Less pain. Less opioids.

OFIRMEV® 1 g + PCA morphine vs placebo + PCA morphine

Listen to the experts
Learn about Dr. Mantyh’s clinical use of OFIRMEV and link to hear other experiences from your peers
Christopher Mantyh, MD
Colorectal surgeon

Associate Professor of Surgery/Chief, Gastrointestinal and Colorectal Surgery at Duke University Medical Center

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LESS PAIN
Take a closer look at the clinical data from Pain Study 1
OFIRMEV + PCA morphine demonstrated significant pain relief vs placebo + PCA morphine in mean pain scores
Sinatra et al. (Pain Study 1)
Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed.
LESS OPIOIDS
See how OFIRMEV + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine1
OFIRMEV + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine
• The clinical benefit of reduced opioid consumption was not evaluated or demonstrated
Sinatra et al. (Pain Study 1)
Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed.
OFIRMEV FROM THE START
Post-op pain intensity scores were significantly lower at all time points for the IV acetaminophen groups (pre-op and intra-op) compared to placebo (P<0.05)

See how pre-op administration of IV acetaminophen 1 g demonstrated greater reductions in post-op pain intensity scores vs placebo5

Arici et al.
Randomized, placebo-controlled, parallel-group, single-site study. Patients scheduled for total abdominal hysterectomy received IV acetaminophen 1 g 30 minutes prior to induction (pre-op), IV acetaminophen 1 g prior to skin closure (intra-op), or placebo. PCA morphine was available to all patients. Pain intensity, based on VAS, at rest and with movement, sedation, and total morphine consumption were measured at 15 and 30 minutes, 1, 2, 4, 8, 12, and 24 h.
Clinical Experts Pain Opioids Administration
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OFIRMEV® (acetaminophen injection) bottle

4 g daily maximum

The dosing recommendation for OFIRMEV is 4000 mg per day for adults ≥50 kg

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INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102(4):822-831. 2. Sinatra RS, Jahr JS, Reynolds L, et al. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012;12(5):357-365. 3. Data on file. Mallinckrodt Hospital Products, Inc. 4. Wininger SJ, Miller H, Minkowitz HS, et al. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010;32(14):2348-2369. 5. Arici S, Gurbet A, Türker G, Yavaȿcaoğlu B, Sahin S. Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Agri. 2009;21(2):54-61. 6. Crews JC. Multimodal pain management strategies for office-based and ambulatory procedures. JAMA. 2002;288(5):629-632. 7. American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273. 8. The Joint Commission. Safe use of opioids in hospitals. Sentinel Event Alert. 2012;49:1-5. http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Accessed November 4, 2013. 9. OFIRMEV [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products, Inc; 2014. 10. Kett DH, Breitmeyer JB, Ang R, Royal MA. A randomized study of the efficacy and safety of intravenous acetaminophen vs. intravenous placebo for the treatment of fever. Clin Pharmacol Ther. 2011;90(1):32-39. 11. Singla NK, Parulan C, Samson R, et al. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012;12(7):523-532.

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INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with:
    known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.
    severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
  • Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
  • Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102(4):822-831. 2. Sinatra RS, Jahr JS, Reynolds L, et al. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012;12(5):357-365. 3. Data on file. Mallinckrodt Hospital Products, Inc. 4. Wininger SJ, Miller H, Minkowitz HS, et al. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010;32(14):2348-2369. 5. Arici S, Gurbet A, Türker G, Yavaȿcaoğlu B, Sahin S. Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Agri. 2009;21(2):54-61. 6. Crews JC. Multimodal pain management strategies for office-based and ambulatory procedures. JAMA. 2002;288(5):629-632. 7. American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273. 8. The Joint Commission. Safe use of opioids in hospitals. Sentinel Event Alert. 2012;49:1-5. http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Accessed November 4, 2013. 9. OFIRMEV [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products, Inc; 2014. 10. Kett DH, Breitmeyer JB, Ang R, Royal MA. A randomized study of the efficacy and safety of intravenous acetaminophen vs. intravenous placebo for the treatment of fever. Clin Pharmacol Ther. 2011;90(1):32-39. 11. Singla NK, Parulan C, Samson R, et al. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012;12(7):523-532.
SCROLL DOWN FOR ADDITIONAL IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

TAP FOR IMPORTANT RISK INFORMATION

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with:
    known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.
    severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
  • Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
  • Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102(4):822-831. 2. Sinatra RS, Jahr JS, Reynolds L, et al. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012;12(5):357-365. 3. Data on file. Mallinckrodt Hospital Products, Inc. 4. Wininger SJ, Miller H, Minkowitz HS, et al. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010;32(14):2348-2369. 5. Arici S, Gurbet A, Türker G, Yavaȿcaoğlu B, Sahin S. Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Agri. 2009;21(2):54-61. 6. Crews JC. Multimodal pain management strategies for office-based and ambulatory procedures. JAMA. 2002;288(5):629-632. 7. American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273. 8. The Joint Commission. Safe use of opioids in hospitals. Sentinel Event Alert. 2012;49:1-5. http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Accessed November 4, 2013. 9. OFIRMEV [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products, Inc; 2014. 10. Kett DH, Breitmeyer JB, Ang R, Royal MA. A randomized study of the efficacy and safety of intravenous acetaminophen vs. intravenous placebo for the treatment of fever. Clin Pharmacol Ther. 2011;90(1):32-39. 11. Singla NK, Parulan C, Samson R, et al. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012;12(7):523-532.