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Pharmaceutical Approval Update
27 Mar2010
Posaconazole Oral Suspension (Noxafil)
Manufacturer: Schering-Plough Corporation, Kenil-worth, NJ
Indication: Posaconazole is indicated for the treatment of oropharyngeal candidiasis, including infections refractory to generic itraconazole (Sporonox drug, (PriCara) and/or fluconazole (Diflucan, Pfizer). Oral candidiasis is a fungal infection of the mouth and throat caused by the yeast Candida.
- In: Drugs
- Tags: Brovana, Noxafil, Travatan Z
The Clinical Use of Tipranavir in HIV Infection: DRUG INTERACTIONS AND CONTRAINDICATIONS
26 Mar2010
TPV is given with ritonavir to increase its therapeutic concentration, thereby inhibiting HIV replication.
In clinical studies, TPV was an inhibitor of CYP 1A2, CYP 2C9, CYP 2C19, and CYP 2D6, but the net effect in vivo is not known. When given with 200 mg of ritonavir, TPV is an inhibitor of CYP 3A4, and it may increase concentrations of drugs that are metabolized via this iso-enzyme. These drug interactions include: Read the rest of this entry »
- In: HIV
- Tags: HIV Infection, Tipranavir
The FDA’s approval of TPV was based on two randomized, controlled, open-label, multicenter phase 3 clinical trials, RESIST-1 and RESIST-2 (Randomized Evaluation of Strategic Intervention in Multidrug-Resistant Patients with Tipranavir). The trials enrolled a combined 1,159 triple antiretroviral class-experienced patients with a history of at least two prior PI-based antiretroviral regimens, including one therapeutic failure and at least one (but not more than two) primary protease gene mutations.
- In: HIV
- Tags: HIV Infection, Tipranavir
Protease inhibitors work at the last stage of the viral reproduction cycle. TPV is an inhibitor of the HIV-1 protease, thereby preventing cleavage of the polyprotein. This inhibition leads to the production of an immature, noninfec-tious virus.
- In: HIV
- Tags: HIV Infection, Tipranavir
The Clinical Use of Tipranavir in HIV Infection
23 Mar2010
INTRODUCTION
Highly active antiretroviral therapy (HAART) has augmented the treatment and outcome of human immunodeficiency virus (HIV-1) infection. The inclusion of protease inhibitors (PIs) with a HAART regimen has been responsible for dramatic reductions in morbidity and mortality in cases of advanced infection. It is estimated that nearly 40 million people worldwide are infected with HIV. Suppression of HIV-1 replication is the goal of HAART. Lack of success in achieving this target usually leads to drug-resistant variants and subsequent virological rebound.
- In: HIV
- Tags: HIV Infection, Tipranavir
Medicare Update: Into the Doughnut Hole part 2
19 Mar2010
All prescription plans are required to offer Medication Therapy Management (MTM) services. Although MTM is aimed at optimizing therapy, including the efficient and effective use of medications, this service, unfortunately, is limited to the following Medicare beneficiaries:
- those who are taking multiple medications.
- those who have multiple chronic diseases.
- those who are likely to incur expenditures of more than $4,000 per year in medication costs. (This sum of $4,000 remains the same for 2007.)
- In: Main
- Tags: Medicare Update
Medicare Update: Into the Doughnut Hole
18 Mar2010
The so-called “doughnut hole” in Medicare’s Part D prescription drug benefit is a difficult concept for many people to understand. The term raises such questions as these: What are the exact out-of-pocket requirements? When and where does this doughnut hole begin and end?
- In: Main
- Tags: Medicare Update