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Important Safety Information

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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

For intravenous use only.

The recommended dose of PRAXBIND is 5 g, provided as two separate vials, each containing 2.5 g/50 mL of PRAXBIND.

One recommended dose for all PRADAXA patients.

For intravenous use only.

Recommended Dosage:

 Ready to use immediately.

  • The recommended dose of PRAXBIND is 5 g, provided as two separate 50 mL vials, each containing 2.5 g idarucizumab. Both vials are packaged together in one carton.
  • There are limited data to support administration of an additional 5 g of PRAXBIND
  • No reconstitution needed

Preparation:

  • Remove both vials (each containing 2.5 g/50 mL idarucizumab) from carton.
  • Ensure aseptic handling when preparing and administering 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
praxbind recipient

 

Flexible administration for immediate reversal:

  • Do not mix with other medicinal products
  • A pre-existing intravenous line may be used for administration of PRAXBIND. The line must be flushed with sterile 0.9% Sodium Chloride Injection, USP solution prior to infusion. No other infusion should be administered in parallel via the same intravenous access

OPTION 1: INFUSION

Hang vials and administer as two consecutive infusions1

infusion administration of Praxbind
OPTION 2: BOLUS INJECTION

Inject both vials consecutively via syringe1

bolus injection of Praxbind

Watch Prep & Administration Video

PRADAXA can be re-initiated after 24 hours following PRAXBIND administration.

PRAXBIND is a humanized monoclonal antibody fragment (Fab) that specifically binds to dabigatran and its acyl glucuronide metabolites and reverses their anticoagulant effect immediately after administration.

Watch How PRAXBIND Works

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The most frequently reported adverse reactions in ≥5% of patients were constipation (7%) and nausea (5%).

Thromboembolic Risk

Inform patients that reversing dabigatran therapy exposes them to the thromboembolic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as the patient is sufficiently stable.

Recurrence of Bleeding

Inform patients to get immediate medical attention for any signs or symptoms of bleeding.

Hypersensitivity Reactions

Inform patients of signs and symptoms of allergic hypersensitivity reactions such as anaphylactoid reactions that may be
experienced during or after injection of PRAXBIND.

Risk of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient

Inform patients with hereditary fructose intolerance (HFI) that PRAXBIND contains sorbitol. Parenteral administration of sorbitol in patients who have HFI has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death and may occur during or after injection of PRAXBIND.

Elimination

Renal clearance: 47.0 mL/minute (gCV 18.4%)

Initial half-life: 47 minutes (gCV 11.4%)

<1% recovered in urine after 24 hours; 32.1% after 6 hours

  • Remainder of dose assumed to be eliminated via protein catabolism

Specific Populations

  • Age, sex, race (Caucasian vs Asian) and body weight had no clinically important effect on exposure*

Drug Interactions

In vitro data suggest that reversal of PRADAXA is not affected by:

  • Coagulation factor concentrates†

In animal studies, it was suggested that neutralization of anticoagulant activity is not influenced by 50% hemodilution with routinely used volume replacement strategies‡

For complete information on the pharmacokinetics of PRAXBIND, please see the Prescribing Information.

  • *
    Based on population pharmacokinetic analyses which included data from 220 volunteers and 486 patients.
  • †
    Based on in vitro assessment of 3‑ or 4‑factor prothrombin complex concentrates (PCCs), activated PCC, or recombinant Factor VIIa.
  • ‡
    Based on assessment of crystalloids, colloids, and retransfusion of washed red blood cells.

No dose adjustment is required in renally‑impaired patients.

  • In a study of subjects with renal impairment (mild, n=12; moderate, n=6)*, the total clearance was reduced vs healthy subjects
  • This led to an increase in PRAXBIND’s area under the curve (mild 43.5%; moderate 83.5%)
  • *
    Mild renal impairment: creatinine clearance ≥60 to <90 mL/min by Cockcroft-Gault equation. Moderate renal impairment: ≥30 to <60 mL/min.

  • Store PRAXBIND vials in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake
  • Prior to use, the unopened vial may be kept at room temperature 25°C (77°F) for up to 48 hours, if it’s kept in its original packaging. This packaging protects it from light. When exposed to light, it may be kept for 6 hours

Please click here for the latest information on how to order PRAXBIND.

The Boehringer Ingelheim Pharmaceuticals, Inc. Return Goods Policy for PRAXBIND applies to products purchased from an Authorized Distributor of Record (ADR) that is duly licensed as a provider to dispense BIPI product. Please contact BI
Customer Service at (800) 243‑0127 for additional details.

INDICATIONS AND USAGE FOR PRADAXA

Pradaxa® (dabigatran etexilate) Capsules is indicated:

Pradaxa® (dabigatran etexilate) Capsules is indicated:

  • to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation;
  • for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5-10 days;
  • to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated;
  • for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery.
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS

Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant

(B) SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • use of indwelling epidural catheters
  • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • a history of traumatic or repeated epidural or spinal punctures
  • a history of spinal deformity or spinal surgery
  • optimal timing between the administration of PRADAXA and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated.

