new DRUGS for 2008 as approved by FDA

ENDOCRINOLOGY

Accretropin (somatropin rDNA Original)

Accretropin is specifically indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone and for the treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

Accretropin is supplied as a solution designed for subcutaneous administration. The recommended initial dose of the drug is as follows:Growth Hormone DeficiencyThe recommended weekly dose is 0.18 mg/kg body weight to 0.3 mg/kg (0.90 IU/kg) body weight. The dose should be divided into equal daily doses given 6 or 7 times per week subcutaneously.Turner SyndromeThe recommended weekly dose is 0.36 mg/kg of body weight. The dose should be divided into equal daily doses given 6 or 7 times per week subcutaneously.

Side Effects

Adverse events associated with the use of Accretropin for growth hormone deficiency may include, but are not limited to, the following:
injection site reactions
nausea
headache
fatigue
scoliosis

Adverse events associated with the use of Accretropin for Turner Syndrome may include, but are not limited to, the following:
injection site reactions, including erythema, edema, pain, pruritis

Mechanism of Action

Accretropin is a sustained release formulation of recombinant human growth hormone product. This protein is produced by recombinant DNA technology during fermentation in E. coli, yielding a protein containing 192 amino acids. The N-terminal amino acid, methionine, is later removed to yield a protein that is chemically and physicochemically identical to pituitary derived human growth hormone, consisting of 191 amino acids in a single polypeptide chain.

Welchol (colesevelam hydrochloride)

Welchol contains colesevelam hydrochloride, a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent. It works by binding bile acids, including the major bile acid in humans known as glycocholic acid. However, the exact mechanism by which Welchol improves glycemic control is unknown.

Welchol is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Welchol is supplied as a 625 mg tablet designed for oral administration. The recommended initial dose of the drug is 6 tablets once daily or 3 tablets twice daily. Welchol should be taken with a meal and liquid.

Side Effects

Adverse events associated with the use of Welchol may include, but are not limited to, the following:
Constipation
Nasopharyngitis
Dyspepsia
Hypoglycemia
Nausea
Hypertension

Mechanism of Action

Colesevelam hydrochloride, the active pharmaceutical ingredient in Welchol, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. However, the exact mechanism by which Welchol improves glycemic control is unknown.

GASTROENTOLOGY

Cimzia (Certolizumab Pegol)

Cimzia is specifically indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Cimzia is supplied as a powder for reconstitution into a liquid formulation designed for subcutaneous administration. The recommended initial dose of the drug is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.

Side Effects

Adverse events associated with the use of Cimzia may include, but are not limited to, the following:
upper respiratory infection
urinary tract infection
arthralgia
abdominal pain
diarrhea
intestinal obstruction

Mechanism of Action

Certolizumab pegol is a humanized, pegylated tumor necrosis factor alpha (TNF-a) inhibitor. TNFa is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol selectively neutralizes TNFa (IC90 of 4 ng/mL for inhibition of human TNFa in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralize lymphotoxin a (TNFß). Certolizumab pegol was shown to neutralize membrane-associated and soluble human TNFa in a dose-dependent manner.

Entereg (alvimopan)

Entereg is specifically indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.

Side Effects

Adverse events associated with the use of Enetereg may include, but are not limited to, the following:
Constipation
Flatulence
Hypokalemia
Dyspepsia
Anemia
Urinary retention
Back pain

Mechanism of Action

Entereg is an oral, peripherally-acting, mu-opioid receptor (PAMOR) antagonist. Following oral administration, alvimopan antagonizes the peripheral effects of opioids on gastrointestinal motility and secretion by competitively binding to gastrointestinal tract mu-opioid receptors.

Rotarix (Rotavirus Vaccine, Live, Oral)

Rotarix is specifically indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.

Side Effects

Adverse events associated with the use of Rotarix may include, but are not limited to, the following:
Fussiness/irritability
Cough/runny noseFever
Loss of appetite
Loss of appetite
Diarrhea
Dehydration
Gastroenteritis

Mechanism of Action

Rotarix is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.The exact immunologic mechanism by which Rotarix protects against rotavirus gastroenteritis is unknown.

Tysabri (natalizumab)

Tysabri is specifically indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-a.

