New Drugs and Devices 2002

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Sof-Tact (Abbott)

Sof-Tact is a new device which allows you to combine the separate steps of blood glucose testing into one single meter. It is causes less pain than finger-stick systems and holds up to 450 results.

Aranesp (Darbepoetin)

Amgen - this is a newer form of erythropoietin (EPO). EPO stimulates the bone marrow production of red blood cells. It, like earlier versions, is used to treat moderate to sever anemia, a consequence of chronic infections, kidney dialysis, or chemotherapy for cancer. This new preparation has the advantage of needing to be given every two-three weeks instead of once weekly as with the older preparations of EPO.

Arixtra (Fondaparinux)

This injection has been approved for the prevention of deep vein thrombosis and pulmonary emboli associated with orthopedic surgical procedures. It acts by inhibiting the clotting factor X thus preventing the formation of blood clots. It appears to be twice as effective as enoxaparin, one of the current standards in thrombosis prevention. Limited data suggest that there may be a higher risk of bleeding with this agent compared to others in its field. After administration it has a half-life of 14-18 hours.

Avinza (Morphine-Extended Release)

Ligand - This oral morphine preparation can be taken once a day. It has both an immediate release and delayed release component giving a morphine blood level which is maintained for 24 hours.

Avodart (Dutasteride)

Lilly - Avodart is the second drug of its class to treat the symptoms of prostatic hypertrophy. It produces a reduction in prostate volume, an improvement in symptoms of urinary retention and hestancy and a reduction in the need for BPH-related surgery. It acts to inhibit the action of the 5-alpha reductase, a necessary step in the production of testosterone. Side effects are mild and include: impotence (4.7%), decreased libido (3%), breast tenderness (0.5%) and ejaculation disorders (1.4%). More Patient Medication Info

Bextra (Valdecoxib)

Pharmacis - this is the third drug in the class of Cox-2 inhibitors which are used to treat inflammation. These drugs are use mainly to treat arthritis and although likely no more effective than the non-steroidal antiinflammatory drugs such as ibuprofen and naproxen, there is a lower incidence of gastrointestinal side effects. There is a suggestion that while the other two market drugs Celebrex and Vioxx may increase the risk for heart attacks and stroke, Bextra may not increase the risk for those diseases. Side effects were very mild and did not exceed those of a placebo.

Bravelle (Urofolitropin)

Ferring - This newly approved injectable drug is indicated for the treatment of infertility due to inadequate levels of gonadotropin. It may have an advantage over other similar drugs containing only Urolfolitropin in purified form while other similar products also contain luteinizing hormone (LH). Side effects: Pain at the site of injection, lower abdominal tenderness, fluid retention, and breast discomfort.

Doxil (Liposomal Doxorubicin)

Sequus - This new dose form of doxorubicin has been approved for the treatment of refractory Kaposi's sarcoma, a complication of infections with the HIV virus. Improvement was observed in 60% of patients receiving DOXIL however less than 3% of patients had a complete response. The major side effect is a decrease in white blood cells (neutropenia).

Elidel (Pimecrolimus)

Novartis - this new topical cream as been approved for use in the treatment of mild to moderate eczema or atopic dermatitis. the most common side effect was a mild to moderate feeling of warmth experienced in 8-26% of patients - fewer children experienced side effects than adults.

Elitek (Rasburicase)

Sanofi - Elitek is indicated for the treatment of elevated blood levels of uric acid, a common complication of anti-cancer chemotherapy. It is a particular value in children with leukemia or lymphoma, tumors with a high cell turnover rate. It is given intravenously. Major side effects are: hemolysis, methemolglobenia, and possible electrolyte disturbances.

Eloxatin (Oxaliplatin)

Sanofi - this newly approved injectable drug is indicated for the treatment of colorectal cancer. Due to the fact there are only a few drugs active against this form of cancer, this newly approved drug is a significant addition to the therapy available for cancer of the colon. 10% of patients whose tumors has become unresponsive to standard therapy had a significant reduction in tumor size which was maintained for 4.6 months.

Faslodex (Fulvestrant)

AstraZeneca - This new drug is indicated for the treatment of estrogen receptor positive breast cancer. Faslodex is given by injection once a month. Side effects include headache, back pain, hot flashes and pharyngitis.

Focalin (dexmethylhenidate)

Novartis - This is the dextrorotary isomer of methylphenidate which as Ritalin consists of both the d- and l- forms. It is indicated for the treatment of attention deficit/hyperreactivity disorder. The effective dose is 1/2 that of methylphenidate. It is unclear whether this offers any advantage over the d-, l-isomer.

