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Expert insights for healthcare professionals

Learn more about Oxbryta from SCD medical experts who treat patients with sickle cell disease

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Meet the medical experts

Disclosure: All healthcare professionals are paid by Global Blood Therapeutics for participating in these online sessions.

Photo of Pat Adams-Graves, MD
Pat Adams-Graves, MD
Professor of Medicine
Memphis, Tennessee
Dr. Adams-Graves earned her medical degree from the University of Louisville in Kentucky and served her internship and residency at the University of Louisville/Humana University Hospital. She held fellowship in hematology/oncology at the University of Tennessee, Memphis/Veterans Administration Hospital/Baptist Memorial Hospital in Memphis. Dr. Adams-Graves is certified in internal medicine and clinical pathology. She has been involved with 15 clinical trials studying sickle cell disease as an investigator, as well as published more than 30 articles in peer-reviewed medical journals and 40 abstracts/posters at major medical conferences. In addition, Dr. Adams-Graves serves as a reviewer for *Journal of Hematology*.
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Photo of Alan Anderson, MD
Alan Anderson, MD
Assistant Professor of Clinical Pediatrics
Greenville, South Carolina
Dr. Anderson is an Associate Professor of Clinical Pediatrics, specializing in sickle cell disease (SCD) in his teaching. He received his medical degree from the Medical University of South Carolina in Charleston, where he completed a residency in general pediatrics. He completed a fellowship in pediatric hematology and oncology at Emory University School of Medicine in Atlanta, Georgia. Dr. Anderson has lectured on SCD and pediatric oncology in the United States and internationally. His articles have appeared in the *European Journal of Hematology*, *American Journal of Transplantation*, *Blood Transfusion in Clinical Medicine*, and the *Journal of Global Oncology*, including a recent report on his work in establishing a pediatric hematology-oncology program in Botswana.
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Photo of Susan M. Carson, RN, MSN, CPNP
Susan M. Carson, RN, MSN, CPNP
Pediatric Nurse Practitioner
Los Angeles, California
Ms. Carson is a board-certified nurse practitioner, caring for patients in Thalassemia and Chronic Transfusion Programs and Red Cell Programs in an Institute for Cancer and Blood Diseases. She also serves as an Assistant Clinical Professor at a School of Nursing. She is a graduate of the University of Toronto, earning her BSN. She earned her MSN as a Pediatric Nurse Practitioner from UCLA and has been involved in research as a clinical resource and investigator, including evaluations of transfusional iron overload in pediatric oncology and transplant patients; thalassemia and pain; and early fetal intervention for thalassemia. Ms. Carson has presented on thalassemia and sickle cell disease at numerous international, national and regional conferences and workshops.
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Photo of Tammuella Chrisentery-Singleton, MD
Tammuella Chrisentery-Singleton, MD
Chief of Pediatric Hematology
Madison, Mississippi
Dr. Chrisentery-Singleton provides care for children and adults with sickle cell disease, hemophilia, von Willebrand disease, and other rare bleeding disorders. She received her medical degree from Louisiana State University School of Medicine and completed a residency, as well as a clinical fellowship in pediatric hematology/oncology, at Johns Hopkins University. She completed the Baxter/National Hemophilia Foundation clinical fellowship program at Tulane University School of Medicine. A principal investigator for more than 30 clinical trials, Dr. Chrisentery-Singleton has published more than 10 articles and abstracts in peer-reviewed journals such as the *Journal of the American Board of Family Medicine*, *Pediatric Blood and Cancer*, the *Chinese Journal of Cancer Research*, and *Hemophilia*. She has been a speaker at numerous national and international grand rounds and symposia on thrombosis, hemostasis, rare bleeding disorders, and pediatric hematology/oncology.
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Photo of Coretta Collins, MSN, FNP-BC
Coretta Collins, MSN, FNP-BC
Family Nurse Practitioner
Birmingham, Alabama
Ms. Collins is a Family Nurse Practitioner who treats hematology and oncology patients. She received her nursing degree from the University of Alabama, Huntsville, and her master's degree from the college's Birmingham location. From there, she held several positions, including patient care associate, relief charge nurse, staff RN, and clinical coordinator. Since developing a clinical interest in hematology and oncology as a nurse practitioner, Ms. Collins has delivered lectures on cancer awareness, chemotherapy treatments, and clinical indicators of hospice patient decline at local conferences throughout the state.
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Photo of Richard Drachtman, MD
Richard Drachtman, MD
Pediatric Hematologist/Oncologist
New Brunswick, New Jersey
After earning his medical degree from Chicago Medical School in Illinois, Dr. Drachtman completed his pediatric internship and residencies at North Shore University Hospital in New York. He then completed a pediatric hematology/oncology fellowship at Mount Sinai Medical Center in New York City. Certified by the American Board of Pediatrics, with specialty certification in pediatric hematology/oncology, Dr. Drachtman has a special interest in sickle cell disease (SCD). Dr. Drachtman serves as a reviewer for a number of journals, including *Clinical Cancer Research*, *Journal of Clinical Oncology*, *Journal of Pediatrics*, *Journal of Pediatric Hematology/Oncology*, and *Pediatric Blood and Cancer*. An active researcher, Dr. Drachtman has served as principal investigator for trials in hematologic disorders, including SCD. He has authored more than 50 peer-reviewed publications and has lectured extensively throughout the New York Tri-state area.
