Avastin – Another Potentially Deadly Cancer Drug with an Astronomical Price

Very Serious Side Effects
Can Cause Death Suddenly
Do You Think It Is Worth the Risk?
We don’t!
Important Information
Be Sure to Read Everything

Avastin a Deadly Toxic Cancer Drug with and Astronomical Pricetag.

UNDER CONSTRUCTION

Avastin, the wonder drug, cuts off tumors’ blood supply. It can cost $100,000 a year, with sales of about $3.5 billion per year. Do we ask how this toxic deadly, not very effective drug is one of the most popular drugs in the USA for the cancer for-profit business? It can but not always extend life by a month or two. They also claim better functioning, but where is the evidence behind that? There is no compelling evidence, yet doctors prescribe this profitable, potentially deadly, debilitating drug anyway. It is a biologic, not chemotherapy but just as deadly.

But don’t worry only 2% of people who take the drug will have a stroke and the really great news only 0.15% will go blind. Even better—not all who have a stroke will die.

Avastin became available in the United States in 2004. It was the first anti-angiogenic therapy for the treatment of advanced cancers. It is available in over 70 other countries for the treatment of progressive brain tumors following prior therapy. It is approved in Japan for colorectal cancer, non-small cell lung cancer, ovarian and breast cancer, and glioblastoma. In Europe, it is approved for colorectal, non-small cell lung, ovarian, kidney, advanced-stage breast cancer, and cervical cancers. It is approved in the US for colorectal, non-small cell lung, kidney, cervical, ovarian cancers, and recurrent glioblastoma.

In the United States, insurance companies have refused to pay for all or part of the costs of Avastin therapy and reimbursement is also restricted in Canada due to the low benefit-to-cost ratio.

Across clinical studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions.

Your doctor will not hand you the BLACK BOX WARNING (as seen to the right) and discuss the possibility that this drug can cause blindness, leave you with permanent life-altering adverse side effects or kill you. This is a for-profit business. This is not about curing you. If they wanted to heal you, they would tell you that chemotherapy is toxic and possibly deadly, and you would have a better survival rate if you did not do it.

Boxed WARNINGS

Gastrointestinal (GI) perforation
- Serious and sometimes fatal GI perforation occurs at a higher incidence in Avastin-treated patients compared to patients treated with chemotherapy
- The incidence of GI perforation ranged from 0.3% to 3% across clinical studies
- Discontinue Avastin in patients with GI perforation
Surgery and wound healing complications
- The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients
- Withhold Avastin for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed
- Discontinue in patients with wound healing complications requiring medical intervention
Hemorrhage
- Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving Avastin. In clinical studies, the incidence of grade ≥3 hemorrhagic events among patients receiving Avastin ranged from 0.4% to 7%
- Do not administer Avastin to patients with serious hemorrhage or a recent history of hemoptysis (≥1/2 tsp of red blood)
- Discontinue Avastin in patients who develop Grade 3-4 hemorrhage

WARNING: GASTROINTESTINAL PERFORATIONS, SURGERY
AND WOUND HEALING COMPLICATIONS and HEMORRHAGE
See full prescribing information for complete boxed warning. Gastrointestinal Perforations: Discontinue for gastrointestinal
perforation.

(5.1) Surgery and Wound Healing Complications: Discontinue in
patients who develop wound healing complications that require
medical intervention. Withhold for at least 28 days prior to
elective surgery. Do not administer Avastin for at least 28 days
after surgery and until the wound is fully healed.

(5.2) Hemorrhage: Severe or fatal hemorrhages have occurred. Do not
administer for recent hemoptysis. Discontinue for Grade 3-4
hemorrhage

Avastin (Bevacizumab) Side Effects

We ask you to read these side effects and decide if your body is really fighting off cancer with this drug or is it contributing to your demise? It is a for-profit drug.

