DRUG PRESENTATION
SKYCLARYS (Omaveloxolone)
Presented by:
SIBQATHULLAH K
Pharm D intern
Surgery ward
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Skyclarys (Omaveloxolone) - A Prescription Medicine for Friedreich's Ataxia, Slides of Infectious disease
An in-depth presentation of skyclarys, a prescription drug used for the treatment of friedreich's ataxia, a rare neuromuscular disorder. The chemistry, structure, mechanism of action, pharmacological effects, pharmacodynamics, pharmacokinetics, dose and dose adjustment, adverse drug reactions, contraindications, use in special populations, monitoring parameters, drug interactions, patient counseling, therapeutic class, fda approval history, and references. It is a valuable resource for students, healthcare professionals, and lifelong learners interested in pharmacology, neurology, and rare diseases.
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2022/2023
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DRUG PRESENTATION
SKYCLARYS (Omaveloxolone)
Presented by:
SIBQATHULLAH K
Pharm D intern
Surgery ward
CONTENTS
01 INTRODUCTION
CHEMISTRY, STRUCTURE
MOA, PHARMACOLOGICAL
EFFECT
USE IN SPECIAL
POPULATION
ADR MONITORING, DRUG
INTERACTIONS
PATIENT COUNSELLING
THERAPEUTIC CLASS
FDA APPROVAL HISTORY
CHEMISTRY OF SKYCLARYS
- (^) Skyclarys contains Omaveloxolone , an activator of the nuclear factor-erythroid 2 related factor 2 (Nrf2) pathway, which is suppressed in people with Friedreich’s ataxia.
- (^) Appearance: Blue and green colored capsule
- (^) Solubility: Insoluble in water, soluble in DMSO
- (^) Molecular formula: C33H44F2N2O
- (^) Molecular weight: 554.7g/mol
- (^) Synonyms: Omaveloxolone, Propanamide
THERAPEUTUC CLASS OF SKYCLARYS
- (^) SKYCLARYS belongs to class of a
medication known as, an activator of
the nuclear factor-erythroid 2 related
factor 2 (Nrf2) pathway.
- (^) SKYCLARYS is indicated for the
treatment of Friedreich’s ataxia in
adults and adolescents aged 16 years
and older.
MECHANISM OF ACTION The mechanism of action of Omaveloxolone and its related compounds has been demonstrated to be through a combination of activation of the antioxidative transcription factor Nrf2 and inhibition of the pro inflammatory transcription factor. Nrf2 transcriptionally regulates multiple genes that play both direct and indirect roles in producing antioxidative potential and the production of cellular energy within the mitochondria. Consequently, unlike exogenously administered antioxidants which provide a specific and finite antioxidative potential, Omaveloxolone, through Nrf2,broadly activates intracellular and mitochondrial antioxidative pathways, in addition to pathways that may directly increase mitochondrial biogenesis(such as PGC alpha) and bioenergetics.
MOA
PHARMACOLOGICAL EFFECTS
- (^) Skyclarys belongs to class of a medication
known as Miscellaneous central nervous
system agents.
- (^) Skyclarys is indicated for the treatment of
Friedreich’s ataxia in adults and
adolescents aged 16 years and older.
PHARMACOKINETICS
- (^) Absorption: Tmax oral - 7 to 14 hours
- (^) Distribution: Protein binding , plasma proteins : 97% Vd :7361 L.
- (^) Metabolism : Primary: CYP3A Minor: CYP2C8,CYP2J Substrate of CYP3A Inducer of CYP3A4 and CYP2C Inhibitor of OAT
- (^) Excretion: Renal excretion: 0.1% Fecal: 92% Total body clearance: 109L/hr Half-life: The estimated half-life is 57 hours
DOSE AND DOSE ADJUSTMENT (^) The recommended dosage of SKYCLARYS is 150 mg ( capsules) taken orally once daily. (^) Administer SKYCLARYS on an empty stomach at least one hour before eating. (^) Swallow SKYCLARYS capsules whole. Do not open, crush, or chew. (^) Missed Doses- If a dose of SKYCLARYS is missed, take the next dose at its scheduled time the following day. (^) A double dose should not be taken to make up for a missed dose.
CONTRAINDICATIONS Use of Skyclarys should not be used in patients: (^) Hypersensitivity to drug or ingredient (^) Hepatic impairment, (^) Child-Pugh Class C (^) Child-Pugh Class B (^) Caution: Female Patients of reproductive (^) Potential Caution: B-type natriuretic peptide elevated (^) Caution: cardiac dz (^) Significant Caution: left ventricular disfunction significant
USE IN SPECIAL POPULATION
- (^) Avoid use of Skyclarys in severe child pugh class C.
- (^) 100 mg once daily with close monitoring for adverse
reactions in case of moderate child-pugh class B.
- (^) No dose adjustment required in mild child pugh class A.
**DRUG INTERACTIONS
- OMAVELOXOLONE+ALPRAOLAM** Omaveloxolone may decrease the plasma concentration of drugs that are substrates of CYP450 2C8/3A4 via induction of these isoenzymes 2) OMAVELOXOLONE+ERYTHROMYCIN Erythromycin increase the plasma concentrations of Omaveloxolone 3) OMAVELOXOLONE+HYDROCORTISONE Omaveloxolone decrease the plasma concentrations of hydrocortisone 4) OMAVELOXOLONE+MONTELUKAST Omaveloxolone may decrease the plasma concentration of montelukast
PATIENT COUNSELLING