Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • 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.

  • July 7, 2002

    Uses:

    Management of seizures and a variety of pain conditions

    Lupin Pharmaceuticals announced that it has received FDA approval to market its generic version of Pfizer’s Lyrica capsules. The pregabalin capsules are AB rated to Pfizer's product and will be available in 25-, 50-, 75-, 100-, 150-, 200-, 225-, and 300-mg strengths.

    Pregabalin is indicated for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures, neuropathic pain associated with spinal cord injury, and fibromyalgia.

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