SOUTH SAN FRANCISCO, Calif. — February 11th, 2013 — Roche and Genentech have been informed that the U.S. Food and Drug Administration (FDA) has discovered additional counterfeit product that has been distributed by a U.S. company, Medical Device King (also known as Pharmalogical). The new counterfeit product identified by the FDA is labeled as "Altuzan," which is the brand name that Roche and Genentech's cancer medicine bevacizumab (Avastin®) is sold under in Turkey.
Patient safety is Roche and Genentech's primary concern. We fully support the FDA's investigations and are committed to working with the FDA to assist where possible.
Counterfeit product is not safe or effective and should not be used. According to the FDA, lab tests conducted by the FDA confirmed that at least one batch of the counterfeit version of Altuzan 400 mg/mL contains no active ingredient. FDA has advised that packaging or vials found in the United States that claim to be Roche's Altuzan with batch numbers B6022B01 and B6024B01 should be considered counterfeit.
The only Avastin (bevacizumab) that is FDA-approved for use to treat certain cancers in the United States is Avastin that is manufactured by Genentech. Even authentic Altuzan is only approved for use in Turkey and not approved for use in the United States.
For more information, please see the FDA's notice regarding this issue:
In February 2012 and April 2012, the FDA and Genentech issued alerts about other counterfeit products labeled as Altuzan and Avastin that were distributed in the United States. For more information, please see the FDA notices and Genentech statements:
Important Information for Healthcare Providers to Identify Suspected Counterfeit Product
If a healthcare provider has any product in their possession that they suspect may be counterfeit, they should immediately contact the FDA's Office of Criminal Investigations (OCI) at 1-800-551-3989 or Genentech's Product Quality Assurance department at 1-800-334-0290.
Genentech distributes Avastin through a defined number of licensed wholesalers and licensed specialty distributors.
The image below shows authentic Avastin FDA-approved for use in the United States. In addition, the following is true for all authentic Avastin that is FDA-approved for use in the United States:
Authentic Avastin FDA-Approved for Use in the United States
Implications for Patients
If a patient taking Avastin is experiencing any side effects, they should contact their healthcare provider immediately. If the patient is experiencing any side effects that the healthcare provider thinks may be related to Avastin or the use of the counterfeit drug, the healthcare provider should immediately call FDA's MedWatch Program (1-800-FDA-1088) or Genentech's Drug Safety Department at 1-888-835-2555.
Roche and Genentech's Anti-Counterfeiting Measures
As the implications for public health and safety are high, we take the issue of counterfeiting extremely seriously. Roche and Genentech have implemented various approaches to combat counterfeiting that include working with relevant stakeholders to secure the distribution system, and implementing special packaging and printing techniques that make counterfeits both more difficult to make and easier to spot. We work closely with health authorities and law enforcement agencies to combat the unsafe distribution of our products through unauthorized sources.
Counterfeit medicines are mostly offered for sale by unlicensed sources. In order to help ensure the integrity of the supply chain for Genentech's medicines in the United States, our medicines are sold directly to a defined number of licensed wholesalers and specialty distributors.
Roche and Genentech take very seriously compliance with relevant national and international standards, guidelines and regulations aimed at combating counterfeit active pharmaceutical ingredients (APIs), medicines and diagnostics. We fully support governmental efforts and are committed to cooperating with the authorities whenever one of our products is concerned. Further, we participate in national and international industry and governmental efforts to develop stronger laws and improve enforcement, educate the public and train local officials.
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.
Avastin is approved, in combination with intravenous 5-fluorouracil-based chemotherapy, for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum; in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen; Avastin is not approved for adjuvant treatment of colon cancer. In combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); and for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
BOXED WARNINGS and Additional Important Safety Information
People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:
Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this event occurred in more people who received Avastin than in the comparison group (2.4 percent to 0.3 percent). In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs.
Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with metastatic colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15 percent for patients who received Avastin and four percent for patients who did not receive Avastin.
Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined. Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that require medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing.
Severe bleeding: Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.
In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.6 percent of people. Too much protein in the urine that led to kidney problems was seen in less than one percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in five percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than three percent of people, and severe reactions occurred in 0.2 percent of people. Avastin can cause fertility issues for women. Avastin could cause a woman's ovaries to stop working and may impair her ability to have children.
Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.
Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin.
Women should be advised to discontinue nursing or discontinue treatment with Avastin, taking into account the importance of Avastin to the mother.
First-line Metastatic Colorectal Cancer
In the first-line metastatic colorectal cancer trial, the most common severe to life-threatening side effects that increased by two percent or more in people who received Avastin plus IFL chemotherapy vs. IFL alone were weakness (10 percent vs. 7 percent), abdominal pain (8 percent vs. 5 percent), pain (8 percent vs. 5 percent), high blood pressure (12 percent vs. 2 percent), blood clots in the veins of the body (9 percent vs. 5 percent), blood clots inside the abdomen (3 percent vs. 1 percent), a brief loss of consciousness (3 percent vs. 1 percent), diarrhea (34 percent vs. 25 percent), constipation (4 percent vs. 2 percent), reduced white blood cell counts (37 percent vs. 31 percent), and reduced white blood cell counts that may increase the chance of infection (21 percent vs. 14 percent).
Second-line Metastatic Colorectal Cancer
In the second-line metastatic colorectal cancer trial, the most common severe to life-threatening and fatal side effects that increased by two percent or more in people who received Avastin plus FOLFOX4 chemotherapy vs. FOLFOX4 alone were diarrhea (18 percent vs. 13 percent), nausea (12 percent vs. 5 percent), vomiting (11 percent vs. 4 percent), dehydration (10 percent vs. 5 percent), blockage of the bowel (4 percent vs. 1 percent), numbness and tingling in fingers and toes (17 percent vs. 9 percent), nervous system disturbances (5 percent vs. 3 percent), tiredness (19 percent vs. 13 percent), abdominal pain (8 percent vs. 5 percent), headache (3 percent vs. 0 percent), high blood pressure (9 percent vs. 2 percent), and severe bleeding (5 percent vs. 1 percent).
Second-line Metastatic Colorectal Cancer in Patients who Have Progressed on an Avastin Containing Regimen in First-line mCRC In this second-line trial, no new safety signals were observed when Avastin was administered in second-line mCRC patients who progressed on an Avastin containing regimen in first-line mCRC. The safety data was consistent with the known safety profile established in first- and second-line mCRC.
First-line Advanced Non-Squamous Non-Small Cell Lung Cancer
In the non-small cell lung cancer trial, the most common life-threatening to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group were reduced white blood cell counts (27 percent vs. 17 percent), tiredness (16 percent vs. 13 percent), high blood pressure (8 percent vs. 0.7 percent), infection without reduced white blood cell counts (7 percent vs. 3 percent), blood clots in the veins of the body (5 percent vs. 3 percent), fever with reduced white blood cell counts (5 percent vs. 2 percent), inflammation of the lungs (5 percent vs. 3 percent), infection with severe or life-threatening reduced white blood cell counts (4 percent vs. 2 percent), low sodium levels in the blood that could lead to seizure or coma (4 percent vs. 1 percent), headache (3 percent vs. 1 percent), and too much protein in the urine (3 percent vs. 0 percent).
Metastatic Kidney Cancer
In the metastatic kidney cancer trial, the most common severe to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group included tiredness (13 percent vs. 8 percent), weakness (10 percent vs. 7 percent), too much protein in the urine (7 percent vs. 0 percent), high blood pressure (6 percent vs. 1 percent), and severe bleeding (3 percent vs. 0.3 percent).
For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.