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Powerful Relief + Built-in Gastroprotection

POWERFUL RELIEF FROM PAIN & INFLAMMATION OF OA/RA

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

  • Ibuprofen has anti-inflammatory effects at 2,400 mg/day.2*

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).

*Study did not include DUEXIS.1-3

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

IMMEDIATE-RELEASE FORMULATION3,4

  • In a single dose, acute dental pain study of 800 mg ibuprofen, a difference in pain intensity score was detected within 30 minutes3‡§
  • No enteric coating to delay release of either active ingredient4

DUEXIS is not indicated for acute pain.

§Study did not include DUEXIS.

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

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 ulcer

INCIDENCE OF UPPER GI ULCERS VS IBUPROFEN ALONE4#

See Prescribing Information for alternative statistical analyses relating to such patients.4

#This analysis excludes patients who dropped out of the study prior to the first endoscopy (at 8 weeks).4

**In REDUCE-1 (Study 303), the secondary endpoint was incidence of upper GI ulcers.4

††In REDUCE-2 (Study 301), the primary endpoint was incidence of upper GI ulcers.4

GI=gastrointestinal.

CLINICAL TRIALS PRIMARILY ENROLLED PATIENTS LESS THAN 65 YEARS OF AGE WITHOUT A PRIOR HISTORY OF GASTROINTESTINAL ULCER4

STUDY PROTOCOL4

  • 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/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

IBUPROFEN + FAMOTIDINE IN 1 TABLET MAKES DUEXIS UNLIKE OTHER RX & OTC NSAIDS4-9

PRESCRIBING INFORMATION STATES:
“DO NOT SUBSTITUTE DUEXIS WITH THE SINGLE-INGREDIENT PRODUCTS OF IBUPROFEN AND FAMOTIDINE”4

GI protection specifically engineered to match the PK profile of high-dose ibuprofen10‡‡

Famotidine is not available as an Rx or OTC tablet in the 26.6 mg dose in DUEXIS and is not approved for TID dosing11

Therefore, no Rx or OTC products have been deemed therapeutically equivalent to DUEXIS4

‡‡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.10

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

DOSING GUIDELINES

  • One DUEXIS tablet administered orally 3 times per day4
  • Use ibuprofen at the lowest effective dose for the shortest duration consistent with individual patient treatment goals4

AS THE ONLY 2-IN-1 COMBINATION TABLET OF RX-STRENGTH IBUPROFEN + FAMOTIDINE, DUEXIS MAY HELP INCREASE ADHERENCE TO GASTROPROTECTION4-9,12

SCIENTIFIC STUDIES HAVE SHOWN:

≥80%

adherence to a gastroprotective therapy is required for risk reduction13§§

§§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

Powerful OA/RA relief1,3,4

Significant reduction in upper GI ulcers4

Unlike other therapies4-9

May help increase adherence12

DUEXIS SAMPLES

Start your OA/RA patients with samples of DUEXIS.

Request samples

WE’LL COME TO YOU

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

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Other NSAID+ options for your patients

For your OA/RA patients:

Reliable relief + effective gastroprotection

Review the data

For your OA knee pain patients:

Targeted pain relief + reduced systemic exposure of a topical

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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.
  • DUEXIS® (ibuprofen and famotidine), VIMOVO® (naproxen and esomeprazole magnesium), and PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) are 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.
  • 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.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Long-term administration of NSAIDs can result in renal papillary necrosis, other renal injury, and renal toxicity. Use DUEXIS with caution in patients at greatest risk of this reaction.
  • DUEXIS is not recommended in patients with creatinine clearance <50 mL/min.
  • 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.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen, which is a component of DUEXIS.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • 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 IN SPECIFIC POPULATIONS

  • DUEXIS should not be used in pregnant or lactating women. 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.

For further information on DUEXIS, please see full Prescribing Information, including Boxed Warning and the Medication Guide.
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.

