Note: This document contains side effect information about coagulation factor ix. Some dosage forms listed on this page may not apply to the brand name Ixinity.

Summary

More frequent side effects include: dizziness, nausea, skin rash, and urticaria. Continue reading for a comprehensive list of adverse effects.

Applies to coagulation factor ix: intravenous powder for solution.

Serious side effects of Ixinity

Along with its needed effects, coagulation factor ix (the active ingredient contained in Ixinity) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking coagulation factor ix:

More common

• Cough
• fever

Less common

• Back or side pain
• blurred vision
• chest tightness
• chills
• confusion
• difficult or labored breathing
• fast heartbeat
• hives
• itching, pain, redness, swelling, tenderness, blue discoloration, or warmth of the skin at the injection site
• nausea
• swelling of the foot or leg
• vomiting

Incidence not known

• Anxiety
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• cloudy or bloody urine
• difficulty with swallowing
• dizziness
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• pain, redness, or swelling in the arm or leg
• pains in the chest, groin, or legs, especially calves of the legs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• severe headaches of sudden onset
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sweating
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• trouble breathing
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vision problems

Other side effects of Ixinity

Some side effects of coagulation factor ix may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Change in or loss of taste
• drowsiness
• feeling of warmth
• pain in the arms or legs
• redness of the face, neck, arms, and occasionally, the upper chest
• shaking

For Healthcare Professionals

Applies to coagulation factor ix: intravenous kit, intravenous powder for injection.

Hypersensitivity

Frequency not reported: Hypersensitivity (including bronchospastic reactions and/or hypotension, anaphylaxis, development of high-titer inhibitors necessitating alternative treatment)^[Ref]

Hematologic

Common (1% to 10%): Factor IX inhibition^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting^[Ref]

Dermatologic

Common (1% to 10%): Rash pruritic, hives^[Ref]

Local

Common (1% to 10%): Injection site discomfort, injection site pain^[Ref]

Nervous system

Common (1% to 10%): Headache, dysgeusia, lethargy, dizziness, shaking, drowsiness^[Ref]

Respiratory

Common (1% to 10%): Dry cough, hypoxia, chest tightness, dyspnea^[Ref]

Renal

The renal infarct occurred in a hepatitis C antibody positive patients 12 days after treatment of a bleeding episode; the relation of the infarct to the prior administration of this drug is uncertain.^[Ref]

Common (1% to 10%): Renal infarct^[Ref]

Ocular

Common (1% to 10%): Blurred vision^[Ref]

Immunologic

Common (1% to 10%): Influenza, cellulitis at injection site, phlebitis at injection site^[Ref]

Psychiatric

Common (1% to 10%): Apathy, depression^[Ref]

Other

Common (1% to 10%): Hemophilia (lack of efficacy), asthenia, fever, chills^[Ref]

Cardiovascular

Common (1% to 10%): Flushing^[Ref]