EFFICACY DATA
GASTROPROTECTION DATA
FORMULATION INFORMATION
ADHERENCE CONSIDERATIONS

EFFICACY DATA

POWERFUL RELIEF FROM INFLAMMATION & PAIN OF OA & RA

800 MG IBUPROFEN TID DEMONSTRATED RELIEF COMPARABLE TO ROFECOXIB (FORMERLY MARKETED AS VIOXX®)1*

DEMONSTRATED SIGNIFICANT EFFICACY: ASSESSED BY 3 PRIMARY ENDPOINTS IN A STUDY OF 809 PATIENTS WITH OA1*

Placebo 12.5 mg VIOXX 25 mg VIOXX 2400 mg ibuprofen
P≤0.009 for rofecoxib, ibuprofen vs placebo.

LS=least squares; OA=osteoarthritis; RA=rheumatoid arthritis; TID=3 times a day; WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index, a 100 mm visual analog scale (VAS).

*This trial did not include patients treated with DUEXIS.1

†Test was measured on a Likert scale (0-4).

fast acting fast acting fast acting

FAST-ACTING, IMMEDIATE-RELEASE FORMULATION2

  • No enteric coating to delay release of either active ingredient2

SELECT IMPORTANT SAFETY INFORMATION

  • The most common adverse reactions in the pivotal trials (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache
  • Use ibuprofen at the lowest effective dose for the shortest duration consistent with individual patient treatment goals

GASTROPROTECTION DATA

BUILT-IN GASTROPROTECTION

SIGNIFICANT REDUCTION IN THE RISK OF DEVELOPING UPPER GI ULCERS

  • DUEXIS reduced the risk of developing upper GI ulcers by ~50%. Patients who dropped out without an endoscopic evaluation within 14 days of their last dose were not counted as having an ulcer2‡

INCIDENCE OF UPPER GI ULCERS VS IBUPROFEN ALONE2§

‡See Prescribing Information for alternative statistical analyses relating to such patients.2

§This analysis excludes patients who dropped out of the study prior to the first endoscopy (at 8 weeks).2

In REDUCE-1 (Study 303), the secondary endpoint was incidence of upper GI ulcers.2

#In REDUCE-2 (Study 301), the primary endpoint was incidence of upper GI ulcers.2

GI=gastrointestinal.

CLINICAL TRIALS PRIMARILY ENROLLED PATIENTS LESS THAN 65 YEARS OF AGE WITHOUT A PRIOR HISTORY OF GASTROINTESTINAL ULCER2

STUDY PROTOCOL2

  • Two multicenter, double-blind, active-controlled, randomized 24-week studies of DUEXIS were conducted in 1,533 patients who were expected to require daily administration of an NSAID for at least the coming 6 months for conditions such as OA and RA, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain
  • REDUCE-1 and REDUCE-2 compared the incidence of upper gastrointestinal (gastric and/or duodenal) ulcer formation in a total of 930 patients taking DUEXIS (ibuprofen and famotidine) and 452 patients taking ibuprofen only, either as a primary or secondary endpoint
  • Controlled trials did not extend beyond 6 months

FORMULATION INFORMATION

APPROVED PRESCRIBING INFORMATION STATES:

“DO NOT SUBSTITUTE DUEXIS WITH THE SINGLE-INGREDIENT PRODUCTS OF IBUPROFEN AND FAMOTIDINE”2

  • stomach white

    Gastroprotection specifically engineered to match the PK profile of high-dose ibuprofen3**

  • release

    Famotidine is not available as a prescription or OTC tablet in the 26.6‑mg dose, and dosing instructions do not provide for TID administration4,5

  • no pills

    Therefore, no Rx or OTC products have been deemed therapeutically equivalent to DUEXIS2

**Phase I, randomized, open-label, crossover study in 13 healthy adults designed to compare effects on gastric pH and the safety of 80 mg of famotidine when administered in 2 vs 3 divided doses each day. Additionally, PK/PD modeling was performed to compare the effect of the dosing schedules on steady-state intragastric pH.3

NSAID=nonsteroidal anti-inflammatory drug; OTC=over the counter; PD=pharmacodynamic; PK=pharmacokinetic.

DOSING GUIDELINES

  • One DUEXIS tablet administered orally 3 times per day2
  • Use ibuprofen at the lowest effective dose for the shortest duration consistent with individual patient treatment goals2

ADHERENCE CONSIDERATIONS

AS A 2-IN-1 COMBINATION TABLET OF RX-STRENGTH IBUPROFEN + FAMOTIDINE, DUEXIS MAY HELP INCREASE ADHERENCE TO GASTROPROTECTION2,6

SCIENTIFIC STUDIES HAVE SHOWN:

Scientific studies show 80% or greater adherence to gastroprotective therapy is required to reduce risk

adherence to a gastroprotective therapy is required for risk reduction7††

††In this study, adherence to gastroprotective agents was calculated as the proportion of NSAID treatment days covered by a gastroprotective agent prescription.

These studies did not include patients being treated with DUEXIS.

‡‡Patients were classified as non-adherent to gastroprotective agents if these agents were available for less than 75% of the NSAID treatment days.

