New Drugs and Devices 2003

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Advate (Antihemophelia Factor (Recombinent))

Baxter - this new preparation is unique in that it is derived from a human cell line and does not use donated plasma as a source for the factor 8. Thus, it guarantees that there is no chance for inadvertent contamination by any human blood-borne viruses. Side effects are generally mild and consist of strange taste, dizziness, chills, hot flashes, diarrhea and lower limb edema.

Aldurazyme (Laronidase)

Genzyme - this new drug given by injection is indicated for the treatment of mucopolysaccharidosis (Hurler and Huler-Schele forms). It provides alpha-L-iduronidase, the deficiency of which is partially responsible for the symptoms of the disease. Following administration of Aldurazyme patients demonstrated a significant improvement in lung function and distance walked. Side effects include Upper respiratory tract infections, rash, hyperreflexia, numbness of extremities and edema.

Aloxi (Palonosetron)

MGI Pharma - this is a new addition to the of drugs indicated for the preventon of the delayed nausea and vomiting associated with cancer chemotherapy. It is given as a single dose 30 minutes prior to the beginning of the chemotherapy. Adverse reactions are generally mild and include: headache (9%) and constipation (5%). it should be administered with caution to patients with cardiac conduction disorders.

Amevive (Alefacept)

Biogen - this drug is a significant advance in the treatment of moderate to severe plaque psoriasis for which little satisfactory therapy exists. It acts by inhibiting the activity of t-cells, one of the mediators responsible for the reaction producing psoriasis.

Amevive is given once a week for 12 doses. There is a very high response rate to the initial course of therapy with results improving with a second course. Improvement can last for months before another course of therapy may be needed. Side effects include: sore throat, dizziness, itching, muscle aches, chills, and injection site pain and inflammation.

Aralast (Alpha1-Proteinase Inhibitor)

Baxter - This new agent is given intravenously to patients with emphysema due to a deficiency of Alpha1-proteinase inhibitor, an estimated 3% of all patients with chronic obstructive pulmonary disease. there is another similar medication on the approved in the U.S.A. (Prolastin). Both work by restoring normal levels of the enzyme thus preventing the lung damage due to unopposed alpha1-proteinase.

Bexxar (Tositumomab)

Glaxo - Bexxar is a significant addition to the drugs used to treat B-Cell non-hodgkin's lymphoma. In clinical trials it has produced a >50% reduction in tumor load in the vast majority of patients receiving Bexxar. the mechanism of action is for the monoclonal antibody which is linked to I-131 to attach to the B-Cells. The I-131 then destroys the cells. Bexxar is given by intravenous infusion. Side effects include: Flu-like symptoms, increased risk of infections and occasional allergic reactions.

Boniva (Ibandronate)

Roche - Boniva is the latest of a category of oral drugs indicated for the treatment and prevention of osteoporosis. it acts by destroying osteoclast-mediated bone breakdown and thus allow for a better balance between bone formation and breakdown. Boiva use results in a 62% reduction in the risk of vertebral bone fractures. it will also increase bone density in patients whose bone density indicates a possibility for spontaneous fractures. side effects include: unset stomach, diarrhea, and infections. In one study 18% of patients withdrew because of side effects.

Cialis (Tadalafil)

Lilly - Cialis is the most recent addition to the class of agents used to treat erectile dysfunction. it differs from the other two agents approved in the United States in that it combines a rapid onset of action (30 min) with a prolonged effect (up to 36 hours). It acts by inhibiting the removal of cyclic GMP which results in the relaxation of the muscles surrounding penile arteries thus allowing for increased blood flow to the penis. Data suggest that the effectiveness approaches 80% unless the erectile dysfunction is a result of nerve dmage such as seen with diabetes. Side effects occur in 5% of patients and consist of headaches and upset stomach.

Crestor (Rosuvastatin)

AstraZeneca - this is the most recent addition to the group of "statins" use to lower elevated cholesterol and lipid levels. Elevated cholesterol and lipids are both risk factors in the development of atherosclerosis. Drugs in the "statin" class have a similar mechanism of action, namely, the inhibition of HMG-CoA reductase which is a key enzyme in the production of lipids. Side effects include: Stomach pain, headache, constipation, and dizziness. Occasionally, muscle pain may develop which may indicate the development of a serious side effect requiring discontinuation of Crestor.