Foradil(Formoterol)

Novartis - this newly approved steroid drug for inhalation has been approved for the treatment of bronchoconstriction associated with chronic obstructive pulmonary disease. It is given two times a day.

Forteo(Teriparatide)

Lilly - Forteo is indicated for the treatment of osteoporosis both in postmenopausal women and men with primary or hypogonadal osteoporosis. It is given as an injection once a month at home using a disposable injection pen which comes with the medication. It must be refrigerated. Side effects are mild and include: dizziness and leg cramps.

Hepsera (Eplerenone)

Gilead - This orally administered new drug is indicated for the treatment of chronic hepatitis B in adults with evidence of persistent presence of virus and/or continued abnormalities of liver function markers in patients with a previous history of hepatitis B infection. Normalization of liver function (ALT) occurred in 48% of patients on Hepsera compared with 16% on placebo. Side effects include: weakness (13%), headache (9%), abdominal pain (9%) and nausea (5%).

Inspra (Eplerenone)

Pharmacia - this new aldosterone blocking drug is given orally and is indicated for the treatment of hypertension. It may be useful in patients, particularly blacks, whose response to older agents has not been satisfactory. Side effects are mild and included dizziness and weakness.

Invanz (Ertapenem)

Merck - An injectable antibiotic of the beta-lactam class. It is active against a wide variety of organisms including gram positive, gram negative, and importantly, anaerobic bacilli. It is indicated in the treatment of moderate to severe infections. Because it has a penicillin-like structure it should be used with extreme caution in patients allergic to penicillin and cephalosporins.

Kytril (Granisetron)

This drug is available both as oral tablets and as an injection. It joins Zofran (Ondansetron) as an antiemetic and antinauseant with 69% of patients undergoing cancer chemotherapy completely responding with no nausea or vomiting following chemotherapy. The main side effect was headache experienced by 14% of patients.

Lexapro (Escitalopram)

Forest - This is the levoisomer of the antidepressant Celexa, also by Forest Laboratories. Lexapro may have advantages over Celexa in that it workds more quickly (in 1-2 weeks) and may have a lower incidence of nausea and dry mouth. It is unclear whether it any more effective than Celexa or other serotnin-reuptake inhibitors (SSRI's)

Neulasta (Pegfilgastrim)

Amgen this is a a new formulation of human G-CSF (Colony Stimulating Factor). It is used to stimulate the bone-marrow following cancer chemotherapy which produces severe bone marrow depression. The most common adverse attributed to Neulasta was bone pain in 26% of patients. This required pain medication in 18% of affected patients. The advantage to this new form is that it is administered only once during the chemotherapy cycle. Neulasta requires refrigeration. Available in April 2002.

Orfadin (Nitisinone)

Orphan - Orfadin which is taken by mouth, is indicated for the treatment of hereditary tyrosinemia (HT-1), which is an overproduction of the amino acid tyrosine. This is a rare disease affecting children which results in progressive liver failure and liver cancer. This drug should be used in conjunction with a diet low in tyrosine. It acts by preventing the metabolism. It acts by preventing the metabolism of tyrosine to two toxic metabolites which are believed to be responsible for the symptoms of this disease.

Ortho Evra (Norelgestromin/ethinyl Estradiol)

Ortho - This is a transdermal patch used for birth control. Each patch is worn for one week. This new dose form may result in increased compliance and a lower failurerate than the birth control pills.

Rebif (Interferon Beta-1a)

Rebif® is a type of beta interferon, which is a family of naturally occurring proteins and glycoproteins that are produced by cells in response to biological inducers such as interleukin 2 (IL-2), IL-1, tumor necrosis factor (TNF), and viruses. Rebif® is indicated for the treatment of patients with the relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability. In a comparative study, patients were almost twice as likely to be free of relapses on Rebif® than when using another available interferon beta-1a, Avonex®. Side effects of Rebif® appear to be similar to those seen with Avonex®, but injection site reactions, liver problems, and reductions in white blood cell counts may be greater with Rebif®. Avonex® is given as an intramuscular injection once a week whereas Rebif® is given by subcutaneous injection three times a week. At the indicated doses, Rebif® has more antiviral activity than Avonex®. Rebif®, marketed by Serono A.G., will be available in 0.5 mL pre-filled, single-use syringes containing 44 mcg interferon beta-1a and in a starter pack of syringes containing 22 mcg interferon beta-1a.

