NovoThirteen: Uses, Dosage & Side Effects
Catridecacog - Recombinant human coagulation Factor XIII A-subunit for congenital FXIII deficiency
NovoThirteen (international nonproprietary name: catridecacog) is a recombinant form of the A-subunit of human coagulation Factor XIII (FXIII), indicated for the long-term prophylactic treatment of bleeding in adults and children with congenital FXIII A-subunit deficiency - a rare, inherited bleeding disorder. Produced in yeast cells (Saccharomyces cerevisiae), catridecacog replaces the missing A-subunit that is essential for fibrin clot stabilization. In the United States the same medicine is marketed under the brand name TRETTEN.
Administered as a once-monthly intravenous injection at a dose of 35 IU/kg body weight, NovoThirteen dramatically reduces the risk of spontaneous bleeding - including potentially fatal intracranial hemorrhage - in patients whose congenital FXIII activity is typically less than 5% of normal. It carries orphan drug designation from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Quick Facts
- Active Ingredient
- Catridecacog (recombinant FXIII A-subunit)
- Drug Class
- Antihemorrhagic - Blood coagulation factor
- ATC Code
- B02BD11
- Primary Use
- Prophylaxis in congenital FXIII A-subunit deficiency
- Available Form
- Powder & solvent for IV injection, 2,500 IU
- Prescription Status
- Prescription only (Rx), orphan drug
What Is NovoThirteen and What Is It Used For?
Quick answer: NovoThirteen is a prescription-only recombinant Factor XIII replacement therapy used for long-term prevention of bleeding in people with congenital Factor XIII A-subunit deficiency, one of the rarest inherited bleeding disorders.
NovoThirteen contains the active substance catridecacog, a recombinant version of the A-subunit of human blood coagulation Factor XIII. It is manufactured by Novo Nordisk using genetically modified yeast cells (Saccharomyces cerevisiae), which produce a protein structurally and functionally identical to the human FXIII A-subunit. NovoThirteen was granted marketing authorization in the European Union in September 2012 and by the U.S. Food and Drug Administration in December 2013 (as TRETTEN), with orphan drug designation due to the extreme rarity of the disease it treats.
Factor XIII, also known as fibrin-stabilizing factor, is the final enzyme in the coagulation cascade. It circulates in plasma as a heterotetramer composed of two catalytic A-subunits and two carrier B-subunits (A2B2). When a clot forms, thrombin converts Factor XIII into its active form, FXIIIa, which covalently cross-links fibrin strands and binds alpha-2-antiplasmin into the clot. This cross-linking transforms a fragile fibrin mesh into a mechanically robust, fibrinolysis-resistant clot that can hold until healing occurs.
In congenital FXIII A-subunit deficiency (ICD-10: D68.2), patients inherit two defective copies of the F13A1 gene and cannot synthesize functional FXIII A-subunits. Their baseline FXIII activity is typically below 1-5% of normal. Although the initial clot forms, it is mechanically unstable and breaks down prematurely - resulting in delayed bleeding hours to days after injury. Without treatment, patients face life-threatening risks, including umbilical cord bleeding in newborns, intracranial hemorrhage (lifetime risk up to 30%), poor wound healing, and near-universal miscarriage in women.
NovoThirteen is indicated specifically for long-term prophylactic treatment - regular scheduled infusions that raise FXIII activity above 10% of normal - to prevent these bleeding events before they occur. It is not intended for on-demand treatment of active bleeds, where plasma-derived FXIII concentrates, fresh frozen plasma, or cryoprecipitate are typically used. Because NovoThirteen replaces only the A-subunit, it is not effective in the much rarer form of FXIII deficiency caused by B-subunit mutations, nor in acquired FXIII deficiency (for example, autoantibody-mediated or consumption states).
Congenital FXIII deficiency is estimated to occur in approximately 1 in 2-3 million people worldwide, with regional clusters (for example, in regions of Iran and southern Italy) where consanguinity is more common. Before recombinant and plasma-derived therapies, median survival into adulthood was severely compromised; with modern monthly prophylaxis, life expectancy now approaches that of the general population.
What Should You Know Before Taking NovoThirteen?
