Ofirmev

Ofirmev

Generic Name: acetaminophen

Company: Cadence Pharmaceuticals, Inc.

Treatment for: Pain and Fever

FDA Approves Ofirmev

The U.S. Food and Drug Administration (FDA) has granted marketing approval for Ofirmev (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. Ofirmev 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.

Highlights of Ofirmev Prescribing Information

These highlights do not include all the information needed to use Ofirmev safely and effectively. See full prescribing information for Ofirmev.

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

Reduction of fever

Dosage and Administration

Ofirmev may be given as a single or repeated dose.

Ofirmev should be administered only as a 15-minute intravenous infusion.

Adults and Adolescents Weighing 50 kg and Over:

1000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4000 mg per day. Minimum dosing interval of 4 hours.

Adults and Adolescents Weighing Under 50 kg:

15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours.

Children:

Children ? 2 to 12 years old: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours.

Dosage Forms and Strengths

Injection for intravenous infusion.

Each 100 mL glass vial contains 1000 mg acetaminophen (10 mg/mL).

Contraindications

Acetaminophen is contraindicated:

In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation.

In patients with 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 severe hepatotoxicity and death.

Do not exceed the maximum recommended daily dose of acetaminophen.

Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance = 30 mL/min).

Discontinue Ofirmev immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy.

Ofirmev side effects

Adverse Reactions

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.

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.

Drug Interactions

Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential.

Chronic oral acetaminophen use at a dose of 4000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.

Use In Specific Populations

Pregnancy: Category C. There are no studies of intravenous acetaminophen in pregnant women. Use only if clearly needed.

Nursing Mothers: Caution should be exercised when administered to a nursing woman.

Pediatric Use: The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 years of age. The safety and effectiveness of Ofirmev in pediatric patients older than 2 years is supported by evidence from adequate and well controlled studies in adults with additional safety and pharmacokinetic data for this age group.

Geriatric Use: No overall differences in safety or effectiveness were observed between geriatric and younger subjects.

Hepatic Impairment: Ofirmev is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease.

Renal Impairment: In cases of severe renal impairment, longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted.