(Effective as of October 22, 2013)
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Cadence Pharmaceuticals, Inc.
12481 High Bluff Drive, Suite 200
San Diego, California 92130
Phone: (858) 436-1400
Fax: (858) 436-1401
OFIRMEV® (acetaminophen) Injection is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever.
Take care when prescribing, preparing, and administering OFIRMEV injection to avoid dosing errors which could result in accidental overdose and death.
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.
OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation.
Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. 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.
Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur, or at the first appearance of skin rash. Do not use in patients with acetaminophen allergy.
The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.
The antipyretic effects of OFIRMEV may mask fever in patients treated with postsurgical pain.
OFIRMEV is approved for use in patients ≥2 years of age.
Do not exceed the recommended maximum daily dose of OFIRMEV.
OFIRMEV should be administered only as a 15-minute infusion.
To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1‑877‑647‑2239 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Cadence, OFIRMEV, and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc.
© 2013 Cadence Pharmaceuticals, Inc. All rights reserved. OFV12921013