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OpioId-Level Analgesia1

A novel formulation of ketorolac, an NSAID, and a proven pain reliever

SPRIX® (ketorolac tromethamine) provides short-term pain relief in adult patients for up to 5 days to manage moderate to moderately severe pain that requires analgesia at the opioid level1

SPRIX is a potent NSAID and is NOT a controlled substance

SPRIX is rapidly absorbed through the nasal mucosa2

FOR YOUR ADULT PATIENTS

WHO EXPERIENCE ACUTE PAIN

SPRIX® (ketorolac tromethamine) Nasal Spray is a non-narcotic medication delivering short-term (for up to 5 days) opioid-level analgesia to manage moderate to moderately severe pain1

Post-Surgical Pain

David, High School Teacher

Pain history: Rotator cuff tear requiring arthroscopic repair

Presenting concern: Scheduled for surgery; need to plan for post-surgery pain control

Treatment protocol: Physician typically prescribes immediate-release opioid, 6-day supply

Physician assessment: Patient prefers a short-term opioid alternative to manage moderate to moderately severe acute pain

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles at pre-surgical consult for discharge treatment

Acute Onset of Pain

Lisa, Computer Programmer

Pain history: None

Presenting concern: Acute onset of moderate knee pain after gardening over the weekend

Treatment protocol: Physician typically prescribes intramuscular ketorolac tromethamine injection

Physician assessment: In favor of patient self-treating

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles, to provide treatment for her moderate acute pain

Pain history: None

Presenting concern: Acute onset of moderate knee pain after gardening over the weekend

Treatment protocol: Physician typically prescribes intramuscular ketorolac tromethamine injection

Physician assessment: In favor of patient self-treating

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles, to provide treatment for her moderate acute pain

Post-Procedural Pain

Scott, General Contractor

Pain history: Chronic discogenic low back pain

Current treatment protocol: Extended-release opioid, BID; immediate-release opioid, PRN

Presenting concern: Scheduled for RFA; need to plan for post-procedure pain control

Physician assessment: Unwilling to prescribe an additional or increased dosage of an immediate-release opioid

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles at pre-procedural consult as a non-narcotic treatment for moderate to moderately severe acute pain

Pain history: Chronic discogenic low back pain

Current treatment protocol: Extended-release opioid, BID; immediate-release opioid, PRN

Presenting concern: Scheduled for RFA; need to plan for post-procedure pain control

Physician assessment: Unwilling to prescribe an additional or increased dosage of an immediate-release opioid

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles at pre-procedural consult as a non-narcotic treatment for moderate to moderately severe acute pain

Post-Surgical Pain

David, High School Teacher

Pain history: Rotator cuff tear requiring arthroscopic repair

Presenting concern: Scheduled for surgery; need to plan for post-surgery pain control

Treatment protocol: Physician typically prescribes immediate-release opioid, 6-day supply

Physician assessment: Patient prefers a short-term opioid alternative to manage moderate to moderately severe acute pain

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles at pre-surgical consult for discharge treatment

Acute Onset of Pain

Lisa, Computer Programmer

Pain history: None

Presenting concern: Acute onset of moderate knee pain after gardening over the weekend

Treatment protocol: Physician typically prescribes intramuscular ketorolac tromethamine injection

Physician assessment: In favor of patient self-treating

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles, to provide treatment for her moderate acute pain

Pain history: None

Presenting concern: Acute onset of moderate knee pain after gardening over the weekend

Treatment protocol: Physician typically prescribes intramuscular ketorolac tromethamine injection

Physician assessment: In favor of patient self-treating

Conclusion: Prescribe 1 carton of SPRIX, with 5 single-day bottles, to provide treatment for her moderate acute pain

Dosage and Administration

  • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals.
  • SPRIX is not an inhaled product. For adult patients < 65 years of age: 31.5 mg (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg.
  • For patients ≥ 65 years of age, renally impaired patients, and patients less than 50 kg (110 lbs): 15.75 mg (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg.
  • SPRIX nasal spray should be discarded within 24 hours of taking the first dose, even if the bottle still contains some medication.

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.
  • SPRIX® 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.

Indications and Usage

SPRIX® (ketorolac tromethamine) is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Contraindications

SPRIX is contraindicated in the following patients:

  • Known hypersensitivity to ketorolac or any components of the drug product.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
  • In the setting of coronary artery bypass graft (CABG) surgery.
  • Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
  • Use as a prophylactic analgesic before any major surgery.
  • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
  • Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
  • Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
  • Concomitant use with probenecid or pentoxifylline.

Warnings and Precautions

Cardiovascular Thrombotic Events: increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Contraindicated in the setting of CABG. Patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.

Gastrointestinal Bleeding, Ulceration, and Perforation: contraindicated in patients with active peptic ulcers and/or GI bleeding and in patients with recent gastrointestinal bleeding or perforation. Can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms. Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Hypertension: NSAIDs, including SPRIX, can lead to new onset or worsening of preexisting hypertension. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of SPRIX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SPRIX in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).

Serious Skin Reactions: NSAIDs, including SPRIX, can cause serious skin reactions, which can be fatal. Discontinue SPRIX at first appearance of skin rash or other signs of hypersensitivity.

Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.

Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Do not use SPRIX in patients for whom hemostasis is critical.

Limitations of Use: SPRIX should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs.

