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Targeted OA Knee Pain Relief + Reduced Systemic Exposure of a Topical

TARGETED OA KNEE PAIN RELIEF1-3

  • PENNSAID 2% provided 36.3% pain relief after 4 weeks (compared with 28.6% with vehicle control)1,3
    • Vehicle control contained dimethyl sulfoxide (DMSO) and all other inactive ingredients in PENNSAID 2%4
  • Relief measured as reduction of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline at 4 weeks1,3

Significantly greater reductions in pain scores for Pennsaid 2% versus vehicle-control at 4 weeks3

Solution with DMSO and all other inactive ingredients (n=129) PENNSAID 2% (n=130)

SELECT IMPORTANT SAFETY INFORMATION

  • 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
  • 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

REDUCED SYSTEMIC EXPOSURE OF A TOPICAL2

93% REDUCTION IN SYSTEMIC EXPOSURE

When compared with oral diclofenac sodium, PENNSAID 2% reduced systemic exposure by 93%.2

In a pharmacokinetic (PK) study of 22 healthy individuals, PENNSAID 2% demonstrated only 7% systemic absorption compared with oral diclofenac sodium, 75 mg twice daily.2

Oral diclofenac

Alternate Text

PENNSAID 2%

Alternate Text

93% reduction

ENHANCED PENETRATION RIGHT AT THE SITE OF PAIN

DMSO FACILITATES PENETRATION THROUGH THE SKIN

DMSO facilitates penetration of diclofenac through the skin barrier.5 DMSO enhances the permeability of cell membranes, facilitating localized delivery of diclofenac sodium by driving it through the skin barrier directly to the source of pain.1,5

2X DAILY DOSING THAT’S EASY TO APPLY

CONSISTENT ACCURATE DOSING WITH A METERED-DOSE PUMP

  • PENNSAID 2%: no measuring and little mess1
  • 2 pumps, 2 times daily1

CONVENIENT 2X DAILY DOSING1

  • Compared with PENNSAID 2%:
    • Voltaren® Gel (diclofenac sodium topical gel) requires application 4x daily6
    • Voltaren Gel requires patients to use a dosing card for accurate dosing6

OTHER PRODUCTS ARE DOSED 4X DAILY6,7

SELECT IMPORTANT SAFETY INFORMATION

Patients should:

  • 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
  • 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

TARGETED OA KNEE PAIN RELIEF + REDUCED SYSTEMIC EXPOSURE OF A TOPICAL

Significant OA knee pain relief1-3

93% reduction in systemic exposure compared to oral diclofenac2

Targeted at the site of pain1,5

2X daily dosing that’s easy to apply1

PENNSAID 2% SAMPLES

Start your OA knee pain patients with samples of PENNSAID 2%.

Request samples

WE’LL COME TO YOU

Get more information by having your PENNSAID 2% representative come to your practice.

Request a representative

Other NSAID+ options for your patients

For your OA/RA patients:

Powerful relief + built-in gastroprotection

Review the data

For your OA/RA patients:

Reliable relief + effective gastroprotection

Get the details

OA=osteoarthritis; RA=rheumatoid arthritis.

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.

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.

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.

REFERENCES

  1. PENNSAID (diclofenac sodium topical solution) 2% [package insert]. Lake Forest, IL: Horizon Pharma USA, Inc; May 2016.
  2. Holt RJ, Taiwo T, Kent JD. Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers. Postgrad Med. 2015;127(6):581-590.
  3. Wadsworth LT, Kent JD, Holt RJ. Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Curr Med Res Opin. 2016;32(2):241-250.
  4. Data on file. Horizon Pharma USA, Inc.
  5. Marren K. Dimethyl sulfoxide: an effective penetration enhancer for topical administration of NSAIDs. Phys Sportsmed. 2011;39(3):75-82.
  6. Voltaren Gel (diclofenac sodium topical gel) [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.; 2016.
  7. PENNSAID Topical Solution (diclofenac sodium topical solution) 1.5% [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; February 2009.

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.

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.

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.