POWERFUL RELIEF + BUILT-IN GASTROPROTECTION

Pain icon

Powerful OA and RA relief1,2

stomach white icon

Significant reduction in upper GI ulcers2

no pills icon

Unlike other Rx and OTC NSAIDs2

checkmark icon

May help increase adherence2,6

Narcotic Duexis

Non-narcotic & non-addictive2

Prescription pad and a cross section of a DUEXIS (ibuprofen and famotidine) tablet
sample duexissample duexissample duexis

DUEXIS samples

Start your OA or RA patients with samples of DUEXIS.

REQUEST SAMPLES
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We’ll come to you

Get more information by having your DUEXIS representative come to your practice.

REQUEST A REPRESENTATIVE

OTHER HORIZON INFLAMMATION CARE PRODUCT OPTIONS FOR YOUR PATIENTS

FOR YOUR OA KNEE PAIN PATIENTS

Targeted pain relief + reduced systemic exposure of a topical

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FOR YOUR RA PATIENTS

The only delayed-release prednisone for the treatment of RA

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INDICATIONS AND IMPORTANT SAFETY INFORMATION
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DUEXIS® (IBUPROFEN AND FAMOTIDINE) SELECT 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 (CV) thrombotic events, including myocardial infarction (MI) 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.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) INDICATIONS AND USAGE

DUEXIS® (ibuprofen and famotidine), a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DUEXIS is contraindicated in patients:
    • With a known hypersensitivity to ibuprofen or famotidine or any components of the drug product or known hypersensitivity to other H2-receptor antagonists
    • 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 ibuprofen at 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. The concurrent use of aspirin and an NSAID, such as DUEXIS, increases the risk of serious GI events.
  • Avoid use of DUEXIS in patients with a recent MI unless benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DUEXIS is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. DUEXIS should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with DUEXIS treatment.
  • Avoid use of DUEXIS in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to DUEXIS and in patients with aspirin-sensitive asthma.
  • DUEXIS 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.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DUEXIS. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue DUEXIS and evaluate the patient immediately.
  • Limit use of NSAIDs, including DUEXIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in clinical trials (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including DUEXIS, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs, including DUEXIS, in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of DUEXIS in pediatric patients has not been established.

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.

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) SELECT 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.
  • 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.

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) INDICATIONS AND USAGE

PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s).

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • PENNSAID is contraindicated in patients with:
    • known hypersensitivity to diclofenac or any component of the drug product
    • a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs,
    • in the setting of CABG surgery.

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose of PENNSAID 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. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious GI events. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Measure transaminases at baseline and periodically in patients receiving long-term therapy with PENNSAID. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen or if clinical signs and/or symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely.
  • Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expect to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.
  • NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue PENNSAID and evaluate the patient immediately.
  • Limit use of NSAIDs, including PENNSAID between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of premature closure of the fetal ductus arteriosus and oligohydramnios/fetal renal dysfunction.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Concurrent use of PENNSAID with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • When applying PENNSAID, DO NOT: apply to open wounds, shower for at least 30 minutes after applying, wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. When applying PENNSAID, DO: wash and dry hands before and after use, avoid contact of PENNSAID with the eyes and mucous membranes, protect treated knee(s) from natural or artificial sunlight, wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in the PENNSAID 1.5% or PENNSAID 2% clinical trials were: application site reactions such as dryness, exfoliation, erythema, pruritus, pain, induration, rash, scabbing, contact dermatitis characterized by skin erythema and induration, contact dermatitis with vesicles; urinary tract infection; contusion; sinus congestion; nausea; dyspepsia; abdominal pain; flatulence; diarrhea; constipation; and edema.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including PENNSAID, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of PENNSAID in pediatric patients has not been established.

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.

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS INDICATIONS AND USAGE

RAYOS is a corticosteroid indicated:

  • As an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation
  • For the treatment of certain endocrine conditions
  • For palliation of certain neoplastic conditions

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Known hypersensitivity to prednisone or any excipients in the formulation

WARNINGS AND PRECAUTIONS

  • Corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia. Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use
  • RAYOS may increase susceptibility to new infection and increase risk of exacerbation, dissemination or reactivation of latent infection. RAYOS may mask signs and symptoms of infection. The rate of infectious complications increases with increasing doses of corticosteroids
  • Corticosteroids can cause elevated blood pressure, salt and water retention and hypokalemia. Monitor blood pressure and sodium, potassium serum levels. RAYOS should be used with caution in patients with a history of recent myocardial infarction, congestive heart failure, hypertension or renal insufficiency
  • There is an increased risk of gastrointestinal (GI) perforation in patients with certain GI disorders. RAYOS may mask signs and symptoms of GI perforation
  • Corticosteroid use may be associated with behavioral and mood disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated
  • Corticosteroid use may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Give special consideration to patients at increased risk of osteoporosis (eg, postmenopausal women) before initiating corticosteroid therapy, and bone density should be monitored in patients on long-term corticosteroid therapy
  • Prolonged use of corticosteroids may result in cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks
  • Do not administer live or attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids
  • Long‐term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long‐term corticosteroid therapy
  • Corticosteroids can cause fetal harm, including a small but inconsistent risk of orofacial clefts during the first trimester. Advise pregnant women of potential harm to the fetus
  • Prednisolone has been found in human milk following administration to lactating women; use the lowest dose in lactating women to achieve desired clinical effect

ADVERSE REACTIONS

  • Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain

Please see full Prescribing Information.