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Photo of William Ershler, MD
William Ershler, MD
Director of Hematology
Falls Church, Virginia
Dr. Ershler received his medical degree from the State University of New York Upstate Medical University. He completed a residency at the University of Wisconsin, continuing there with a clinical fellowship in human oncology and a research fellowship in hematology, working primarily in pediatrics. A lifetime focus on geriatrics, with special interest in hematologic conditions related to the aging process, has characterized Dr. Ershler's clinical and research career. He has served on study sections pertaining to aging, aging systems, and geriatrics. The author of more than 300 articles, he has also authored a textbook chapter for *Hematology: Basic Principles and Practice* and edited several books related to geriatric oncology and anemia.
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Photo of Mica Ferlis, ACNP, MSN
Mica Ferlis, ACNP, MSN
Nurse Practitioner
Richmond, Virginia
Ms. Ferlis is a board-certified Nurse Practitioner, who earned her undergraduate degree in nursing and a Master of Science in Nursing at Virginia Commonwealth University in Richmond. She is also certified in critical care nursing. In her primary role, Ms. Ferlis provides assessment, diagnosis, treatment, and management of complex patients with sickle cell disease; helps prevent illness/injury and provides comfort and maintenance of wellness; and works to gain greater knowledge and understanding of the management of sickle cell disease to provide a medical home for the patient population.
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Photo of Amber Flaherty, MD
Amber Flaherty, MD
Hematologist/Oncologist
Phoenix, Arizona
Dr. Flaherty earned a medical degree from St. George's University in Grenada. She completed her residency in internal medicine at the University of Texas Health Science Center, followed by a fellowship in hematology/oncology at the University of San Francisco Moffitt Cancer Center. Dr. Flaherty has published papers in *Urologic Oncology* and *Clinical Genitourinary Cancer*, with topics including immunotherapy treatments in renal cell cancer; patient outcomes in metastatic renal cell carcinoma with dialysis for end-stage renal disease; and human papillomavirus in penile cancer. She has presented her research at ASCO annual meetings.
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Photo of Renee Gardner, MD
Renee Gardner, MD
Professor of Pediatrics
New Orleans, Louisiana
Dr. Gardner received her medical degree from Harvard Medical School and completed her residency in pediatrics at the State University of New York (SUNY), Buffalo. She completed fellowships at SUNY Buffalo, The Jackson Laboratory in Bar Harbor, Maine, and at the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Maryland. An avid researcher, Dr. Gardner is currently participating in 3 ongoing clinical trials. She has spoken at numerous grand rounds on sickle cell disease and cancer therapies, as well as at national and international conferences. She has presented nearly 100 abstracts and published more than 50 peer-reviewed articles and book chapters on topics related to pediatric hematology and oncology.
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Photo of Shevta Gupta, MD
Shevta Gupta, MD
Attending Physician for Pediatric Hematology/Oncology
Orlando, Florida
Dr. Gupta is Attending Physician for Pediatric Hematology/Oncology and Assistant Professor of Pediatrics in Orlando, Florida. She earned her medical degree from the All India Institute of Medical Sciences in New Delhi, India and fulfilled internship and residency requirements in pediatrics at the Children’s Hospital of Los Angeles, California. Dr. Gupta completed a fellowship in hematology/oncology at the Children’s Hospital of Los Angeles, as well as an additional fellowship in transfusion medicine and coagulation disorders at the Baylor College of Medicine in Houston, Texas. Dr. Gupta holds primary clinical interests in sickle cell disease and bleeding and clotting disorders, including hemophilia and von Willebrand disease. She serves as a reviewer to multiple medical journals and holds active memberships with various professional societies. She is currently a Hematology and Sickle Cell Program Leader and the Director of a Hemophilia Treatment Center.
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Photo of Christine Hoehner-Cooper, MSN, RN, NP-C
Christine Hoehner-Cooper, MSN, RN, NP-C
Nurse Practitioner
Oakland, California
Ms. Hoehner-Cooper is a Nurse Practitioner in California. She earned her undergraduate nursing degree from San Diego State University in California and her Master of Science in nursing from Holy Names University in Oakland, before completing a fellowship at Samuel Merritt University School of Nursing. Serving as a coinvestigator for multiple clinical trials studying various treatments for patients with sickle cell disease, Ms. Hoehner-Cooper has coauthored numerous abstracts and posters published in peer-reviewed medical literature, presented at medical conferences and was coauthor of an article published in a peer-reviewed journal. She has also been an invited lecturer at various community health events.
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Photo of Modupe Idowu, MD
Modupe Idowu, MD
Associate Professor of Medicine and Hematology