Proteinuria – Excessive protein excretion in the urine. It is a significant risk factor for renal disease and cardiovascular morbidity and mortality.
Generalized Weakness
Poor appetite
Abdominal pain
Nausea & vomiting
Pain
Constipation
Upper respiratory infection
Low white blood cell count. (This can put you at increased risk for infection.)
Nose bleed
Bleeding problems
Hair loss
Diarrhea
Mouth sores
Headache

GI Perforation
Wounds that do not heal
Shortness of breath
Dizziness
High blood pressure
Weight loss
Muscle aches and pain
Hemorrhage (severe bleeding)
Hypertensive crisis (severe high blood pressure)
Nephrotic Syndrome – a condition marked by very high levels of protein in the urine (proteinuria), low levels of protein in the blood, swelling, especially around the eyes, feet, and hands. This syndrome is caused by damage to the glomeruli (tiny blood vessels in the kidney that filter waste and excess water from the blood and send them to the bladder as urine).
Congestive heart failure in patients who have received prior treatment with anthracycline-based chemotherapy or radiation therapy to the chest wall.

They say see a doctor when you have:

Swelling of the feet or ankles.
Sudden weight gain.
Abdominal pain
Nausea (interferes with the ability to eat and unrelieved with prescribed medication).
Vomiting (vomiting more than 4-5 times in a 24 hour period).
Diarrhea (4-6 episodes in a 24-hour period).
Constipation unrelieved by laxative use.
Coughing up blood.
Black or tarry stools, or blood in your stools.
Blood in the urine.
Mouth sores (painful redness, swelling or ulcers).
Swelling, redness and/or pain in one leg or arm and not the other.
Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination.
Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness.

SERIOUS AND FATAL SIDE EFFECTS

Serious or fatal pulmonary hemorrhage occurred in 31% of patients with squamous NSCLC and 4% of patients with non-squamous NSCLC receiving Avastin with chemotherapy compared to none of the patients receiving chemotherapy alone.

(5.1) Surgery and Wound Healing Complications:

Discontinue in patients who develop wound healing complications that require medical intervention. Withhold for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed.

(5.2) Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4

5.4 Arterial Thromboembolic Events

Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, and angina, occurred at a higher incidence in patients receiving Avastin compared to patients receiving chemotherapy.

Across clinical studies, the incidence of Grades 3-5 ATE was 5% in patients receiving Avastin with chemotherapy compared to
≤ 2% in patients receiving chemotherapy alone; the highest incidence occurred in patients with GBM. The risk of developing ATE was increased in patients with a history of arterial thromboembolism, diabetes, or greater than 65 years old

5.5 Venous Thromboembolic Events

An increased risk of venous thromboembolic events (VTE) was observed across clinical studies. In Study GOG-0240, Grade 3-4

VTE was reported in 11% of patients receiving Avastin with chemotherapy compared with 5% of patients receiving chemotherapy alone. VTE –

Deep vein thrombosis (DVT) Deep vein thrombosis is a clot in a deep vein, usually in the leg. DVT sometimes affects the arm or other veins.

Pulmonary embolism (PE) A pulmonary embolism occurs when a DVT clot breaks free from a vein wall, travels to the lungs and then blocks some or all of the blood supply. Blood clots originating in the thigh are more likely to break off and travel to the lungs than blood clots in the lower leg or other parts of the body.

In EORTC 26101, the incidence of Grade 3-4 VTE was 5% in patients receiving Avastin with chemotherapy compared to 2% in patients receiving chemotherapy alone.

5.7 Posterior Reversible Encephalopathy Syndrome (PRES)
PRES was reported in 0.5% of patients across clinical studies. The onset of symptoms occurred from 16 hours to 1 year after the first dose. PRES 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 is necessary to confirm the diagnosis of PRES.

5.8 Renal Injury and Proteinuria
The incidence and severity of proteinuria are higher in patients receiving Avastin as compared to patients receiving chemotherapy. Grade 3 (defined as urine dipstick 4+ or > 3.5 grams of protein per 24 hours) to Grade 4 (defined as nephrotic syndrome) ranged from 0.7% to 7% in clinical studies.
The overall incidence of proteinuria (all grades) was only adequately assessed in Study BO17705, in which the incidence was 20%. Median onset of proteinuria was 5.6 months (15 days to 37 months) after initiating Avastin. The median time to resolution was 6.1 months (95% CI: 2.8, 11.3). Proteinuria did not resolve in 40% of patients after a median follow-up of 11.2 months and required discontinuation of Avastin in 30% of the patients who developed proteinuria.

Nephrotic syndrome occurred in 1% of patients receiving Avastin across clinical studies, in some instances with fatal outcome. In a published case series, kidney biopsy of 6 patients with proteinuria showed findings consistent with thrombotic microangiopathy. Results of a retrospective analysis of 5805 patients who received Avastin with chemotherapy and 3713 patients who received chemotherapy alone, showed higher rates of elevated serum creatinine levels (between 1.5 to 1.9 times baseline levels) in patients who received Avastin. Serum creatinine levels did not return to
the baseline in approximately one-third of patients who received Avastin.

