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Avastin

 

In 2004 approved by FDA as a first-line treatment of patients with metastatic carcinoma of the colon and rectum (in combination with intravenous 5-fluorouracil-based chemotherapy).
In 2006 approved by FDA as a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy.
In February 2008, the FDA approved Avastin for use with chemotherapy to treat certain cases of advanced breast cancer.
In 2009 the FDA has approved the drug Avastin to treat a type of brain cancer called glioblastoma that progresses despite treatment with other therapies. key phrases: avasting side effects, clinical trials for avastin, avastin cost, avastin breast cancer, avastin ovarian cancer.
Avastin is widely used "off label" as a considerably cheaper alternative to the approved drug ranibizumab (Lucentis) to prevent wet age related macular degeneration (AMD) and several large trials comparing the two drugs are now underway.

Avastin generic (generic - what is it?)

Dosage Packing Price Add to basket
100 mg per 4 mL single-use vial USD 795.00 Add to Basket
400 mg per 16 mL single-use vial USD 1997.00 Add to Basket


Avastin: Medications and Prescriptions

Generic name: Bevacizumab


Avastin description

Indications and Usage:

1.1.Metastatic Colorectal Cancer (mCRC)
Avastin is indicated for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil–based chemotherapy.

1.2 Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
Avastin is indicated for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer in combination with carboplatin and paclitaxel.

1.3 Metastatic Breast Cancer (MBC)
Avastin is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer in combination with paclitaxel. The effectiveness of Avastin in MBC is based on an improvement in progression free survival. There are no data demonstrating an improvement in disease-related symptoms or increased survival with Avastin.

Avastin is not indicated for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.

1.4 Glioblastoma
Avastin is indicated for the treatment of glioblastoma with progressive disease following prior therapy as a single agent.
The effectiveness of Avastin in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with Avastin.

Description:
Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Avastin has an approximate molecular weight of 149 kD. Bevacizumab is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
Avastin is a clear to slightly opalescent, colorless to pale brown, sterile, pH 6.2 solution for intravenous infusion. Avastin is supplied in 100 mg and 400 mg preservative-free, single-use vials to deliver 4 mL or 16 mL of Avastin (25 mg/mL). The 100 mg product is formulated in 240 mg α,α-trehalose dihydrate, 23.2 mg sodium phosphate (monobasic, monohydrate), 4.8 mg sodium phosphate (dibasic, anhydrous), 1.6 mg polysorbate 20, and Water for Injection, USP. The 400 mg product is formulated in 960 mg α,α-trehalose dihydrate, 92.8 mg sodium phosphate (monobasic, monohydrate), 19.2 mg sodium phosphate (dibasic, anhydrous), 6.4 mg polysorbate 20, and Water for Injection, USP.

Mechanism of Action:
Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused reduction of microvascular growth and inhibition of metastatic disease progression.

Pharmacokinetics:
The pharmacokinetic profile of bevacizumab was assessed using an assay that measures total serum bevacizumab concentrations (i.e., the assay did not distinguish between free bevacizumab and bevacizumab bound to VEGF ligand). Based on a population pharmacokinetic analysis of 491 patients who received 1 to 20 mg/kg of Avastin weekly, every 2 weeks, or every 3 weeks, the estimated half-life of bevacizumab was approximately 20 days (range 11−50 days). The predicted time to reach steady state was 100 days. The accumulation ratio following a dose of 10 mg/kg of bevacizumab every 2 weeks was 2.8. The clearance of bevacizumab varied by body weight, gender, and tumor burden. After correcting for body weight, males had a higher bevacizumab clearance (0.262 L/day vs. 0.207 L/day) and a larger Vc (3.25 L vs. 2.66 L) than females. Patients with higher tumor burden (at or above median value of tumor surface area) had a higher bevacizumab clearance (0.249 L/day vs. 0.199 L/day) than patients with tumor burdens below the median. In Study 1, there was no evidence of lesser efficacy (hazard ratio for overall survival) in males or patients with higher tumor burden treated with Avastin as compared to females and patients with low tumor burden. The relationship between bevacizumab exposure and clinical outcomes has not been explored.

