Idarucizumab
Generic Name: idarucizumab
Brand Names:
Praxbind
11 DESCRIPTION Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. Using recombinant expression technology, idarucizumab is produced in a well characterized recombinant (mammalian) CHO cell line and is purified using standard technology.
Overview
11 DESCRIPTION Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. Using recombinant expression technology, idarucizumab is produced in a well characterized recombinant (mammalian) CHO cell line and is purified using standard technology.
Uses
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
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.
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate. ( 2.4 , 5.1 ) Re-elevation of Coagulation Parameters: In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or requiring a second emergency surgery/urgent procedure, an additional 5 g dose of PRAXBIND may be considered. ( 5.2 ) Hypersensitivity reactions: Discontinue administration and evaluate. ( 5.3 ) Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient: Patients with hereditary fructose intolerance may be at risk of adverse reactions. 4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on PRAXBIND use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproductive and development studies have not been conducted with idarucizumab. It is also not known whether PRAXBIND can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PRAXBIND should be given to a pregnant woman only if clearly needed. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Storage
16.2 Storage and Handling Store PRAXBIND vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. PRAXBIND vials may be stored at room temperature, 25°C (77°F), for up to 48 hours in the original carton to protect from light.
Frequently Asked Questions
What is Idarucizumab used for?▼
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 )
What are the side effects of Idarucizumab?▼
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.
Can I take Idarucizumab during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on PRAXBIND use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproductive and development studies have not been conducted with idarucizumab. It is also not known whether PRAXBIND can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PRAXBIND should be given to a pregnant woman only if clearly needed. The background risk of major birth defects and miscarriage for the indicated population is unknown.
What are the important warnings for Idarucizumab?▼
5 WARNINGS AND PRECAUTIONS Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate. ( 2.4 , 5.1 ) Re-elevation of Coagulation Parameters: In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or requiring a second emergency surgery/urgent procedure, an additional 5 g dose of PRAXBIND may be considered. ( 5.2 ) Hypersensitivity reactions: Discontinue administration and evaluate. ( 5.3 ) Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient: Patients with hereditary fructose intolerance may be at risk of adverse reactions. 4 CONTRAINDICATIONS None. None ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.