Quick answer: NovoThirteen must be prescribed and supervised by a physician specializing in bleeding disorders. It is contraindicated in people with hypersensitivity to catridecacog, is not appropriate for FXIII B-subunit deficiency, and requires careful monitoring in patients with prior thromboembolic events, liver disease, or during pregnancy.
Contraindications
NovoThirteen must not be used in the following situations:
- Known hypersensitivity to catridecacog or to any of the excipients listed in the product leaflet (sodium chloride, sucrose, polysorbate 20, L-histidine, sodium hydroxide, and hydrochloric acid for pH adjustment).
- Congenital FXIII B-subunit deficiency - these patients lack the carrier B-subunit, so replacing A-subunit alone will not restore normal FXIII function.
- Active thromboembolic disease, including deep vein thrombosis, pulmonary embolism, or recent arterial thrombosis. In these scenarios, additional FXIII activity may worsen clot formation.
Warnings and Precautions
Several important safety considerations apply to all patients receiving NovoThirteen:
Hypersensitivity reactions. As with any biologic protein therapy, allergic and anaphylactic reactions are possible. The first several infusions should be given where resuscitation equipment is immediately available. Symptoms such as urticaria, angioedema, wheeze, chest tightness, rapid heartbeat, or dizziness during or shortly after infusion should prompt immediate discontinuation and emergency treatment.
Inhibitor (neutralizing antibody) development. A small proportion of patients may develop antibodies that bind or neutralize catridecacog, reducing its effectiveness. Patients whose bleeding pattern worsens despite regular prophylaxis, or who fail to achieve expected FXIII activity trough levels, should be screened for inhibitors at a specialist laboratory. Non-neutralizing anti-catridecacog antibodies have been reported in clinical trials without loss of efficacy, but should be monitored.
Thromboembolism. Because FXIII stabilizes clots, excessive replacement or use in patients with underlying prothrombotic risk (major surgery, immobilization, active cancer, inherited thrombophilia, hormonal therapy) may theoretically increase thrombotic risk. The monthly dosing schedule is designed to avoid supra-physiological FXIII levels.
Infusion-related adverse effects. NovoThirteen should be injected slowly (typically 1-2 mL per minute). Injection-site pain, transient lightheadedness, or flushing can occur if given too rapidly.
Hepatic and renal impairment. Formal studies in patients with severe liver or kidney disease are limited. Since catridecacog is cleared by catabolism rather than renal or hepatic metabolism, dose adjustments are generally not required, but clinical monitoring is recommended.
Pregnancy and Breastfeeding
Pregnancy is a particularly high-risk situation in congenital FXIII deficiency: nearly all untreated pregnancies end in first-trimester miscarriage due to failure of placental fibrin stabilization. Without replacement therapy, placental abruption, antepartum bleeding, and severe postpartum hemorrhage are also common. Therefore, FXIII replacement is not only permitted but considered essential throughout pregnancy in women with congenital FXIII deficiency.
Formal data on catridecacog in human pregnancy are limited; however, international consensus guidelines (ISTH, WFH, EHTSB) recommend continuing FXIII replacement, often with increased frequency (every 1-2 weeks) and dose adjustments during the third trimester, in coordination with a multidisciplinary hemostasis and maternal-fetal medicine team. Target trough FXIII activity is typically higher (>20-30%) during pregnancy, especially around delivery.
Breastfeeding is considered compatible with NovoThirteen therapy. FXIII is a large protein unlikely to pass into breast milk or to be absorbed by the infant gastrointestinal tract in active form.
Driving and Using Machines
NovoThirteen has no known effect on the ability to drive or use machines. However, patients experiencing infusion-related headache or lightheadedness should wait until those symptoms resolve before operating vehicles or machinery.
How Does NovoThirteen Interact with Other Drugs?
Quick answer: No formal drug-drug interaction studies have been conducted with NovoThirteen, but clinically relevant interactions may occur with antifibrinolytic agents, other coagulation factors, and hormonal contraceptives. Always inform your hematologist of every medication you take.
As a recombinant protein that acts directly in the coagulation cascade, catridecacog is not metabolized by cytochrome P450 enzymes and does not affect drug transporters. Conventional small-molecule pharmacokinetic interactions are therefore unlikely. The relevant interactions are pharmacodynamic - involving the balance between clot formation and breakdown.
