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Oxbryta (Voxelotor)
Ericka Asamoah RN BSN
NURS 231 Spring Pharmacology for Advanced Practice
Objectives
1. Readers will gain more knowledge on sickle cell disease, its pathophysiology, and its complications.
2. Readers will understand the pharmacodynamics and pharmacokinetics of Oxbryta.
3. Readers will be able to identify the common side effects of Oxbryta.
4. Readers will be able to list the safety precautions and contraindictions for the medication Oxbryta.
5. Readers will complete 5 question Quiz at end of presentation.
Background of SCD
Sickle Cell Disease Pathophysiology
-Sickle cell disease is caused by a mutation in the beta-globin chain of the haemoglobin molecule.
-A group of inherited rare blood disorders that mainly affect red blood cells (RBCs) in the body.
-The hemoglobin in the RBCs clump together and become rigid and sticky.
-RBC shape changes from round to a crescent “C- shaped”
-Can result in a shortage of RBCs and can lead to multiple organ failure and eventually death.
Sickle Cell Disease
3 serious consequences of SCD:
1) Hemolysis
2) Anemia
3) Pain Crises
Common types of Sickle Cell Disease are HbSS, HbSC, HbS beta-thalassemia, HbSD, HbSE and HbSO.
Vaso-Occlusion Illustration
Impact on Health and Quality of Life
-An inherited condition in an autosomal recessive pattern
-SCD occurs in 1 out of every 365 African American births vs 1 out of every 16,300 Hispanic American births
-Estimated that 1 in every 13 African American babies are born with sickle cell trait
-More than 75% of the SCD cases in the world are found in Africa
-Life long condition from childhood to adulthood
-Pain crises leads to multiple hospital admissions each year for most patients with SCD
-Patients with SCD complain of physical, psychological, emotional, and social problems
-Increase in depression rates among SCD patients
-Negative perceptions from community regarding health problems (drug seeking)
-Mortality: SCD death for black children younger than 4 years has declined due to the introduction of a vaccine from 2000 that protects against invasive pneumococcal disease.
Introducing Oxbryta
Oxbryta Medication
-Oxbryta (voxelotor) is the first and only FDA-approved sickle haemoglobin polymerization inhibitor for the treatment of sickle cell disease (SCD).
-It was developed by Global Blood Therapeutics (GBT)
-Accepted by the US Food and Drug Administration (FDA) in September 2019.
Phramacodynamics of Oxbryta
Pharmacodynamics
-Oxbryta is different from other medications because it directly works on Hemoglobin S to stop the sickling process called Polymerization
-Prevents the RBCs from going through Hemolysis-> prevents Anemia from occurring
-Decreases blood viscosity
-Oxbryta assists the hemoglobin to perform its job by stabilizing RBCs in its oxygenated stage
Pharmacokinetics
Oxbryta molecular structure
Pharmacokinetics
Absorption: Oxbryta is absorbed into the plasma. The median plasma and whole blood Tmax after oral administration is 2 hours. The mean peak concentrations in RBCs are observed between 6 and 18 hours after oral administration.
Distribution: Administered orally and distributed into the RBCs due to its binding to the the hemoglobin. 99.8% protein bound
Metabolism: Oxbryta is metabolized through Phase I, Phase II, and combinations of both. Oxidation of medication is mediated primarily by CYP3A4 (an important enzyme in the body found in the liver and intestines).
Excretion: The elimination half-life of Oxbryta in patients with SCD is 35.5 hours and is excreted from body through feces and urine.
Phase 3 HOPE (Haemoglobin Oxygen Affinity Modulation to Inhibit HbS Polymerisation) clinical study.
Evidenced Based
Randomized clinical trial involving 274 patients with sickle cell disease:
90 patients received 1500mg of Oxbryta
92 patients received 900mg of Oxbryta
And 92 patients received a placebo during the study
Results after 24 weeks of treatment:
1) -Oxbryta increased Hemoglobin levels
More than 51.1% of the patients who took 1500mg of the drug had a rise of hemoglobin levels of more than 1gram per deciliter, Compared to the 6.5% in the placebo group.
2) -Oxbryta decreased hemolysis
3) -Oxbryta lowered bilirubin levels
Bilirubin levels fell by 29.08% vs 3.16% from placebo group
4) -Oxbryta lowered reticulocyte count
Reticulocyte count fell by 19.93% vs 4.54% from placebo group
Medication Safety
-Comes in 500 mg tablets; can take with or without food; swallow pill whole
-Recommended dosage: 1500 mg orally once a day
-Recommended dosage for severe hepatic impairment: 1000 mg orally once a day
-May take with or without Hydroxyurea
-It is not known if Oxbryta is safe and effective in children below 12 years of age.
