Factor X (Human)

1-10%

Infusion site erythema (5.6%)

Fatigue (5.6%)

Back pain (5.6%)

Infusion site pain (5.6%)

Contraindications

Documented life-threatening hypersensitivity to factor X, human or its components

Cautions

Allergic-type hypersensitivity reactions may occur (eg, anaphylaxis, angioedema, infusion site inflammation, chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing); discontinue product immediately and administer appropriate emergency treatment

Formation of neutralizing antibodies (inhibitors) to factor X may occur; if expected factor X activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor X inhibitor concentration

Transmission of infectious agents may occur; the product is derived from human blood, and despite measures to screen and inactivate/remove certain viruses, it may carry risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent)

Monitor plasma factor X activity and monitor for factor X inhibitors

Caution when coadministered with other plasma products that may contain factor X (eg, fresh frozen plasma, prothrombin complex concentrates)

Based on the mechanism of action, factor X, human is likely to be counteracted by direct and indirect factor Xa inhibitors (eg, apixaban, edoxaban, dabigatran)

• If you have an allergy to factor X (human) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take factor X with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about factor X, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about factor X. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using factor X (human).

Review Date: October 4, 2017

(FAK ter ten HYU man)

• Coagulation Factor X
• Stuart-Prower Factor

Life-threatening hypersensitivity reactions to factor X (human) or any component of the formulation

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Store intact vials at 2°C to 30°C (36°F to 86°F); do not freeze. Protect from light. After reconstitution, use within 1 hour.