Major Interactions
| Interacting Drug / Class | Nature of Interaction | Clinical Recommendation |
|---|---|---|
| Tranexamic acid, aminocaproic acid (antifibrinolytics) | Both stabilize clots; combined use may increase thrombotic risk | Use together only when clearly needed (e.g., major surgery, dental extraction); specialist supervision required |
| Other coagulation factor concentrates (FVIII, FIX, prothrombin complex) | Additive procoagulant effect | Coordinate dosing with the hemostasis team; avoid unnecessary overlap |
| Fresh frozen plasma or cryoprecipitate (alternative FXIII sources) | Risk of FXIII over-replacement | Do not combine for routine prophylaxis; measure FXIII activity before additional doses |
Minor or Theoretical Interactions
| Interacting Drug / Class | Nature of Interaction | Clinical Recommendation |
|---|---|---|
| Combined hormonal contraceptives, estrogens | Modestly increase baseline thrombotic risk | Weigh contraceptive benefits against thrombotic risk with a hematologist |
| Anticoagulants (warfarin, DOACs, heparin, LMWH) | Opposing pharmacodynamics; may reduce prophylactic benefit | Only combine under specialist guidance when anticoagulation is unavoidable |
| NSAIDs, aspirin, other antiplatelets | Increase bleeding risk by impairing platelet function | Avoid routine use; paracetamol (acetaminophen) is preferred for pain or fever |
| Live vaccines | No direct interaction; but IM injection site bleeding is a risk | Administer vaccines by subcutaneous route where possible, or after a prophylactic dose |
What Is the Correct Dosage of NovoThirteen?
Quick answer: The standard dose of NovoThirteen is 35 IU per kilogram of body weight, given as a slow intravenous injection once every 28 days. Dosing is the same on a per-kilogram basis for adults and children.
NovoThirteen is supplied as a powder (2,500 IU per vial) and a separate vial of sterile water for injection. After reconstitution, each vial contains approximately 2,500 IU/3.2 mL (about 781 IU/mL). The reconstituted solution should appear clear and colorless; do not use if cloudy or discolored.
| Patient Group | Dose | Frequency | Comments |
|---|---|---|---|
| Adults (≥18 years) | 35 IU/kg body weight | Once every 28 days | Round to nearest full vial (2,500 IU); adjust to maintain trough FXIII activity >10% |
| Children (all ages, including infants) | 35 IU/kg body weight | Once every 28 days | Weight-based dosing; clearance is slightly higher in young children - trough level monitoring advised |
| Elderly (≥65 years) | 35 IU/kg body weight | Once every 28 days | No dose adjustment; monitor for thrombotic risk factors (atrial fibrillation, cardiovascular disease) |
| Pregnancy | 35-50 IU/kg (individualized) | Every 7-14 days, often intensified near term | Specialist-led; higher troughs (>20-30%) targeted to prevent placental abruption |
| Peri-operative cover | Single top-up if >7 days since last dose | Before surgery; repeat based on bleeding risk | Aim for FXIII activity >30-50% at time of incision |
Adults
Standard adult prophylaxis
Dose: 35 IU/kg body weight (rounded to nearest vial).
Schedule: One intravenous injection every 28 days - ideally on the same day of each monthly cycle to maintain steady-state trough levels.
Administration: Inject slowly (1-2 mL/min) through a peripheral vein after reconstitution with the supplied diluent. Do not mix with any other medication or infusion solution.
Children
Pediatric prophylaxis (birth to 17 years)
Dose: 35 IU/kg body weight - identical to adult per-kg dose.
Schedule: Once every 28 days. Because children (especially under 6 years) may have faster catridecacog clearance, trough FXIII activity should be measured after 3-4 doses and the regimen adjusted if levels fall below 10%.
Starting therapy: Ideally initiated in early infancy once diagnosis is confirmed, to prevent early-life intracranial bleeding, which has peak incidence in the first year of life.
Elderly
Patients 65 years and older
No separate dose reduction is needed. Because age-related cardiovascular comorbidities (atrial fibrillation, coronary artery disease, prior stroke) may increase the background risk of thromboembolism, careful individual assessment of thrombotic risk factors is recommended before and during treatment.
