ASH News Daily 2012 - Sunday, December 9, 2012 - (Page B-33)

Sunday, December 9, 2012 www.thebusybeecafe.com Price: $ Attire: Casual Open: Mon. – Fri. from 11:00 a.m. to 7:00 p.m., Sun. from 12:00 noon to 7:00 p.m. Closed Saturdays. Praised as one of the best soul food restaurants in Atlanta, The Bee is known for its award-winning fried chicken. Don’t be fooled by the no-frills décor, this Southern specialty is “prepared with love, seasoned with soul.” The Colonnade Restaurant 1879 Cheshire Bridge Road colonnadeatl.com Price: $ ASH NewS DAily Attire: Casual Open: Mon. – Thurs. from 5:00 to 9:00 p.m., Fri. from 5:00 to 10:00 p.m., Sat. from 12:00 noon to 10:00 p.m., and Sun. from 11:30 a.m. to 9:00 p.m. Founded in 1927, The Colonnade is truly a Southern tradition. Their traditional, local fare includes North Georgia rainbow trout, prime rib, and fresh vegetables. Empire State South 999 Peachtree Street empirestatesouth.com Price: $-$$ Attire: Smart casual Open: Breakfast- Mon. – Fri. from 7:00 to 10:00 a.m.; lunch- Mon. – Fri. from 11:00 a.m. to 3:00 p.m.; dinnerMon. – Sun. from 5:30 to 11:00 p.m.; and brunch- Sat. and Sun. from 10:30 a.m. to 3:00 p.m. Taking a modern approach to Southern dishes, Culinary Institute of America graduate and Executive Chef Ryan Smith and his Empire State South were awarded 2011 Restaurant of the Year by Atlanta Magazine. His head chef, Hugh Acheson, was also praised in the New York Times for his innovative vegetarian dishes and on the Bravo TV show “Top Chef” for his overall culinary expertise. Enjoy a range of menu options from glazed pork belly to ricotta gnudi. Page B–33 ® Price Guide (Averages) $ $$ $$$ $$$$ Under $25 $25 to $50 $50 to $75 $75 to $100 Adverse reactions of Grade 3 or greater were reported in 96% of patients. Adverse reactions of Grade 3 or greater and occurring in ≥5% of patients are summarized in Table 2. Table 2. Most Commonly Reported (>5%) Gradea 3 or Greater Adverse Reactions among 83 Patients Receiving the Clinical Dosing Regimen Adverse Reactions ≥3 Blood and Lymphatic System Disorders Febrile Neutropenia Neutropenia Anemia Thrombocytopenia Infections Pneumonia Septic Shock Staphylococcal Bacteremia Neuropathyb Peripheral Sensory and Motor Neuropathy Constipation Ileus, Colonic Pseudo-Obstruction Asthenia Muscular Weakness Respiratory Thoracic and Mediastinal Disorders Respiratory Distress Respiratory Failure General Disorders and Administration Site Condition Pyrexia Fatigue Pain Gastrointestinal Disorders Abdominal Pain Investigations Aspartate Aminotransferase Increased Vascular Disorders Hypotension Psychiatric Disorders Mental Status Changes Cardiac Disorders Cardiac Arrest Renal and Urinary Disorders Musculoskeletal and Connective Tissue Disorders a b Study 1 and 2 (N=83) n (%) 47 (56.6) 26 (31.3) 15 (18.1) 14 (16.9) 14 (16.9) 33 (39.8) 7 (8.4) 5 (6.0) 5 (6.0) 27 (32.5) 14 (16.7) 4 (4.8) 5 (6.0) 4 (4.8) 1 (1.2) 17 (20.5) 5 (6.0) 4 (4.8) 31 (37.3) 12 (14.5) 10 (12.0) 7 (8.4) 21 (25.3) 7 (8.4) 20 (24.1) 6 (7.2) 8 (9.6) 5 (6.0) 9 (10.8) 3 (3.6) 9 (10.8) 5 (6.0) 6 (7.2) 7 (8.4) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Including neuropathy-associated adverse reactions. A total of 75.9% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%). Dose reduction, delay, or omission occurred in 53% of patients during the treatment. Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%). Adverse reactions related to neuropathy and leading to treatment discontinuation were decreased vibratory sense, facial palsy, hyporeflexia, constipation, asthenia, fatigue, and musculoskeletal pain, each reported in at least 1 patient. Deaths occurred in 23% of patients in study 1. The non-leukemia related causes of deaths were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multi system organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1). DRUG INTERACTIONS No formal drug interaction studies have been conducted with Marqibo. Marqibo is expected to interact with drugs known to interact with non-liposomal vincristine sulfate. Simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included non-liposomal vincristine sulfate have been reported to reduce blood levels of phenytoin and to increase seizure activity. CYP3A Interactions Vincristine sulfate, the active agent in Marqibo, is a substrate for cytochrome P450 3A isozymes (CYP3A); therefore, the concomitant use of strong CYP3A inhibitors should be avoided (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). Similarly, the concomitant use of strong CYP3A inducers should be avoided (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort). P-glycoprotein Interactions Vincristine sulfate, the active agent in Marqibo, is also a substrate for P-glycoprotein (P-gp). The effect of concomitant use of potent P-gp inhibitors or inducers has not been investigated; it is likely that these agents will alter the pharmacokinetics or pharmacodynamics of Marqibo. Therefore the concomitant use of potent P-gp inhibitors or inducers should be avoided. