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.
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.
- 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 Cadence Pharmaceuticals, Inc., a Mallinckrodt company, at 1.800.778.7898 or 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. Cadence Pharmaceuticals, a Mallinckrodt company. 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]. San Diego, CA: Cadence Pharmaceuticals, a Mallinckrodt company, 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.
Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks
of a Mallinckrodt company. © 2014 Mallinckrodt OFV1504 11/14