Cubicin (Daptomycin)

Cubist Pharmaceuticals - The newly approved injection is indicated for the treatment of skin infections due to gram positive bacteria resistant to other antibiotics. Cubicin is the first antibiotic of the class of drugs called cyclic lipopeptides.

Elestat (Epinastine)

Allergan - this is ocular (eye) drop indicated for the treatment of allergic conjunctivitis. It acts by preventing allergy cells (mast cells) from releasing inflammatory mediators such as prostaglandins and leukotrienes thus reducing inflammation. It also appears to block the action of released histamine which reduces itching. Side effects are mild and occurr in 1-10% of patients. These include redness and of the eyes. 1-3% of patient reported headache, runny nose, cough, sore throat and respiratory infections.

Emend (Aprepitant)

Merck - Emend is indicated for preventing the nausea and vomiting associated with cancer chemotherapy. Emend is most effective when combined with other agents given prior to chemotherapy to reduce nausea and vomiting. Side effects include tiredness, dehydration, dizziness and hiccoughs.

Emtriva (Emtricitabine)

Gilead - this is a new addition to drugs used to treat the HIV virus. Emtriva belongs to the class of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTI's). It can be given once a day and is always used with other anti-HIV drugs. It may be useful in those infections which have become resistant to other AIDS drugs in the same or similar classes. Side effects are generally mild to moderate and include headache, diarrhea, and rashes.

Ertaczo (Sertonconazole)

Mylan - Ertaczo is a topical medication approved for the treatment of tinea pedis (athlete's foot) in patient over 12 years old. Improvement should be noted in 2 weeks. The cream is aplied two times a day for 4 weeks. At 2%, Side effects are rare and include burning skin, contact dermitis and skin tenderness.

Estrasorb (Estradiol)

Novavax - this new product is a topical emulsion which is applied to the leggs once a day in the morning. It is indicated for the reduction of severe smptoms which accompany menopause.

Fabrazyme (Agalsidase Beta)

Genzyme - Fabrazyme is the first drug available to treat this rare heridatory disorder. It is a recombinent for of alpha-galactosidase, the enzyme lacking in those with Fabry's disease. Organ accumulation of alpha galactoside leads to multi-organ damage which leads to strokes, heart attacks, kidney damage, and severe pain.

Factive (Gemifloxacin)

LG Life Sciences - Factive is an new addition to the of the currently available fluoroquinolone class of antibiotics. It is indicated for the treatment of bronchitis and pneumonia in adults over 18 years. Side effects include phototoxicity (similar to other flurorquinolones), prolongation of heart QTc interval which can produce cardiac arrhythmias, tendonitis, rash, diarrhea, and altered taste perception. The significance of this new drug in minimal.

FluMist (Influenza Virus Vaccine, Live)

Wyeth - this is the first non-injectable form of influenza vaccine available in the United States. It is given once at the beginning of the influenza season as a nasal mist. it has the obvious advantage over the injection in that it does not require a visit to the clinic or doctors office for the immunization.

Fuzeon (Enfuvirtide)

Roche - for resistant HIV virus infections. Fuzeon is a long awaited significant addition to drugs effective in treating the virus causing AIDS. Fuzeon acts by preventing the fusion of the HIV virus to the white blood cell, a step necessary for incorporation of the virus into the cell and viral replication. Fuzeon is given by injection twice daily. It is effective in HIV infections resistant to other drugs used to treat AIDS. Side effects include: Skin reactions at the injection site, headache, pain, and numbness of feet or legs, dizziness, and insomnia. The annual cost of therapy is expected to be in the $20,000.00 range.

Humira (Adalimumab)

Abbott - this is a significant new addition to the treatment of rheumatoid arthritis. Its mechanism of action, the complexation and inactivation of tumor necrosis factor (TNF) is similar to that of Enbrel and Remicade. Humira has an advantage over the other two drugs in that it is given subcutanously once every two weeks (compared to two times a week for Enbrel while Remicade must be given intravenously). Side effects are similar to Enbrel and include injection site reactions, rashes, and back pain. Like the other TNF-acting antiinflammatory drugs, patients taking Humira may be at risk for the development of infections.