Adverse Reactions

Serious adverse reactions include: cardiovascular thrombotic events; GI bleeding, ulceration and perforation; hepatotoxicity; hypertension; heart failure and edema; renal toxicity and hyperkalemia; anaphylactic reactions; serious skin reactions; hematologic toxicity.

The most common adverse reactions (incidence ≥2%) in patients treated with SPRIX and occurring at a rate at least twice that with placebo include: nasal discomfort; rhinalgia; increased lacrimation; throat irritation; oliguria; rash; bradycardia; decreased urine output; increased ALT and/or AST; hypertension; rhinitis.

In controlled clinical trials in major surgery, primarily knee and hip replacements and abdominal hysterectomies, 1.5% of patients treated with SPRIX experienced serious adverse events of bleeding or hematoma at the operative site versus 0.4% of patients treated with placebo who experienced hematoma.

In patients taking ketorolac or other NSAIDs in clinical trials, the most frequently reported adverse reactions in approximately 1% to 10% of patients are:

Gastrointestinal (GI): abdominal pain, constipation/diarrhea, dyspepsia, flatulence, GI fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, nausea (incidence >10%), stomatitis, vomiting.

Other: abnormal renal function, anemia, dizziness, drowsiness, edema, elevated liver enzymes, headache (incidence >10%), hypertension, increased bleeding time, injection site pain, pruritus, purpura, rash, tinnitus, sweating.

Drug Interactions

Drugs that interfere with hemostasis: increased risk of serious bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is contraindicated.

ACE inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers: may diminish the antihypertensive effect of these drugs; monitor blood pressure.

ACE Inhibitors and ARBs: In elderly, volume depleted, or those with renal impairment may result in deterioration of renal function; monitor for signs of worsening renal function.

Diuretics: reduces the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

Digoxin: has been reported to increase the serum concentration and prolong the half-life of digoxin.

Use in Specific Populations

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SPRIX in women who have difficulties conceiving.

Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.

Please see full Prescribing Information, including Boxed Warning.

References

  1. SPRIX® [package insert]. Wayne, PA : Egalet US Inc. 2016.
  2. McAleer SD, Majid O, Venables E, Polack T, Sheikh MS. Pharmacokinetics and safety of ketorolac following single intranasal and intramuscular administration in healthy volunteers. J Clin Pharmacol. 2007;47(1):13-18.

Important Safety Information

Important Safety Information

Indications and Usage

SPRIX® (ketorolac tromethamine) is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

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.
  • SPRIX® 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

SPRIX is contraindicated in the following patients:

  • Known hypersensitivity to ketorolac or any components of the drug product.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
  • In the setting of coronary artery bypass graft (CABG) surgery.
  • Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
  • Use as a prophylactic analgesic before any major surgery.
  • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
  • Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
  • Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
  • Concomitant use with probenecid or pentoxifylline.

Warnings and Precautions

Cardiovascular Thrombotic Events: increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Contraindicated in the setting of CABG. Patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.

Gastrointestinal Bleeding, Ulceration, and Perforation: contraindicated in patients with active peptic ulcers and/or GI bleeding and in patients with recent gastrointestinal bleeding or perforation. Can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms. Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Hypertension: NSAIDs, including SPRIX, can lead to new onset or worsening of preexisting hypertension. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of SPRIX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SPRIX in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).

Serious Skin Reactions: NSAIDs, including SPRIX, can cause serious skin reactions, which can be fatal. Discontinue SPRIX at first appearance of skin rash or other signs of hypersensitivity.

Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.

Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Do not use SPRIX in patients for whom hemostasis is critical.

Limitations of Use: SPRIX should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs.

Adverse Reactions

Serious adverse reactions include: cardiovascular thrombotic events; GI bleeding, ulceration and perforation; hepatotoxicity; hypertension; heart failure and edema; renal toxicity and hyperkalemia; anaphylactic reactions; serious skin reactions; hematologic toxicity.

The most common adverse reactions (incidence ≥2%) in patients treated with SPRIX and occurring at a rate at least twice that with placebo include: nasal discomfort; rhinalgia; increased lacrimation; throat irritation; oliguria; rash; bradycardia; decreased urine output; increased ALT and/or AST; hypertension; rhinitis.

In controlled clinical trials in major surgery, primarily knee and hip replacements and abdominal hysterectomies, 1.5% of patients treated with SPRIX experienced serious adverse events of bleeding or hematoma at the operative site versus 0.4% of patients treated with placebo who experienced hematoma.

In patients taking ketorolac or other NSAIDs in clinical trials, the most frequently reported adverse reactions in approximately 1% to 10% of patients are:

Gastrointestinal (GI): abdominal pain, constipation/diarrhea, dyspepsia, flatulence, GI fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, nausea (incidence >10%), stomatitis, vomiting.

Other: abnormal renal function, anemia, dizziness, drowsiness, edema, elevated liver enzymes, headache (incidence >10%), hypertension, increased bleeding time, injection site pain, pruritus, purpura, rash, tinnitus, sweating.

Drug Interactions

Drugs that interfere with hemostasis: increased risk of serious bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is contraindicated.

ACE inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers: may diminish the antihypertensive effect of these drugs; monitor blood pressure.

ACE Inhibitors and ARBs: In elderly, volume depleted, or those with renal impairment may result in deterioration of renal function; monitor for signs of worsening renal function.

Diuretics: reduces the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

Digoxin: has been reported to increase the serum concentration and prolong the half-life of digoxin.

Use in Specific Populations

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SPRIX in women who have difficulties conceiving.

Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.