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Quick highlights1

  • SKYCLARYS is a once-daily oral prescription medicine
  • Some inhibitors and even foods like grapefruit can intervene with treatment. See more details below
  • Increases in ALT/AST were generally asymptomatic and reversible. Maximum increases in ALT and AST occurred within 12 weeks of starting SKYCLARYS

SKYCLARYS is a once-daily oral prescription medicine1

The recommended dose is 150 mg taken as 3 capsules (50 mg each) once daily.1

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.

Follow the instructions in the Prescribing Information.

Tips for your patients taking SKYCLARYS1
  • Swallow SKYCLARYS capsules whole. Do not open, crush, or chew
  • Take on an empty stomach 1 hour before eating
  • Avoid grapefruit and grapefruit juice
  • 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
  • Discuss all medications they are taking, including other prescription medications, non-prescription medications, or herbal products (eg, St. John’s wort)
Additional dosing considerations

A lower dose of SKYCLARYS (<150 mg) may be appropriate for some patients taking CYP3A4 inhibitors or inducers, or patients with hepatic impairment.1

Consult the full Prescribing Information for specific dosing considerations for these patients.

Safety data from the MOXIe trial1,2

Adverse events were generally considered mild to moderate.

The most common adverse reactions (≥20% and greater than placebo) were elevated liver enzymes (AST/ALT), headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.1

  • Adverse reactions1
    SKYCLARYS
    (N=51)
    PLACEBO
    (N=52)
  • Elevated liver enzymes (AST/ALT)
    37%
    2%
  • Headache
    37%
    25%
  • Nausea
    33%
    13%
  • Abdominal pain
    29%
    6%
  • Fatigue
    24%
    14%
  • Diarrhea
    20%
    10%
  • Musculoskeletal pain
    20%
    15%
  • Oropharyngeal pain
    18%
    6%
  • Influenza
    16%
    6%
  • Vomiting
    16%
    12%
  • Muscle spasms
    14%
    6%
  • Back pain
    13%
    8%
  • Decreased appetite
    12%
    4%
  • Rash
    10%
    4%

AST=aspartate aminotransferase; ALT=alanine aminotransferase.

  • 3 patients reported serious adverse events (SAEs) while taking SKYCLARYS2
  • 2 patients reported SAEs ~2 weeks after discontinuation1,2
  • 4 patients in the SKYCLARYS group and 2 patients in the placebo group discontinued treatment because of adverse reactions2

Warnings and precautions1

elevation

Elevation of aminotransferases
Treatment with SKYCLARYS can cause an elevation in hepatic transaminases (ALT and AST).

values

Monitor ALT, AST, and total bilirubin prior to initiation of SKYCLARYS, every month for the first 3 months of treatment, and periodically thereafter.

If transaminases increase to levels greater than 5 times the ULN, or greater than 3 times the ULN with evidence of liver dysfunction (eg, elevated bilirubin), immediately discontinue SKYCLARYS and repeat liver function tests as soon as possible.

If transaminase levels stabilize or resolve, SKYCLARYS may be reinitiated with an appropriate increased frequency of monitoring of liver function.

Maximum increases in ALT and AST occurred within 12 weeks after starting SKYCLARYS. Increases in serum aminotransferases were generally asymptomatic and reversible following discontinuation of SKYCLARYS.

elevation

Elevation of B-type natriuretic peptide (BNP)
Treatment with SKYCLARYS can cause an increase in BNP, a marker of cardiac function. Elevations in BNP may indicate cardiac failure and should prompt an evaluation of cardiac function. Check BNP prior to initiation of SKYCLARYS.

Monitor patients for the signs and symptoms of fluid overload, such as sudden weight gain (3 pounds or more of weight gain in one day, or 5 pounds or more of weight gain in a week), peripheral edema, palpitations, and shortness of breath. Management of fluid overload and heart failure may require discontinuation of SKYCLARYS.

elevation

Lipid abnormalities
Treatment with SKYCLARYS can cause changes in cholesterol.

