Posted by James
Venous Thromboembolism. In the estrogen-alone sub-study, the risk of VTE (DVT and pulmonary embolism), was increased for women taking conjugated estrogens compared with those receiving placebo (30 vs. 22 per 10,000 women-years), although only the increased risk of DVT reached statistical significance (23 vs. 15 per 10,000 women-years). The increased risk of VTE was demonstrated during the first two years.
In the estrogen-plus-progestin substudy, a statistically significant two-fold greater rate of VTE was reported for conjugated estrogens plus MPA compared with placebo (35 vs. 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 vs. 13 per 10,000 women-years) and pulmonary embolism (18 vs. 8 per 10,000 women-years) were also noted. The increased VTE risk occurred during the first year and persisted.
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Posted by James
Manufacturer: Upsher-Smith Laboratories, Inc., Maple Grove, MN
Indication: Estradiol gel 0.1% is indicated for the treatment of moderate-to-severe hot flashes associated with menopause.
Drug Class: The clear, colorless topical gel is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin, quick-drying layer. The active component of the gel is estra-diol, chemically defined as estra-1,3,5(10)-triene-3,17f>-diol.
Uniqueness of Product: Estradiol, the major estrogenic hormone secreted by the human ovary, is delivered to the systemic circulation after topical application. The gel offers the lowest approved dose of estradiol available for women with menopausal vasomotor symptoms.
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Posted by James
Manufacturer: Novo Nordisk, Princeton, NJ Indications:
Pediatric Patients: Norditropin is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). GH is also known as somatotropin.
Adult Patients: Norditropin injection cartridges (soma-tropin) can replace endogenous GH in adults with GH deficiency who meet either of these criteria:
Adult onset: Patients with GH deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma.
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Posted by James
Temsirolimus (Torisel)
Manufacturer: Wyeth Pharmaceuticals, Philadelphia, PA
Indication: Temsirolimus is indicated for the treatment of advanced renal cell carcinoma.
Drug Class: As an inhibitor of the mammalian target of rapamycin kinase (mTOR), temsirolimus is considered to be an antineoplastic agent.
Uniqueness of Drug: Temsirolimus is the only marketed cancer therapy that specifically inhibits mTOR kinase, a key protein in cells that regulates cell proliferation, cell growth, and cell survival. Temsirolimus binds to an intracellular protein, and the protein-drug complex inhibits the mTOR activity that controls cell division. Inhibition of mTOR activity resulted in arrested growth of treated tumor cells in phase G1. Clinically, temsirolimus resulted in prolonged overall survival in patients with renal cell carcinoma.
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Posted by James
Patients with cutaneous T-cell lymphoma (CTCL) experienced durable major responses with good tolerability when they were treated with denileukin diftitox (Ontak, Seragen/ Ligand), according to results of a phase 3 clinical trial. A recombinant DNA-derived cytotoxic protein, denileukin diftitox (Dd) was approved by the Food and Drug Administration (FDA) for patients with persistent or recurrent cutaneous T-cell lym-phoma whose malignant cells express the CD25 component of the interleukin-2 (IL-2) receptor.
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Posted by James
In stage IIIB/IV non-small-cell lung cancer (NSCLC), the combination of pemetrexed (Alimta, Eli Lilly) plus carboplatin (Paraplatin, Bristol-Myers Squibb) as a first-line chemotherapy produced significantly less toxicity than the combination of gemcitabine (Gemzar, Eli Lilly) plus carboplatin. In addition, patients receiving the pemetrexed/carboplatin (Pem/Carbo) regimen needed fewer transfusions than those receiving the gemcitabine/carboplatin (Gem/Carbo) combination.
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Posted by James
The tyrosine kinase inhibitor (TKI) dasatinib (Sprycel, Bristol-Myers Squibb) is approved for the second-line treatment of chronic myeloid leukemia (CML) that is resistant to imatinib mesylate (Gleevec, Novartis). Most TKIs have long half-lives, resulting in continuous target inhibition, according to Dr. Shah. Because dasatinib has a short half-life (3 to 5 hours, compared with 18 to 60 hours with other TKIs), twice-daily dosing (70 mg) was chosen to provide more consistent target inhibition in phase 2 studies of dasatinib. The adverse event of pleu-ral effusions, however, was more common with twice-daily dosing in early studies, whereas the major cytogenetic response rate with once-daily dosing was equivalent to that for patients who were treated twice a day.
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