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Nausea / Vomiting - Chemotherapy Induced News

Heron Therapeutics Announces FDA Approval of Sustol (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Posted 10 Aug 2016 by Drugs.com

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Aug. 10, 2016-- Heron Therapeutics, Inc. (NASDAQ:HRTX), today announced that the U.S. Food and Drug Administration (FDA) has approved Sustol (granisetron) extended-release injection. Sustol is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. Sustol is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer® polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV). “Despite advances in the management of CINV, u ... Read more

Related support groups: Nausea/Vomiting - Chemotherapy Induced, Sustol, Granisetron

Insys Therapeutics Announces FDA Approval of Syndros (dronabinol) Oral Solution

Posted 5 Jul 2016 by Drugs.com

PHOENIX, July 05, 2016 (GLOBE NEWSWIRE) – Insys Therapeutics, Inc. (“Insys” or “the Company”) (NASDAQ:INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, Syndros, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC"). Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration. "We are very pleased to announce FDA approval of Syndros. We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemothe ... Read more

Related support groups: Anorexia, Chemotherapy, Nausea/Vomiting - Chemotherapy Induced, AIDS Related Wasting, Dronabinol, Syndros

Cancer's Heavy Financial Burden

Posted 8 Jun 2016 by Drugs.com

WEDNESDAY, June 8, 2016 – Many cancer patients can't afford to see their doctor or take the medications they've been prescribed, a new study finds. And the problem will likely only get worse as the cost of cancer treatments continues to rise, the study authors said. "You can prescribe the best drug in the world, but if patients can't afford it and they can't get it, then it won't be effective," said study author Dr. Greg Knight. He is chief fellow with the University of North Carolina School of Medicine's division of hematology and oncology. "We saw a significant portion of patients in our study who were stretching their prescriptions or not coming to the doctor's office," Knight said in a university news release. The researchers reviewed survey results from nearly 2,000 patients at the N.C. Cancer Hospital in Chapel Hill, N.C. The participants were all 18 and older, and had been ... Read more

Related support groups: Cancer, Breast Cancer, Prostate Cancer, Gleevec, Lung Cancer, Colorectal Cancer, Votrient, Brain Tumor, Tarceva, Avastin, Melanoma, Skin Cancer, Tasigna, Sutent, Ovarian Cancer, Sprycel, Endometrial Cancer, Afinitor, Herceptin, Nausea/Vomiting - Chemotherapy Induced

Researchers Find 8 Immune Genes in Aggressive Brain Cancer

Posted 25 May 2016 by Drugs.com

WEDNESDAY, May 25, 2016 – Researchers have identified immune genes that may affect how long people live after diagnosis with a common type of brain cancer. If confirmed in other studies, the researchers say their findings could lead to improved treatment in the future. The type of brain cancer in the study is glioblastoma multiforme, a fast-growing tumor. People with this type of cancer survive an average of less than two years, even after treatment with surgery, radiation and chemotherapy, the study authors said. "We've had luck with other types of cancer in removing the brakes on the immune system to allow it to fight the tumors, but this has not been the case with glioblastoma," said study author Dr. Anhua Wu, of First Hospital of China Medical University in Shenyang, China. "If our discovery of these genes is validated in other studies, we could use this 'gene signature' to ... Read more

Related support groups: Surgery, Brain Tumor, Nausea/Vomiting - Chemotherapy Induced, Head & Neck Surgery, Glioblastoma Multiforme, Diagnosis and Investigation, Malignant Glioma, Head Imaging

Additional Treatments Offer Little Benefit for Pancreatic Cancer: Study

Posted 3 May 2016 by Drugs.com

TUESDAY, May 3, 2016 – Additional treatments for locally advanced pancreatic cancer don't appear to boost survival, a new French study reports. Researchers looked at the effects of adding a second drug – erlotinib (Tarceva) – to the initial round of chemotherapy. They also tested whether adding radiation to a second round of chemotherapy (chemoradiotherapy) would offer any survival benefit. Unfortunately, the addition of the second drug didn't help people live longer, and those on chemoradiotherapy didn't fare any better. "Chemoradiotherapy was not superior to chemotherapy," said the study's senior author, Dr. Pascal Hammel. Hammel is from the department of gastroenterology-pancreatology at Beaujon Hospital, in Clichy, France. The study was funded by the pharmaceutical company Roche, the maker of Tarceva, and the French National Institute of Cancer. More than 53,000 Americans are ... Read more

Related support groups: Tarceva, Pancreatic Cancer, Nausea/Vomiting - Chemotherapy Induced, Erlotinib, History - Radiation Therapy

Could Talk Therapy Ease Chemo-Related Memory Issues?

