Zueino™ is now approved in the United States.
Zueino™ (diclofenac sodium) injection, 37.5 mg/mL, for intravenous use · Rx only
For the management of mild to moderate pain, and the management of moderate to severe pain alone or in combination with opioid analgesics, in adults.
A nonsteroidal anti-inflammatory drug indicated for use in adults.
- Management of mild to moderate pain
- Management of moderate to severe pain alone or in combination with opioid analgesics
One strength. One single-dose vial.
Zueino is for intravenous administration only, given as a bolus injection.
To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of Zueino. Use for the shortest duration consistent with individual patient treatment goals.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.
A clear, colorless to yellowish solution in a 1 mL glass vial.
Zueino is supplied as a 1 mL fill in a clear glass vial with a blue tamper-evident top. Not made with natural rubber latex.
- Established name
- diclofenac sodium injection
- Strength
- 37.5 mg/mL
- Single-dose vial
- NDC 88015-101-01
- Carton of 25 vials
- NDC 88015-101-02
- Application
- NDA 218379
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. Keep Zueino out of reach and sight of children.
Important Safety Information
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
ZUEINO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Contraindications
Zueino is contraindicated in the following patients:
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
- In the setting of coronary artery bypass graft (CABG) surgery
- Moderate to severe renal insufficiency in the perioperative period and who are at risk for volume depletion
Warnings and precautions
In addition to the Boxed Warning above, the Prescribing Information carries warnings and precautions for:
- Hepatotoxicity — discontinue if abnormal liver tests persist or worsen, or if clinical signs and symptoms of liver disease develop
- Hypertension — patients taking some antihypertensive medications may have an impaired response when taking NSAIDs; monitor blood pressure
- Heart failure and edema; renal toxicity and hyperkalemia
- Anaphylactic reactions; exacerbation of asthma related to aspirin sensitivity
- Serious skin reactions, and drug reaction with eosinophilia and systemic symptoms (DRESS)
- Fetal toxicity; hematologic toxicity; masking of inflammation and fever; laboratory monitoring
Most common adverse reactions
The most common adverse reactions (>5%) in controlled clinical trials include nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia.
This is not a complete summary of the safety information for Zueino. Please see the full Prescribing Information, including the Boxed Warning, for complete information on contraindications, warnings and precautions, adverse reactions, drug interactions and use in specific populations.
To report suspected adverse reactions, contact AdventaPharma DWC LLC at 1-844-ADVENTA (1-844-238-3682) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Learn more about Zueino.
In case of interest to learn more about the product, please get in touch with Adventa Pharma. We will respond directly.
Please do not include patient information in your message. To report an adverse reaction, use the telephone numbers above.