HIV & AIDS Dec 10, 2008
Among these drugs are saquinavir (Invirase), ritonavir (Norvir), indinavir (Crixivan), nelfinavir (Viracept), amprenavir (Agenerase), lopinavir/ritonavir (Kaletra), atazanavir (Reyataz) and tipranavir (Aptivus). Darunavir (Prezista) is intended for people who haven't responded to treatment with other drugs. (CNN -- Health)
More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies Dec 4, 2008
The concomitant use of strong CYP3A4 inhibitors should be avoided (including, but not limited to, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Should treatment with any of these agents be required, it is recommended that therapy with Tasigna be interrupted. (PR Newswire)
Abbott Study Shows Investigational Heat-Stable Norvir(R) Tablet Provides Similar Drug Levels to Current Norvir Capsule Aug 8, 2008
KALETRA should not be given once-daily in combination with Sustiva(R) (efavirenz), Viramune(R) (nevirapine), Agenerase(R) (amprenavir), fosamprenavir, Viracept(R) (nelfinavir), phenobarbital, Dilantin(R) (phenytoin) or Tegretol(R) (carbamazepine). Patients and/or their care providers should pay special attention to accurate administration of the KALETRA dose to reduce the risk of accidentally giving too much or too little medicine. (PR Newswire)
Landmark studies assess risk of exposure to elevated levels of EMS confirm clear toxicity threshold Aug 5, 2008
The studies were designed to determine the impact of elevated EMS levels in some batches of Roche's Viracept (nelfinavir mesylate) and demonstrated a clear threshold response at which DNA damage, the underlying mechanism for the carcinogenesis of EMS, occurs ... Viracept (nelfinavir) is an HIV protease inhibitor supplied by Roche outside the US, Canada and Japan. (EurekAlert!)
Studies conclude impurity in Roche's Viracept did not increase patients' risk of cancer Jul 25, 2008
The European Committee for Human Medicinal Products (CHMP) has confirmed that the presence of an impurity called ethyl methanesulfonate (EMS) in Roche's Viracept (nelfinavir mesylate) did not increase patients' risk of developing cancer. The discovery of the EMS impurity in some batches of nelfinavir led to a global recall of this HIV medication in June 2007 ... In collaboration with the CHMP, Roche designed and commissioned in-depth animal studies to better define the potential impact of EMS.... (EurekAlert!)
Combo HIV Drug Therapy Safe, Effective In Children Jun 11, 2008
Rudin from University Children's Hospital, Basel, Switzerland and colleagues evaluated the safety, tolerability, and effectiveness of a combination drugs that included one or more protease inhibitors -- ritonavir, nelfinavir, and a lopinavir/ritonavir compound -- in 133 HIV-infected children previously exposed to anti-HIV drug therapy ... Significant reductions in average blood levels of the virus and increases in average blood levels of CD4 T cells, white blood cells that decrease as HIV... (MEDLINEplus)
FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML Nov 9, 2007
g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Concomitant use of dasatinib and drugs that inhibit CYP3A4 should be avoided. (PR Newswire)
EU Experts: Lift Ban on Roche HIV Drug Sep 23, 2007
Roche needs the backing of the EU's head office, the European Commission, before it can put Viracept - the brand name for nelfinavir - back on sale. It said the soonest it could do this would be early 2008. (Forbes)
HIV Drug Might Fight Cancer Sep 2, 2007
Based on this new finding, the HIV protease inhibitor nelfinavir is being used in a phase I clinical trial to determine what might be the safest and most effective dose for cancer patients ... The researchers hit upon the idea of testing nelfinavir and other protease inhibitors as cancer drugs, because these drugs block Akt, a protein essential for the development of many types of cancer, including non-small cell lung cancer ... At doses that are safe in HIV-infected patients, three of the... (Forbes)
HIV drug tackles cancer cells Sep 1, 2007
The HIV drug nelfinavir is now going through its first trial in patients with a range of cancers, in light of the new evidence ... The most effective of the three, nelfinavir, which impedes the activity of protein-degrading enzymes in the cell, also blocked tumour growth in mice injected with cancer cells ... Cancer-causing mutations can also activate the proteasome, so drugs that block protein breakdown, such as nelfinavir, could theoretically halt both diseases. (Nature News Service)
HIV drug may harbor cancer cure Sep 1, 2007
The discovery that the HIV drug nelfinavir has the potential to slow cancer growth gives hope that drugs designed to battle one killer disease may also help fight another ... Nelfinavir was found to be the most effective of the three drugs ... Therefore, he says, drugs that block protein breakdown, such as nelfinavir, can theoretically halt both diseases. (South Asian Women's Forum)
AIDS drug shows potential as weapon against cancer Aug 31, 2007
