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HCP TELEMEDICINE PORTAL

Watch physicians and a patient discuss ways to provide the best telemedicine experience for your osteoarthritis (OA) and rheumatoid arthritis (RA) patients.

Third-party Telemedicine Resources

Visit these online resources for additional telemedicine guidance.

OA & RA TELEMEDICINE RESOURCES

Communications to send to patients before their telemedicine visits

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DOWNLOAD a guide to
help connect your patients to a Horizon medication access program

PENNSAID 2% RESOURCES

Information to show patients during their telemedicine visits

PENNSAID 2%


PENNSAID 2% RESOURCES

Communications to send to patients after their telemedicine visits

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DOWNLOAD a guide to
help connect your patients to a Horizon medication access program

DUEXIS RESOURCES

Information to show patients during their telemedicine visits

DUEXIS


DUEXIS RESOURCES

Communications to send to patients after their telemedicine visits

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DOWNLOAD a guide to
help connect your patients to a Horizon medication access program

RAYOS RESOURCES

Information to show patients during their telemedicine visits

RAYOS


RAYOS RESOURCES

Communications to send to patients after their telemedicine visits

INDICATION 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.

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.
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 paitents for signs of cardiac ischemia.
  • Dicontinue 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 renel function in patients with renal or hepatic impairment, heart failure, dehydration, or hyovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh the 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 the 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.
For further information on DUEXIS, please see the Medication Guide and full Prescribing Information, including boxed warning, at www.DUEXIS.com.
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%) is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s).

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.
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 the Medication Guide and full Prescribing Information, including boxed warning, at www.PENNSAID.com.
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 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
    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.
    For further information on RAYOS, please see the Medication Guide and full Prescribing Information, including boxed warning, at www.RAYOSRX.com.
    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.
    INDICATION 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.

    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.
    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 paitents for signs of cardiac ischemia.
    • Dicontinue 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 renel function in patients with renal or hepatic impairment, heart failure, dehydration, or hyovolemia. Avoid use of DUEXIS in patients with advanced renal disease unless benefits are expected to outweigh the 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 the 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.
    For further information on DUEXIS, please see the Medication Guide and full Prescribing Information, including boxed warning, at www.DUEXIS.com.
    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%) is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s).

    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.
    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 the Medication Guide and full Prescribing Information, including boxed warning, at www.PENNSAID.com.
    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 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
      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.
      For further information on RAYOS, please see the Medication Guide and full Prescribing Information, including boxed warning, at www.RAYOSRX.com.
      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.