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Ofirmev 1000mg/100mL Injection
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Indications & Clinical Uses
- Ofirmev 1000mg/100mL is the brand name for intravenous acetaminophen (paracetamol) injection, given only by hospital or clinic staff as an intravenous infusion, never as a tablet, oral liquid, or injection by any other route.
- It is approved for the management of mild to moderate pain, for moderate to severe pain when used together with opioid analgesics, and for the reduction of fever, in adults and children aged 2 years and older.
- Ofirmev is intended for short-term hospital or perioperative use and is not a self-administered home medicine.
- Because acetaminophen is contained in many other prescription and over-the-counter products, the total daily dose from all sources, including this injection, must be tracked carefully to avoid exceeding the maximum safe amount.
- Ofirmev is administered exclusively under direct medical supervision in a hospital or clinical setting.
Side Effects
- Ofirmev carries a boxed warning for the risk of serious medication errors and acetaminophen-induced hepatotoxicity: doses above the recommended maximum, whether from Ofirmev alone or combined with other acetaminophen-containing products, can cause severe liver injury, liver failure, the need for a liver transplant, and death, and healthcare staff must take particular care with prescribing, preparing, and administering this medicine to avoid dosing errors, especially in patients weighing less than 50 kg.
- The most commonly reported side effects in adults are nausea, vomiting, headache, and insomnia; in children, nausea, vomiting, constipation, and itching are most frequent.
- Serious allergic reactions, including facial swelling and difficulty breathing, are rare but can occur.
- Staff monitor for signs of liver injury, such as yellowing of the skin or eyes, dark urine, or unusual tiredness, since these require immediate assessment.
- Because this is a clinician-administered infusion, patients are monitored throughout treatment for any reaction.
Precautions & Warnings
- Ofirmev is for intravenous infusion only, given over 15 minutes; it must never be given as a rapid IV push or bolus injection.
- The maximum daily dose is 4000mg for adults and adolescents weighing 50kg or more, and 75mg/kg per day (not exceeding the adult maximum) for those under 50kg and for children aged 2 to 12 years; lower weight-based limits apply to infants and neonates.
- Ofirmev is contraindicated in patients with known hypersensitivity to acetaminophen or any component of the formulation, and in those with severe active liver disease.
- It should be used with caution and at a reduced total daily dose in patients with hepatic impairment, active liver disease, chronic alcoholism, chronic malnutrition, or severe dehydration, because of increased risk of liver injury.
- Every source of acetaminophen a patient is receiving, including other injections, oral products, and combination pain medicines, must be added together and kept below the maximum daily limit.
Avoid Interactions
- The risk of liver damage from Ofirmev increases when it is combined with other medicines that also contain acetaminophen, so all other acetaminophen-containing products, whether prescription or over-the-counter, must be identified and their combined daily dose kept within the safe maximum.
- Chronic, heavy alcohol use increases the risk of liver toxicity and should be disclosed to the care team.
- Drugs that induce the CYP2E1 liver enzyme, and medicines associated with glutathione depletion, may increase the risk of hepatotoxicity from acetaminophen.
- In patients stabilized on warfarin, prolonged regular use of acetaminophen, including Ofirmev, can increase the international normalized ratio (INR) and bleeding risk, so more frequent monitoring may be needed.
- Ofirmev must not be mixed or diluted with other medicines in the same infusion bag or line.
- Hospital staff review every other medicine a patient is receiving before and during treatment to avoid acetaminophen overexposure.
References
Frequently Asked Questions
Ofirmev is intravenous acetaminophen (paracetamol) given in hospital for mild to moderate pain, for moderate to severe pain alongside opioids, and to reduce fever. It's approved for adults and children aged 2 and older. Ofirmev is only given by injection into a vein by hospital staff, never taken at home.
Ofirmev is given as a slow intravenous infusion over 15 minutes, never as a fast injection or push. Adults weighing 50 kg or more usually receive 1000 mg every 6 hours. Dosing for children and lighter adults is calculated by body weight, and only clinical staff administer it.
Common effects include nausea, vomiting, headache, and insomnia in adults, and nausea, vomiting, constipation, and itching in children. Ofirmev has a boxed warning: doses above the maximum, from this or any acetaminophen product, can cause serious liver damage, liver failure, or death. Hospital staff track every dose carefully.
Avoid taking any other acetaminophen or paracetamol-containing medicine while receiving Ofirmev, since the doses add together and can cause liver damage. Tell staff about regular or heavy alcohol use, liver disease, poor nutrition, or warfarin use, as these increase risk and may need closer monitoring or dose limits.
A nurse gives Ofirmev through a vein over 15 minutes; it is never pushed in quickly. Your weight is used to calculate a safe dose, and staff monitor you for reactions during and after the infusion. This is a clinician-only medicine, so there is no missed-dose or home-storage concern for patients.
Ofirmev should be used cautiously and at a reduced total daily dose in people with liver impairment, chronic alcohol use, or poor nutrition, and is contraindicated in severe active liver disease. Because acetaminophen overdose is a leading cause of liver failure, your care team tracks every dose closely.
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