Inspra (Eplerenone)

Pfizer - this is a new oral drug indicated for the treatment of congestive heart failure (CHF) due to heart damage following and acute myocardial infarction (MI). It acts by binding to the mineralocorticoid (aldosterone) receptor which is one system regulating fluid balance in the body. Blockade of this receptor reduces the blood volume and reduces the workload on the heart. It is also effective as an antihypertensive. Clinical studies have shown a Inspra can reduce the mortality associated with CHF following an acute MI. The most significant side effect is hyperkalemia.

Iressa (Gefitinib)

AstraZeneca - Iressa is a significant addition to those drugs available for the treatment of non-small cell lung cancer (NSCLC). Its effect on the cancer is to block a number of growth signals in the cell including tyrosine kinases and also it may block the Epidermal Growth Factor receptor, This oral drug is indicated for patients whose disease continues to progress despite treatment with standard chemotherapy. The response rate of 10% is higher in women and those with adenocarcinoma. Side effects include nausea, vomiting diarrhea and a rash. Of major concern is a rare but sometime fatal interstitial lung disease.

Levitra (Vardenafil)

GSK - Levitra is the second drug approved in the USA for the treatment of male impotence. the mechanism of action is similar to that of Viagra, the first released for that purpose. The mechanism of action is similar which is the inhibition of phosphodiesterase which in turn leads to vasodilitation in the penis followed by an erection. Unlike Viagra, Levitra does not appear to affect vision. It has a duration of action of 16 hors compared to four hours with Viagra. Side effects include: moderate headache, nasal stuffiness, and mild flushing. Like Viagra, Levitra should be used with caution in men with a history of cardiovascular disease.

Lexiva (Fosamprenavir)

GlaxoSmithKline - this is another addition to the class of protease inhibitors used to treat infections due to the HIV virus. Like, Reyataz, also recently approved for use in the USA, Lexiva can be given one daily. The side effect profile is similar to other protease inhibitors.

Namenda (Memantine)

This newly approved drug is a significant addition to the drugs available for the treatment of moderate to severe Alzheimer's disease. Because its mechanism of action is different from that of other agents approved for Alzheimer's disease. It acts by blocking the NMDA receptor which in turn lowers the amount of calcium which enters brain cells. This reduction of the influx of calcium results in a lessening ao many of the symptoms associated with Alzheimer's disease. Side effects are minimal and consist of agitation, drowsiness, lethergy, and occasional nausea. Drug-drug interactions are not know. Namenda should be used with caution for patients with seizure disorders.

Ortho Evra (Norelgestromin with Ethinyl Estradiol)

Ortho-Mcneil - this is the first skin patch approved for use as a contraceptive drug. It is applied weekly for 3 weeks followed by one week where no patch is used. Failure rates of 0.4 to 0.7% were observed with breakhrough bleeding in in 7-18% of women using the patch. 25 of the patches had to be replaced because they came off before the week had ended.

Plenaxis (Abarelix)

Praecis Pharmaceuticals - This is a new injectable drug for the treatment of advance prostate cancer which is unresponsive to other currently available therapies. It acts by blocking the effect of gonadotropin-releasing hormone(GnRH) on stimulating the production of testosterone (testosterone stimulates the growth of prostatic cancer). The result of blocking the effect of GnRH is a lowering of testosterone levels and a reduction in the rate of tumor growth. Side effects include: hot flashes, sleep disturbances, pain, breast enlargement and constipation. Serious allergic reactions are rare but have the potential for being fatal.

Radiogardase (Prussian Blue)

Heyl - this new preparation is indicated for the treatment of radiation contamination due to the ingestion or inhalation of harmful levels of cesium-137 or thallium. This product when taken orally, binds thallium and cesium isotopes in the stomach and intestine allowing them to be passed in the stool thus reducing the body burden of the ingested or inhaled radioisotope.

Raptiva (Efalizumab)

Genetech - this novel and important addition to therapy is a monoclonal antibody is indicated for the treatment of moderate to severe psoriasis. It acts by binding to a class of white blood cells called CD11a leukocytes. These cells are believed to be involved in the skin reactions which produce psoriasis. Binding and inactivation of the CD11a cells prevents them from migrating to the skin and reduces the skin manifestations of psoriasis. Side effects include: serious infections due to suppression of the immune system, low platelet counts, headache, chills, fever,back and joint pain and on occasion, worsening of the psoriasis. Vaccines should be used with caution in those given Raptiva.