Side Effects

Adverse events associated with the use of Tysabri may include, but are not limited to, the following:
Headache
Upper respiratory tract infection
Nausea
Influenza
Back pain
Fatigue
Arthralgia
Rash
Pharyngolaryngeal pain

In addition, Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients who have significantly compromised immune system function should not ordinarily be treated with Tysabri. Because of the risk of PML, Tysabri is available only through a special restricted distribution program called the TOUCH Prescribing Program. Under this program only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the product.

Mechanism of Action

Tysabri is a humanized monoclonal antibody that belongs to a class of potential therapeutics known as alpha-4 integrin inhibitors. Tysabri binds to the cell surface receptors known as alpha-4-beta-1 (VLA-4) and alpha-4-beta-7. The receptors for the a4 family of integrins include vascular cell adhesion molecule-1 (VCAM-1), which is expressed on activated vascular endothelium, and mucosal addressin cell adhesion molecule-1 (MAdCAM-1) present on vascular endothelial cells of the gastrointestinal tract. The interaction of the a4ß7 integrin with the endothelial receptor MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of the disease. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T lymphocytes to gut lymph tissue found in Peyer’s patches. MAdCAM-1 expression has been found to be increased at active sites of inflammation in patients with CD, which suggests it may play a role in the recruitment of leukocytes to the mucosa and contribute to the inflammatory response characteristic of CD.

INFECTIOUS DISEASES

Aptivus (tipranavir)

Aptivus is specifically indicated in combination with ritonavir for the treatment of HIV-1 infected patients, adult and pediatrics, who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.

side effects

Adverse events associated with the use of Aptivus in adults may include, but are not limited to, the following:
Diarrhea
Nausea
Pyrexia
Vomiting
Fatigue
Headache
Abdominal pain
Hypertriglyceridemia
Anemia

Adverse events associated with the use of Aptivus in pediatrics may include, but are not limited to, the following:
Pyrexia
Vomiting
Cough
Rash
Nausea
Diarrhea
Epistaxis

Mechanism of Action

Tipranavir is an HIV-1 protease inhibitor that inhibits the virus-specific processing of the viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, thus preventing formation of mature virions. Tipranavir demonstrates antiviral activity in cell culture against a broad panel of HIV-1 group M nonclade B isolates (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF). Group O and HIV-2 isolates have reduced susceptibility in cell culture to tipranavir with EC50 values ranging from 0.164 -1 µM and 0.233-0.522 µM, respectively.

Intelence (etravirine)

Intelence, in combination with other antiretroviral agents, is specifically indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.

Side Effects

Adverse events associated with the use of Intelence may include, but are not limited to, the following:
Rash
Diarrhea
Nausea
Fatigue
Abdominal pain
Peripheral neuropathy
Hypertension
Headache

Mechanism of Action

Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). Etravirine binds directly to reverse transcriptase and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. Etravirine does not inhibit the human DNA polymerases alpha, beta, and gamma.

Moxatag (amoxicillin)

Moxatag is specifically indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 yrs and older.

Side Effects

Adverse events associated with the use of Moxatag may include, but are not limited to, the following:
Vulvovaginal mycotic infection
Diarrhea
Nausea
Vomiting
Headache
Abdominal pain

Mechanism of Action

Moxatag contains amoxicillin, a semi-synthetic antimicrobial belonging to the penicillin class of antimicrobials with activity against gram-positive and gram-negative bacteria. Moxatag is an extended release tablet formulation consisting of three components, one immediate-release and two delayed-release, each containing amoxicillin. The three components are combined in a specific ratio to prolong the release of amoxicillin from Moxatag compared to immediate-release amoxicillin. Amoxicillin exerts its bactericidal action against susceptible organisms during the stage of multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. To date there are no known mechanisms of resistance to penicillin or amoxicillin in Streptococcus pyogenes

MUSCULOSKELETAL

Orencia (abatacept)

Orencia is specifically indicated for reducing signs and symptoms in pediatric patients 6 to 17 years of age with moderately to severely active polyarticular juvenile idiopathic arthritis. It may be used as monotherapy or concomitantly with methotrexate (MTX).