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category D [see Warnings and Precautions ] Based on its mechanism of action and findings from animal studies, Marqibo can cause fetal harm when administered to pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. In an embryofetal developmental study, pregnant rats were administered vincristine sulfate liposome injection intravenously during the period of organogenesis at vincristine sulfate doses of 0.022 to 0.09 mg/kg/day. Drug-related adverse effects included fetal malformations (skeletal and visceral), decreases in fetal weights, increased numbers of early resorptions and post-implantation losses, and decreased maternal body weights. Malformations were observed at doses ≥0.044 mg/kg/day in animals at systemic exposures approximately 20-40% of those reported in patients at the recommended dose. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Marqibo in pediatric patients have not been established. Geriatric Use Safety and effectiveness in elderly individuals have not been established. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Renal Impairment The influence of renal impairment on the safety, efficacy, and pharmacokinetics of Marqibo has not been evaluated. Hepatic Impairment Non-liposomal vincristine sulfate is excreted primarily by the liver. The influence of severe hepatic impairment on the safety and efficacy of Marqibo has not been evaluated. The pharmacokinetics of Marqibo was evaluated in patients with moderate hepatic dysfunction (Child-Pugh B) secondary to melanoma liver metastases. The dose-adjusted maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) of Marqibo in patients with moderate hepatic impairment was comparable to the Cmax and AUC of patients with ALL who had otherwise normal hepatic function. OVERDOSAGE When Marqibo (vinCRIStine sulfate LIPOSOME injection) was administered at a dose of 2.4 mg/m2, severe toxicities including motor neuropathy of Grade 3, grand mal seizure of Grade 4, and elevated aspartate aminotransferase and hyperbilirubinemia of Grade 4 were reported in 1 patient each. There is no known antidote for overdosage. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity studies have been conducted with Marqibo or non-liposomal vincristine sulfate. Based on the mechanism of action and genotoxicity findings in nonclinical studies conducted with non-liposomal vincristine sulfate, Marqibo may be carcinogenic. No genotoxicity studies have been conducted with Marqibo. Non-liposomal vincristine was genotoxic in some in vitro and in vivo studies. The single- and repeat-dose animal toxicology study results indicate that Marqibo can impair male fertility, consistent with the literature on non-liposomal vincristine sulfate. Administration of vincristine liposome injection causes testicular degeneration and atrophy, and epididymal aspermia in rats. Gonadal dysfunction has been reported in both male and female post-pubertal patients who received multi-agent chemotherapy including non-liposomal vincristine sulfate. The degree to which testicular or ovarian functions are affected is age-, dose-, and agent-dependent. Recovery may occur in some but not all patients. Animal Toxicology and/or Pharmacology In a repeat-dose comparative toxicology study in rats, vincristine sulfate liposome injection or non-liposomal vincristine sulfate was administered to animals intravenously once per week for 6 weeks. Clinical signs of toxicity consistent with neurotoxicity were greater with vincristine sulfate liposome injection than with non-liposomal vincristine sulfate at equal vincristine sulfate doses of 2 mg/m2 /week and included uncoordinated movements, weakness, reduced muscle tone, and limited usage of the limbs. Neurological testing indicated drug-induced peripheral neurotoxicity with both drugs. Based on the histopathology examination after 6 weekly doses, vincristine sulfate liposome injection induced greater peripheral neurotoxicity (nerve fiber degeneration) and secondary skeletal muscle atrophy than the equal dose of non-liposomal vincristine sulfate. In a separate tissue distribution study in rats, administration of 2 mg/m2 of intravenous liposomal or non-liposomal vincristine sulfate showed greater accumulation of vincristine sulfate in sciatic and tibial nerves (as well as