Manufactured in the USA (sourced using components from Italy), KYMBEE™ is the only deflazacort backed by the Company's comprehensive Promise of Support® Program, designed to help children living with Duchenne muscular dystrophy receive the treatment they need as easily, quickly and reliably as possible.
"At Upsher-Smith, we recognize the importance of treatment options and support resources for families navigating deflazacort therapy," said Michelle Zachman, PharmD, BCPS, BCMAS, Medical Affairs Director, Upsher-Smith. "With KYMBEE™ (deflazacort) now available in both tablet and liquid formulations, we offer options to help meet the needs of patients and caregivers, including children who may have difficulty swallowing tablets. Through our Promise of Support® Program, families also have access to personalized assistance designed to help make access to treatment easier and more reliable."
Upsher-Smith's Promise of Support® Program for KYMBEE™
KYMBEE™ is backed by the Upsher-Smith Promise of Support® Program, designed to assist families throughout their treatment journey. The comprehensive program provides:
- Expert help with benefits investigation and coverage navigation
- Prior authorization and appeal support
- Copay assistance for eligible commercially insured patients*
- Bridge supply for therapy continuity and Quick Start available as needed
- 24/7 access to a pharmacist for personalized help
- Free home delivery and medication refill reminders
*Limitations apply.
For Families and Prescribers
Please see Important Safety Information below for KYMBEE™ (deflazacort) Tablets and Oral Suspension. Families are encouraged to ask their doctor about KYMBEE™ (deflazacort) Tablets and Oral Suspension. To learn more, visit https://mykymbee.com/caregiver. Healthcare professionals can visit: https://mykymbee.com/hcp. If you or your doctor have questions about KYMBEE™, reach out to Upsher-Smith at 1-888-650-3789.
IMPORTANT SAFETY INFORMATION for KYMBEE™ (deflazacort)
Who should not take KYMBEE?
Do not take if you have had hypersensitivity, including allergic reactions, to deflazacort (the active ingredient in KYMBEE) or to any of the inactive ingredients in KYMBEE.
What is the most important information I should know about KYMBEE?
- KYMBEE can cause changes in endocrine (hormone) function. Do not stop taking KYMBEE, or change the amount being taken, without first checking with a 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, including KYMBEE, are withdrawn abruptly, and can be life threatening. A steroid "withdrawal syndrome" 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 KYMBEE. Tell a healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Seek medical advice immediately if the patient develops fever or other signs of infection. Some infections can potentially be severe and life threatening. Patients should avoid exposure to chickenpox or measles and alert their healthcare provider immediately if they are exposed.
- KYMBEE can cause an increase in blood pressure and water retention. If this occurs, dietary salt restriction and potassium therapy may be needed.
- There is an increased risk of developing a hole in the stomach or intestines in patients with certain gastrointestinal disorders when taking corticosteroids like KYMBEE.
- KYMBEE can cause behavior and mood changes that can be severe. Seek medical attention if any behavioral or mood changes develop.
- There is a risk of osteoporosis with prolonged use of KYMBEE, which can lead to fractures in the spine and in long bones.
- KYMBEE may cause cataracts or glaucoma. A healthcare provider should monitor for these conditions if therapy is continued for more than 6 weeks.
- Immunizations should be up-to-date according to immunization guidelines prior to starting therapy with KYMBEE. Live attenuated or live vaccines should be administered at least 4 to 6 weeks prior to starting KYMBEE. Live attenuated or live vaccines should not be used in patients taking KYMBEE.
- KYMBEE can cause serious skin rashes. Seek medical attention at the first sign of a rash.
- Rare instances of anaphylaxis, a severe allergic reaction, have occurred in patients receiving corticosteroid therapy, including KYMBEE.
- KYMBEE Oral Suspension contains the preservative benzyl alcohol which can cause serious side effects in infants. It is not approved for use in patients less than 2 years of age.
Before taking KYMBEE, tell a healthcare provider about all medical conditions, including if the patient:
- is pregnant or planning to become pregnant. KYMBEE can harm an unborn baby.
- is breastfeeding or planning to breastfeed. Deflazacort may appear in breastmilk and could affect a nursing child.
Certain medications can cause an interaction with KYMBEE. Tell a healthcare provider about all the medicines you are taking, including over-the-counter medicines (such as insulin, aspirin or other non-steroidal anti-inflammatory drugs), 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 KYMBEE?
The most common side effects include: facial puffiness or Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, frequent daytime urination, unwanted hair growth, abdominal obesity, and colds. These are not all of the possible side effects. Call a healthcare provider for medical advice about side effects.
What is KYMBEE?
KYMBEE (deflazacort) is a prescription medicine used to treat Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
KYMBEE is available in 6 mg, 18 mg, 30 mg, and 36 mg tablets. KYMBEE is also available as a 22.75 mg/mL oral suspension.
This safety information is not comprehensive. For more information, please see the full Prescribing Information for KYMBEE and the Instructions for Use for KYMBEE Oral Suspension. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report suspected adverse reactions to the FDA by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a rare genetic condition that causes progressive muscle weakness due to a change in the gene that encodes for dystrophin, a protein needed for normal muscle function. It impacts around 15,000 individuals in the United States, and over 300,000 globally. It primarily affects boys, who are diagnosed around 4 years of age, and can impact mobility, breathing, and heart function over time. While there is currently no cure, early diagnosis and comprehensive care—including physical therapy, medication, and monitoring of cardiac and respiratory health—can help slow progression.
About Upsher-Smith Laboratories, LLC
Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.
About Bora
Founded in 2007, Bora Pharmaceuticals ("Bora" or "the Company", 6472.TW and BORAY.OTCQX) is a leading pharmaceutical services company with a vision and goal of "Contributing to Better Health All Over the World". Operating under a "Dual Engine" model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients' quality of life.
By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. Committed to making success "certain," Bora sets new standards in the pharmaceutical and CDMO industries. For more, please visit: https://www.bora-corp.com and https://www.boracdmo.com.
KYMBEE and Promise of Support are trademarks of Upsher-Smith Laboratories, LLC.
SOURCE Upsher-Smith Laboratories, LLC
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