Remodulin (Treprostinil)

United Therapeutics - Remodulin is the second drug approved for the treatment of pulmonary artery hypertension. It is given by constant infusion via a mini pump connected to a subcutaneous catheter implanted in various locations in the stomach. The duration is 4-6 hours. Side effects include jaw pain, headache, flushing, nausea, and pain at the subcutaneous injection site.

Secreflo (Secretin)

Repligen - this new drug is a synthetic form of the natural stimulant for pancreatic flow, secretin. It has been approved in the USA for diagnostic test purposes evaluating pancreatic function.

Strattera (Atomoxetine)

Lilly - this is a significant advance in the treatment of Attention Deficit Hyperreactivity Disorder (ADHD). Unlike the amphetamines currently used to treat ADHD, this medication taken by mouth is not classified as a Controlled Drug and thus prescriptions can be written for more than a limited supply and may be FAXed to a pharmacy. Strattera should not be used within 2 weeks of taking a MAO-inhibitor. Side effects in children are: deceased appetite, nausea, tiredness, and mood swings. In adults, dry mouth, insomnia, decreased appetite, dizziness and decreased libido. Urinary retention or hesitancy may be possible.

Tracleer (Bosentan)

Genentech - Indication: Pulmonary Artery Hypertension (PAH) - This oral preparation is a significant addition for the treatment of this serious condition. Tracleer acts by acting as a endothelin receptor antagonist. Endothelin is a vasoconstricting agent normally produced in the body. A significant improvement occurred in functioning (walking) and other exercise measures. In addition, Tracleer delayed the time before hospitalization and intravenous treatment for PAH was required.

Vfend (Voriconazole)

Pfizer - This is a new antifungal drug available both as an oral and intravenous preparation. It is indicated for the primary treatment of Aspergillosis. It is also approved for the treatment of S. apiospermum and Fusarium spp. It appears to be more effective than amphotericin B. The most common side effects are: skin rash, visual disturbances, and elevations of liver function tests. (available Summer 2002).

Viread (Tenofovir)

Gilead - this is a new addition to the drugs used to treat AIDS. It acts by inhibiting viral reverse transcriptase, an enzyme required for the replication of the virus which produces AIDS. It has the advantage of once daily dosing which should improve patient compliance. Viread is effective in patients who have become resistant to other older treatments for AIDS. Unlike most other antiretroviral drugs, side effects are in most part mild to moderate and are mostly gastrointestinal including nausea, diarrhea, vomiting and flatulence.

Xigris (Drotrecogin Alfa, Activated)

Indication: Systemic sepsis - This new injectable form of activated protein C is indicated in the treatment of gram positive and negative systemic sepsis in patients who are very ill. The death rate in severely ill patients was reduced from 44 to 31%. No benefit was seen in less severely ill patients. The major side effect is bleeding.

Zelnorm (Tegaserod)

Novartis - This new oral agent is indicated for the treatment of women with irritable bowel syndrome. It joins Lotronex (highly restricted in the USA) as being the second drug for this debilitating condition. It is a serotonin-4 receptor agonist (stimulates the receptor). In studies in over 2400 women, Zelnorm provided relief of symptoms of abdominal pain, bloating and constipation. Side effects were generally mild with headache in 15%of patients and diarrhea in 9%. The diarrhea resolved with continued therapy.

Zetia (Exetimibe)

Merck/Schering - this new drug taken orally acts to reduce blood lipids via a mechanism different from other cholesterol reducing agents. It acts by inhibiting the intestinal absorption of cholesterol and related lipids. It is proposed to be used in conjunction with other lipid lowering agents and the “statins” and should have an additive effect with those other agents. Side effects were reported in 4% of patients with diarrhea (3.7%), abdominal pain (3%), back pain (4.1%), and sinusitis (3.6%) being the most common.

Zevalin (90Y-Ibritumomab Tiuxetan)

IDEC - this agent which combines radioactive yttrium with an antibody specific for receptors on the beta cells associated with non-Hodgkin's lymphoma. As would be expected the major side effect is bone marrow depression which returns to normal in 4-8 weeks after therapy. The combination therapy was found to be more effective than Rituxan (rituximab), which is now available in the United States.

Zometa (Zoledronate)

Novartis - This injection is used to treat high blood calcium (hypercalcemia). It acts by inhibiting bone resorption thus preventing the release of calcium from the bone when bone resorption occurs. The primary indication for Zometa is hypercalcemia occurring as a result of a malignancy which has expanded to affect the bone.