Side Effects

Adverse events associated with the use of Orencia in this population may include, but are not limited to, the following:
Upper respiratory tract infection
Nasopharyngitis
Headache
Nausea
Diarrhea
Cough
Pyrexia
Abdominal pain
Concurrent administration of a TNF antagonist with ORENCIA has been associated with an increased risk of serious infections and no significant additional efficacy over use of the TNF antagonists alone. Concurrent therapy with ORENCIA and TNF antagonists is not recommended.

Mechanism of Action

Abatacept, a selective costimulation modulator, inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. Activated T lymphocytes are implicated in the pathogenesis of RA and are found in the synovium of patients with RA.

NEUROLOGY

Durezol (difluprednate)

Durezol is specifically indicated for the treatment of inflammation and pain associated with ocular surgery.

Side Effects

Adverse events associated with the use of Durezol may include, but are not limited to, the following:
elevated intraocular pressure
visual acuity and field defects
posterior subcapsular cataract formation
posterior subcapsular cataract formation
secondary ocular infection from pathogens
perforation of the globe
corneal edema
ciliary and conjunctival hyperemia
eye pain
photophobia
posterior capsule opacification
anterior chamber flare
conjunctival edema
blepharitis

Mechanism of Action

Durezol is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Corticosteroids inhibit the inflammatory response to a variety of inciting agents that may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid.

ONCOLOGY

Treanda (bendamustine hydrochloride)

Treanda for Injection is specifically indicated for the treatment of chronic lymphocytic leukemia.

Side Effects

Adverse events associated with the use of Treanda may include, but are not limited to, the following:
Neutropenia
Pyrexia
Thrombocytopenia
Nausea
Anemia
Leukopenia
Vomiting
Diarrhea
Fatigue
Asthenia

Mechanism of Action

Treanda contains bendamustine hydrochloride, an alkylating drug and PARP modulator, as the active ingredient. Bendamustine is a bifunctional mechlorethamine derivative. Mechlorethamine and its derivatives dissociate into electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties. The bifunctional covalent linkage can lead to cell death via several pathways. However, the exact mechanism of action is unknown.

OTOLARYNGOLOGY

Patanase (olopatadine hydrochloride)

Patanase is specifically indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

Side Effects

Adverse reactions associated with the use of Patanase may include, but are not limited to, the following:
Bitter taste
Headache
Epistaxis
Pharyngolaryngeal Pain
Post-nasal drip
Cough
Urinary tract infection

Mechanism of Action

Patanase is an antihistamine with selective H1 -receptor antagonist activity: its principal effects are mediated via inhibition of H1 receptors. These drugs selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. They act in the bronchi, capillaries, and other smooth muscles. Histamine acts as a pro-inflammatory signal released from mast cells in response to allergic reactions or tissue damage.

Alvesco (ciclesonide)

Alvesco is specifically indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

Side Effects

Adverse events associated with the use of Alvesco may include, but are not limited to, the following:
Headache
Nasopharyngitis
Upper respiratory Infection
Sinusitis
Pharyngolaryngeal pain
Nasal congestion
Back pain
Arthralgia
Pain in extremity

Mechanism of Action

Alvesco is a non-halogenated glucocorticoid prodrug delivered via a metered dose inhaler. It is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following oral inhalation. Des-ciclesonide has anti-inflammatory activity with affinity for glucocorticoid receptors that is 120 times greater than the parent compound and 12 times greater than dexamethasone.

PSYCHIATRIC

Aplenzin (bupropion hydrobromide)

Aplenzin is an orally-active enhanced-absorption salt of bupropion. It belongs to the class of antidepressants known as aminoketones.
Aplenzin is specifically indicated for the treatment of major depresive disorder.

Side Effects

Adverse events associated with the use of Cimzia may include, but are not limited to, the following:
Dry mouth
nausea
insomnia
dizziness
pharyngitis
abdominal pain
agitation
anxiety
tremor
palpitation
sweating
tinnitus
myalgia
anorexia
urinary frequency
rash

Mechanism of Action

Aplenzin is an orally-active enhanced-absorption salt of bupropion. It belongs to the class of antidepressants known as aminoketones. Aplenzin is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. The mechanism of action of bupropion is unknown, however it is presumed that the action is mediated by noradrenergic and/or dopaminergic mechanisms.