Applies to factor ix complex: intravenous powder for injection.

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

Stop using this medicine and call your doctor at once if you have:

• sweating and feeling short of breath;

• a light-headed feeling, like you might pass out;

• easy bruising, increased bleeding episodes;

• bleeding from a wound or where the medicine was injected;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• headache;

• flushing (warmth, redness, or tingly feeling);

• nausea, vomiting;

• fever, chills; or

• lack of energy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to factor ix complex: intravenous powder for injection.

General

Adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, urticaria, and manifestations of allergic reactions.^[Ref]

Cardiovascular

Frequency not reported: Flushing, hypotension

Postmarketing reports: Thrombosis, deep vein thrombosis, tachycardia^[Ref]

Immunologic

Frequency not reported: Allergic reaction

Postmarketing reports: Hypersensitivity reaction, inhibitor antibody development, anaphylactic/anaphylactoid reaction^[Ref]

Respiratory

Postmarketing reports: Pulmonary embolism, shortness of breath, dyspnea, bronchospasm, wheezing, cough^[Ref]

Dermatologic

Frequency not reported: Urticaria, erythema

Postmarketing reports: Diaphoresis, angioedema, rash, pruritus^[Ref]

Hematologic

Postmarketing reports: Disseminated intravascular coagulation^[Ref]

Nervous system

Frequency not reported: Headache, tingling, lethargy, dizziness

Postmarketing reports: Thrombotic stroke^[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting

Postmarketing reports: Abdominal pain^[Ref]

Other

Frequency not reported: Fever, chills

Postmarketing reports: Facial edema^[Ref]

Renal

Postmarketing reports: Nephrotic syndrome (following attempted immune tolerance induction)

Local

Postmarketing reports: Infusion site reactions, infusion site pain