the dosing and indication differences between Prolia and Xgeva, both of which contain denosumab. Prolia is dosed as a 60-mg subcutaneous injection once every 6 months and is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

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