Andexxa

Last updated on RxList: 5/17/2018
Andexxa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/11/2018

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Common side effects of Andexxa include:

There are two dosing regimens of Andexxa: low dose and high dose. The low dose regimen is an initial IV bolus of 400 mg Andexxa at a target rate of 30 mg/min, with a follow-on IV infusion of 4 mg/min for up to 120 minutes. The high dose regimen is an initial IV bolus of 800 mg Andexxa at a target rate of 30 mg/min, with a follow-on IV infusion of 8 mg/min for up to 120 minutes. Andexxa may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Andexxa; it is unknown how it would affect a fetus. It is unknown if Andexxa passes into breast milk. Consult your doctor before breastfeeding.

Our Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Andexxa Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain or burning when you urinate;
  • cough with mucus, chest pain, and shortness of breath;
  • fever, chills; or
  • continued bleeding after treatment.

Reversing the effects of anticoagulant medication may increase your risk of a blood clot, heart attack, stroke, or death. Get emergency medical help if you have any of these symptoms after being treated with coagulation factor Xa, especially if you have not started taking anticoagulant medication again:

  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg; or
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects of coagulation factor Xa may include:

  • lung problems;
  • painful urination; or
  • pain, swelling, burning, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Andexxa (Coagulation Factor Xa (recombinant), Inactivated-zhzo for Injection)

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Andexxa Professional Information

SIDE EFFECTS

The most common adverse reactions (≥ 5%) in patients receiving ANDEXXA were urinary tract infections and pneumonia.

The most common adverse reactions (≥ 3%) in healthy volunteers treated with ANDEXXA were infusion-related reactions.

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 the pooled safety analysis of clinical trials of ANDEXXA, 223 healthy volunteers received FXa inhibitors followed by treatment with ANDEXXA. The frequency of adverse reactions was similar in the ANDEXXA-treated group (120/223, 54%) and the placebo-treated group (54/94, 57%). Infusion-related adverse reactions occurred in 18% (39/223) of the ANDEXXA-treated group, and was the only adverse reaction that occured more frequently than in the placebo group. No serious or severe adverse reactions were reported.

The ANNEXA-4 study is an ongoing multinational, prospective, open-label study using ANDEXXA in patients presenting with acute major bleeding who have recently received a FXa inhibitor. To date, safety data are available for 185 patients. Approximately half of the patients are male with median age of 78 years. Patients had received either apixaban (98/185, 53%) or rivaroxaban (72/185, 40%), as anticoagulation treatment for atrial fibrillation (143/185, 77%) or venous thromboembolism (48/185, 26%). In the majority of patients, ANDEXXA was used to reverse anticoagulant therapy following either an intracranial hemorrhage (106; 57%) or a gastrointestinal bleed (58; 31%), with the remaining 21 patients (11%) experiencing bleeding at other sites. Patients were assessed at a 30-day follow-up visit following infusion of ANDEXXA.

Deaths

In the ongoing ANNEXA-4 study, there were 25 deaths (14%) prior to the Day 30 follow-up visit. Eight patients died within 10 days after the ANDEXXA infusion. The percentage of patients, by bleeding type, who died prior to the Day 30 follow-up visit was: 14% for intracranial bleeding, 10% for gastrointestinal bleeding, and 19% for other bleeding types.

Thromboembolic Events

In the ongoing ANNEXA-4 study, 33/185 (17.8%) patients experienced one or more of the following events: deep venous thrombosis (11/33; 33%), ischemic stroke (9/33; 24%), acute myocardial infarction (5/33; 15%), pulmonary embolism (5/33; 15%), cardiogenic shock (3/33; 9%), sudden death (2/33; 6%), congestive heart failure (2/33; 6%), acute respiratory failure (2/33; 6%), cardiac arrest (1/33; 3%), cardiac thrombus (1/33; 3%), embolic stroke (1/33; 3%), iliac artery thrombosis (1/33; 3%), and non-sustained ventricular tachycardia (1/33; 3%). The median time to the first event in these 33 subjects was 6 days. Eleven of 33 (33%) patients were on antithrombotic therapy at the time of the event. [see WARNINGS AND PRECAUTIONS].

No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with ANDEXXA.

Infusion-Related Reactions

Infusion-related reactions occurred in 18% (39/223) of ANDEXXA-treated healthy volunteers vs. 6% (6/94) of placebo-treated subjects. These reactions were characterized by a range of symptoms including flushing, feeling hot, cough, dysgeusia, and dyspnea. Symptoms were mild to moderate in severity, and 90% (35/39) did not require treatment. One subject with a history of hives prematurely discontinued ANDEXXA after developing mild hives.

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 as well as antibodies cross-reacting with Factor X (FX) and FXa. Low titers of anti-ANDEXXA antibodies were observed in 26/145 healthy subjects (17%); 6% (9/145) were first observed at Day 30 with 20 subjects (14%) still having titers at the last time point (Days 44 to 48). To date, the pattern of antibody response in patients in the ANNEXA-4 study has been similar to that observed in healthy volunteers with 6% (6/98) of the patients having antibodies against ANDEXXA. None of these anti-ANDEXXA antibodies were neutralizing. No antibodies cross-reacting with FX or FXa were detected in healthy subjects (0/145) or in bleeding patients (0/98) to date.

Detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ANDEXXA with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Andexxa (Coagulation Factor Xa (recombinant), Inactivated-zhzo for Injection)

© Andexxa Patient Information is supplied by Cerner Multum, Inc. and Andexxa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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