Missed Dose
If a scheduled dose is missed
If the patient misses the planned 28-day infusion, the missed dose should be administered as soon as possible. The next dose should then be scheduled 28 days from the date of the catch-up infusion (not from the original scheduled date).
Do not double the dose to compensate for a missed injection. If more than 6 weeks have passed since the last dose, contact your hemophilia or rare-bleeding-disorder treatment center for advice and possible FXIII activity measurement before resuming.
Overdose
Overdose: Accidental administration of more than the recommended dose has not been associated with specific toxic effects in clinical trials, but theoretically may increase thrombotic risk. There is no specific antidote. In the event of suspected overdose, the patient should be observed for signs of thrombosis (leg swelling, chest pain, shortness of breath, sudden neurological changes) and managed supportively. Contact a poison control center or emergency services.
What Are the Side Effects of NovoThirteen?
Quick answer: In clinical trials most patients tolerated NovoThirteen well. The most common side effects were headache, limb pain, injection-site pain, and elevated fibrin degradation products. Serious side effects such as allergic reactions and thromboembolism are rare.
Side-effect frequency categories below follow the Council for International Organizations of Medical Sciences (CIOMS) convention used in European product information: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (<1/1,000), and very rare (<1/10,000).
Very Common Side Effects
Frequency: more than 1 in 10 patients (≥10%)- Headache
Common Side Effects
Frequency: 1 in 100 to 1 in 10 patients (1-10%)- Pain in extremities (arms or legs)
- Pain or reaction at the injection site
- Elevated fibrin D-dimer (a laboratory finding, not necessarily symptomatic)
- Non-neutralizing anti-catridecacog antibodies (monitored by lab testing)
- Fatigue or tiredness on the day of infusion
Uncommon Side Effects
Frequency: 1 in 1,000 to 1 in 100 patients (0.1-1%)- Nausea
- Muscle pain (myalgia)
- Fever (pyrexia)
- Rash or pruritus (itching)
- Mild hypersensitivity reactions (flushing, mild wheeze)
Rare Side Effects
Frequency: fewer than 1 in 1,000 patients (<0.1%)- Anaphylaxis or severe allergic reaction
- Neutralizing antibodies (inhibitors) against catridecacog
- Thromboembolic events (deep vein thrombosis, pulmonary embolism)
- Elevated liver enzymes
Because congenital FXIII deficiency is so rare, clinical trial populations are small (the pivotal Mentor 2 study enrolled 77 patients followed for a median of 2 years). Rare or long-term effects may only emerge from post-marketing surveillance registries such as the PASS (Post-Authorisation Safety Study) program coordinated with Novo Nordisk and the European Haemophilia Safety Surveillance (EUHASS).
When to seek urgent medical attention: Stop the injection and seek immediate help for sudden swelling of the face or throat, difficulty breathing, chest pain, severe rash or hives, fainting, one-sided weakness or speech changes, sudden severe headache, or painful swelling of a leg. These may indicate anaphylaxis or a thromboembolic event.
Reporting Suspected Side Effects
Reporting suspected adverse reactions after authorization is important to continually monitor the benefit/risk balance. Patients and healthcare professionals are encouraged to report side effects to their national pharmacovigilance system - for example, the MHRA Yellow Card Scheme (UK), the FDA MedWatch program (US), or the national competent authority in EU member states.
How Should You Store NovoThirteen?
Quick answer: Store unopened NovoThirteen vials refrigerated at 2-8 °C (36-46 °F) in the original carton, protected from light. Do not freeze. After reconstitution, use within 3 hours at room temperature.
Because catridecacog is a therapeutic protein, correct storage is essential to preserve activity and patient safety. Improperly stored vials can lose potency or become contaminated.
- Unopened vials: Keep refrigerated at 2-8 °C (36-46 °F) in the original carton. Do not expose to direct light. Do not freeze - freezing damages the protein structure and causes loss of activity.
- Room-temperature tolerance: Before reconstitution, vials may be stored at up to 25 °C (77 °F) for a single continuous period of up to 6 months, but must not be returned to the refrigerator after this and should be used within the shelf-life printed on the carton.
- After reconstitution: Use the reconstituted solution within 3 hours. Do not refrigerate or freeze the reconstituted solution - precipitation may occur.