Mean increases were observed within 2 weeks of initiation of SKYCLARYS and returned to baseline within 4 weeks of discontinuing treatment.1 Assess lipid parameters prior to initiation of SKYCLARYS and monitor periodically during treatment.

ULN=upper limit of normal.
Treat the progression of Friedreich ataxia with SKYCLARYS
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References:
1. Skyclarys. Prescribing Information. Reata Pharmaceuticals, Inc.; 2023. 2. Lynch DR, Chin MP, Delatycki MB, et al. Safety and efficacy of omaveloxolone in Friedreich ataxia (MOXIe study). Ann Neurol. 2021;89(2):212-225. 3. Parkinson MH, Boesch S, Nachbauer W, Mariotti C, Giunti P. Clinical features of Friedreich’s ataxia: classical and atypical phenotypes. J Neurochem. 2013;126(suppl 1):103-117. 4. Schulz JB, Boesch S, Bürk K, et al. Diagnosis and treatment of Friedreich ataxia: a European perspective. Nat Rev Neurol. 2009;5(4):222-234. 5. Rummey C, Farmer JM, Lynch DR. Predictors of loss of ambulation in Friedreich’s ataxia. EClinical Medicine. 2020;18:1-9. 6. Rummey C, Corben LA, Delatycki MB, et al. Psychometric properties of the Friedreich Ataxia Rating Scale. Neurol Genet. 2019;5(6):371. 7. Patel M, Isaacs CJ, Seyer L, et al. Progression of Friedreich ataxia: quantitative characterization over 5 years. Ann Clin Transl Neurol. 2016;3(9):684-694. 8. Lynch DR, Chin MP, Boesch S, et al. Efficacy of omaveloxolone in Friedreich’s ataxia: delayed-start analysis of the MOXIe extension. Mov Disord. Published online November 29, 2022. doi://10.1002/mds.29286 9. Galea CA, Huq A, Lockhart PJ, et al. Compound heterozygous FXN mutations and clinical outcome in Friedreich ataxia. Ann Neurol. 2016;79(3):485-495. 10. Fogel BL, Perlman S. Clinical features and molecular genetics of autosomal recessive cerebellar ataxias. Lancet Neurol. 2007;6(3):245-257. 11. Wallace SE, Bird TD. Molecular genetic testing for hereditary ataxia: what every neurologist should know. Neurol Clin Pract. 2018;8(1):27-32. 12. Lynch DR, Goldsberry A, Rummey C, et al. Direct utility of natural history data in analysis of clinical trials: propensity match-based analysis of omaveloxolone in Friedreich ataxia using the FA-COMS dataset. Preprint. Posted online August 16, 2022. medRxiv 2022.08.12.22278684. doi: https://doi.org/10.1101/2022.08.12.22278684 13. Beaulieu-Jones BK, Finlayson SG, Yuan W, et al. Examining the use of real-world evidence in the regulatory process. Clin Pharmacol Ther. 2020;107(4):843-852.

Important Safety Information

WARNINGS AND PRECAUTIONS

Elevation of Aminotransferases: Treatment with SKYCLARYS can cause an elevation in hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]). The incidence of elevations of ALT or AST above 5 times and 3 times the upper limit of normal (ULN) was 16% and 31%, respectively, in patients treated with SKYCLARYS. There were no cases of concomitant elevation of transaminases and total bilirubin observed. Maximum increases in ALT and AST occurred within 12 weeks after starting SKYCLARYS. Increases in serum aminotransferases were generally asymptomatic and reversible following discontinuation of SKYCLARYS. Patients with clinically significant liver disease were excluded from the pivotal study.

Monitor ALT, AST, and total bilirubin prior to initiation of SKYCLARYS, every month for the first 3 months of treatment, and periodically thereafter. If transaminases increase to levels greater than 5 times the ULN, or greater than 3 times the ULN with evidence of liver dysfunction (e.g., elevated bilirubin), immediately discontinue SKYCLARYS and repeat liver function tests as soon as possible. If transaminase levels stabilize or resolve, SKYCLARYS may be reinitiated with an appropriate increased frequency of monitoring of liver function.

