Rayos

Generic Name: prednisone
Date of Approval: July 26, 2012
Company: Horizon Pharma, Inc.
Treatment for: Rheumatoid Arthritis, Polymyalgia Rheumatica, Psoriatic Arthritis, Ankylosing Spondylitis, Asthma, Chronic Obstructive Pulmonary Disease and Related Conditions

FDA Approves Rayos

The U.S. Food and Drug Administration (FDA) has approved Rayos (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). Rayos works by preventing the release of substances in the body that cause inflammation.

About Rayos

Rayos is a proprietary delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of Rayos is different with an approximately four-hour lag time from that of immediate-release prednisone formulations. In clinical trials studying use of Rayos in RA, patients were administered Rayos at 10 p.m. with food. Given the delayed-release profile, this helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night. While the pharmacokinetic profile of Rayos differs in terms of lag time from immediate-release prednisone, its absorption, distribution and elimination processes are comparable.

This medicine is contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients. Rare instances of anaphylaxis have occurred in patients receiving corticosteroids.

Important Information about Rayos

  • Do not use Rayos if you are allergic to prednisone.
  • Long-term use of Rayos can affect how your body responds to stress. Symptoms can include weight gain, severe fatigue, weak muscles, and high blood sugar.
  • 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.
  • Rayos can cause high blood pressure, salt and water retention and low blood potassium.
  • There is an increased risk of developing holes in the stomach or intestines if you have certain stomach and intestinal disorders.
  • Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes or severe depression.
  • Long-term use of prednisone can cause decreases in bone density.
  • Rayos can cause cataracts, eye infections and glaucoma.
  • Do not receive a "live" vaccine while taking this medicine. The vaccine may not work as well during this time, and may not fully protect you from disease.
  • Taking prednisone during the first trimester of pregnancy can harm an unborn baby.
  • Long-term use of prednisone can slow growth and development in children.
  • 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.

Rayos Clinical Data

The FDA approval was supported by data bridging the pharmacokinetics of Rayos to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with Rayos experienced a statistically significant improvement in ACR20 response criteria compared to placebo. The CAPRA-1 trial supported the overall safety of Rayos.

Rayos Patient Information

Read this Patient Information before you start taking Rayos and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Slideshow: Flashback: FDA Drug Approvals 2013

What is Rayos?

Rayos (prednisone) is in a class of drugs called corticosteroids. Prednisone prevents the release of substances in the body that cause inflammation.

Rayos is used to treat many different conditions such as rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

Rayos may also be used for purposes not listed in this medication guide.

Important information

You should not use this medication if you are allergic to prednisone, or if you have a fungal infection anywhere in your body.

Before taking Rayos, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your dosage needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

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. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

Do not receive a "live" vaccine while using Rayos. The vaccine may not work as well during this time, and may not fully protect you from disease.

Wear a medical alert tag or carry an ID card stating that you take Rayos. Any medical care provider who treats you should know that you are using this medicine.

Before taking this medicine

You should not use Rayos if you are allergic to prednisone, or if you have a fungal infection anywhere in your body.

Rayos can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medicine, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure you can safely take Rayos, tell your doctor if you have any of these other conditions:

  • liver disease (such as cirrhosis);
  • kidney disease;
  • a thyroid disorder;
  • diabetes;
  • a history of malaria;
  • tuberculosis;
  • osteoporosis;
  • a muscle disorder such as myasthenia gravis;
  • glaucoma or cataracts;
  • herpes infection of the eyes;
  • stomach ulcers, ulcerative colitis, or diverticulitis;
  • depression or mental illness;
  • congestive heart failure; or
  • high blood pressure

FDA pregnancy category D. Taking Rayos during the first trimester of pregnancy can harm an unborn baby. Rayos should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Prednisone can pass into breast milk and should only be used in nursing mothers when the benefit outweighs the risk.

See also: Pregnancy and breastfeeding warnings (in more detail)

Prednisone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take Rayos?

Take Rayos exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Rayos should be taken with food. The tablets should be swallowed whole and not broken, divided or crushed.

Your dosage needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Rayos can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.

Do not stop using Rayos suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Wear a medical alert tag or carry an ID card stating that you take Rayos. Any medical care provider who treats you should know that you are using this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Long-term use of high Rayos doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

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. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid drinking alcohol while you are taking Rayos.

Rayos side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Rayos: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • blurred vision, eye pain, or seeing halos around lights;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious Rayos side effects may include:

  • sleep problems (insomnia), and mood changes;
  • acne, dry skin, thinning skin, bruising or discoloration;
  • slow wound healing;
  • increased sweating;
  • headache, dizziness, spinning sensation;
  • nausea, stomach pain, bloating; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Rayos dosing information

Dosage should be individualized based on disease severity and patient response. The timing of administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated:

  • Initial dose: Rayos 5 mg administered once per day. Patients currently on immediate-release prednisone, prednisolone, or methylprednisolone should be switched to Rayos at an equivalent dose based on relative potency.
  • Maintenance dose: Use lowest dosage that will maintain an adequate clinical response.
  • Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy.
  • The tablets should be taken daily with food.
  • The tablets should be swallowed whole and not broken, divided, or chewed.

What other drugs will affect Rayos?

Many drugs can interact with Rayos. Below is just a partial list. Tell your doctor if you are using:

  • digoxin;
  • amphotericin B;
  • estrogens including birth control pills and hormone replacement therapy;
  • aspirin (taken on a daily basis or at high doses) and other NSAIDs;
  • barbiturates;
  • a diuretic (water pill);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • insulin or diabetes medications you take by mouth;
  • ketoconazole (Nizoral);
  • rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
  • seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

This list is not complete and other drugs may interact with Rayos. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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