- Travel: For transport, use an insulated container with ice packs but prevent direct contact between the vial and the ice pack to avoid freezing. Airport security guidelines generally permit medical medications with a letter from the treating physician.
- Disposal: Any unused product or waste material (used vials, syringes, needles) should be discarded according to local regulations - typically in a sharps container returned to the pharmacy or hospital.
- Keep out of reach of children (although the product itself requires trained administration).
Do not use NovoThirteen after the expiry date (EXP) printed on the label and carton. The expiry date refers to the last day of the stated month. Do not use if the vial seal is broken, if particulate matter is visible after reconstitution, or if the solution is cloudy or discolored.
What Does NovoThirteen Contain?
Quick answer: Each vial contains 2,500 IU of catridecacog (recombinant FXIII A-subunit) as the active ingredient, plus sodium chloride, sucrose, polysorbate 20, L-histidine, and pH adjusters. The diluent is sterile water for injection.
Active Ingredient
- Catridecacog 2,500 IU per vial - a recombinant human Factor XIII A-subunit produced in Saccharomyces cerevisiae yeast cells. After reconstitution with the supplied solvent, the concentration is approximately 781 IU/mL.
Excipients (Inactive Ingredients) - Powder
- Sodium chloride (osmolality regulator)
- Sucrose (stabilizer)
- Polysorbate 20 (surfactant, prevents protein aggregation)
- L-histidine (buffer)
- Sodium hydroxide and hydrochloric acid (for pH adjustment)
Solvent
- Sterile water for injections (3.2 mL per vial of diluent)
NovoThirteen is latex-free and does not contain any human or animal-derived plasma components, which eliminates the theoretical risk of transmitting blood-borne pathogens associated with plasma-derived FXIII concentrates. Patients with yeast allergy should discuss the risks with their hematologist, although the final product contains only trace yeast residue that is well below levels likely to cause reactions.
Marketing Authorization Holder and Manufacturer
NovoThirteen is developed, manufactured, and marketed by Novo Nordisk A/S (Bagsvaerd, Denmark). In the United States the identical product is marketed under the brand name TRETTEN. It holds orphan drug designation from the EMA (EU/3/04/213) and FDA, which supports continued availability despite the very small global patient population.
Frequently Asked Questions About NovoThirteen
What is NovoThirteen used for?
NovoThirteen (catridecacog) is a prescription recombinant coagulation Factor XIII used for long-term prophylactic treatment of bleeding in patients with congenital Factor XIII A-subunit deficiency, a very rare inherited bleeding disorder. It replaces the missing FXIII A-subunit and restores the body's ability to stabilize blood clots, preventing spontaneous bleeding episodes including potentially life-threatening intracranial hemorrhage.
How is NovoThirteen administered?
NovoThirteen is given as a slow intravenous (IV) injection, typically over 1 to 2 minutes. The standard dose is 35 IU/kg body weight administered once every 28 days. It must be reconstituted with the supplied sterile water for injection immediately before use and administered by a healthcare professional or by a trained patient or caregiver under specialist supervision in a home-treatment program.
Who should not use NovoThirteen?
NovoThirteen should not be used by patients with known hypersensitivity to catridecacog or any excipient in the formulation. It is not indicated for treatment of congenital FXIII B-subunit deficiency - only A-subunit deficiency - and is not effective as treatment for acquired FXIII deficiency. It must be used with caution in patients with a history of thromboembolic events or active thrombotic disease.
What are the most common side effects of NovoThirteen?
The most commonly reported side effects (occurring in at least 1% of patients) include headache, pain in the extremities (arms or legs), pain at the injection site, and increased levels of fibrin degradation products in the blood. Development of non-neutralizing anti-catridecacog antibodies is uncommon but has been reported. Serious allergic reactions and thromboembolic events are rare but require immediate medical attention.
Is NovoThirteen safe during pregnancy?
There are limited data on the use of NovoThirteen during pregnancy and breastfeeding. Because congenital FXIII deficiency carries a very high risk of miscarriage, placental abruption, and severe postpartum hemorrhage without replacement therapy, the benefits of continuing FXIII replacement during pregnancy typically outweigh the theoretical risks. Pregnancy in women with congenital FXIII deficiency should be managed by a specialist hemophilia or rare-bleeding-disorder treatment center with an individualized dosing regimen.