-Before taking Oxbryta, tell your healthcare provider if you have one of these conditions:
• have liver problems
• are pregnant or plan to become pregnant. It is not known if Oxbryta can harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Oxbryta can pass into your breast milk and if it can harm your baby. Do not breastfeed during treatment with Oxbryta and for at least 2 weeks after the last dose
Contraindications
Contraindications
The most common side effects of Oxbryta include: headache, diarrhea, stomach pain, nausea, tiredness, rash, and fever
Hypersensitivity to medication include: generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia.
CALL MEDICAL PROVIDER IMMEDIATELY!
Drug interactions:
o Avoid co administration with strong CYP3A4 inhibitors or fluconazole
-Decrease voxelotor dose if unable to avoid
o Avoid co administration with strong or moderate CYP3A4 inducers
-Increase voxelotor dose if unable to avoid
References
American College of Clinical Pharmacology (2020). FDA approves oxbryta (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older. Retrieved from https://www.accp1.org/Members/Publications_News/FDA_Bursts/ACCP1/5Publications_and_News/OXBRYTA-Sickle-Cell-Disease-Adults-Patients-12-Years.aspx
Centers for Disease Control and Prevention (2020). Data and statistics on sickle cell disease. Retrieved from https://www.cdc.gov/ncbddd/sicklecell/data.html
Clinical Trials Arena (2019). Oxbryta (voxelotor) for the treatment of sickle cell disease. Retrieved from https://www.clinicaltrialsarena.com/projects/oxbryta-voxelotor/
Global Blood Therapeutics (2020). Oxbryta (voxelotor). Retrieved from https://oxbryta.com
Medscape (2020). Voxelotor. Retrieved from https://reference.medscape.com/drug/oxbryta-voxelotor-1000320#0
Salih, K. (2019). The impact of sickle cell anemia on the quality of life of sicklers at school age. Journal of Family Medicine and Primary Care, 8 (2), 468-471. doi: 10.4103/jfmpc.jfmpc_444_18
Pictures
Clinical Trials Arena (2019). Oxbryta (voxelotor) for the treatment of sickle cell disease. Retrieved from https://www.clinicaltrialsarena.com/projects/oxbryta-voxelotor/
Donnelly, K. (2014). Eight signs life is improving for African children. Retrieved from https://www.path.org/articles/eight-signs-life-is-improving-for-african-children/
Freepik (2020). People vectors, photos. Retrieved from https://www.freepik.com/free-photos-vectors/people
From To Translation Agency (2020). Medical and pharmacy translations. Retrieved from https://fromtotranslations.com/specialized-translation/medical-translations/
Genetics Home Reference (2020). Sickle cell disease. Retrieved from https://ghr.nlm.nih.gov/condition/sickle-cell-disease#sourcesforpage
Harrington, J. (2019). New hope for a sickle cell cure. Retrieved from https://www.sicklecelldisease.org/2019/12/02/new-hope-for-a-sickle-cell-cure/
Paddock, C. (2018). Anemia treatments may arise from red blood cells discovery. Retrieved from https://www.medicalnewstoday.com/articles/320717
US Food and Drug Administration (2020). Are you taking medication as prescribed? Retrieved from https://www.fda.gov/consumers/consumer-updates/are-you-taking-medication-prescribed
Wikipedia (2020). Voxelotor. Retrieved from https://en.wikipedia.org/wiki/Voxelotor
Quiz
QUIZ
1. Oxbryta (voxelotor) is a sickle haemoglobin polymerization inhibitor for the treatment of sickle cell disease (SCD).
TRUE OR FALSE
2. What are the 3 serious consequences of SCD? (Select all that apply)
A) Hemolysis B) Anemia C) Loss of Consciousness D) Pain Crises E) Infertility
3. Oxbryta is safe and effective in children below 12 years of age.
TRUE OR FALSE
4. Most common side effects of Oxbryta include: (Select all that apply)
A) Stomach pain B) Headache C) Diarrhea D) Blindness E) Anuria
5. The recommended dosage of Oxbryta for a person with severe hepatic impairment is:
A) 1000mg orally once a day
B) 1000mg orally twice a day
C) 1500mg orally once a day
D) 1500mg intramuscularly once a day