5.10 Embryo-Fetal Toxicity
Avastin may cause fetal harm based on its mechanism of action and findings from animal studies. Congenital malformations were observed with the administration of bevacizumab to pregnant rabbits during organogenesis every 3 days at a dose as low as a clinical dose of 10 mg/kg. Furthermore,
animal models link angiogenesis and VEGF and VEGFR 2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development.

Avastin (Bevacizumab)

Possible serious side effects

Everyone reacts differently to Avastin therapy. So, it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects.

Most serious side effects (not common, but sometimes fatal):

GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
Wounds that don’t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects

Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). These can sometimes be fatal
Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Avastin or bevacizumab

Avastin® (bevacizumab) is the first biologic medicine (not chemotherapy) designed to inhibit angiogenesis. Angiogenesis is
the growth of new blood vessels. This process helps a tumor grow and spread by connecting the tumor to the body’s blood supply.

One of the most expensive drugs that is currently marketed. In many countries with national health services, the use of bevacizumab has been restricted based on cost-benefit calculations that suggest the drug is not cost-effective. One study published in the New England Journal of Medicine reported that bevacizumab extended life by 4.7 months (20.3 months versus 15.6 months) at a cost of $42,800 to $55,000.

SIDE EFFECTS:

% = Percentage of patients who had this side effect in clinical studies across different cancers

UP TO 18% – Severe high blood pressure – Blood pressure that severely spikes or shows signs of affecting the brain.

UP TO 7% – Kidney problems – These may be caused by too much protein in the urine and can sometimes be fatal.

UP TO 2% – SEVERE stroke or heart problems -These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal.

UP TO 0.15 – nervous system and vision problems, Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness.

Possible serious side effects

Everyone reacts differently to Avastin therapy. So, it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects.

Most serious side effects (not common, but sometimes fatal):

GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
Wounds that don’t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects:

Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment.
Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). These can sometimes be fatal
Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often:

In clinical studies across different types of cancer, some patients experienced the following side effects:

High blood pressure 18%
Too much protein in the urine
Nosebleeds
Rectal bleeding
Back pain
Headache
Taste change
Dry skin
Inflammation of the skin
Inflammation of the nose
Watery eyes

For Doctors and Caregivers

Most common adverse events

Across studies, the most common adverse reactions observed in Avastin patients at a rate >10% were:

— Lacrimation disorder
— Back pain
— Exfoliative dermatitis

— Proteinuria
— Taste alteration
— Dry skin
— Rectal hemorrhage

— Epistaxis
— Headache
— Hypertension
— Rhinitis

Across all studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions

Side effects seen most often:

We question why they list different most common side effects for Patients and caregivers vs. doctors

For Patients and Caregivers

In clinical studies across different types of cancer, some patients experienced the following side effects:

High blood pressure
Too much protein in the urine
Nosebleeds
Rectal bleeding
Back pain
Headache
Taste change
Dry skin
Inflammation of the skin
Inflammation of the nose
Watery eyes

Most common adverse events – Version for Doctors

Lacrimation disorder
Back painExfoliative dermatitis
Proteinuria
Taste alterationDry skin
Rectal hemorrhage
Epistaxis
Headache
Hypertension
Rhinitis

Across all studies, Avastin was discontinued in 8% to 22% of patients because of adverse reaction.

Very Serious Side Effects

Can Cause Death Suddenly

Do You Think It Is Worth the Risk?

We don’t!

Important Information

Be Sure to Read Everything

Avastin a Deadly Toxic Cancer Drug with and Astronomical Pricetag.

UNDER CONSTRUCTION

Boxed WARNINGS

Avastin (Bevacizumab) Side Effects

SERIOUS AND FATAL SIDE EFFECTS

Avastin (Bevacizumab)

Possible serious side effects

Other possible serious side effects

Avastin or bevacizumab

SIDE EFFECTS:

Possible serious side effects

Other possible serious side effects:

Side effects seen most often:

Most common adverse events

Side effects seen most often:

For Patients and Caregivers

Most common adverse events – Version for Doctors

Disclaimer

Get Healthy!

Archive