Praxbind 50 mg/mL
idarucizumab · INJECTION · Boehringer Ingelheim Pharmaceuticals, Inc.
Praxbind is a injection containing idarucizumab at 50 mg/mL, taken intravenous. Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Praxbind
- Generic Name
- idarucizumab
- NDC Code (Product)
0597-0197- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761025
- Drug Class
- Humanized Monoclonal Antibody Fragment [EPC]
- Marketing Start
- 10/21/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa ® when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous use only. The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab. ( 2.1 ) There is limited data to support administration of an additional 5 g of PRAXBIND. ( 2.1 ) 2.1 Recommended Dose The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1 ). Both vials are packaged together in one carton. For intravenous use only. There is limited data to support administration of an additional 5 g of PRAXBIND [see Warnings and Precautions (5.2) ]. 2.2 Preparation Remove both vials (each containing 2.5 g/50 mL idarucizumab) from carton. Ensure aseptic handling when preparing the infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Once solution has been removed from the vial, administration should begin promptly. The solution in vials may be stored at room temperature, 25°C (77°F), but must be used within 6 hours [see How Supplied/Storage and Handling (16.2) ] . 2.3 Administration Do not mix with other medicinal…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient [see Warnings and Precautions (5.4) ] In healthy volunteers, the most frequently reported adverse reactions in ≥5% of subjects treated with idarucizumab was headache. ( 6.1 ) In patients, the most frequently reported adverse reactions in ≥5% of patients treated with idarucizumab were constipation and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In three healthy volunteer clinical trials, 224 subjects were treated …
Frequently Asked Questions
What is Praxbind used for?
Praxbind contains idarucizumab. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Praxbind a controlled substance?
Praxbind is not classified as a controlled substance by the DEA.
What is the generic name for Praxbind?
The generic name for Praxbind is idarucizumab. There are no other listed brand versions of idarucizumab.
What is the NDC code for Praxbind 50 mg/mL?
The NDC (National Drug Code) for Praxbind 50 mg/mL is 0597-0197, listed by Boehringer Ingelheim Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)