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Tretten

factor XIII A-subunit recombinant
Used for Hemophilia
Used for Hemophilia

Tretten (factor XIIIa) is a recombinant (lab-made) clotting factor replacement for factor XIII A-subunit. It's used to prevent bleeding in adults and children who are missing factor XIIIa. Tretten (factor XIIIa) is given as an injection into the veins (IV) once per month. Some side effects of this medication include headache and injection-site pain.

Reviewed by:
reviewer
Robert Chad Hakim, PharmD, BCCCP
reviewer
Allison Gourley, PharmD
Last reviewed on October 31, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageCostReferencesPricesMedicare
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What is Tretten (factor XIIIa)?

What is Tretten (factor XIIIa) used for?

  • Prevention of bleeding in people who are missing clotting factor XIII A-subunit in their blood

How Tretten (factor XIIIa) works

Your body makes different kinds of clotting factors that work together to help the blood clot whenever there's an injury. But some people have don't have enough clotting factors or their clotting factors don't work well, which raises their risk of bleeding that's difficult to stop.

Tretten (factor XIIIa) is a recombinant (lab-made version) clotting factor XIIIa. It lowers the risk of bleeding by replacing factor XIIIa in people who don't have enough of this clotting factor. Because it's made in a lab, it doesn't contain any human blood products.

There's another clotting factor XIII replacement called Corifact that's made from human blood products.

Drug Facts

Common BrandsTretten
Drug ClassCoagulation factor replacement
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Tretten (factor XIIIa)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Headache
  • Pain in arms or legs
  • Injection site pain

Other Side Effects

  • Allergic reaction

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious allergic reaction (anaphylaxis): difficulty breathing, hives, itching, fast heartbeat, tightness in the throat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
  • Blood clots: in the lungs (cough, difficulty breathing, chest pain); in the leg (redness, pain, tenderness, swelling of the skin); near the heart (chest pain, pain in the arms or shoulders, pain in the neck or jaw); in the brain (difficulty speaking, numbness on one side of the body, confusion)

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

  • Headache
  • Pain in the hands, arms, legs, or feet
  • Pain, redness, or irritation at injection site
pros-and-cons

Pros and cons of Tretten (factor XIIIa)

thumbs-up

Pros

Works well to raise factor XIII levels and lower number of bleeding episodes

Given once per month

Injections are quick, typically last less than 2 minutes

thumbs-down

Cons

Raises your risk for blood clots in veins

Might not work as well over time if you develop antibodies against the medication during treatment

No lower-cost generic available

pharmacist-tips

Pharmacist tips for Tretten (factor XIIIa)

pharmacist

  • Mark your appointments on your calendar to see your provider and receive Tretten (factor XIIIa). It's important to see your provider on time so you don't miss any doses and your treatment is monitored properly.

    • Let your provider know if you experience any bleeding that's difficult to stop while receiving Tretten (factor XIIIa). This can be a sign that the medication isn't working well for you. Your provider might need to order labs to check the level of factor XIII activity in you body.

      • Go to the emergency room right away if you experience symptoms of blood clots, including cough, difficulty breathing, chest pain, headache, trouble speaking, or weakness on one side of your body. Though rare, Tretten (factor XIIIa) products can raise your risk of blood clots.

        If receiving Tretten (factor XIIIa) at home:

        • Tretten (factor XIIIa) is typically given under the supervision of a provider who is trained and experienced in the treatment of rare bleeding conditions. Sometimes, it might be possible to receive Tretten (factor XIIIa) at home with the help of a home health nurse if your provider thinks it's appropriate.

          • If you're receiving Tretten (factor XIIIa) at home, make sure you know how to store the medication properly. It comes as a powder that needs to be mixed with the provided sterile water. Unopened Tretten (factor XIIIa) vials should be stored in the refrigerator in its original packaging away, from light.

            • Your nurse will prepare the Tretten (factor XIIIa) injection when you're ready to receive it. Once mixed, the medication can be stored in the refrigerator or at room temperature for up to 3 hours.

              • Tretten (factor XIIIa) is given as an injection into the veins. Never inject Tretten (factor XIIIa) into a muscle or under the skin.

                • After your injection, throw Tretten (factor XIIIa) vials, syringes, and needles in a sharps container or a heavy-duty plastic container (e.g., empty milk carton, laundry detergent bottle) to lower the risk of needle-stick injuries. Visit the FDA's website for guidance on how to throw away your sharps container safely in your specific state.

                  faqs

                  Frequently asked questions about Tretten (factor XIIIa)