Administration
Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion.
Do not initiate Avastin until at least 28 days following major surgery. Administer Avastin after the surgical incision has fully healed.
First infusion: Administer infusion over 90 minutes.
Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated; administer all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Recommended Doses and Schedules:
Patients should continue treatment until disease progression or unacceptable toxicity.
Metastatic Colorectal Cancer (mCRC)
The recommended doses are 5 mg/kg or 10 mg/kg every 2 weeks when used in combination with intravenous 5-FU-based chemotherapy.
Administer 5 mg/kg when used in combination with bolus-IFL.
Administer 10 mg/kg when used in combination with FOLFOX4.
Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
The recommended dose is 15 mg/kg every 3 weeks.
Metastatic Breast Cancer (MBC)
The recommended dose is 10 mg/kg every 2 weeks.
Glioblastoma
The recommended dose is 10 mg/kg every 2 weeks.

Preparation for Administration:
Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Withdraw necessary amount of Avastin and dilute in a total volume of 100 mL of 0.9% Sodium Chloride Injection, USP. Discard any unused portion left in a vial, as the product contains no preservatives.
DO NOT ADMINISTER OR MIX WITH DEXTROSE SOLUTION.

Dose Modifications
There are no recommended dose reductions.
Discontinue Avastin for:
• Gastrointestinal perforations (gastrointestinal perforations, fistula formation in the gastrointestinal tract, intra-abdominal abscess), fistula formation involving an internal organ [See Boxed Warning, Warnings and Precautions.
• Wound dehiscence and wound healing complications requiring medical intervention [See Warnings and Precautions.
• Serious hemorrhage (i.e., requiring medical intervention) [See Boxed Warning, Warnings and Precautions.
• Severe arterial thromboembolic events [See Warnings and Precautions.
• Hypertensive crisis or hypertensive encephalopathy [See Warnings and Precautions.
• Reversible posterior leukoencephalopathy syndrome (RPLS) [See Warnings and Precautions.
• Nephrotic syndrome [See Warnings and Precautions.
Temporarily suspend Avastin for:
• At least 4 weeks prior to elective surgery [See Warnings and Precautions.
• Severe hypertension not controlled with medical management [See Warnings and Precautions.
U.S. BL 125085/169 Amendment: Bevacizumab⎯Genentech, Inc.
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• Moderate to severe proteinuria pending further evaluation [See Warnings and Precautions.
• Severe infusion reactions [See Warnings and Precautions.

Dosage forms and strengths:
100 mg per 4 mL single-use vial
400 mg per 16 mL single-use vial

Contraindications:
None.

Warnings and precautions
5.1 Gastrointestinal Perforations
Serious and sometimes fatal gastrointestinal perforation occurs at a higher incidence in Avastin treated patients compared to controls. The incidence of gastrointestinal perforation ranged from 0.3 to 2.4% across clinical studies. [See Adverse Reactions.
The typical presentation may include abdominal pain, nausea, emesis, constipation, and fever. Perforation can be complicated by intra-abdominal abscess and fistula formation. The majority of cases occurred within the first 50 days of initiation of Avastin.
Discontinue Avastin in patients with gastrointestinal perforation. [See Boxed Warning, Dosage and Administration.

5.2 Surgery and Wound Healing Complications
Avastin impairs wound healing in animal models. [See Nonclinical Toxicology. In clinical trials, administration of Avastin was not allowed until at least 28 days after surgery. In a controlled clinical trial, the incidence of wound healing complications, including serious and fatal complications, in patients with mCRC who underwent surgery during the course of Avastin treatment was 15% and in patients who did not receive Avastin, was 4%. [See Adverse Reactions.
Avastin should not be initiated for at least 28 days following surgery and until the surgical wound is fully healed. Discontinue Avastin in patients with wound healing complications requiring medical intervention.
The appropriate interval between the last dose of Avastin and elective surgery is unknown; however, the half-life of Avastin is estimated to be 20 days. Suspend Avastin for at least 28 days prior to elective surgery. Do not administer Avastin until the wound is fully healed. [See Boxed Warning, Dosage and Administration.

5.3 Hemorrhage
Avastin can result in two distinct patterns of bleeding: minor hemorrhage, most commonly Grade 1 epistaxis; and serious, and in some cases fatal, hemorrhagic events. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently in patients receiving Avastin compared to patients receiving only chemotherapy. Across indications, the incidence of Grade ≥ 3 hemorrhagic events among patients receiving Avastin ranged from 1.2 to 4.6%. [See Adverse Reactions.
Serious or fatal pulmonary hemorrhage occurred in four of 13 (31%) patients with squamous cell histology and two of 53 (4%) patients with non-squamous non-small cell lung cancer receiving Avastin and chemotherapy compared to none of the 32 (0%) patients receiving chemotherapy alone.
In clinical studies in non−small cell lung cancer where patients with CNS metastases who completed radiation and surgery more than 4 weeks prior to the start of Avastin were evaluated with
U.S. BL 125085/169 Amendment: Bevacizumab⎯Genentech, Inc.
6 of 22/Regional (Glioblastoma): Final Avastin PI (May 2009).doc
serial CNS imaging, symptomatic Grade 2 CNS hemorrhage was documented in one of 83 Avastin-treated patients (rate 1.2%, 95% CI 0.06%−5.93%).
Intracranial hemorrhage occurred in 8 of 163 patients with previously treated glioblastoma; two patients had Grade 3−4 hemorrhage.
Do not administer Avastin to patients with recent history of hemoptysis of ≥1/2 teaspoon of red blood. Discontinue Avastin in patients with hemorrhage. [See Boxed Warning, Dosage and Administration.

5.4 Non-Gastrointestinal Fistula Formation
Serious and sometimes fatal non-gastrointestinal fistula formation involving tracheo-esophageal, bronchopleural, biliary, vaginal and bladder sites occurs at a higher incidence in Avastin-treated patients compared to controls. The incidence of non-gastrointestinal perforation was <0.3% in clinical studies. Most events occurred within the first 6 months of Avastin therapy.
Discontinue Avastin in patients with fistula formation involving an internal organ. [See Dosage and Administration (2.4).]

5.5 Arterial Thromboembolic Events
Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and a variety of other ATE occurred at a higher incidence in patients receiving Avastin compared to those in the control arm. Across indications, the incidence of Grade ≥ 3 ATE in the Avastin containing arms was 2.6% compared to 0.8% in the control arms. Among patients receiving Avastin in combination with chemotherapy, the risk of developing ATE during therapy was increased in patients with a history of arterial thromboembolism, or age greater than 65 years. [See Use in Specific Populations.
The safety of resumption of Avastin therapy after resolution of an ATE has not been studied. Discontinue Avastin in patients who experience a severe ATE. [See Dosage and Administration.

5.6 Hypertension
The incidence of severe hypertension is increased in patients receiving Avastin as compared to controls. Across clinical studies the incidence of Grade 3 or 4 hypertension ranged from 5-18%.
Monitor blood pressure every two to three weeks during treatment with Avastin. Treat with appropriate anti-hypertensive therapy and monitor blood pressure regularly. Continue to monitor blood pressure at regular intervals in patients with Avastin-induced or -exacerbated hypertension after discontinuation of Avastin.
Temporarily suspend Avastin in patients with severe hypertension that is not controlled with medical management. Discontinue Avastin in patients with hypertensive crisis or hypertensive encephalopathy. [See Dosage and Administration.

