Factor XIII Concentrate (Human)

• It is used to treat or prevent bleeding.

• Store in a refrigerator. Do not freeze.
• Store in original container.
• Protect from light.
• If needed, you may store at room temperature.
• If stored at room temperature, throw this medicine away after 6 months.
• If stored at room temperature, make a note of the date it was placed at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Prophylaxis against bleeding episodes and management of perioperative surgical bleeding in patients with congenital factor XIII deficiency

There are no dosage adjustments provided in the manufacturer’s labeling.

Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. May be stored at room temperature (≤25°C [≤77°F]) for up to 6 months; do not return to refrigerator if stored at room temperature.

Concerns related to adverse effects:

• Antibody formation: The development of factor XIII inhibitory antibodies has been reported. Factor XIII inhibitory antibodies should be measured when clinical response (breakthrough bleeding) and/or factor XIII trough levels are suboptimal after apparent adequate dosing.

• Hypersensitivity reactions: Hypersensitivity and anaphylactic reactions have been reported with use; discontinue immediately if develops and initiate appropriate management.

• Thrombotic events: Thromboembolic events have been reported; pregnant women may be at increased risk due to hypercoagulable state. Use with caution in patients with known risk factors for thrombosis.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer. Vaccination with hepatitis A and hepatitis B vaccines is recommended.

Factor XIII trough levels in conjunction with clinical response to assess efficacy (ie, approximately every 28 days for prophylaxis, during and after surgery for perioperative management of surgical bleeding). Factor XIII inhibitory antibodies if inadequate clinical response and/or factor XIII trough levels are suboptimal. Signs/symptoms of hypersensitivity reactions, thrombotic events, and infection.

Use in pregnant women only when benefit exceeds potential risk to the fetus. Thromboembolic events have been reported with use of factor XIII; pregnant women may be at increased risk due to hypercoagulable state.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, joint pain, or chills. Have patient report immediately to prescriber signs of infection, signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), shortness of breath, angina, coughing up blood, severe dizziness, passing out, tachycardia, mouth discoloration, abdominal edema, abdominal pain, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.