Ofirmev

It is very important that your doctor check you closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you or your child are receiving this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you or your child are using this medicine.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen (eg, Tylenol®). It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

• It is used to ease pain and fever.

• If you have an allergy to acetaminophen or any other part of Ofirmev (acetaminophen injection).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have liver disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Ofirmev with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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

• the reduction of fever in adult and pediatric patients.

Acetaminophen is contraindicated:

• in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
• in patients with severe hepatic impairment or severe active liver disease [see Warnings and Precautions (5.1)].

Signs and Symptoms

In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma acetaminophen levels > 300 mcg/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 mcg/mL or < 37.5 mcg/mL at 12 hours after ingestion. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment

If an acetaminophen overdose is suspected, obtain a serum acetaminophen assay as soon as possible, but no sooner than 4 hours following oral ingestion. Obtain liver function studies initially and repeat at 24-hour intervals. Administer the antidote N-acetylcysteine (NAC) as early as possible. As a guide to treatment of acute ingestion, the acetaminophen level can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew). The lower toxic line on the nomogram is equivalent to 150 mcg/mL at 4 hours and 37.5 mcg/mL at 12 hours. If serum level is above the lower line, administer the entire course of NAC treatment. Withhold NAC therapy if the acetaminophen level is below the lower line.

For additional information, call a poison control center at 1-800-222-1222.

Adult Acute Pain

The efficacy of Ofirmev in the treatment of acute pain in adults was evaluated in two randomized, double-blind, placebo-controlled clinical trials in patients with postoperative pain.

Pain Study 1 evaluated the analgesic efficacy of repeated doses of Ofirmev 1000 mg vs. placebo every 6 hours for 24 hours in 101 patients with moderate to severe pain following total hip or knee replacement. Ofirmev was statistically superior to placebo for reduction in pain intensity over 24 hours. There was an attendant decrease in opioid consumption, the clinical benefit of which was not demonstrated.

Pain Study 2 evaluated the analgesic efficacy of repeated doses of Ofirmev 1000 mg every 6 hours or 650 mg every 4 hours for 24 hours versus placebo in the treatment of 244 patients with moderate to severe postoperative pain after abdominal laparoscopic surgery. Patients receiving Ofirmev experienced a statistically significant greater reduction in pain intensity over 24 hours compared to placebo.

Adult Fever

 The efficacy of Ofirmev 1000 mg in the treatment of adult fever was evaluated in one randomized, double-blind, placebo-controlled clinical trial. The study was a 6-hour, single-dose, endotoxin-induced fever study in 60 healthy adult males. A statistically significant antipyretic effect of Ofirmev was demonstrated through 6 hours in comparison to placebo. The mean temperature over time is shown in Figure 1.

Figure 1:       Mean Temperature (°C) Over Time

Pediatric Acute Pain and Fever

Ofirmev was studied in pediatric patients in three active-controlled trials and three open-label safety and pharmacokinetic trials [see Use in Specific Populations (8.4)].

Ofirmev®
(acetaminophen) injection

1000 mg/100mL
(10 mg/mL)

For Intravenous Use Only

Single Use Vial. Doses less than 1000 mg require aseptic transfer to a separate container prior to dispensing. Discard unused portion.

Rx Only

07/2014

1291264A0

NDC 43825-102-03

TO OPEN
TEAR AT NOTCH

Ofirmev®
(acetaminophen) injection
1000 mg/100 mL
(10 mg/mL)

For Intravenous Use Only

Rx only

Single Use Container. Discard unused portion.
Doses less than 1000 mg require aseptic transfer to a separate container prior to dispensing. See Package Insert for recommended dosage and Full Prescribing Information.

Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF). Do not refrigerate or freeze.

LEAVE BAG IN OVERWRAP UNTIL USE
After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.
Each 100 mL contains 1000 mg acetaminophen, USP, 3850 mg mannitol, USP, 25 mg cysteine hydrochloride, monohydrate, USP, 10.4 mg dibasic sodium phosphate, USP.
pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

Manufactured for:
Mallinckrodt Hospital Products Inc.
Hazelwood, MO 63042 USA
Patented: US 6,028,222; US 6,992,218

Rev 08/2016

FUM 0021 01-79-01-001

90
C/PP

Mallinckrodt™