5.7 Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
RPLS has been reported with an incidence of <0.1% in clinical studies. The onset of symptoms occurred from 16 hours to 1 year after initiation of Avastin. RPLS is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present. Magnetic resonance imaging (MRI) is necessary to confirm the diagnosis of RPLS.
Discontinue Avastin in patients developing RPLS. Symptoms usually resolve or improve within days, although some patients have experienced ongoing neurologic sequelae. The safety of reinitiating Avastin therapy in patients previously experiencing RPLS is not known. [See Dosage and Administration (2.4).

5.8 Proteinuria
The incidence and severity of proteinuria is increased in patients receiving Avastin as compared to controls. Nephrotic syndrome occurred in < 1% of patients receiving Avastin in clinical trials, in
U.S. BL 125085/169 Amendment: Bevacizumab⎯Genentech, Inc.
7 of 22/Regional (Glioblastoma): Final Avastin PI (May 2009).doc
some instances with fatal outcome. [See Adverse Reactions (6.1).] In a published case series, kidney biopsy of six patients with proteinuria showed findings consistent with thrombotic microangiopathy.
Monitor proteinuria by dipstick urine analysis for the development or worsening of proteinuria with serial urinalyses during Avastin therapy. Patients with a 2 + or greater urine dipstick reading should undergo further assessment, e.g. a 24-hour urine collection.
Suspend Avastin administration for ≥ 2 grams of proteinuria/24 hours and resume when proteinuria is < 2 gm/24 hours. Discontinue Avastin in patients with nephrotic syndrome. [See Use in Specific Populations (8.5).] The safety of continued Avastin treatment in patients with moderate to severe proteinuria has not been evaluated. [See Dosage and Administration (2.4).]

5.9 Infusion Reactions
Infusion reactions reported in the clinical trials and post-marketing experience include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, chest pain, headaches, rigors, and diaphoresis. In clinical studies, infusion reactions with the first dose of Avastin were uncommon (< 3%) and severe reactions occurred in 0.2% of patients.
Stop infusion if a severe infusion reaction occurs and administer appropriate medical therapy.

Adverse reactions:
The following serious adverse reactions are discussed in greater detail in other sections of the label:
• Gastrointestinal Perforations [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.1).]
• Surgery and Wound Healing Complications [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.2).]
• Hemorrhage [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.3).]
• Non-Gastrointestinal Fistula Formation [See Dosage and Administration (2.4), Warnings and Precautions (5.4).]
• Arterial Thromboembolic Events [See Dosage and Administration (2.4), Warnings and Precautions (5.5).]
• Hypertensive Crisis [See Dosage and Administration (2.4), Warnings and Precautions (5.6).]
• Reversible Posterior Leukoencephalopathy Syndrome [See Dosage and Administration (2.4), Warnings and Precautions (5.7).]
• Proteinuria [See Dosage and Administration (2.4), Warnings and Precautions (5.8).]
The most common adverse reactions observed in Avastin patients at a rate > 10% and at least twice the control arm rate, are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, and exfoliative dermatitis.
Across all studies, Avastin was discontinued in 8.4 to 20.3% of patients because of adverse reactions.

6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data below reflect exposure to Avastin in 2324 patients with mCRC, non-squamous NSCLC, MBC, or glioblastoma in controlled (Studies 1, 2, 4, 5 and 6) or uncontrolled, single arm (Study 7) trials treated at the recommended dose and schedule for a median of 8 to 11 doses of Avastin. [see Clinical Studies (14).] The population was aged 21-88 years (median 59), 42.8% male and 82.4% white. The population included 1089 first- and second-line mCRC patients who received a median of 11 doses of Avastin, 480 first-line metastatic NSCLC patients who received a median of 8 doses
U.S. BL 125085/169 Amendment: Bevacizumab⎯Genentech, Inc.
8 of 22/Regional (Glioblastoma): Final Avastin PI (May 2009).doc
of Avastin, 592 MBC patients who had not received chemotherapy for metastatic disease received a median of 8 doses of Avastin, and 163 glioblastoma patients who received a median of 9 doses of Avastin.
Surgery and Wound Healing Complications
The incidence of post-operative wound healing and/or bleeding complications was increased in patients with mCRC receiving Avastin as compared to patients receiving only chemotherapy. Among patients requiring surgery on or within 60 days of receiving study treatment, wound healing and/or bleeding complications occurred in 15% (6/39) of patients receiving bolus-IFL plus Avastin as compared to 4% (1/25) of patients who received bolus-IFL alone.
In Study 7, events of post-operative wound healing complications (craniotomy site wound dehiscence and cerebrospinal fluid leak) occurred in patients with previously treated glioblastoma: 3/84 patients in the Avastin alone arm and 1/79 patients in the Avastin plus irinotecan arm. [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.2).]
Hemorrhage
The incidence of epistaxis was higher (35% vs. 10%) in patients with mCRC receiving bolus-IFL plus Avastin compared with patients receiving bolus-IFL plus placebo. All but one of these events were Grade 1 in severity and resolved without medical intervention. Grade 1 or 2 hemorrhagic events were more frequent in patients receiving bolus-IFL plus Avastin when compared to those receiving bolus-IFL plus placebo and included gastrointestinal hemorrhage (24% vs. 6%), minor gum bleeding (2% vs. 0), and vaginal hemorrhage (4% vs. 2%). [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.3).]
Venous Thromboembolic Events
The incidence of Grade 3−4 venous thromboembolic events was higher in patients with mCRC or NSCLC receiving Avastin with chemotherapy as compared to those receiving chemotherapy alone. The risk of developing a second subsequent thromboembolic event in mCRC patients receiving Avastin and chemotherapy was increased compared to patients receiving chemotherapy alone. In Study 1, 53 patients (14%) on the bolus-IFL plus Avastin arm and 30 patients (8%) on the bolus-IFL plus placebo arm received full dose warfarin following a venous thromboembolic event. Among these patients, an additional thromboembolic event occurred in 21% (11/53) of patients receiving bolus-IFL plus Avastin and 3% (1/30) of patients receiving bolus-IFL alone.
The overall incidence of Grade 3−4 venous thromboembolic events in Study 1 was 15.1% in patients receiving bolus-IFL plus Avastin and 13.6% in patients receiving bolus-IFL plus placebo. In Study 1, the incidence of the following Grade 3−4 venous thromboembolic events was higher in patients receiving bolus-IFL plus Avastin as compared to patients receiving bolus-IFL plus placebo: deep venous thrombosis (34 vs. 19 patients) and intra-abdominal venous thrombosis (10 vs. 5 patients).
Neutropenia and Infection
The incidences of neutropenia and febrile neutropenia are increased in patients receiving Avastin plus chemotherapy compared to chemotherapy alone. In Study 1, the incidence of Grade 3 or 4 neutropenia was increased in mCRC patients receiving IFL plus Avastin (21%) compared to patients receiving IFL alone (14%). In Study 4, the incidence of Grade 4 neutropenia was increased in NSCLC patients receiving paclitaxel/carboplatin (PC) plus Avastin (26.2%) compared with patients receiving PC alone (17.2%). Febrile neutropenia was also increased (5.4% for PC plus Avastin vs. 1.8% for PC alone). There were 19 (4.5%) infections with Grade 3 or 4 neutropenia in the PC plus Avastin arm of which 3 were fatal compared to 9 (2%) neutropenic infections in patients receiving PC alone, of which none were fatal. During the first 6 cycles of treatment, the incidence of serious infections including pneumonia, febrile neutropenia, catheter infections and wound infections was
U.S. BL 125085/169 Amendment: Bevacizumab⎯Genentech, Inc.

