ANDEXXA Powder for solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Portola Pharmaceuticals

Λέξεις κλειδιά

69853-0101 69853-0102

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WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: (5.1) Arterial and venous thromboembolic events Ischemic events, including myocardial ...

1. Indications and Usage

ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This indication is approved under accelerated ...

2. Dosage and Administration

For intravenous (IV) use only. 2.1 Dose There are two dosing regimens (see Table 1). The safety and efficacy of an additional dose have not been established. Table 1. ANDEXXA Dosing Regimens: Dose ...

3. Dosage Forms and Strengths

ANDEXXA is available as a white to off-white lyophilized powder in single-use vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Thromboembolic and Ischemic Risks The thromboembolic and ischemic risks were assessed in 352 bleeding subjects who received ANDEXXA. Of the 63 subjects who experienced a thrombotic event, the median ...

6. Adverse Reactions

The most common adverse reactions (≥5%) in bleeding subjects receiving ANDEXXA were urinary tract infections and pneumonia. The most common adverse reactions (≥3%) in healthy subjects treated with ANDEXXA ...

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 compared directly to rates in the clinical trials of another ...

6.2. Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. Using an electrochemiluminescence (ECL)-based assay, 145 ANDEXXA-treated healthy subjects were tested for antibodies to ANDEXXA ...

8.1. Pregnancy

Risk Summary There are no adequate and well-controlled studies of ANDEXXA in pregnant women to inform patients of associated risks. Animal reproductive and developmental studies have not been conducted ...

8.2. Lactation

Risk Summary There is no information regarding the presence of ANDEXXA in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding ...

8.4. Pediatric Use

The safety and efficacy of ANDEXXA in the pediatric population have not been studied.

8.5. Geriatric Use

Of the 352 subjects in the ANNEXA-4 study of ANDEXXA, 314 were 65 years of age or older, and 231 were 75 years of age or older. No overall differences in safety or efficacy were observed between these ...

11. Description

ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a sterile, white to off-white lyophilized powder available in single-use vials. Each 200 mg vial delivers 200 mg of coagulation factor ...

12.1. Mechanism of Action

Coagulation factor Xa (recombinant), inactivated-zhzo exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. Another observed procoagulant effect of the ...

12.2. Pharmacodynamics

The effects of ANDEXXA can be measured using assays for its anti-FXa activity, free fraction of FXa inhibitor, and thrombin generation. In addition to its ability to sequester the FXa inhibitors, rivaroxaban ...

12.3. Pharmacokinetics

A summary of the pharmacokinetic (PK) properties of ANDEXXA in healthy subjects is shown in the table below (see Table 3). Table 3. Summary of PK Parameters with High and Low Doses:   Low Dose High ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies were performed to evaluate the effects of ANDEXXA on carcinogenesis, mutagenesis, or impairment of fertility.

14. Clinical Studies

The safety and efficacy of ANDEXXA were evaluated in two prospective, randomized, placebo-controlled studies, conducted in healthy volunteers (Study 1 ANNEXA-A; Study 2 ANNEXA-R). Both studies examined ...

16.1. How Supplied

ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a white to off-white lyophilized cake or powder supplied as 4 single-use vials in a carton. ANDEXXA is not made with natural rubber latex. ...

16.2. Storage and Handling

Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.

17. Patient Counseling Information

Inform patients that reversing FXa inhibitor therapy increases the risk of thromboembolic events. Arterial and venous thromboembolic events, ischemic events, cardiac events, and sudden death were observed ...