Skyclarys

About Skyclarys 

• The US FDA administration granted approval to Skyclarys on  February 28, 2023.
• Skyclarys is used to treat Friedreich’s ataxia in adults and adolescents aged 16 years and older.
• Friedreich’s ataxia is a rare neuromuscular disorder leading to strength and coordination loss, often necessitating wheelchair use. It contains omaveloxolone, an activator of the Nrf2 pathway, which is suppressed in Friedreich’s ataxia.
• Friedreich’s ataxia symptoms often begin in childhood, including coordination loss, muscle weakness, and fatigue, which can lead to incapacity in late teens or early twenties. Visual and hearing issues, diabetes, and cardiomyopathy are also common. 
• Safety and efficacy of this medicine in children under 16 are unknown.

Strength

Capsules are delivered in a strength of Skyclarys 50 mg respectively, for oral consumption.

Recommended Dosage

Before starting Skyclarys, it’s important to obtain ALT, AST, bilirubin, BNP, and lipid parameter measurements. When taking Skyclarys capsules, ensure you swallow them whole and do not open, crush, or chew them for proper administration. Additionally, for safety while consuming Skyclarys capsules, remember to take them with a full glass of water, follow your healthcare provider’s instructions meticulously, and promptly report any unusual side effects or concerns during your treatment.

• Take Skyclarys at a recommended dose of 150 mg (3 capsules) orally once daily. Administer it on an empty stomach, at least one hour before eating.

Important

Skyclarys can be administered orally or through a gastrostomy (G) tube. For doses given via gastrojejunal (GJ) tubes, they should be administered through the G-port. To ensure precise dosing, use a calibrated measuring device, like an oral syringe or dosing cup obtained from the pharmacy, and avoid using a household measuring cup. It’s important to discard any unused Skyclarys oral solution after 14 days from the bottle’s initial opening.

Warnings & Precautions

Prior to initiating this medication, please notify your healthcare provider of any preexisting medical conditions. Monitoring and safety considerations include

• If you have a history of elevated Aminotransferases (ALT, AST, and total bilirubin), it is imperative to inform your healthcare provider. Monitoring these levels is necessary before starting the treatment, with monthly assessments during the first three months, and periodic follow-ups thereafter.
• If you have concerns related to elevated Elevation of B-type Natriuretic Peptide (BNP), it is essential to be vigilant about recognizing signs and symptoms of fluid overload. Promptly inform your healthcare provider if any such symptoms arise.
• Individuals with lipid abnormalities should remain watchful, as cholesterol levels require periodic monitoring throughout the course of treatment.
• Always engage in open and thorough discussions with your healthcare provider to ensure your safety and the effectiveness of this medicine in light of your medical history and conditions.
• Before using Skyclarys, inform your healthcare provider about your medical history, including if you have liver issues, a history of heart problems, such as heart failure, or elevated blood cholesterol levels.
• Before commencing treatment, it is essential to disclose any existing liver or kidney conditions to your physician. 
• This information is vital to ensure that the healthcare provider can make any necessary adjustments to the dosage, if required, to account for these conditions and promote your safety and well-being throughout the course of treatment.

Common Skyclarys Side Effects:

• Elevated liver enzymes (AST/ALT)
• Headache
• Nausea
• Abdominal pain
• Fatigue
• Diarrhea
• Musculoskeletal pain
• Vomiting
• Dizziness
• Rash
• Constipation
• Back pain

Use in Specific Population

• If you are pregnant or considering pregnancy, please note that the potential impact of Skyclarys on your unborn child is not well-established. It’s recommended for women using hormonal birth control to also use an additional non-hormonal contraceptive method, like condoms, while on Skyclarys and for 28 days after discontinuing the treatment.
• If you are currently breastfeeding or planning to breastfeed, it is uncertain whether Skyclarys passes into breast milk. It’s crucial to discuss the optimal feeding approach for your baby with your healthcare provider when taking Skyclarys.

Storage and Handling

• Store between 20°C to 25°C (68°F to 77°F), with excursions allowed between 15°C and 30°C (59°F to 86°F).
• Protect Skyclarys from light and moisture.
• Do not store Skyclarys in the bathroom or in other areas where it may be exposed to heat or humidity.
• Keep Skyclarys out of the reach of children and pets.