VIMOVO® (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) INDICATIONS AND USAGE

VIMOVO® (naproxen and esomeprazole magnesium) is a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID) and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers.

The naproxen component of VIMOVO is indicated for relief of signs and symptoms of:

  • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.
  • juvenile idiopathic arthritis (JIA) in adolescent patients.

The esomeprazole magnesium component of VIMOVO is indicated to decrease the risk of developing naproxen-associated gastric ulcers.

Limitations of Use:

  • Do not substitute VIMOVO with the single-ingredient products of naproxen and esomeprazole magnesium.
  • 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.

VIMOVO® (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • VIMOVO is contraindicated in patients:
    • With known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to 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
    • Receiving rilpivirine-containing products

WARNINGS AND PRECAUTIONS

  • Use the lowest naproxen 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 VIMOVO, increases the risk of serious GI events. Concomitant use of VIMOVO and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. 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. VIMOVO should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Avoid use of VIMOVO in patients with severe hepatic impairment.
  • 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 (Vitamin B-12), hypomagnesemia, increased risk of diarrhea associated with Clostridium difficile infection, increased risk for osteoporosis-related fractures of the hip, wrist, or spine, and increased risk of fundic gland polyps.
  • Concomitant use of PPIs with methotrexate may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity.
  • 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
  • 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 less than 12 years of age or less than 38 kg with JIA have not been established.

For further information on VIMOVO, please see full Prescribing Information, including Boxed Warning and the Medication Guide.

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%) 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 a known hypersensitivity to diclofenac or any components of the drug product
    • 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. The concurrent use of aspirin and an NSAID, such as PENNSAID, increases the risk of serious GI events.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. 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 with PENNSAID treatment.
  • Avoid use of PENNSAID 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 PENNSAID with caution in patients at greatest risk of this reaction.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to PENNSAID and in patients with aspirin-sensitive asthma.
  • PENNSAID 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.
  • Do not:
    • Apply PENNSAID to open wounds
    • Shower for at least 30 minutes after applying PENNSAID
    • Wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry
  • 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
  • Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions to PENNSAID 1.5% or PENNSAID 2% in 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; edema.

USE IN SPECIFIC POPULATIONS

  • PENNSAID should not be used in pregnant or lactating women. Consider withdrawal of NSAIDs, including PENNSAID, 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.

For further information on PENNSAID, please see full Prescribing Information, including Boxed Warning and the Medication Guide.

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.

REFERENCES

  1. Day R, Morrison B, Luza A, et al; for the Rofecoxib/Ibuprofen Comparator Study Group. A randomized trial of the efficacy and tolerability of the COX-2 inhibitor rofecoxib vs ibuprofen in patients with osteoarthritis. Arch Intern Med. 2000;160:1781-1787.
  2. Godfrey RG, de la Cruz S. Effect of ibuprofen dosage on patient response in rheumatoid arthritis. Arthritis Rheumat. 1975;18:135-137.
  3. Laska EM, Sunshine A, Marrero I, Olson N, Siegel C, McCormick N. The correlation between blood levels of ibuprofen and clinical analgesic response. Clin Pharmacol Ther. 1986;40:1-7.
  4. DUEXIS (ibuprofen and famotidine) [package insert]. Lake Forest, IL: Horizon Pharma USA Inc; June 2017.
  5. Advil [drug facts]. Madison, NJ; Pfizer Consumer Healthcare; 2014.
  6. Aleve [drug facts]. Whippany, NJ: Bayer Healthcare Consumer Care; 2014.
  7. Ibuprofen. Overview. https://www.drugs.com/ibuprofen.html. Accessed September 19, 2016.
  8. MOBIC (meloxicam) [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. May 2016.
  9. Naproxen [drug facts]. Nutley, NJ: Roche Laboratories Inc; 2004.
  10. Kent JD, Holt RJ, Jung D, et al. Pharmacodynamic evaluation of intragastric pH and implications for famotodine dosing in the prophylaxis of non-steroidal anti-inflammatory drug induced gastropathy-a proof of concept analysis. J Drug Assess. 2014;3(1):20-27.
  11. Pepcid (famotidine) [package insert]. Northbrook, IL: Marathon Pharmaceuticals, LLC; February 2014.
  12. Sturkenboom MC, Burke TA, Tangelder MJD, Dieleman JP, Walton S, Goldstein JL. Adherence to proton pump inhibitors or H2-receptor antagonists during the use of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther. 2003;18:1137-1147.
  13. van Soest EM, Sturkenboom MC, Dieleman JP, Verhamme KM, Siersema PD, Kuipers EJ. Adherence to gastroprotection and the risk of NSAID-related upper gastrointestinal ulcers and haemorrhage. Aliment Pharmacol Ther. 2007;26(2):265-275.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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.
  • DUEXIS® (ibuprofen and famotidine), VIMOVO® (naproxen and esomeprazole magnesium), and PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) are 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.
  • 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.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Long-term administration of NSAIDs can result in renal papillary necrosis, other renal injury, and renal toxicity. Use DUEXIS with caution in patients at greatest risk of this reaction.
  • DUEXIS is not recommended in patients with creatinine clearance <50 mL/min.
  • 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.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen, which is a component of DUEXIS.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • 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 IN SPECIFIC POPULATIONS