AVASTIN NEWS:
Avastin Dramatically Improves Response, Survival In Deadly Recurrrent Glioblastomas, Study Finds
ScienceDaily (Sep. 3, 2009) — A study has found that the targeted therapy Avastin, alone and in combination with the chemotherapy drug CPT-11, significantly increased response rates, progression-free survival times and survival rates in patients with a deadly form of brain cancer that had recurred.
Patients with recurrent glioblastoma have a grim prognosis, and conventional treatments were typically limited to largely ineffective and highly toxic chemotherapies. Only about 5 percent of patients respond to further treatment – meaning their tumors shrink by 50 percent or more. And only 15 to 20 percent of patients make it to the six month mark before their disease progresses again. Survival is limited to six to seven months.

But a randomized Phase II study of Avastin alone and Avastin given with CPT-11 have improved those statistics, dramatically increasing response rates, progression-free survival times and overall survival. Early results from the study prompted the U.S. Food and Drug Administration to agree to an accelerated approval of Avastin in May 2009 for use in patients with recurrent glioblastomas, said Dr. Timothy Cloughesy, director of the Neuro-Oncology Program at UCLA's Jonsson Comprehensive Cancer Center and senior author of the study. The program allows provisional approval of medicines for cancer or other life-threatening diseases.

The study, conducted at 11 centers across the county, was published this week in the early online version of the Journal of Clinical Oncology.

"This is a huge breakthrough for us. In all the years we've been treating recurrent glioblastomas using conventional and investigational agents, we've never had anything like the responses we're seeing with Avastin," said Cloughesy, who also is a professor of neurology. "You just don't get these kinds of responses in this patient population. We're seeing dramatic improvements."

The two-armed study enrolled 167 patients with recurrent glioblastoma. One arm evaluated Avastin used as a single agent, the other Avastin given with CPT-11. An independent radiological facility was used to measure tumor responses, Cloughesy said.

In the Avastin only arm, 28.2 percent of patients responded to the treatment, meaning their tumors shrunk by 50 percent or more, a significant increase from the historic 5 percent response rates. Of the 80 patients, 42.6 percent surpassed the six month mark without their disease progressing, up from the historic 15 to 20 percent of patients. Survival was 9.2 months, a slight increase of the typical six to seven month survival time.

In the arm studying Avastin with CPT-11, 37.8 percent of patients responded to the treatment, while 50.3 percent surpassed the six month progression-free survival mark. Overall survival was 8.7 months, a little less than the Avastin only study.

Cloughesy believes the study shows the apparent power of Avastin when used alone in treating deadly brain cancers for which few effective treatments now exist.

"I think what this tells us is that the majority of the effects we're seeing are due to the Avastin," he said.

In addition, Avastin was well tolerated. While some serious side effects were noted – brain hemorrhage, strokes and heart attacks – they were seen in a very small number of patients. Avastin also appeared to reduce brain swelling, allowing patients to significantly lower the steroid dose they had to take, eliminating a number of debilitating side effects.

"Because their brain swelling went down and they could lower their doses of steroids, some patients saw a marked improvement in function," Cloughesy said.

About 20,000 patients will be diagnosed with glioblastoma this year, of those 14,000 will die.

The last new systemic therapy for recurrent glioblastoma was approved in 1976. Until Avastin, all other experimental therapies tested in this type of cancer failed to meet the FDA guidelines for approval. It's vital that less toxic, more effective therapies are found to fight glioblastoma, Cloughesy said, both when it recurs and when it is first diagnosed. Studies are underway now to see if the study results can be validated in patients with newly diagnosed glioblastomas.

A significant study finding was that Avastin was nearly as effective alone as it was when given with chemotherapy, but was much better tolerated. In consultation with their doctor, a patient facing less than a year to live might opt for Avastin alone to promote better quality of life and avoid the toxic side effects of chemotherapy.

Avastin is an angiogenesis inhibitor, meaning it cuts off the independent blood supply that a tumor develops to feed and oxygenate itself. A molecularly targeted therapy, Avastin neutralizes vascular endothelial growth factor (VEGF), a chemical signal that stimulates the growth of new blood vessels, or angiogenesis. In addition to recurrent glioblastoma, Avastin has been approved for use in metastatic colorectal, breast and kidney cancers as well as non-small cell lung cancer.