                  What is factor XIII deficiency?
                  Factor XIII deficiency is a rare bleeding condition that's passed from parent to child. If you have factor XIII deficiency, you don't have enough of a clotting (or coagulation) factor called factor XIII. This clotting factor is one of many clotting factors your body needs to form blood clots in case of an injury. Without factor XIII, you're at higher risk for bleeding that's difficult to stop.
                  What does Factor XIII do?
                  Factor XIII is one of many clotting factors made by the body to help form clots in case of an injury. It helps to make the blood clot stronger so it works well to stop bleeding. People who don't have enough factor XIII are at higher risk of bleeding because the blood clots that form are weak and break apart easily. Tretten (factor XIIIa) is a lab-made version of factor XIIIa used to prevent bleeding in people who missing the A-subunit of factor XIII.
                  What year was Tretten (factor XIIIa) approved?
                  Tretten (factor XIIIa) was approved in 2013 for the prevention of bleeding in people who are missing clotting factor XIII A-subunit. It's not approved for those missing the B-subunit of factor XIII.
                  How is Tretten (factor XIIIa) given?
                  Tretten (factor XIIIa) is given as a quick injection into the veins that typically lasts less than 5 minutes. You usually receive Tretten (factor XIIIa) in a hospital or infusion clinic setting, under the supervision of a provider who's trained and experienced in rare bleeding conditions. Your provider will determine your dose of Tretten (factor XIIIa) based on your body weight. They might need to adjust your dose based on the level of factor XIII activity determined through blood tests.
                  How long do I need to be treated with Tretten (factor XIIIa)?
                  Talk with your provider about your Tretten (factor XIIIa) treatment plan. Since factor XIII deficiency is a genetic problem, you'll likely need treatment for the rest of your life. But, the length of time you'll need to use Tretten (factor XIIIa) specifically will depend on how serious your condition is, how well the medication is working for you, and if you're having side effects. You'll likely continue Tretten (factor XIIIa) as long as it's helping your condition and you're not having severe side effects. Otherwise, your provider might suggest other options to switch you to.
                  Can I take Tretten (factor XIIIa) if I'm pregnant or breastfeeding?
                  Tretten (factor XIIIa) hasn't been well studied in human pregnancy, so it's not known whether this medication is safe in pregnant females. Similarly, there is currently no information on the safety of breastfeeding while taking Tretten (factor XIIIa). If you're breastfeeding, pregnant, or thinking of becoming pregnant, talk with your provider about the risks and benefits of using Tretten (factor XIIIa) before starting this medication.
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                  What are the risks and warnings for Tretten (factor XIIIa)?

                  Tretten (factor XIIIa) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                  risk-warning

                  Serious allergic reactions

                  Allergic reactions to Tretten (factor XIIIa) are possible. These reactions can be serious or life-threatening like anaphylaxis (e.g., closing of the throat). This can happen anytime during or after an infusion. If you notice difficulty breathing, a choking sensation, dizziness, sweating, nausea, rash, or swelling around your eyes, lips, or tongue at any time during Tretten (factor XIIIa) treatment, get medical attention right away.

                  risk-warning

                  Risk of blood clots

                  • Risk factors: History of blood clot problems | High blood pressure | High cholesterol | High blood sugar | Cancer | Surgery | Taking estrogen-containing birth control | Not moving much or exercising | Tobacco use | Pregnancy

                    Taking Tretten (factor XIIIa) can raise your risk of getting blood clots in various parts of your body. While anyone can get a blood clot during treatment, there are certain factors that can put you at higher risk. Symptoms of a blood clot can be different depending on the location of the clot. They can include swelling, warmth, or tenderness in the legs. But more seriously, clots can lead to breathing problems, heart attack, or stroke and cause chest pain, difficulty breathing, or weakness of the face, legs, or arms. Call 911 if you have any of these symptoms, because this is a medical emergency.

                    risk-warning

                    Lack of response to Tretten (factor XIIIa)

                    It's possible for Tretten (factor XIIIa) to not work as well for you as you continue taking the medication. This is because as you continue therapy, your body might make antibodies against Tretten (factor XIIIa). These antibodies can block the medication from working and lower its ability to work well for you. Your provider will check your factor XIII levels through bloodwork while you take the medication. Let your provider know if you experience any breakthrough bleeding while taking Tretten (factor XIIIa).

                    dosage

                    Tretten (factor XIIIa) dosage forms

                    Typical dosing for Tretten (factor XIIIa)

                    Your provider will determine your dose of Tretten (factor XIIIa) based on your body weight. The dose of Tretten (factor XIIIa) is measured in international units (IU).

                    • The typical dose is 35 IU/kg of body weight injected into the vein once per month. Your provider will adjust your dose of Tretten (factor XIIIa) based on the level of factor XIII activity found through labs.

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                    References

                    Best studies we found

                    American Society of Hematology. (n.d.). Blood clots.

                    Bleedingdisorders.com. (n.d.). A quick look at bleeding disorders & coagulation. Takeda Pharmaceuticals U.S.A., Inc.

                    Centers for Disease Control and Prevention. (2023). Treatment of hemophilia.

                    View All References (12)

                    Centers for Disease Control and Prevention. (2023). What is venous thromboembolism?

                    CSL Behring GmbH. (2020). Corifact(factor xiii concentrate- human kit [package insert]. DailyMed.

                    Malkhassian, D. et al. (2023). Physiology, Factor XIII. StatPearls.

                    Mangla, A., et al. (2022). Factor XIII deficiency. StatPearls.

                    National Bleeding Disorders Foundation. (n.d.). Factor XIII.

                    National Human Genome Research Institute. (2024). ​Antibody.

                    National Organization for Rare Disorders. (2022). Factor XIII deficiency.

                    Novo Nordisk, Inc. (n.d.). Proven efficacy and safety profile.

                    Novo Nordisk, Inc. (n.d.). The only recombinant therapy for congenital factor XIII (FXIII) A-subunit deficiency.

                    Novo Nordisk. (2020). Tretten (coagulation factor xiii a-subunit- recombinant kit [package insert]. DailyMed.

                    Reuters. (2013). U.S. FDA approves Novo Nordisk's drug for rare blood clotting disorder.

                    U.S. Food and Drug Administration. (2021). Safely using sharps (needles and syringes) at home, at work and on travel.

                    GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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