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with:

  • active pathological bleeding;
  • history of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of PRADAXA (e.g., anaphylactic reaction or anaphylactic shock);
  • mechanical prosthetic heart valve

WARNINGS & PRECAUTIONS

Increased Risk of Thrombotic Events after Premature Discontinuation

Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation, increases the risk of thrombotic events. If PRADAXA Capsules is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA Capsules as soon as medically appropriate.

Risk of Bleeding

  • PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA Capsules in patients with active pathological bleeding.
  • Risk factors for bleeding include concomitant use of medications that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). PRADAXA’s anticoagulant activity and half-life are increased in patients with renal impairment.
  • Reversal of Anticoagulant Effect: In adults, a specific reversal agent (idarucizumab) for PRADAXA is available when reversal of the anticoagulant effect of dabigatran is needed:
  • For emergency surgery/urgent procedures
  • In life-threatening or uncontrolled bleeding
  • Hemodialysis can remove dabigatran; however clinical experience for hemodialysis as a treatment for bleeding is limited. Prothrombin complex concentrates or recombinant Factor VIIa may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves

The use of PRADAXA is contraindicated in all patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.

Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure

Concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.

Reduction of Risk of Stroke/Systemic Embolism in NVAF in Adult Patients.

  • For patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dose of PRADAXA Capsules to 75 mg twice daily when dronedarone or systemic ketoconazole is co-administered with PRADAXA.
  • For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA Capsules and P-gp inhibitors.

Treatment and Reduction in the Risk of Recurrence of DVT/PE & Prophylaxis of DVT/PE Following Hip Replacement Surgery in Adult Patients.

  • For patients with CrCl <50 mL/min, avoid use of PRADAXA Capsules and concomitant P-gp inhibitors.

Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome

There is an increased risk of thrombosis in patients with triple-positive antiphospholipid syndrome. PRADAXA use is not recommended.

ADVERSE REACTIONS

The most common adverse reactions (>15%) reported with PRADAXA are gastrointestinal adverse reactions and bleeding.

Other Measures Evaluated

In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

USE IN SPECIFIC POPULATIONS

Pregnancy: The limited available data on PRADAXA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.

Lactation: Breastfeeding is not recommended.

Females and Males of Reproductive Potential: Discuss pregnancy planning with females of reproductive potential requiring anticoagulation. Assess the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, in females of reproductive potential and those with abnormal uterine bleeding.

Pediatric Use: The safety and effectiveness of PRADAXA Capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age. Other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age for these indications. Safety and effectiveness of PRADAXA Capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery.

Geriatric: Risk of bleeding increases with age.

CL-PX-100063 06.28.2021

Please see full Prescribing Information, including boxed WARNING and Medication Guide.

INDICATIONS AND USAGE FOR PRADAXA

Praxbind® (idarucizumab) is indicated in patients treated with Pradaxa® when

Praxbind® (idarucizumab) 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
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

WARNINGS AND PRECAUTIONS

Thromboembolic Risk

  • Dabigatran-treated patients have underlying diseases predisposing them to thromboembolic events. Reversing dabigatran therapy exposes patients to thrombotic risk. Consider resumption of anticoagulant therapy as soon as medically appropriate.

Re-elevation of Coagulation Parameters

  • Elevated coagulation parameters (e.g., activated partial thromboplastin time or ecarin clotting time) have been observed in a limited number of PRAXBIND-treated patients. If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed, or if patients requiring a second emergency surgery/urgent procedure have elevated coagulation parameters, an additional full dose may be considered.

Hypersensitivity Reactions

  • There is insufficient clinical experience evaluating risk of hypersensitivity to idarucizumab, but a possible relationship could not be excluded. Risk of hypersensitivity (e.g., anaphylactoid reaction) to idarucizumab or excipients needs to be weighed cautiously against the potential benefit. If serious allergic reaction occurs, immediately discontinue PRAXBIND and institute appropriate treatment.

Risk in Patients With Hereditary Fructose Intolerance

  • PRAXBIND contains 4 g sorbitol as an excipient. When prescribing PRAXBIND in patients with hereditary fructose intolerance, consider the total daily amount of sorbitol/fructose consumption from all sources, as serious adverse reactions (e.g., hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure, and death) may occur.

ADVERSE REACTIONS

  • The most frequently reported adverse reaction in ≥5% of idarucizumab-treated healthy volunteers was headache (5%). The most frequently reported adverse reactions in ≥5% of patients were constipation (7%) and nausea (5%).
  • Treatment-emergent antibodies with low titers were observed in 4% of healthy subjects and 2% of patients treated with idarucizumab.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation

  •  PRAXBIND should be given to a pregnant woman only if clearly needed. Caution should be exercised when PRAXBIND is administered to a nursing woman.

CL-PB-100001 April 2018

Please click here for full Prescribing Information for PRAXBIND.