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Reliable Relief + Effective Gastroprotection

RELIABLE RELIEF FROM CHRONIC PAIN & INFLAMMATION OF OA/RA/AS1-3

VIMOVO provides proven relief from the signs and symptoms of OA/RA/AS1-3

Naproxen has anti-inflammatory effects at 1,000 mg/day.4*

VIMOVO demonstrated overall effectiveness in OA symptom relief, including pain relief, in 2 randomized, double-blind, placebo-controlled, multicenter studies1-3

Patients reported a 40% improvement in their OA symptoms as shown by PGA-VAS scores1

Placebo VIMOVO

Co-primary outcomes of WOMAC pain, WOMAC function, and PGA-VAS after 12 weeks of treatment.

AS=ankylosing spondylitis; BID=2 times per day; CI=confidence interval; LS=least squares; OA=osteoarthritis; PGA-VAS=patient global assessment of osteoarthritis using a 100 mm visual analog scale; RA=rheumatoid arthritis; WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index.

*This trial did not include patients treated with VIMOVO.

SELECT IMPORTANT SAFETY INFORMATION

  • 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
  • Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals

EFFECTIVE GASTROPROTECTION

Significant reduction in the risk of developing gastric ulcers

VIMOVO reduced the incidence of naproxen-induced gastric ulcers by up to 82% vs enteric-coated (EC) naproxen over 6 months.3

Study 1

Cumulative observed incidence of gastric ulcers at 1, 3, and 6 months

EC naproxen (n=216) VIMOVO (n=218)

Study 2

Cumulative observed incidence of gastric ulcers at 1, 3, and 6 months

EC naproxen (n=210) VIMOVO (n=210)
  • Studies demonstrated 10%-13% of gastric ulcers occurred within the first month without gastroprotection3,5
  • Up to 89% risk reduction as early as month13,5
  • Clinical trials enrolled at-risk patients ≥50 years of age or 18-49 with a documented history of uncomplicated gastric or duodenal ulcer within the past 5 years3,5

STUDY PROTOCOL3,5

  • Two 6-month, randomized, double-blind, multicenter studies were conducted in a total of 854 patients who required chronic NSAIDs for conditions such as OA, RA, and AS for at least 6 months
  • STUDY 1 and STUDY 2 compared the cumulative incidence of endoscopic gastric ulcers (≥3 mm diameter with depth) at 1, 3, and 6 months in a total of 428 patients taking VIMOVO (naproxen and esomeprazole magnesium) BID and 426 patients taking EC naproxen BID

NAPROXEN + ESOMEPRAZOLE IN 1 TABLET MAKES VIMOVO UNLIKE OTHER RX & OTC NSAIDS3,6-10

Prescribing information states: “Do not substitute VIMOVO with the single-ingredient products of naproxen and esomeprazole magnesium”3

Please see other limitations of use below.

GI protection specifically engineered to match the PK profile of high-dose naproxen11†

The immediate-release esomeprazole in VIMOVO has a different PK profile than the delayed-release formulations available as Rx and OTC11†

Therefore, no Rx or OTC products have been deemed therapeutically equivalent to VIMOVO3

Phase I, randomized, open-label study of 28 healthy adults who received PN 400 BID (naproxen 500 mg plus immediate-release esomeprazole 10, 20, and 30 mg) and non-enteric-coated naproxen 500 mg BID plus enteric-coated esomeprazole 20 mg OD, each for 9 days in a crossover fashion. The primary endpoint was percentage of time on day 9 that intragastric pH was >4.0; secondary endpoints included pharmacokinetics and safety.11

BID=2 times a day; GI=gastrointestinal; NSAID=nonsteroidal anti-inflammatory drug; OD=once a day; OTC=over the counter; PK=pharmacokinetic; PPI=proton pump inhibitor.

If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered.

Other limitations of use:

  • VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products3
  • Controlled studies do not extend beyond 6 months3

AS THE ONLY 2-IN-1 COMBINATION TABLET OF RX-STRENGTH NAPROXEN + A PPI, VIMOVO MAY HELP INCREASE ADHERENCE TO GASTROPROTECTION3,6-10,12

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 VIMOVO.

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

RELIABLE RELIEF + EFFECTIVE GASTROPROTECTION

Proven OA/RA relief1-3

Significant reduction in gastric ulcers3

Unlike other therapies3,6-10

May help increase adherence12

VIMOVO SAMPLES

Start your OA/RA patients with samples of VIMOVO.

Request samples

WE’LL COME TO YOU

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

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Other NSAID+ options for your patients

For your OA/RA patients:

Powerful relief + built-in gastroprotection

Review the data

For your OA knee pain patients:

Targeted pain relief + reduced systemic exposure of a topical

Get the details

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.

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.

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.

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. Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015;43(3):200-213.
  2. Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011;27:1243-1253.
  3. VIMOVO (naproxen/esomeprazole magnesium) [package insert]. Lake Forest, IL: Horizon Pharma USA, Inc; June 2018.
  4. Todd PA. Clissold SP. Naproxen: A Reappraisal of its Pharmacology, and Therapeutic Use in Rheumatic Diseases and Pain States. Drugs. 1990;40(I):91-137.
  5. Goldstein JL, Hochberg MC, Fort JG, Zhang Y, Hwang C, Sostek M. Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. Aliment Pharmacol Ther. 2010;32:401-413.
  6. Advil [drug facts]. Madison, NJ; Pfizer Consumer Healthcare; 2014.
  7. Aleve [drug facts]. Whippany, NJ: Bayer Healthcare Consumer Care; 2014.
  8. Ibuprofen. Overview. https://www.drugs.com/ibuprofen.html. Accessed September 19, 2016.
  9. MOBIC (meloxicam) [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. May 2016.
  10. Naproxen [drug facts]. Nutley, NJ: Roche Laboratories Inc; 2004.
  11. Miner P Jr, Plachetka J, Orlemans E, Fort JG, Sostek M. Clinical trial: evaluation of gastric acid suppression with three doses of immediate-release esomeprazole in the fixed-dose combination of PN 400 (naproxen/esomeprazole magnesium) compared with naproxen 500 mg and enteric-coated esomeprazole 20 mg: a randomized, open-label, Phase I study in healthy volunteers. Aliment Pharmacol Ther. 2010;32(3):414-424.
  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.

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.

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.

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.