Elevation of B-Type Natriuretic Peptide: Treatment with SKYCLARYS can cause an increase in B-type natriuretic peptide (BNP), a marker of cardiac function. A total of 14% of patients treated with SKYCLARYS had an increase from baseline in BNP value above the ULN (100 pg/mL), compared to 4% of patients who received placebo. The incidence of elevation of BNP above 200 pg/mL was 4% in patients treated with SKYCLARYS. Cardiomyopathy and cardiac failure are common in patients with Friedreich ataxia. Patients were excluded from the pivotal study if they had BNP levels > 200 pg/mL prior to study entry, or a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, with the exception of mild to moderate cardiomyopathy associated with Friedreich ataxia. Whether the elevations in BNP are related to SKYCLARYS or cardiac disease associated with Friedreich ataxia is unclear.

Elevations in BNP may indicate cardiac failure and should prompt an evaluation of cardiac function. Check BNP prior to initiation of SKYCLARYS. Monitor patients for the signs and symptoms of fluid overload, such as sudden weight gain (3 pounds or more of weight gain in one day, or 5 pounds or more of weight gain in a week), peripheral edema, palpitations, and shortness of breath. If signs and symptoms of fluid overload develop, worsen, or require hospitalization, evaluate BNP and cardiac function, and manage appropriately. Management of fluid overload and heart failure may require discontinuation of SKYCLARYS.

Lipid Abnormalities: Treatment with SKYCLARYS can cause changes in cholesterol. In the pivotal study, 29% of patients treated with SKYCLARYS reported elevated cholesterol above ULN at one or more time points. Mean increases were observed within 2 weeks of initiation of SKYCLARYS and returned to baseline within 4 weeks of discontinuing treatment. A total of 16% of patients treated with SKYCLARYS had an increase in low-density lipoprotein cholesterol (LDL-C) from baseline, compared to 8% of patients who received placebo. The mean increase in LDL-C for all SKYCLARYS-treated patients was 23.5 mg/dL at 48 weeks. A total of 6% of patients treated with SKYCLARYS had decreases in high-density lipoprotein cholesterol (HDL-C) from baseline compared to 4% of patients who received placebo. The mean decrease in HDL-C for all SKYCLARYS-treated patients was 5.3 mg/dL at 48 weeks.

Assess lipid parameters prior to initiation of SKYCLARYS and monitor periodically during treatment. Manage lipid abnormalities according to clinical guidelines.

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

Adverse reactions reported in 10% or more of patients and greater than placebo were elevated liver enzymes (AST/ALT) (37%), headache (37%), nausea (33%), abdominal pain (29%), fatigue (24%), diarrhea (20%), musculoskeletal pain (20%), oropharyngeal pain (18%), influenza (16%), vomiting (16%), muscle spasms (14%), back pain (13%), decreased appetite (12%), rash (10%).

DRUG INTERACTIONS

  • Moderate or Strong CYP3A4 Inhibitors: Avoid concomitant use. Consider SKYCLARYS dosage reduction with monitoring if use is unavoidable.
  • Moderate or Strong CYP3A4 Inducers: Avoid concomitant use.
  • Hormonal Contraceptives: Counsel females to use an alternative contraceptive method (e.g., non-hormonal intrauterine system) or additional non-hormonal contraceptive (e.g., condoms) during concomitant use and for 28 days after discontinuation of SKYCLARYS.

This is not a complete list of potential drug interactions.

Specific Population: The effects on milk production and the breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYCLARYS and any potential adverse effects on the breastfed infant from SKYCLARYS or from the underlying maternal condition.

To report SUSPECTED ADVERSE REACTIONS, contact Reata Pharmaceuticals, Inc. at 1-800-314-3934 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

SKYCLARYS is indicated for the treatment of Friedreich ataxia in adults and adolescents aged 16 years and older.

For more information about SKYCLARYS, please see the full Prescribing Information.

US-SKY-2300055 v4.0

Skyclarys (omaveloxolone) 50mg capsules