Houston, Texas
Dr. Idowu is Associate Professor and Medical Director in the Division of Hematology. She earned her medical degree from Texas Tech University School of Medicine and completed a residency in internal medicine at Texas Tech University Health Sciences Center. She completed a fellowship in hematology at the University of Florida. Dr. Idowu's clinical interests include sickle cell anemia, other anemias, thrombocytopenia, leukopenia, myelodysplastic syndrome, bone marrow disorders, and multiple myeloma. In addition to serving as an investigator for more than 12 clinical trials, Dr. Idowu is a reviewer for the journal *Scientific Reports*.
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Photo of Zahra Pakbaz, MD
Zahra Pakbaz, MD
Health Sciences Associate Clinical Professor
Orange, California
Dr. Pakbaz is an adult hematologist practicing benign hematology in Orange, California. Dr. Pakbaz received her medical degree from Tehran University of Medical Sciences in Iran. She completed an internship and residency in internal medicine at Union Memorial Hospital/University of Maryland in Baltimore, Maryland, followed by a fellowship in clinical hematology in the hematology branch of the National Heart, Lung, and Blood Institute of the National Institutes of Health in Bethesda, Maryland. Dr. Pakbaz’s research interests include sickle cell disease (SCD), thalassemia, iron overload, and nonmalignant hematology. Her research findings have led to improved outcomes for patients with SCD and thalassemia. She is passionate about delivering patient-centered care to people with blood disorders. Dr. Pakbaz serves as a national speaker on SCD awareness.
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Photo of Santosh Saraf, MD, MS
Santosh Saraf, MD, MS
Associate Professor of Medicine
Chicago, Illinois
Dr. Saraf earned his medical degree from Temple University School of Medicine in Pennsylvania and fulfilled his internship, internal medicine residency, and hematology/oncology fellowship requirements at the University of Illinois at Chicago Medical Center. In addition, he completed a Master of Science degree in clinical and translational research at the University of Chicago School of Public Health. He is board certified in hematology and medical oncology. Dr. Saraf serves as a reviewer for multiple peer-reviewed medical journals, such as *Blood*, *Journal of the American Society of Nephrology*, *American Journal of Clinical Nutrition*, *American Journal of Hematology*, *PLOS One*, and *Frontiers in Oncology*, and has authored 60 articles published in such journals.
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Photo of Nirmish Shah, MD
Nirmish Shah, MD
Associate Professor
Durham, North Carolina
Dr. Shah's practice and research focuses on treating children and adults with sickle cell disease. When working with children, he focuses on teaching them about their condition and how to transition successfully to living with the disease as an adult. Dr. Shah earned his medical degree from the American University of the Caribbean, prior to fulfilling internship, residency, and fellowship requirements at East Carolina University. He also completed a Clinical Research Training Program at Duke University. Dr. Shah is board certified in pediatrics and pediatric hematology/oncology. For all patients, he provides the medical, social, and psychological support they need to remain healthy. His research aims to increase engagement of patients with sickle cell with their own care using mobile technology. Through the use of applications, he hopes to help patients, specifically children, better manage their symptoms and medications.
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Photo of Wally Smith, MD
Wally Smith, MD
Florence Neal Cooper Smith Professor of Sickle Cell Disease
Richmond, Virginia
Dr. Smith earned his medical degree from the University of Alabama School of Medicine, prior to completing an internship at University of Alabama Hospitals. He completed his residency at University of Tennessee Hospitals and is board certified in internal medicine. Dr. Smith is best known as Principal Investigator of the landmark Pain in Sickle Cell Epidemiology Study (PiSCES), the largest and most detailed adult cohort study of sickle cell disease (SCD) pain. Author of more than 130 publications, Dr. Smith has served as an investigator on more than 55 externally funded grants and contracts. He is Principal Investigator of likely the first-ever randomized controlled trial of implementation science in SCD, Start Healing in Patients with Hydroxyurea (SHiP HU). Dr. Smith also participated in the published evidence-based classification systems for acute and chronic SCD pain.
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Photo of Kusum Viswanathan, MD
Kusum Viswanathan, MD
Director of Pediatric Hematology/Oncology
New York, New York
Dr. Viswanathan is Director of the Division of Pediatric Hematology/Oncology, Chair of the Department of Pediatrics, and President of a Hospital Medical Board in Brooklyn, New York. She earned her medical degree from the All-India Institute of Medical Sciences in New Delhi, India, prior to fulfilling residency requirements in pediatrics at Long Island College Hospital in New York, where she also completed a fellowship in pediatric hematology/oncology. Dr. Viswanathan is board certified to practice pediatric medicine and pediatric hematology/oncology. Dr. Viswanathan's research has been published in multiple peer-reviewed medical journals, and she has presented posters and abstracts throughout the country. In addition, she has served as an invited lecturer at nationwide symposia, including as a keynote speaker.
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INDICATIONS AND USAGE

OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older.

This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Contraindications

OXBRYTA is contraindicated in patients with a history of serious drug hypersensitivity reaction to voxelotor or excipients. Clinical manifestations may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia.

Warnings and precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions after administration of OXBRYTA have occurred in <1% of patients treated. Clinical manifestations may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia.

If hypersensitivity reactions occur, discontinue OXBRYTA and administer appropriate medical therapy. Do not reinitiate OXBRYTA in patients who experience these symptoms with previous use.

Laboratory Test Interference

OXBRYTA administration may interfere with measurement of Hb subtypes (HbA, HbS, and HbF) by high-performance liquid chromatography (HPLC). If precise quantitation of Hb species is required, chromatography should be performed when the patient has not received OXBRYTA therapy in the immediately preceding 10 days.

Adverse reactions

Clinical Trials Experience

Adults and Pediatric Patients 12 Years of Age and Older

Serious adverse reactions occurred in 3% (3/88) of patients receiving OXBRYTA 1,500 mg, which included headache, drug hypersensitivity, and pulmonary embolism occurring in 1 patient each. Permanent discontinuation due to an adverse reaction (Grades 1-4) occurred in 5% (4/88) of patients who received OXBRYTA 1,500 mg.

The most common adverse reactions (≥10%) in patients receiving OXBRYTA 1,500 mg with a difference of >3% compared to placebo: Headache (32% vs. 25%), Diarrhea (23% vs. 11%), Abdominal Pain (23% vs. 16%), Nausea (19% vs. 10%), Rash (15% vs. 11%), and Pyrexia (15% vs. 8%).

Pediatric Patients 4 to <12 Years

The safety of OXBRYTA in pediatric patients 4 to <12 years with SCD was evaluated in an open-label, Phase 2 study. In this study, 45 patients 4 to <12 years of age received doses of OXBRYTA tablets for oral suspension based on weight at baseline. Thirty-five patients received OXBRYTA for 24 weeks and 26 patients for 48 weeks. The most common adverse reactions (>10%) reported in pediatric patients 4 to <12 years were pyrexia (36%), vomiting (33%), rash (20%), abdominal pain (18%), diarrhea (18%), and headache (18%).

The overall safety profile of OXBRYTA in pediatric patients 4 to <12 years was similar to that seen in adults and pediatric patients 12 years and older.

Drug interactions

Strong or Moderate CYP3A4 Inducers

Coadministration of strong or moderate CYP3A4 inducers may decrease voxelotor plasma and whole blood concentrations and may lead to reduced efficacy. Avoid coadministration of OXBRYTA with strong or moderate CYP3A4 inducers. Increase the OXBRYTA dosage when coadministration with a strong or moderate CYP3A4 inducer is unavoidable.

