• Horizon Pharma Patients

Horizon Cares(TM) Improving Access. Supporting Care.

The following products are participating in certain HORIZONCARES™ retail programs:


Duexis(R)
Click here to learn more about DUEXIS (ibuprofen and famotidine) Tablets including full prescribing information and boxed warning.


PENNSAID(R)
Click here to learn more about PENNSAID® (diclofenac sodium topical solution) 2% w/w including full prescribing information and boxed warning.


Rayos(R)

Click here to learn more about RAYOS (prednisone) Delayed-Release Tablets including full prescribing information.


vimovoLogo290
Click here to learn more about VIMOVO (naproxen and esomeprazole magnesium) Tablets including full prescribing information and boxed warning.


The following is important contact information relating to our marketed products in the United States:

Safety Information – To Report an Adverse Event or Side Effect
1-866-479-6742 {Option 1} or www.fda.gov/medwatch or call 1-800-FDA-1088

Product Complaint – To Report any Product Quality Issues
1-866-479-6742 {Option 1}

All Other Inquiries
1-866-479-6742 {Option 2}
Email: customerservice@horizonpharma.com

Additional patient resources can be found here.

DUEXIS Indications and Usage

What is DUEXIS® (ibuprofen and famotidine)?
DUEXIS contains two medicines: ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and famotidine, a histamine H2-receptor antagonist. DUEXIS is used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing ulcers in the stomach and upper intestines (upper gastrointestinal ulcers) in people who are taking ibuprofen for rheumatoid arthritis and osteoarthritis. DUEXIS was mostly studied in people less than 65 years of age and who did not have any history of ulcers of the stomach and upper intestines.

Important Safety Information

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • DUEXIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

What is the most important information I should know about DUEXIS?
NSAIDs cause an increased risk of serious blood clotting events, including heart attack and stroke, which can kill you. This risk may occur early in treatment and may increase with longer use. To minimize the potential for increased risk of serious heart events while being treated with an NSAID, use the lowest effective dose for the shortest duration possible.

NSAIDs cause an increased risk of serious esophagus, stomach, and intestine events including bleeding, ulcers, and tears, which can kill you. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a history of ulcer disease or stomach or intestine bleeding are at greater risk for serious esophagus, stomach, and intestine events.

Who should not use DUEXIS?
DO NOT USE DUEXIS if you

  • are in the hospital for a certain heart surgery called coronary artery bypass graft surgery.
  • know you are allergic to ibuprofen or famotidine or any ingredients of the drug product or to other H2-receptor antagonists.
  • have experienced asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs. Serious allergic reactions to NSAIDs, including death, have been reported in such patients.

How should I take DUEXIS?
Take DUEXIS exactly as your health care provider tells you to take it. Do not change your dose or stop DUEXIS without first talking to your health care provider. Swallow DUEXIS tablets whole with liquid. Do not split, chew, crush, or dissolve the DUEXIS tablet. If you forget to take a dose of DUEXIS, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose.

What are the possible side effects of DUEXIS?
The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain, and headache.

What other medications might interact with DUEXIS?
Avoid using DUEXIS while taking other NSAIDs unless your doctor says it is OK. NSAIDs may be present in over-the-counter medications for treatment of colds, fever, or insomnia; refer to the label of over-the-counter medications you are taking or ask your pharmacist. Do not use DUEXIS and low-dose aspirin until you talk to your health care provider. Tell your doctor about all of the medicines you take as some medicines can react with NSAIDs and cause serious side effects.

What should I tell my health care provider?
Before starting DUEXIS, tell your health care provider if you have a history of ulcer disease or esophagus, stomach, or intestine bleeding, liver or kidney problems, high blood pressure, asthma, or are pregnant, trying to become pregnant, or breast feeding. Also tell your doctor about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Do not start taking new medicines without talking to your health care provider first.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact the Horizon Pharma Medical Information Department toll-free at 1-866-479-6742 or medicalinformation@horizonpharma.com.

The risk information provided here is not comprehensive. To learn more, talk about DUEXIS with your health care provider or pharmacist. The FDA-approved product labeling can be found at www.DUEXIS.com or 1-866-479-6742.

PENNSAID Indications and Usage

What is PENNSAID® (diclofenac sodium topical solution) 2% w/w?
PENNSAID® (diclofenac sodium topical solution) 2% w/w is a nonsteroidal anti-inflammatory drug (NSAID) applied to the skin, used for treating the pain of osteoarthritis of the knee(s).

Important Safety Information

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • PENNSAID is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

What is the most important information I should know about PENNSAID?
NSAIDs cause an increased risk of serious blood clotting events, including heart attack and stroke, which can kill you. This risk may occur early in treatment and may increase with longer use. To minimize the potential for increased risk of serious heart events while being treated with an NSAID, use the lowest effective dose for the shortest duration possible.

NSAIDs cause an increased risk of serious esophagus, stomach, and intestine events including bleeding, ulcers, and tears, which can kill you. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a history of ulcer disease or stomach or intestine bleeding are at greater risk for serious esophagus, stomach, and intestine events.

Who should not use PENNSAID?
DO NOT USE PENNSAID if you

  • are in the hospital for a certain heart surgery called coronary artery bypass graft surgery.
  • know you are allergic to diclofenac or any other ingredient of PENNSAID.
  • have experienced asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs. Serious allergic reactions to NSAIDs, including death, have been reported in such patients.

