Horizon Cares logo

Free, convenient delivery right to your patient’s door

Take advantage of the benefits of HorizonCares for your commercially insured patients:

icon administration icon administration

Streamlines office administration activities:

  • Completion of Prior Authorization ensures appropriate patient access
  • Ensures patients receive prescribed medication
  • Assists patients with questions regarding prescriptions and pharmacies
icon support icon support

Supports patient access:

  • Approved prescriptions are $0*
  • 33% of patients have no out-of-pocket costs1
  • Patients may have to pay a low branded co-pay if the prescription is not approved
  • Patient co-pay reduced to $0 if Prior Authorization is approved
  • The average co-pay in 2018 for branded Rx products was $33 (preferred) and $59 (non-preferred)2
icon prescription icon prescription

Helps improve prescription fulfillment:

  • HorizonCares calls 100% of patients†
  • Patients are contacted directly by the pharmacy filling the prescription
  • Prescription is shipped for free within 5–7 business days—no trips to the pharmacy

HorizonCares simplifies the patient experience by enhancing prescription access

  • Addresses patient
    adherence
  • Streamlines the prescription fulfillment process
  • Focuses on minimizing Rx abandonment
  • Enhances patient
    access

GET STARTED

3 ways to support your commercially insured patients today

  1. HORIZONCARES RX CONNECT

    E-prescribe to One Point Patient Care, 8130 Lehigh Ave., Morton Grove, IL 60053.

    Pharmacy ID
    NCPDP/NABP: 1482621
    NPI: 1912151515

    Please fax an SMN form to 1-844-308-9412. Call 866-323-1490 with any questions

  2. HORIZONCARES PARTICIPATING PHARMACY

    Ask your sales representative for information on participating pharmacies

  3. RETAIL

    Have pharmacist call
    844-HZ-CARE1 for money-saving offers

HORIZONCARES DOWNLOADABLE RESOURCES

Download documents about how to submit a Prior Authorization and how HorizonCares works.

DUEXIS Prior Authorization information

Everything you need to start a Prior Authorization for DUEXIS.

DOWNLOAD INFO

213.0 KB

PENNSAID 2% Prior Authorization information

Everything you need to start a Prior Authorization for PENNSAID 2%.

DOWNLOAD INFO

196.0 KB

RAYOS Prior Authorization information

Everything you need to start a Prior Authorization for RAYOS.

DOWNLOAD INFO

164.0 KB

How HorizonCares works

Learn more about how HorizonCares helps patients get the medication they need quickly and affordably.

DOWNLOAD INFO

92.0 KB

Reviewing HorizonCares with your patients

Share this overview of how the HorizonCares program works with your patients.

DOWNLOAD INFO

139.0 KB

HORIZONCARES IS COMMITTED TO EXCELLENCE IN PATIENT ACCESS

More than 2,300 patients are helped every day2

IN 2019,2 the HorizonCares program provided co-pay support for close to 850,000 patients

*Subject to eligibility rules and restrictions.

†HorizonCares calls 100% of patients when correct patient contact information is provided.

IMPORTANT INFORMATION FOR HEALTHCARE PROVIDERS:
  • When you send your patient’s prescription to OnePoint Patient Care, OnePoint will check the prescription to make sure it is complete, as well as check the patient’s prescription benefits. Once complete, pursuant to a Shared Services Agreement, OnePoint will send your patient’s prescription to a pharmacy that participates in the HorizonCares program. While your patient’s prescription does contain protected health information, all parties comply with the Health Insurance Portability and Accountability Act
  • If your patient does not wish to have their prescription sent to OnePoint, please send your patient’s prescription to a pharmacy as directed by your patient. By sending your patient’s prescription to OnePoint Patient Care, you acknowledge that your patient has consented to participate in the HorizonCares RxConnect program
TERMS AND CONDITIONS:
  • Offer cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription. Not valid for prescriptions reimbursed in whole or in part by Medicaid, Medicare, VA, DOD, TriCare, or other federal or state programs (including state prescription drug programs). Offer good only in the United States at participating retail pharmacies. Offer not valid where otherwise prohibited by law, for example by applicable state law prohibiting co-pay cards. Horizon reserves the right to rescind, revoke, or amend the offer without notice. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. This card is not insurance and is not intended to substitute for insurance. Participating patients and pharmacists understand and agree to comply with all Terms and Conditions of this offer. Patients must be 18 or older.

Product samples

Start your patients on therapy with samples of a Horizon Inflammation Care product.