The most effective of the drugs was nelfinavir, sold by Roche Holding AG as Viracept, the researchers said ... The most effective of the drugs was nelfinavir, sold by Roche Holding AG as Viracept, the researchers said ... ADVERTISEMENT (article continues below) The researchers have started an initial clinical trial to test nelfinavir in cancer patients. (Scientific American)
AIDS Drug May Fight Cancer Aug 31, 2007
The most effective of the drugs was nelfinavir, sold by Roche Holding AG as Viracept, the researchers said ... The researchers have started an initial clinical trial to test nelfinavir in cancer patients. (Newsmax)
HIV Patients Suffer as Drug is Recalled Aug 9, 2007
The drug, whose generic name is Nelfinavir, is considered to be an important defence against HIV and is used by patients who don't respond to first-line drugs or suffer side effects and also in the prevention of mother-to-child transmission. The recall has left patients with the painful choice of discontinuing the life-saving medicine or switching to expensive options, which many cannot afford. (allAfrica.com)
European Commission Suspends License To Market Drugs Aug 9, 2007
Roche expects to be able to market Viracept, which is known generically as nelfinavir, again in the European Union beginning in September or October, after EMA has examined new safety data, according to a spokesperson (Reuters, 8/7). Roche spokesperson Claudia Schmitt said the company is in "intensive discussions" with EMA "to validate the new manufacturing process for Viracept." Roche does not expect the suspension to affect the company's financial outlook for this year, the AP/Tribune reports... (allAfrica.com)
Aids Medicine Disaster Aug 9, 2007
Viracept, which is scientifically known as nelfinavir is a second-line Aids medicine which is used by HIV-positive patients whose disease has become resistant to first-line medicines. Roche withdrew the medicine early last month after discovering that some batches had been contaminated with a potentially cancer-causing substance during a flawed manufacturing process at its factory in Switzerland. (allAfrica.com)
Viracept saga continues Jun 26, 2007
The moves follow concerns from the EMEA regarding the genotoxic substance found to be contaminating the drug (nelfinavir) earlier this month. A meeting of toxicology experts at the EMEA concluded that insufficient information was known regarding the contaminant, ethyl mesylate, and its effects on the human body. (In-PharmaTechnologist.com)
HIV drug recalled after cancer contaminant found Jun 10, 2007
The drug company Roche Products has recalled all batches of its drug Viracept (nelfinavir) after some were found to be contaminated with ethyl mesylate, a chemical that can cause cancer ... Viracept is nelfinavir mesylate, so the contamination may have occurred because a stage in manufacturing wasnt completed properly ... Nelfinavir was registered in the EU is January 1998 and for a short period was the most widely-used protease inhibitor drug, but has fallen out of favour as the usually more... (Gay.com UK)
Contamination leads to EU-wide Viracept recall Jun 10, 2007
07/06/2007 - Roche has initiated a recall of its HIV drug Viracept (nelfinavir) right down to the patient level after finding evidence of dangerous contaminants in the tablets ... The contamination is believed to be related to the manufacture of the active substance nelfinavir itself, and thus may have affected all forms and strengths of the drug hence Roche's immediate recall of all packs in the EU.. (LabTechnologist.com)
Cancer fear forces company to recall HIV drug Jun 7, 2007
Tests on batches of the drug Viracept, whose generic name is nelfinavir, revealed higher than normal quantities of methane sulfonic acid ethyl ester. The chemical is used in the drug normally but in smaller quantities, according to the manufacturer Roche. (Scotsman)
Anti-Aids drugs withdrawn worldwide over cancer link Jun 7, 2007
A drug that is taken by hundreds of HIV-positive patients in Britain was recalled across Europe yesterday after the medicine was found to contain a toxic substance that can cause cancer. Patients who take Viracept, an antiretroviral drug, should contact their doctors immediately, health officials advised. (Times Online)
Breaking Merck patent may drive investment away from Brazil May 11, 2007
The same happened with Gilead's Viread (tenofovir), a high-selling NRTI and Roche/Pfizer's Viracept (nelfinavir), a PI that has been facing decreasing sales in the six major markets. Brazil is in continuous talks with the drug companies that manufacture nine of the 17 antiretrovirals used in the country's free treatment program, while the other eight are already produced in local laboratories and are not patented. (Pharmaceutical Business Review)
Abbott Agrees With World Health Organization (WHO) Director-General to Expand Access to Kaletra/Aluvia (lopinavir/ritonavir) Apr 10, 2007
Co-administration of efavirenz, nevirapine, nelfinavir or amprenavir with Kaletra tablets 400/100 mg is not recommended. If co-administration of these products with Kaletra is clinically indicated, a dose increase of Kaletra tablets to 600/150 mg twice daily may be considered. (PR Newswire)