Sensitive CYP3A4 Substrates

Voxelotor increased the systemic exposure of midazolam (a sensitive CYP3A4 substrate). Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. If unavoidable, consider dose reduction of the CYP3A4 substrate(s).

USE IN SPECIFIC POPULATIONS

Lactation

Because of the potential for serious adverse reactions in the breastfed child, including changes in the hematopoietic system, advise patients not to breastfeed while taking OXBRYTA and for at least 2 weeks after the last dose.

Recommended Dosage for Hepatic Impairment

Severe hepatic impairment increases voxelotor exposures. For severe hepatic impairment (Child Pugh C) reduce dose to 1,000 mg orally once daily for adults and pediatric patients ≥ 12 years. Dose reduction for pediatric patients 4 to <12 years is dependent on body weight (please refer to Table 2 in the Full Prescribing Information).

INDICATIONS AND USAGE

OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older.

This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Contraindications

OXBRYTA is contraindicated in patients with a history of serious drug hypersensitivity reaction to voxelotor or excipients. Clinical manifestations may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia.

Warnings and precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions after administration of OXBRYTA have occurred in <1% of patients treated. Clinical manifestations may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia.

If hypersensitivity reactions occur, discontinue OXBRYTA and administer appropriate medical therapy. Do not reinitiate OXBRYTA in patients who experience these symptoms with previous use.

Laboratory Test Interference

OXBRYTA administration may interfere with measurement of Hb subtypes (HbA, HbS, and HbF) by high-performance liquid chromatography (HPLC). If precise quantitation of Hb species is required, chromatography should be performed when the patient has not received OXBRYTA therapy in the immediately preceding 10 days.

Adverse reactions

Clinical Trials Experience

Adults and Pediatric Patients 12 Years of Age and Older

Serious adverse reactions occurred in 3% (3/88) of patients receiving OXBRYTA 1,500 mg, which included headache, drug hypersensitivity, and pulmonary embolism occurring in 1 patient each. Permanent discontinuation due to an adverse reaction (Grades 1-4) occurred in 5% (4/88) of patients who received OXBRYTA 1,500 mg.

The most common adverse reactions (≥10%) in patients receiving OXBRYTA 1,500 mg with a difference of >3% compared to placebo: Headache (32% vs. 25%), Diarrhea (23% vs. 11%), Abdominal Pain (23% vs. 16%), Nausea (19% vs. 10%), Rash (15% vs. 11%), and Pyrexia (15% vs. 8%).

Pediatric Patients 4 to <12 Years

The safety of OXBRYTA in pediatric patients 4 to <12 years with SCD was evaluated in an open-label, Phase 2 study. In this study, 45 patients 4 to <12 years of age received doses of OXBRYTA tablets for oral suspension based on weight at baseline. Thirty-five patients received OXBRYTA for 24 weeks and 26 patients for 48 weeks. The most common adverse reactions (>10%) reported in pediatric patients 4 to <12 years were pyrexia (36%), vomiting (33%), rash (20%), abdominal pain (18%), diarrhea (18%), and headache (18%).

The overall safety profile of OXBRYTA in pediatric patients 4 to <12 years was similar to that seen in adults and pediatric patients 12 years and older.

Drug interactions

Strong or Moderate CYP3A4 Inducers

Coadministration of strong or moderate CYP3A4 inducers may decrease voxelotor plasma and whole blood concentrations and may lead to reduced efficacy. Avoid coadministration of OXBRYTA with strong or moderate CYP3A4 inducers. Increase the OXBRYTA dosage when coadministration with a strong or moderate CYP3A4 inducer is unavoidable.

Sensitive CYP3A4 Substrates

Voxelotor increased the systemic exposure of midazolam (a sensitive CYP3A4 substrate). Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. If unavoidable, consider dose reduction of the CYP3A4 substrate(s).

USE IN SPECIFIC POPULATIONS

Lactation

Because of the potential for serious adverse reactions in the breastfed child, including changes in the hematopoietic system, advise patients not to breastfeed while taking OXBRYTA and for at least 2 weeks after the last dose.

Recommended Dosage for Hepatic Impairment

Severe hepatic impairment increases voxelotor exposures. For severe hepatic impairment (Child Pugh C) reduce dose to 1,000 mg orally once daily for adults and pediatric patients ≥ 12 years. Dose reduction for pediatric patients 4 to <12 years is dependent on body weight (please refer to Table 2 in the Full Prescribing Information).