What is JAYTHARI (deflazacort tablets) used for?

JAYTHARI is a prescription medicine used to treat Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.’s Emflaza™ (deflazacort) tablets. However, due to PTC Therapeutics, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

INDICATION & IMPORTANT SAFETY INFORMATION FOR JAYTHARI (deflazacort)

When should I not take JAYTHARI?

Do not use if you have had hypersensitivity, including allergic reactions, to deflazacort or any of the inactive ingredients.

What warnings should I know about JAYTHARI?

  • JAYTHARI can cause changes in endocrine function. Do not stop taking JAYTHARI, or change the amount you are taking, without first checking with your healthcare provider, as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency and steroid “withdrawal syndrome”. Acute adrenal insufficiency can occur if corticosteroids are withdrawn abruptly and can be fatal. A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids. For patients already taking corticosteroids during times of stress, the dosage may need to be increased.
  • There is an increased risk of infection when taking JAYTHARI. Tell the healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Medical advice should be sought immediately if the patient develops fever or other signs of infection. Patients and/or caregivers should be made aware that some infections can potentially be severe and fatal. Warn patients who are on corticosteroids to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed.
  • JAYTHARI can cause an increase in blood pressure and water retention. If this occurs, dietary salt restriction and potassium supplementation may be needed.
  • There is an increased risk of developing a hole in the stomach or intestines in patients with certain stomach or intestine disorders when taking corticosteroids like JAYTHARI.
  • JAYTHARI can cause severe behavioral and mood changes. Seek medical attention from the healthcare provider if any behavioral or mood changes develop.
  • There is a risk of osteoporosis with prolonged use of JAYTHARI, which can lead to vertebral and long bone fractures.
  • JAYTHARI may cause cataracts or glaucoma and a healthcare provider should monitor for these conditions if corticosteroid therapy is continued for more than 6 weeks.
  • Immunizations should be up-to-date according to immunization guidelines prior to starting therapy with JAYTHARI. Live-attenuated or live vaccines should be administered at least 4 to 6 weeks prior to starting JAYTHARI. Live-attenuated or live vaccines should not be used in patients taking JAYTHARI.
  • JAYTHARI can cause serious skin rashes. Seek medical attention at the first sign of a rash.
  • Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy, including JAYTHARI.

What should I tell my health care provider?

Tell the health care provider about all medical conditions, including if the patient:

  • has had recent or ongoing infections
  • if they have recently received a vaccine
  • has diabetes, high blood pressure, or other chronic conditions
  • is pregnant or planning to become pregnant. JAYTHARI – can harm your unborn baby.
  • is breastfeeding or planning to breastfeed. JAYTHARI may appear in breastmilk and could affect a nursing child.

Certain medications can cause an interaction with JAYTHARI. Tell your healthcare provider of all the medicines you are taking, including over-the-counter medicines (such as insulin, aspirin or other NSAIDS), dietary supplements, and herbal products. Alternate treatment, dosage adjustment, and/or special test(s) may be needed during the treatment.

What are the side effects of JAYTHARI?

The most common side effects of JAYTHARI include facial puffiness or Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, frequent daytime urination, unwanted hair growth, central obesity, and colds. These are not all of the possible side effects of JAYTHARI. Call your doctor for medical advice about side effects.

Please see full Prescribing Information for additional Important Safety Information.

Reporting Side Effects

To report a side effect or adverse event, contact your doctor or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Why JAYTHARI?

A Clinically Proven Option for Families

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JAYTHARI contains the same active ingredient as the brand-name Emflaza®, a corticosteroid indicated for the treatment of DMD in patients 5 years of age and older. As a generic option, JAYTHARI may offer a more affordable option for deflazacort tablets.

Flexible Dosing for Individual Needs

02

With four tablet strengths—6 mg, 18 mg, 30 mg, and 36 mg—JAYTHARI allows for customized dosing that fits each child’s needs while helping families and care teams stay on track. JAYTHARI is available exclusively through Orsini Specialty Pharmacy. See ordering information for healthcare professionals.

Supporting Access Where It Matters Most

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JAYTHARI is brought to you by Zydus, a company focused on removing barriers to essential care. Their mission is to make medicines available to more people by combining quality with greater affordability.

Costs should not be a barrier to getting JAYTHARI.

The Zydus Copay Savings Program can help with your out-of-pocket costs.

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Taking JAYTHARI

The recommended dosage of JAYTHARI is approximately 0.9 mg/kg/day once daily. Any combination of the four JAYTHARI strengths can be used to achieve the dose prescribed by your child’s doctor based on their weight.

It is important to track your child’s weight and talk to your child’s doctor regarding any weight changes and potential dose adjustments that may be needed.

Tablets shown here not actual size

Do not stop taking JAYTHARI without checking with your child’s doctor.

They may recommend a reduction in dose rather than discontinuing treatment altogether. The dosage of JAYTHARI must be decreased gradually if your child has taken it for more than a few days.

  • JAYTHARI can be taken with or without food
  • Tablets may be given whole or crushed and can be taken immediately after mixing with applesauce
  • Your child’s doctor can prescribe multiple tablets to add up to the prescribed dosing, rounding up to the nearest dose amount

Patient portrayal