How should I use PENNSAID?
PENNSAID is applied directly to the front, back, and sides of your knee(s). Avoid contact of PENNSAID with the eyes, nose, and mouth. If eye contact occurs, immediately wash out the eye with water and contact your health care provider if irritation persists for more than an hour. Avoid skin-to-skin contact between other people and the knee(s) to which PENNSAID was applied until the knee(s) is completely dry. DO NOT apply PENNSAID to open wounds, infections, or rashes. DO NOT shower for at least 30 minutes after applying PENNSAID or wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. DO wash and dry hands before and after use, protect your treated knee(s) from natural or artificial sunlight, and wait until the treated knee(s) is completely dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication.

What are the possible side effects of PENNSAID?
The most common side effects of PENNSAID are application site reactions, such as dryness, peeling, redness, itching, pain, skin hardening, rash, blisters, and scabbing. Other side effects are bladder infection, bruising, sinus congestion, nausea, upset stomach, stomach pain, gas, constipation, and diarrhea.

What other medications might interact with PENNSAID?
Avoid using PENNSAID while taking other NSAIDs unless your doctor says it is OK. NSAIDs may be present in over-the-counter medications for treatment of colds, fever, or insomnia; refer to the label of over-the-counter medications you are taking or ask your pharmacist. Do not use PENNSAID and low-dose aspirin until you talk to your health care provider. Tell your doctor about all of the medicines you take as some medicines can react with NSAIDs and cause serious side effects.

What should I tell my health care provider?
Before starting PENNSAID, tell your health care provider if you have a history of ulcer disease or esophagus, stomach, or intestine bleeding, liver or kidney problems, high blood pressure, asthma, or are pregnant, trying to become pregnant, or breast feeding. Also tell your doctor about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Do not start taking new medicines without talking to your health care provider first.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact the Horizon Pharma Medical Information Department toll-free at 1-866-479-6742 or medicalinformation@horizonpharma.com.

The risk information provided here is not comprehensive. To learn more, talk about PENNSAID 2% with your health care provider or pharmacist. The FDA-approved product labeling can be found at www.PENNSAID.com or 1-866-479-6742.

RAYOS Important Safety Information

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information on RAYOS, please see the Full Prescribing Information.

*Outside the United States, RAYOS is approved under the brand name LODOTRA in 16 European countries, Australia and Israel for the treatment of moderate-to-severe active RA when accompanied by morning stiffness. Horizon has granted commercialization rights for LODOTRA in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited.

VIMOVO Indications and Usage

VIMOVO (naproxen and esomeprazole magnesium) is a combination product that contains naproxen and esomeprazole. It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID‐associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

LIMITATIONS OF USE
VIMOVO is not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Important Safety Information

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), a component of VIMOVO, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • VIMOVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs, a component of VIMOVO, cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.


CONTRAINDICATIONS

  • VIMOVO is contraindicated in patients:
    • With known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or any component of the drug product, including omeprazole.
    • Who have a history of asthma, urticaria, or other allergic‐type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients.
    • In the setting of coronary artery bypass graft (CABG) surgery.

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. VIMOVO can be administered with low‐dose aspirin (≤325 mg/day) therapy. The concurrent use of aspirin and an NSAID, such as VIMOVO, increases the risk of serious GI events. As with all NSAIDs, concurrent administration of naproxen and aspirin is not generally recommended because of the increased risk of bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. VIMOVO should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. VIMOVO is not recommended in patients with severe hepatic insufficiency.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with VIMOVO treatment
  • Avoid use of VIMOVO in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Long-term administration of NSAIDs can result in renal papillary necrosis, other renal injury, and renal toxicity. Use VIMOVO with caution in patients at greatest risk of this reaction.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to VIMOVO and in patients with aspirin-sensitive asthma.
  • VIMOVO can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens‐Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Discontinue VIMOVO if active and clinically significant bleeding from any source occurs.
  • In adults, symptomatic response to esomeprazole, a component of VIMOVO, does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
  • PPI use has been associated with acute interstitial nephritis, new onset or exacerbation of cutaneous or systemic lupus erythematosus, malabsorption of cyanocobalamin, hypomagnesemia, increased risk of diarrhea associated with Clostridium difficile infection, and increased risk for osteoporosis‐related fractures of the hip, wrist, or spine.
  • Avoid concomitant use of VIMOVO with:
    • Other naproxen-containing products or other non-aspirin NSAIDs.
    • Clopidogrel due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using esomeprazole consider alternative anti‐platelet therapy.
    • St. John’s Wort or rifampin due to the potential reduction in esomeprazole levels.
    • Methotrexate which may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity.

Note: see full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

The most commonly observed adverse events in clinical trials (experienced by >5% patients in the VIMOVO group) were gastritis and diarrhea.

USE IN SPECIFIC POPULATIONS

  • VIMOVO should not be used in pregnant or lactating women. Consider withdrawal of NSAIDs, including VIMOVO, in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of VIMOVO in pediatric patients has not been established.

For further information on VIMOVO, please see the Medication Guide and full Prescribing Information, including boxed warning, at www.VIMOVO.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

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