Posted 2 May 2016 by Drugs.com

MONDAY, May 2, 2016 – A type of psychotherapy might help cancer survivors deal with the long-term thinking problems some experience after chemotherapy, researchers say. It's estimated that about half of those who undergo chemotherapy for cancer develop what's often called "chemo brain." For instance, they may have trouble following conversations or remembering the steps in a project, according to background notes with the new study. Although usually mild, these changes can affect quality of life, job performance and relationships, said the researchers from the Eastern Maine Medical Center and Lafayette Family Cancer Center in Bangor, Maine. The researchers developed a cognitive-behavioral therapy (CBT) program called Memory and Attention Adaptation Training to help cancer survivors prevent or manage these memory problems. Their study involved 47 breast cancer survivors who underwent ... Read more

Related support groups: Cancer, Methotrexate, Breast Cancer, Prostate Cancer, Fluorouracil, Gleevec, Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Breast Cancer, Metastatic, Brain Tumor, Xeloda, Melanoma, Skin Cancer, Pancreatic Cancer, Tasigna, Ovarian Cancer, Sprycel, Hydroxyurea

Many Breast Cancer Patients May Not Need Chemo: Study

Posted 18 Apr 2016 by Drugs.com

MONDAY, April 18, 2016 – Many breast cancer patients receive chemotherapy they don't need, according to the results of a long-awaited clinical trial. A genetic test called MammaPrint determined that nearly half the women slated for chemotherapy based on standard clinical assessments didn't really need to undergo the challenging treatment. Researchers planned to announce the findings Monday at the American Association for Cancer Research (AACR) meeting in New Orleans. After surgery to remove their tumors, breast cancer patients with a MammaPrint score recommending against chemotherapy had a 95 percent survival rate, said co-researcher Laura van 't Veer, the test's inventor. "That's very high, and we showed that it doesn't differ between those who are treated and those who are not treated by chemotherapy," said van 't Veer, leader of the breast oncology program at the University of ... Read more

Related support groups: Breast Cancer, Nausea/Vomiting - Chemotherapy Induced, Breast Cancer - Adjuvant, Breast Cancer, Prevention, Diagnosis and Investigation

FDA Approves Pediatric Indication for Emend (aprepitant) Capsules in Combination with Other Antiemetic Agents

Posted 2 Sep 2015 by Drugs.com

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Emend (aprepitant) capsules, a substance P/neurokinin 1 (NK1) receptor antagonist. With this expanded indication, Emend capsules are now approved for use in combination with other antiemetic agents in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg (approximately 66 pounds) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin, as well as for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Emend has not been ... Read more

Related support groups: Nausea/Vomiting - Chemotherapy Induced, Emend, Aprepitant

FDA Approves Varubi (rolapitant) for Chemotherapy-Induced Nausea and Vomiting

Posted 2 Sep 2015 by Drugs.com

September 2, 2015 – The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy. Nausea and vomiting are common side effects experienced by cancer patients undergoing chemotherapy. Symptoms can persist for days after the chemotherapy drugs are administered. Nausea and vomiting that occurs from 24 hours to up to 120 hours after the start of chemotherapy is referred to as delayed phase nausea and vomiting, and it can result in serious health complications. Prolonged nausea and vomiting can lead to weight loss, dehydration and malnutrition in cancer patients leading to ... Read more

Related support groups: Nausea/Vomiting - Chemotherapy Induced, Varubi, Rolapitant

Anti-Nausea Drug Varubi Approved

Posted 2 Sep 2015 by Drugs.com

WEDNESDAY, Sept. 2, 2015 – Varubi (rolapitant) has been approved by the U.S. Food and Drug Administration to treat nausea and vomiting among adults undergoing cancer chemotherapy. Nausea and vomiting are common side effects of chemotherapy that can persist for days after the drugs are given. Prolonged bouts of these reactions can lead to weight loss, dehydration and malnutrition, the agency said Wednesday in a news release. Varubi was evaluated by some 2,800 participants in three clinical trials, administered in combination with other anti-nausea drugs. The most common side effects included low white blood cell count, hiccups, loss of appetite and dizziness. The FDA said Varubi should not be taken by people who are taking the drug thioridazine, which is commonly prescribed to treat schizophrenia. Varubi is marketed by Tesaro Inc., based in Waltham, Mass. More information The FDA has ... Read more

Related support groups: Nausea/Vomiting - Chemotherapy Induced, Varubi, Rolapitant

Chemo May Worsen Quality of Life for End-Stage Cancer Patients

Posted 23 Jul 2015 by Drugs.com

THURSDAY, July 23, 2015 – Chemotherapy may worsen quality of life for some cancer patients who are nearing death, a new study finds. "Oncologists may presume there to be no harm in giving dying patients chemotherapy, but these data point to more harm than benefit," study author Dr. Holly Prigerson, from Weill Cornell Medical College in New York City, said in a college news release. The research included more than 300 patients with advanced cancer who had about four months to live. Their average age was about 59. About half of the patients were receiving what's known as palliative chemotherapy when the study began. Palliative chemotherapy is generally given to people who have fewer than six months to live, according to the researchers. The hope is that palliative chemotherapy will ease symptoms and extend survival. But that wasn't the case for those patients who started the study with ... Read more

Related support groups: Cancer, Breast Cancer, Metastatic, Nausea/Vomiting - Chemotherapy Induced, Breast Cancer - Palliative, Neutropenia Associated with Chemotherapy, Hyperuricemia Secondary to Chemotherapy, Anemia - Chemotherapy Induced

FDA Approves Akynzeo (netupitant and palonosetron) for Chemotherapy-Induced Nausea and Vomiting

Posted 14 Oct 2014 by Drugs.com

October 10, 2014 – The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy. “Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. Akynzeo’s effectiveness was established in two clinical trials ... Read more

Related support groups: Cancer, Nausea/Vomiting - Chemotherapy Induced, Palonosetron

FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products

Posted 5 Dec 2012 by Drugs.com

This update is a follow-up to the FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)1 on 6/29/2012. Safety Announcement Table 1.  List of ondansetron products to be voluntarily withdrawn from the U.S. market Reference   Safety Announcement [12-4-2012] The U.S. Food and Drug Administration (FDA) is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks.  This dose has been removed from the Zofran drug label.  FDA is now working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market.  These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers (See Table 1). ... Read more

Related support groups: Zofran, Ondansetron, Nausea/Vomiting - Chemotherapy Induced, Zofran ODT, Zuplenz

FDA Medwatch Alert: Ondansetron (Zofran) 32 mg, Single Intravenous (IV) Dose: Updated Safety Communication – Product Removal due to Potential For Serious Cardiac Risks

Posted 4 Dec 2012 by Drugs.com

ISSUE: FDA is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks. BACKGROUND: The 32 mg, single IV dose of Zofran had been used to prevent chemotherapy-induced nausea and vomiting. A previous Drug Safety Communication (DSC), issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm.  These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers. FDA anticipates these products will be removed from the market through early 2013.  FDA does not anticipate that removal of the 32 mg i ... Read more

Related support groups: Zofran, Ondansetron, Nausea/Vomiting - Chemotherapy Induced, Zofran ODT, Zuplenz

FDA Medwatch Alert: Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

Posted 3 Jul 2012 by Drugs.com

ISSUE: The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. GlaxoSmithKline (GSK) has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single intravenous dose should ... Read more

Related support groups: Zofran, Ondansetron, Nausea/Vomiting - Chemotherapy Induced, Zofran ODT, Zuplenz

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