Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • 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.

  • October 29, 2015

    FDA has approved talimogene laherparepvec for the treatment of melanoma lesions in the skin and lymph nodes. The genetically modified live oncolytic herpes virus therapy, for melanoma lesions that cannot be completely removed by surgery, is injected directly into the lesions. A treatment course with the new therapy involves a series of injections, with the second dose given 3 weeks after the first, followed by additional doses every 2 weeks for at least 6 months.

    A multicenter study of more than 400 patients with metastatic melanoma that could not be surgically removed found that 16.3% of the participants who received talimogene laherparepvec saw a reduction in the size of their skin and lymph node lesions, lasting for at least 6 months, compared with 2.1% of participants who received the comparator therapy.

    The new drug has not been show to improve overall survival, nor to have an effect on melanoma that has spread to the brain, bone liver, lungs, or other internal organs.

    Common adverse events reported among study participants who took the drug included fatigue, chills, fever, nausea, influenza-like symptoms, and pain at the injection site.

    Talimogene laherparepvec should not be given to those with suppressed immune systems or who are pregnant.

  • February 2, 2016

    FDA has expanded the approval of nivolumab in combination with ipilimumab for the treatment of patients with BRAF V600 wild type and BRAF V600 mutation–positive unresectable or metastatic melanoma.

    FDA also expanded the use of nivolumab as a single agent to include previously untreated BRAF mutation–positive advanced melanoma patients. Use of nivolumab as a single agent in patients with BRAF V600 mutation–positive unresectable or metastatic melanoma was approved under accelerated approval based on progression-free survival.

  • May 31, 2011

    A safety communication released by FDA highlighted data from two recently published studies that reported a two- to three-fold greater risk of venous thromboembolic events in women taking oral contraceptives containing drospirenone as compared with those taking contraceptive therapy containing levonorgestrel. FDA noted that previous data have had conflicting results, with other studies not reporting any difference in the venous thromboembolic risk between drospirenone-containing products and products containing levonorgestrel or other progestins. The agency is reviewing these and other data and will communicate any new safety information as it becomes available.

     

  • May 1, 2011

    Teva has voluntarily withdrawn its lansoprazole delayed-release orally disintegrating tablets (ODT) after FDA received reports that the tablets clogged and blocked oral syringes and feeding tubes, including gastric and jejunostomy tubes. The ODT tablets reportedly do not fully disintegrate fully when water is added or disintegrate and later form clumps that clog oral syringes and feeding tubes.

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