Factor XIII A-Subunit (Recombinant)

Absorption

Duration

After IV administration of 35 units/kg, plasma factor XIII activity increases to adequate levels and normal clot solubility is restored for approximately 28–30 days.7 35 36 37

Plasma Concentrations

After IV administration, plasma concentrations increase in dose-dependent manner.7

Distribution

Extent

Remains principally within intravascular space.7 35

Not known whether distributed into human milk.1

Elimination

Half-life

Approximately 5–15 days.1 35 36 37

Storage

Parenteral

2–8°C; avoid freezing.1 Protect from light.1

Reconstituted solutions: May store in refrigerator or at room temperature (≤25°C) for up to 3 hours after reconstitution.1

• If you have an allergy to Factor XIII or any other part of factor XIII A-subunit (recombinant).
• 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.
• If you are getting Factor VIIa.

This is not a list of all drugs or health problems that interact with this medicine.

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 XIII A-subunit with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Blood clots have happened with factor XIII A-subunit. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• Call the doctor right away if the normal dose does not work as well.
• Talk with the doctor before you travel. You will need to bring enough of this medicine for use during travel.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using factor XIII A-subunit while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Pain in arms or legs.
• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Tretten

Administer IV only at a rate not exceeding 1-2 mL/minute. Do not administer with other infusion solutions. Do not administer as drip.

Factor VIIa (Recombinant): Factor XIII A-Subunit (Recombinant) may enhance the thrombogenic effect of Factor VIIa (Recombinant). Monitor therapy

• 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, leg pain, arm pain, or injection site irritation. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), shortness of breath, dizziness, passing out, angina, coughing up blood, 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.