Reyataz (Atazanavir)

Bristol - this newest drug for HIV infections is a protease inhibitor thus is in the same class as Crixivan. It can be taken once daily, an advantage over other protease inhibitors. Importantly, it also does not appear to increase blood lipids to the extent of other protease inhibitors and thus may have a lower incidence of lipodystropy as well as a lower chance for significant hyperlipidemia.

Somavert (Pegvisomant)

Pharmacia - This important new drug is indicated for the treatment of acromegly, a condition characterized by excess production of human growth hormone (HGH). It acts by partially blocking the receptor for HGH effectively normalizing the levels of a marker product of HGH stimulation, insulin growth factor. Side effects include: infection, flu-like syndrome, abnormal liver function test results, diarrhea and nausea.

Striant (Testosterone Buccal)

Columbia Labs - this is the first testosterone preparation which uses the buccal cavity as the route for administering testosterone. The preparation is used twice daily and is available as only one dose.

Uroxatral (Alfuzosin)

Sanofi - This medication is indicated for the treatment of benign prostatic hyperplasia (BPH). It belongs to the drug class of alpha-adrenergic blockers. A significant improvement of BPH symptoms of low urine flow was found with Uroxatral compared with placebo. side effects include: Headache, fatigue, and impotence.

Velcade (Bortezomib)

Millenium - this is an important addition to the drugs used to treat multiple myeloma. Velcade belongs to a new class of anticancer drugs called proteasome inhibitors. Velcade is indicated for patients whose disease has relapsed and who have demonstrated resistance to their last treatment. In one clinical trial, 28% of patients showed a response with the duration of response averaging one year. Side effects included: nausea, fatigue, diarrhea, constipation, headache, and numbness and tingling of the extremities.

Xolair (Omalizumab)

Genentech - This is the first monoclonal antibody approved for use in asthma. It specifically binds to IGE, the immunoglobulin which is important in inflammatory reactions. It is indicated for the prophylaxis of moderate to severe asthma. It is not of use in treating acute asthma attacks. Following a subcutaneous injection side effects include: Inflammation and pain at site of injection (45%), viral and upper respiratory tract infections (23%), headache (15%) and pharyngitis (11%).

Zavesca (Miglustat)

Actelion - this important new addition to drugs released in 2003 is indicated for the treatment of Type 1 Gaucher's disease. Zavesca is available as an oral capsule. The most significant side effect is tremors which can affect up to 30% of patients. Both diarrhea (85%) and weight loss (65%) are common side effects, particularly with initial therapy.

Zemaira (Alpha-1-Proteinase Inhibitor (Human))

Aventis - this new agent is indicated for the treatment of emphysema due to an inherited deficiency of alpha-1-proteinase inhibitor. This deficiency leads to deterioration and fibrosis of lung alveoli thus producing clinical emphysema. Approximately 10% of patients with emphysema have this inherited deficiency and may benefit from this therapy.

Zometa (Zoledronic Acid)

Novartis - This drug is indicated for the palliative treatment of bone pain secondary to multimyeloma and the spread of other cancers to the bone. 88% of treated patients had normalization of excess blood calcium levels within 10 days after Zometa therapy. It is given by a 15 minute infusion every 3-4 weeks. Side effects include a flu-like syndrome, and mild gastrointestinal distress. Zometa should be used with extreme caution in an patient with impaired kidney function and with caution along with drugs known to be renal toxic.

Zorbtive (Somatropin [rDNA origin])

Serono - This is a new injectable drug as been approved for the treatment of short bowel syndrome, a potentially fatal condition following surgical removal of portions of the bowel. Controlled studies have shown that Zorbtive significantly lowered the patient dependence on total parenteral nutrition and frequency of need for intravenous nutrition. Side effects include: muscle and joint pain, which subside with continued therapy. Occasionally, Zorbtive can induce new-onset type 2 diabetes with rare cases of ketoacidosis and diabetic coma reported.