OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.
Take care when prescribing, preparing, and administering OFIRMEV® (acetaminophen) injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
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.
Please see additional Important Safety Information, including Boxed Warning, in the Full Prescribing Information.
The route of administration can impact absorption of acetaminophen. In a clinical study, patients who received OFIRMEV® (acetaminophen) injection exhibited higher and faster absorption rates vs those who received oral or rectal acetaminophen.1
EFFICACY WAS NOT ASSESSED IN THIS STUDY
Efficacy was not assessed in this study
Study Design
This was a 3-way crossover, single-center, single-dose pharmacokinetic study of 6 healthy adult males. Each received 3 single-dose treatments of IV, oral, and rectal acetaminophen, separated by a washout period of 24 hours. Treatment dosage was 1 g IV and oral acetaminophen and 1300 mg rectal.* IV acetaminophen was administered over 15 minutes commencing at 0 hours. Cerebrospinal fluid (CSF) and blood draws were performed prior to study medication administration and at 8 additional time points for 6 hours in each treatment period.
*Rectal acetaminophen data reflect standardization of the 1300-mg dose to 1 g (linear kinetics).
Note: OFIRMEV = IV acetaminophen = IV APAP.
The primary site of action for acetaminophen is within the central nervous system, necessitating a high plasma to cerebrospinal fluid (CSF) concentration.1
OFIRMEV achieves a peak plasma concentration that is 2 times higher and 30 minutes faster than oral acetaminophen.1
*Rectal acetaminophen data reflect standardization of the 1300-mg dose to 1 g (linear kinetics).
Mean AUC0-6 (SD) (µg • h/mL)
OFIRMEV: 42.5 (16.5)
vs PO APAP: 29.4 (52.3)
vs PR APAP: 24.5 (29.2)
OFIRMEV achieved both an earlier and greater CSF concentration than both oral and rectal acetaminophen.1
*Rectal acetaminophen data reflect standardization of the 1300-mg dose to 1 g (linear kinetics).
Mean AUC0-6 (SD) (µg • h/mL)
OFIRMEV: 24.9 (17.4)
vs PO APAP: 14.2 (52.1); P=0.0099
vs PR APAP: 10.3 (24.5); P=0.0004
Efficacy was not assessed in this study
Study Design
This was a randomized, single-blind, 2-way, repeated-dose study in healthy adults to assess how opioids alter the pharmacokinetics (PK) of orally administered acetaminophen. Participants were randomly assigned to receive either 4 repeat doses of oral acetaminophen 1 g with IV placebo every 6 hours (n=11) or 4 repeat doses of IV acetaminophen 1 g with 2 placebo tablets every 6 hours (n=11). Both groups received 2 doses of IV morphine at 0.125 mg/kg at hours 6 and 12. The observed pharmacokinetic profiles of oral and IV acetaminophen were compared with their predicted profiles.
Note: OFIRMEV = IV acetaminophen = IV APAP.
Taking into consideration how opioids affect oral acetaminophen concentration and absorption is an important part of surgical planning.
This study involving healthy adults assessed how opioids alter the pharmacokinetics of oral and IV acetaminophen. Patients were randomized to receive either oral (group A) or IV (group B) acetaminophen in conjunction with IV morphine.2
APAP, acetaminophen; AUC0-6, area under the curve from 0 to 6 hours; C6, concentration at 6 hours; Cmax, maximum concentration; SD, standard deviation; Tmax, time to reach maximum concentration.
aAUC following each dose of APAP.
IV acetaminophen plasma concentrations remained consistent after morphine administration.2
APAP, acetaminophen; AUC0-6, area under the curve from 0 to 6 hours; C0.5, concentration at 0.5 hours; C6, concentration at 6 hours; Cmax, maximum concentration; SD, standard deviation; Tmax, time to reach maximum concentration.
aAUC following each dose of APAP.
bConcentration at first measured time point (0.5 h) post-dose.
Efficacy of acetaminophen was not assessed in this study
Study Design
This was a randomized, double-blind pharmacokinetic study involving 15 patients undergoing orthopedic surgery with spinal anesthesia. Patients were randomized to receive a single dose of intramuscular morphine 10 mg (n=8) or a single dose of intramuscular ketorolac 30 mg (n=7) for post-op pain. As a measure of liquid gastric emptying, oral acetaminophen solution at 20 mg/kg was administered to each patient at 2 time points, at least 12 hours before scheduled surgery (pre-op) and 30 minutes after the first administration of morphine or ketorolac (post-op).
Note: OFIRMEV = IV acetaminophen = IV APAP.
Altered gastric emptying may result in changes in the rate of absorption of orally administered drugs3
In this study, patients undergoing orthopedic surgery were given oral acetaminophen at least 12 hours before surgery and 30 minutes after receiving morphine. Plasma concentrations of oral acetaminophen were significantly lower post-surgery, indicating that gastric impairment impacts absorption.3
[Company Name] was not the sponsor of this study, which was conducted preceding the launch of the product.
*Required field
OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.
Take care when prescribing, preparing, and administering OFIRMEV® (acetaminophen) injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
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.
Please see additional Important Safety Information, including Boxed Warning, in the Full Prescribing Information.
References: 1. Singla NK, et al. Pain Pract. 2012;12(7):523-532. 2. Raffa RB, et al. Clin Drug Investig. 2018;38(3):259-268. 3. Petring OU, et al. Br J Anaesth. 1995;74(3):257-260. 4. Berger MM, et al. Crit Care Med. 2000;28(7):2217-2223. 5. Petring OU, et al. Anaesth Intensive Care. 1993;21(6):774-781. 6. Behm B, et al. Clin Gastroenterol Hepatol. 2003;1(2):71-80.
Already registered?
Send a request regarding your information.
[Company Name], the [“X”] brand mark and the [Company Name] logo are trademarks of a [Company Name] company. Other brands are trademarks of a [Company Name] company or their respective owners.
© 2019 [Company Name]. US-1900939 08/19