the lymph nodes, spleen, and bone marrow) of the animals following vincristine sulfate liposome injection. PATIENT COUNSELING INFORMATION Physicians are advised to discuss the following with patients prior to treatment with Marqibo: Extravasation Tissue Injury: Advise patients to report immediately any burning or local irritation during or after the infusion [see Warnings and Precautions ]. Ability to Drive or Operate Machinery or Impairment of Mental Ability: Marqibo may cause fatigue and symptoms of peripheral neuropathy. Advise patients not to drive or operate machinery if they experience any of these symptoms [see Warnings and Precautions ]. Gastrointestinal/Constipation: Patients receiving Marqibo may experience constipation. Advise patients how to avoid constipation by a diet high in bulk fiber, fruits and vegetables, and adequate fluid intake as well as use of a stool softener, such as docusate. Instruct patients to seek medical advice if they experience symptoms of constipation such bowel movement infrequency, abdominal pain, bloating, diarrhea, nausea, or vomiting [see Warnings and Precautions ]. Pregnancy/Nursing: Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with Marqibo [see Warnings and Precautions ]. Instruct patients to report pregnancy to their physicians immediately. Advise patients that they should not receive Marqibo while pregnant or breastfeeding. If a patient wishes to re-start breastfeeding after treatment, she should be advised to discuss the appropriate timing with her physician [see Use in Specific Populations ]. Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking [see Drug Interactions ]. Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the feet or hands [see Warnings and Precautions ]. Other: Instruct patients to notify their physicians if they experience fever, productive cough, or decreased appetite [see Warnings and Precautions ]. REFERENCES 1. NIOSH Alert: Preventing occupational exposure to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. 2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. 3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. (2006) 63:1172-1193. 4. Polovich M, White JM, Kelleher LO (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society. Distributed by: Talon Therapeutics, Inc., 400 Oyster Point Boulevard, Suite 200, South San Francisco, CA 94080 ©2012 Talon Therapeutics, Inc. Marqibo ® is a registered trademark of Talon Therapeutics, Inc. All rights reserved. October 2012. Printed in the USA. MRQ005 TALONtx.com Gladys Knight and Ron Winans’ Chicken & Waffles 529 Peachtree Street NW www.gladysandron.net Price: $ Attire: Casual Open: Mon. – Thurs. from 11:00 a.m. to 11:00 p.m., Fri. and Sat. from 11:00 to 4:00 a.m., and Sun. from 11:00 a.m. to 8:00 p.m. Experience a “Southern taste sensation” at the culinary home of legendary R&B artist Gladys Knight and gospel sensation Ron Winans. This traditional soul food with a nouvelle twist is sure to be a treat for the senses. Paschal’s Restaurant 180-B Northside Drive www.paschalsatlanta.com Price: $-$$ Attire: Upscale casual Open: Mon. from 11:00 a.m. to 9:00 p.m., Tues. – Thurs. from 11:00 a.m. to 9:00 p.m., Fri. and Sat. from 11:00 a.m. to 11:00 p.m., and Sun. from 11:00 a.m. to 9:00 p.m. Enjoy exceptional Southern cooking where Dr. Martin Luther King Jr. dined. This historic location is known for its lively atmosphere, classy classic presentation, and, of course, hearty fried chicken, smothered pork chops, and peach cobbler, just to name a few. Q Time Restaurant 1120 Ralph David Abernathy Boulevard q-timerestaurant.com Price: $ Attire: Casual Open: Tues. – Sat. from 7:00 a.m. to 8:00 p.m., Sun. from 8:00 a.m. to 8:00 p.m. Closed Mondays. Need to grab a quick bite for breakfast, lunch, or dinner? Enjoy some baked chicken, a turkey dinner, or a veggie special. Dine in or carry out a local meal in less time than most fast food restaurants. Italian Cuisine Alfredo’s Italian Restaurant 1989 Cheshire Bridge Road http://alfredositalianrestaurant.com Price: $-$$ Attire: Casual Open: Mon. – Thurs. from 5:00 to 11:00 p.m., Fri. and Sat. from 5:00 to 11:00 p.m., and Sun. from 5:00 to 10:00 p.m. Constantly introducing new dishes to enhance the array of options »» DINING Page B-34  http://www.thebusybeecafe.com http://www.gladysandron.net http://www.empirestatesouth.com/ http://www.colonnadeatl.com/ http://www.paschalsatlanta.com http://www.q-timerestaurant.com/ http://www.alfredositalianrestaurant.com

Table of Contents for the Digital Edition of ASH News Daily 2012 - Sunday, December 9, 2012

ASH News Daily 2012 - Sunday, December 9, 2012

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