How should NovoThirteen be stored?
Unreconstituted NovoThirteen vials should be stored in a refrigerator at 2 to 8 °C (36 to 46 °F) in the original carton, protected from light, and must not be frozen. Before reconstitution the product may be stored at room temperature up to 25 °C (77 °F) for a single period of up to 6 months, within its shelf life. After reconstitution the solution must be used within 3 hours and should not be refrigerated or frozen.
Can children use NovoThirteen?
Yes. NovoThirteen is approved for use in adults and children of all ages, including infants, for long-term prophylactic treatment of congenital FXIII A-subunit deficiency. The dose in children is weight-based (35 IU/kg once monthly), identical to the adult dose on a per-kilogram basis. Early initiation in childhood is important because intracranial bleeding in untreated FXIII deficiency often occurs within the first year of life.
Is NovoThirteen the same as TRETTEN?
Yes. NovoThirteen and TRETTEN are the same medicine - recombinant human coagulation Factor XIII A-subunit (catridecacog) manufactured by Novo Nordisk. NovoThirteen is the brand name in Europe and most other markets, while TRETTEN is the brand name used in the United States and Canada. The active ingredient, dosage, administration, and safety profile are identical.
Can I administer NovoThirteen at home?
Yes, home administration is possible and is often preferred once the patient or a caregiver has received structured training from a specialist hemophilia or rare-bleeding-disorder treatment center. Training covers reconstitution, venipuncture, sterile technique, recognition of adverse reactions, emergency procedures, and treatment logging. Regular follow-up at the treatment center remains essential.
References
- European Medicines Agency (EMA). NovoThirteen (catridecacog) - Summary of Product Characteristics (SmPC). EMA/CHMP/457863/2012. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). TRETTEN (Coagulation Factor XIII A-Subunit [Recombinant]) - Full Prescribing Information. BLA 125526.
- Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D. Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012;119(22):5111-5117. doi:10.1182/blood-2011-10-386045
- Kerlin BA, Inbal A, Puetz J, et al. Recombinant factor XIII replacement in patients with congenital factor XIII A-subunit deficiency: a phase 3 trial (Mentor 2). J Thromb Haemost. 2014;12(1):1969-1977.
- Menegatti M, Peyvandi F. Factor XIII deficiency: a review of clinical features, laboratory features and management. Br J Haematol. 2016;175(1):12-23.
- World Federation of Hemophilia (WFH). Guidelines for the Management of Rare Bleeding Disorders. 3rd ed. Montreal: WFH; 2023.
- International Society on Thrombosis and Haemostasis (ISTH). Scientific and Standardization Committee Communication: Classification and Management of Factor XIII Deficiency. J Thromb Haemost. 2011;9:1404-1406.
- Carcao M, Fukutake K, Inbal A, et al. Developing the first recombinant factor XIII for congenital factor XIII deficiency: clinical challenges and successes. Semin Thromb Hemost. 2017;43(1):59-68.
- Peyvandi F, Palla R, Menegatti M, et al. Coagulation factor activity and clinical bleeding severity in rare bleeding disorders: results from the European Network of Rare Bleeding Disorders. J Thromb Haemost. 2012;10(4):615-621.
- World Health Organization (WHO). Genes and Human Diseases: Monogenic Diseases - Hemophilia and Other Inherited Bleeding Disorders. Geneva: WHO; updated 2024.
- Orphanet. Congenital Factor XIII Deficiency (ORPHA:331). Available at: www.orpha.net
- British National Formulary (BNF). Catridecacog. London: BMJ Group and Royal Pharmaceutical Society; updated 2025.
About Our Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, a panel of licensed physicians specializing in hematology, clinical pharmacology, and rare bleeding disorders. Every article is referenced against peer-reviewed literature and international guidelines from the World Health Organization (WHO), European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), International Society on Thrombosis and Haemostasis (ISTH), and the World Federation of Hemophilia (WFH).
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Medical Disclaimer: This article is for educational purposes only and does not replace professional medical advice, diagnosis, or treatment. NovoThirteen must only be prescribed and administered under the supervision of a physician experienced in the treatment of congenital bleeding disorders. Always follow the specific instructions given by your hematologist and the product-specific patient information leaflet.