Rayos: (Prednisone) Delayed-release Tablets

Full Prescribing Information For HCPs

The first and only delayed-release prednisone
for the treatment of rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR)

Patient FAQs about RAYOS® (prednisone) delayed-release tablets

These questions are for patients considering RAYOS and patients prescribed RAYOS. This does not replace talking with your health care provider.

Always follow your health care provider's instructions.

  1. What is RAYOS used for?
  2. What should I know about the safety of RAYOS
    before taking it?
  3. What are the most common side effects of RAYOS?
  4. How can I get RAYOS?
  5. Is there a generic substitute for RAYOS?
  6. What is prednisone?
  7. What does delayed release mean?
  8. When should I take RAYOS?
  9. How should I take RAYOS?
  10. Do I take RAYOS with or without food?
  11. What should I do if I miss a dose?
  12. Can I stop taking RAYOS at any time?
  13. How should I store RAYOS?
  14. Where can I get more information about RAYOS?

1. What is RAYOS used for?
RAYOS is an anti-inflammatory medicine that can be used to treat many different conditions, including rheumatologic diseases such as rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR).

It is also used to treat certain allergic, skin, stomach and intestinal, blood, eye, nerve, kidney, breathing, rheumatologic, and specific infectious diseases or conditions, and organ transplantation.

RAYOS can be used in the treatment of certain endocrine conditions and to ease the symptoms, including pain, of certain cancer conditions as well.

For a complete list of indications for RAYOS, please see the full Prescribing Information.

2. What should I know about the safety of RAYOS before taking it?

You should talk to your health care provider before taking RAYOS. Click here to read the Important Safety Information for RAYOS.

For the full Prescribing Information, please see the link at the top of this page.

3. What are the common side effects of RAYOS?
Common side effects of RAYOS may include water retention, high blood sugar, high blood pressure, unusual behavior and mood changes, increased appetite, and weight gain.

4. How can I get RAYOS?
RAYOS is available by prescription only. Your pharmacy should carry RAYOS. In the event they do not have it on the shelf, ask your pharmacist to order it for you. RAYOS can be delivered to your pharmacy typically within 24 hours. Ask your health care provider if RAYOS may be right for you.

5. Is there a generic substitute for RAYOS?
RAYOS is the first and only delayed-release form of prednisone. There are generic forms of prednisone, but there is no generic substitute for delayed-release prednisone. RAYOS is different in that only RAYOS releases the anti-inflammatory action of prednisone about 4 hours after taking the tablets.

6. What is prednisone?
Prednisone is a type of corticosteroid. Corticosteroids are different from anabolic steroids, which are sometimes used by body builders. Corticosteroids closely resemble hormones that your body produces naturally and are used to help reduce inflammation and pain.

7. What does delayed release mean?
A delayed-release medication postpones the drug effect for an amount of time after you take the dose. With RAYOS, the prednisone dose is released in about 4 hours.

8. When should I take RAYOS?
Your health care provider will tell you when to take RAYOS. For example, your health care provider may ask you to take RAYOS at bedtime. In clinical studies, RAYOS was taken around 10 PM.

9. How should I take RAYOS?
RAYOS should be taken once a day. RAYOS tablets should not be broken, divided or chewed because the delayed release of prednisone depends on a whole tablet. RAYOS is available in 1-mg, 2-mg and 5-mg tablets. Your health care provider will decide what dose is right for you based on your symptoms and will talk to you about when to take it. Your health care provider may tell you to take more than 1 pill or a combination of 2 different dose sizes. Always follow the dosing instructions from your health care provider.

10. Do I take RAYOS with or without food?
RAYOS should be taken with food. In a clinical study, RAYOS was taken with a light meal or snack if more than 2.5 hours had passed since the evening meal. RAYOS worked similarly when taken with dinner or with a light meal.

11. What should I do if I miss a dose?
If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take RAYOS at the next regularly scheduled time. Do not take an extra dose to make up for the missed dose.

12. Can I stop taking RAYOS at any time?
Talk to your health care provider before you stop taking RAYOS. You may need to gradually reduce the amount of RAYOS you are taking. Stopping RAYOS suddenly may cause unwanted side effects.

13. How should I store RAYOS?
RAYOS should be stored at room temperature. Be careful not to leave RAYOS anywhere where it may get too hot, like in your car on a hot day.

14. Where can I get more information about RAYOS?
Ask your health care provider about RAYOS; only your health care provider can offer information that is specific to your own health history. You can also read more by downloading the full Prescribing Information for RAYOS.

 

Terms in green are defined in the glossary.

Your health care provider prescribed RAYOS for you. Be sure to ask for RAYOS
by name.

Do not use RAYOS if you are allergic to prednisone.

Long-term use of RAYOS can affect your hormones and one of the ways your body responds to stress. Symptoms, among others, can include weight gain, changes in body appearance (particularly the face), severe fatigue, weak muscles, and high blood sugar. Tell your doctor if you develop any of these symptoms after taking RAYOS.

RAYOS can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Signs and symptoms of infection may be hidden. Tell your doctor if you have had a recent or ongoing infection or if you have been exposed to chickenpox or measles.

RAYOS can cause high blood pressure, salt and water retention, and low blood potassium. Your doctor should monitor these levels.

There is an increased risk of developing perforations in the stomach or intestines if you have certain stomach and intestinal disorders. Signs and symptoms may be hidden.

Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes, severe depression, and psychosis. Existing conditions may become worse.

Long-term use of RAYOS can cause decreases in bone density. You should talk with your doctor about this risk before you initiate therapy, particularly if you are postmenopausal. Your doctor should monitor bone density with long-term therapy.

RAYOS can cause cataracts, eye infections, and glaucoma. Your doctor should monitor eye pressure if you use RAYOS for more than 6 weeks.

Do not receive a “live” vaccine while taking RAYOS. The vaccine may not work as well during this time, and may not fully protect you from disease. Tell your doctor if you have recently received a vaccine.

Taking RAYOS during the first trimester of pregnancy can harm an unborn baby.

Long-term use of RAYOS can slow growth and development in children. Children on long-term therapy should be monitored for this.

The most common side effects with RAYOS are water retention, high blood sugar, high blood pressure, unusual behavior and mood changes, increased appetite, and weight gain.

Talk to your doctor before you stop taking RAYOS. You may need to gradually reduce the amount of RAYOS you are taking. Stopping RAYOS suddenly may cause unwanted side effects.

Approved uses of RAYOS
RAYOS, a corticosteroid, is an anti-inflammatory or immunosuppressive agent used in the treatment of many different conditions, such as certain allergic, skin, stomach and intestinal, blood, eye, nerve, kidney, breathing, rheumatologic, and specific infectious diseases or conditions, and organ transplantation. RAYOS is used in the treatment of certain endocrine conditions and to ease the symptoms, including pain, of certain cancer conditions.

For a complete list of indications for RAYOS, please see full Prescribing Information.

*For eligible patients. Terms and Conditions apply. Please click here for more information.

All rights reserved © 2014 Horizon Pharma USA, Inc.
RAYOS is a registered trademark of Horizon Pharma.
May 2014. 0108RAY01
www.horizonpharma.com