Avastin notes:

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody. It is an angiogenesis inhibitor, which cuts off the independent blood supply that a tumor develops to feed and oxygenate itself. A molecularly targeted therapy, Avastin neutralizes vascular endothelial growth factor (VEGF), a chemical signal that stimulates the growth of new blood vessels, or angiogenesis. Avastin is prescribed for Metastatic Colorectal Cancer, Non-Squamous Non–Small Cell Lung Cancer, Metastatic Breast Cancer and Glioblastoma.

Avastin should be administered only as an intravenous (IV) infusion. It should not be administered or mixed with dextrose solution. Avastin should not be initiated until at least 28 days following major surgery. The dosage form and strength can either be 100mg per 4 ml or 400mg per 16 ml, both on single-use vial. The intake of avastin may result in adverse reactions such as gastrointestinal perforations, surgery and wound healing complications, hemorrhage, non-gastrointestinal fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior eukoencephalopathy syndrome and proteinuria.

The most common undesirable reactions observed in Avastin patients are epistaxis, headache, hypertension, rhinitis, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, and exfoliative. dermatitis.

Administration of avastin alone has proved to be effective in treating cancer. A patient who might live for less than a year could opt for avastin to promote better quality of life and avoid the toxic side effects of chemotherapy.


Anti-aging news:

Researchers find pathways linking caloric restriction to antiaging

University of Washington (UW), November 18, 2005

TOR1 and AKT are protein molecules which signal the pathways after calorie intake in many organisms. TOR proteins are highly conserved from yeast to humans and regulate multiple cellular processes in response to nutrients, including cell size, autophagy, ribosome biogenesis and translation, carbohydrate and amino acid metabolism, stress response, and actin organization. AKT is a mediator protein for insulin response for uptake of glucose of cells.

As there is a link between caloric restriction and age related diseases such as cancer, the identification led to finding of benefits of caloric restriction to the down regulation of gene TOR1 and AKT which play role of signalling after calorie intake. From the yeast cell, the researchers knocked out TOR1 and SCH9 gene which code for proteins TOR1 and SCH9 respectively. The SCH9 gene of yeast is analogous to AKT gene in mammals. The lifespan of gene deleted yeast cell was found to be same to that of the caloric restricted yeast cell.

The experiment explains the mechanism of theory that high nutrient level makes organism grow bigger and reduces lifespan while low nutrient does the reverse.

The research was led by Brian Kennedy and collaborated by Matt Kaeberlein.


 

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- PIKAMILON
- PIRACETAM
- PLAVIX
- PRECOSE
- PREMARIN
- PROSCAR
- PUMPKINSEED OIL
- RED WINE HIGH IN RESVERATROL
- RESVERATROL
- REVALID CAPSULES
- REVALID CREAM
- REVALID HAIR TONIC
- REVALID SHAMPOO AND CONDITIONER
- RHODIOLA ROOT
- RHODIOLA TABLETS
- RIMANTADINE
- RISPERDAL
- ROSUVASTATIN
- RUTIN
- SCHISANDRA
- SEA-BUCKTHORN OIL
- SELEGILIN
- SELENIUM
- SENSIPAR
- SEROQUEL
- SINEMET
- SINGULAIR
- SORAFENIB
- SPORANOX
- STABLON
- SUTENT
- TAMIFLU
- TAMOXIFEN
- TARCEVA
- TAXOL
- TAXOTERE
- TELFAST
- TEMODAR
- TOPAMAX
- TRITICO
- VASOTEC
- VELCADE
- VEPESID
- VIAGRA
- VIAGRA FOR WOMEN
- VINPOCETINE
- VINPOTROPILE
- XALATAN
- XANTHINOL NICOTINATE
- XELODA
- XENICAL
- ZETIA
- ZINC (ZN)
- ZITHROMAX
- ZOCOR
- ZOFRAN
- ZOLADEX
- ZOVIRAX
- ZYPREXA
- ZYRTEC

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