  • DUEXIS should not be used in pregnant or lactating women. 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.

For further information on DUEXIS, please see full Prescribing Information, including Boxed Warning and the Medication Guide.
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.

VIMOVO® (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) INDICATIONS AND USAGE

VIMOVO® (naproxen and esomeprazole magnesium) is a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID) and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers.

The naproxen component of VIMOVO is indicated for relief of signs and symptoms of:

  • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.
  • juvenile idiopathic arthritis (JIA) in adolescent patients.

The esomeprazole magnesium component of VIMOVO is indicated to decrease the risk of developing naproxen-associated gastric ulcers.

Limitations of Use:

  • Do not substitute VIMOVO with the single-ingredient products of naproxen and esomeprazole magnesium.
  • 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.

VIMOVO® (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • VIMOVO is contraindicated in patients:
    • With known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to 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
    • Receiving rilpivirine-containing products

WARNINGS AND PRECAUTIONS

  • Use the lowest naproxen 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 VIMOVO, increases the risk of serious GI events. Concomitant use of VIMOVO and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. 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. VIMOVO should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Avoid use of VIMOVO in patients with severe hepatic impairment.
  • 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 (Vitamin B-12), hypomagnesemia, increased risk of diarrhea associated with Clostridium difficile infection, increased risk for osteoporosis-related fractures of the hip, wrist, or spine, and increased risk of fundic gland polyps.
  • Concomitant use of PPIs with methotrexate may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity.
  • 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
  • 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 less than 12 years of age or less than 38 kg with JIA have not been established.

For further information on VIMOVO, please see full Prescribing Information, including Boxed Warning and the Medication Guide.

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%) 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 a known hypersensitivity to diclofenac or any components of the drug product
    • 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. The concurrent use of aspirin and an NSAID, such as PENNSAID, increases the risk of serious GI events.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. 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 with PENNSAID treatment.
  • Avoid use of PENNSAID 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 PENNSAID with caution in patients at greatest risk of this reaction.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to PENNSAID and in patients with aspirin-sensitive asthma.
  • PENNSAID 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.
  • Do not:
    • Apply PENNSAID to open wounds
    • Shower for at least 30 minutes after applying PENNSAID
    • Wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry
  • 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
  • Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

  • The most common adverse reactions to PENNSAID 1.5% or PENNSAID 2% in 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; edema.

USE IN SPECIFIC POPULATIONS

  • PENNSAID should not be used in pregnant or lactating women. Consider withdrawal of NSAIDs, including PENNSAID, 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.

For further information on PENNSAID, please see full Prescribing Information, including Boxed Warning and the Medication Guide.

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.