Request samples

We’ll come to you

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

Request a representative
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INDICATIONS AND IMPORTANT SAFETY INFORMATION
See more

DUEXIS® (IBUPROFEN AND FAMOTIDINE) SELECT IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

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

Gastrointestinal Bleeding, Ulceration, and Perforation

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

DUEXIS® (IBUPROFEN AND FAMOTIDINE) INDICATIONS AND USAGE

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

DUEXIS® (IBUPROFEN AND FAMOTIDINE) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DUEXIS is contraindicated in patients:
    • With a known hypersensitivity to ibuprofen or famotidine or any components of the drug product or known hypersensitivity to other H2-receptor antagonists
    • Who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients
    • In the setting of coronary artery bypass graft (CABG) surgery

WARNINGS AND PRECAUTIONS

  • Use ibuprofen at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as DUEXIS, increases the risk of serious GI events.
  • Avoid use of DUEXIS in patients with a recent MI unless benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DUEXIS is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. DUEXIS should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with DUEXIS treatment.
  • Avoid use of DUEXIS in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to DUEXIS and in patients with aspirin-sensitive asthma.
  • DUEXIS can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DUEXIS. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue DUEXIS and evaluate the patient immediately.
  • Limit use of NSAIDs, including DUEXIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

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

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

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

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

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

Gastrointestinal Bleeding, Ulceration, and Perforation

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

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

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

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

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose of PENNSAID for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious GI events. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Measure transaminases at baseline and periodically in patients receiving long-term therapy with PENNSAID. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen or if clinical signs and/or symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely.
  • Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expect to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.
  • NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue PENNSAID and evaluate the patient immediately.
  • Limit use of NSAIDs, including PENNSAID between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of premature closure of the fetal ductus arteriosus and oligohydramnios/fetal renal dysfunction.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Concurrent use of PENNSAID with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • When applying PENNSAID, DO NOT: apply to open wounds, shower for at least 30 minutes after applying, wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. When applying PENNSAID, DO: wash and dry hands before and after use, avoid contact of PENNSAID with the eyes and mucous membranes, protect treated knee(s) from natural or artificial sunlight, wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

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

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

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

RAYOS is a corticosteroid indicated:

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

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

CONTRAINDICATIONS

  • Known hypersensitivity to prednisone or any excipients in the formulation

WARNINGS AND PRECAUTIONS

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

ADVERSE REACTIONS

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

Please see full Prescribing Information.

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION
See more

DUEXIS® (IBUPROFEN AND FAMOTIDINE) SELECT IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

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

Gastrointestinal Bleeding, Ulceration, and Perforation

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

DUEXIS® (IBUPROFEN AND FAMOTIDINE) INDICATIONS AND USAGE

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

DUEXIS® (IBUPROFEN AND FAMOTIDINE) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DUEXIS is contraindicated in patients:
    • With a known hypersensitivity to ibuprofen or famotidine or any components of the drug product or known hypersensitivity to other H2-receptor antagonists
    • Who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients
    • In the setting of coronary artery bypass graft (CABG) surgery

WARNINGS AND PRECAUTIONS

  • Use ibuprofen at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as DUEXIS, increases the risk of serious GI events.
  • Avoid use of DUEXIS in patients with a recent MI unless benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DUEXIS is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
  • Discontinue DUEXIS if active and clinically significant bleeding from any source occurs.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. DUEXIS should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with DUEXIS treatment.
  • Avoid use of DUEXIS in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to DUEXIS and in patients with aspirin-sensitive asthma.
  • DUEXIS can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DUEXIS. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue DUEXIS and evaluate the patient immediately.
  • Limit use of NSAIDs, including DUEXIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

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

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

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

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

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

Gastrointestinal Bleeding, Ulceration, and Perforation

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

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

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

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

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose of PENNSAID for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious GI events. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. Measure transaminases at baseline and periodically in patients receiving long-term therapy with PENNSAID. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen or if clinical signs and/or symptoms consistent with liver disease develop.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely.
  • Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expect to outweigh risk of worsening renal function.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.
  • NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or any other sign of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue PENNSAID and evaluate the patient immediately.
  • Limit use of NSAIDs, including PENNSAID between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of premature closure of the fetal ductus arteriosus and oligohydramnios/fetal renal dysfunction.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Concurrent use of PENNSAID with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
  • When applying PENNSAID, DO NOT: apply to open wounds, shower for at least 30 minutes after applying, wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. When applying PENNSAID, DO: wash and dry hands before and after use, avoid contact of PENNSAID with the eyes and mucous membranes, protect treated knee(s) from natural or artificial sunlight, wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication.
  • See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

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

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

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

RAYOS is a corticosteroid indicated:

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

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

CONTRAINDICATIONS

  • Known hypersensitivity to prednisone or any excipients in the formulation

WARNINGS AND PRECAUTIONS

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

ADVERSE REACTIONS

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

Please see full Prescribing Information.

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