Get your patients
started
with treatment
and support
for
SKYCLARYS

Chris, age 42 | Fisherman, outdoorsman | Taking SKYCLARYS since 2023 | Chris is a paid spokesperson for Biogen.

Getting started
Dosing and administration
Testing and monitoring

SKYCLARYS is a once-daily oral
prescription medicine

Standard administration for patients who are able
to swallow whole capsules1
  • Administer SKYCLARYS on an empty stomach, at least 1 hour before or 2 hours after eating
  • Swallow SKYCLARYS capsules whole. Do not crush or chew
Sprinkle administration for patients who are unable to
swallow whole capsules1
  • Administer SKYCLARYS on an empty stomach, at least 1 hour before or 2 hours after eating
  • SKYCLARYS capsules may be opened and the entire contents of both halves of the capsule sprinkled onto 2 tablespoons (30 mL) of applesauce. Stir the mixture until homogenous and swallow all the drug/applesauce mixture immediately
  • Do not store the mixture for future use
  • Contents of the SKYCLARYS capsules should not be mixed with milk or orange juice
  • Not for enteral feeding tube administration
Additional dosing and administration considerations
for patients taking SKYCLARYS1
  • 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
  • For additional information about SKYCLARYS dosing as it relates to concomitant use with strong or moderate CYP3A4 inhibitors/inducers, patients with hepatic impairment, and the use of hormonal contraceptives, please see the full Prescribing Information
  • Discuss all medications your patients are taking, including other prescription medications, non-prescription medications, or herbal products (eg, St John’s wort)
  • Avoid grapefruit and grapefruit juice
Download the digital dosing guide as a reference when starting a patient on SKYCLARYS
Download HCP Dosing Guide

Recommended dosage of SKYCLARYS with concomitant use of CYP3A4 inhibitors and inducers1

Strong CYP3A4 inhibitor

Recommended to avoid concomitant use. If coadministration cannot be avoided:

  • Reduce the dosage of SKYCLARYS to 50 mg once daily with close monitoring for adverse reactions
  • If adverse reactions emerge, coadministration with strong CYP3A4 inhibitors should be discontinued
Moderate CYP3A4 inhibitor

Recommended to avoid concomitant use. If coadministration cannot be avoided:

  • Reduce the dosage of SKYCLARYS to 100 mg once daily with close monitoring for adverse reactions
  • If adverse reactions emerge, further reduce the dosage of SKYCLARYS to 50 mg once daily
Strong or moderate CYP3A4 inducer

Recommend to avoid concomitant use.

Recommended dosage for patients with hepatic impairment1

Severe (Child-Pugh Class C)

Avoid use.

Moderate (Child-Pugh Class B)
  • 100 mg once daily with close monitoring for adverse reactions
  • Consider lowering to 50 mg once daily if adverse reactions emerge
Mild (Child-Pugh Class A)

150 mg once daily.

Considerations for use with hormonal birth control1

SKYCLARYS may reduce the efficacy of hormonal contraceptives. Advise patients to avoid concomitant use with contraceptives such as the pill, patches, or rings, as well as implants and progestin-only pills. See the full Prescribing Information for further details.

Testing and monitoring is required for patients being treated with SKYCLARYS1

Monitoring and testing guidelines
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INDICATION

  • SKYCLARYS® (omaveloxolone) is indicated for the treatment of Friedreich ataxia in adults and adolescents aged 16 years and older

 

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
  • 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. 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 Study 1, 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
 

ADVERSE REACTIONS

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

DRUG INTERACTIONS

  • Avoid concomitant use of SKYCLARYS with moderate or strong CYP3A4 inhibitors. If use cannot be avoided, dosage modifications are recommended
  • Avoid concomitant use of SKYCLARYS with moderate or strong CYP3A4 inducers
  • Refer to the prescribing information for dosing instructions for concomitant use of CYP3A4 and CYP2C8 substrates and monitor for lack of efficacy of the concomitant treatment
  • Advise patients to avoid concomitant use with combined hormonal contraceptives, implants, and progestin only pills
 

SPECIFIC POPULATIONS
Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SKYCLARYS during pregnancy. Healthcare providers are encouraged to enroll pregnant patients, or pregnant women may register themselves in the program by calling 1-866-609-1785 or by sending an email to SkyclarysPregnancySurveillance@ppd.com
  • There are no adequate data on the development risks associated with the use of SKYCLARYS in pregnant women
 

Lactation

  • There are no data on the presence of omaveloxolone or its metabolites in human milk. 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
 

Hepatic Impairment

  • Avoid treatment with SKYCLARYS in patients with severe hepatic impairment, including those who develop severe hepatic impairment
  • Reduced dosage in patients with moderate hepatic impairment with close monitoring for adverse reactions is recommended
 

Please see full Prescribing Information.

Reference

1. Skyclarys. Prescribing information. Biogen; 2024.

Intended for a US HCP audience.
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