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.

INDICATIONS AND IMPORTANT SAFETY INFORMATION
See more

DUEXIS® (IBUPROFEN AND FAMOTIDINE) SELECT 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 (CV) thrombotic events, including myocardial infarction (MI) 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.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) INDICATIONS AND USAGE

DUEXIS® (ibuprofen and famotidine), a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

DUEXIS® (IBUPROFEN AND FAMOTIDINE) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DUEXIS is contraindicated in patients:
    • With a known hypersensitivity to ibuprofen or famotidine or any components of the drug product or known hypersensitivity to other H2-receptor antagonists
    • 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 ibuprofen at 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. The concurrent use of aspirin and an NSAID, such as DUEXIS, increases the risk of serious GI events.
  • Avoid use of DUEXIS in patients with a recent MI unless benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DUEXIS is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. DUEXIS should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with DUEXIS treatment.
  • Avoid use of DUEXIS in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to DUEXIS and in patients with aspirin-sensitive asthma.
  • DUEXIS 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.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DUEXIS. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue DUEXIS and evaluate the patient immediately.
  • Limit use of NSAIDs, including DUEXIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in clinical trials (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including DUEXIS, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs, including DUEXIS, in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of DUEXIS in pediatric patients has not been established.

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.

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) SELECT 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.
  • 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.

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) INDICATIONS AND USAGE

PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s).

PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • PENNSAID is contraindicated in patients with:
    • known hypersensitivity to diclofenac or any component of the drug product
    • a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs,
    • in the setting of CABG surgery.

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose of PENNSAID 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. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious GI events. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Measure transaminases at baseline and periodically in patients receiving long-term therapy with PENNSAID. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen or if clinical signs and/or symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely.
  • Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expect to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.
  • NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue PENNSAID and evaluate the patient immediately.
  • Limit use of NSAIDs, including PENNSAID between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of premature closure of the fetal ductus arteriosus and oligohydramnios/fetal renal dysfunction.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Concurrent use of PENNSAID with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • When applying PENNSAID, DO NOT: apply to open wounds, shower for at least 30 minutes after applying, wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. When applying PENNSAID, DO: wash and dry hands before and after use, avoid contact of PENNSAID with the eyes and mucous membranes, protect treated knee(s) from natural or artificial sunlight, wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions in the PENNSAID 1.5% or PENNSAID 2% clinical trials were: application site reactions such as dryness, exfoliation, erythema, pruritus, pain, induration, rash, scabbing, contact dermatitis characterized by skin erythema and induration, contact dermatitis with vesicles; urinary tract infection; contusion; sinus congestion; nausea; dyspepsia; abdominal pain; flatulence; diarrhea; constipation; and edema.

USE IN SPECIFIC POPULATIONS

  • Use of NSAIDs, including PENNSAID, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of PENNSAID in pediatric patients has not been established.

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.

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS INDICATIONS AND USAGE

RAYOS is a corticosteroid indicated:

  • As an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation
  • For the treatment of certain endocrine conditions
  • For palliation of certain neoplastic conditions

RAYOS® (PREDNISONE) DELAYED-RELEASE TABLETS IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Known hypersensitivity to prednisone or any excipients in the formulation

WARNINGS AND PRECAUTIONS

  • Corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia. Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use
  • RAYOS may increase susceptibility to new infection and increase risk of exacerbation, dissemination or reactivation of latent infection. RAYOS may mask signs and symptoms of infection. The rate of infectious complications increases with increasing doses of corticosteroids
  • Corticosteroids can cause elevated blood pressure, salt and water retention and hypokalemia. Monitor blood pressure and sodium, potassium serum levels. RAYOS should be used with caution in patients with a history of recent myocardial infarction, congestive heart failure, hypertension or renal insufficiency
  • There is an increased risk of gastrointestinal (GI) perforation in patients with certain GI disorders. RAYOS may mask signs and symptoms of GI perforation
  • Corticosteroid use may be associated with behavioral and mood disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated
  • Corticosteroid use may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Give special consideration to patients at increased risk of osteoporosis (eg, postmenopausal women) before initiating corticosteroid therapy, and bone density should be monitored in patients on long-term corticosteroid therapy
  • Prolonged use of corticosteroids may result in cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks
  • Do not administer live or attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids
  • Long‐term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long‐term corticosteroid therapy
  • Corticosteroids can cause fetal harm, including a small but inconsistent risk of orofacial clefts during the first trimester. Advise pregnant women of potential harm to the fetus
  • Prednisolone has been found in human milk following administration to lactating women; use the lowest dose in lactating women to achieve desired clinical effect

ADVERSE REACTIONS

  • Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain

Please see full Prescribing Information.

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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