Immunine

Human Coagulation Factor IX Concentrate for Hemophilia B

Rx – Prescription Only ATC: B02BD04 Blood Coagulation Factor
Active Ingredient
Human coagulation factor IX
Available Forms
Powder & solvent for injection/infusion
Strengths
600 IU, 1200 IU
Manufacturer
Takeda (Baxalta Innovations GmbH)
Medically reviewed | Last reviewed: | Evidence level: 1A
Immunine is a plasma-derived coagulation factor IX concentrate used to treat and prevent bleeding episodes in patients with hemophilia B (Christmas disease). It replaces the missing or dysfunctional factor IX, temporarily correcting the coagulation defect and reducing bleeding tendency. Immunine is administered by slow intravenous injection or infusion and is approved for patients aged 6 years and older.
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Quick Facts About Immunine

Active Ingredient
Factor IX
Human coagulation factor IX
Drug Class
Coag. Factor
Blood Coagulation Factor
ATC Code
B02BD04
Factor IX, human
Primary Use
Hemophilia B
Bleeding treatment & prophylaxis
Available Forms
IV Powder
600 IU and 1200 IU
Prescription Status
Rx Only
Prescription required

Key Takeaways About Immunine

  • Targeted hemophilia B treatment: Immunine replaces deficient factor IX in patients with congenital hemophilia B, both for on-demand treatment of bleeding episodes and as long-term prophylaxis
  • Intravenous administration only: Must be reconstituted with the supplied sterile water and administered slowly intravenously at no more than 2 mL per minute, using only the supplied infusion set
  • Monitor for inhibitors: Patients may develop factor IX inhibitors (antibodies) that reduce treatment effectiveness; persistent bleeding despite adequate dosing should be reported immediately
  • Anaphylaxis risk: Severe allergic reactions are possible, especially in patients with factor IX inhibitors; stop the infusion immediately if any signs of allergic reaction occur
  • Plasma-derived product: Manufactured from human plasma with viral inactivation steps; hepatitis A and B vaccination is recommended for patients receiving regular treatment

What Is Immunine and What Is It Used For?

Immunine is a coagulation factor IX concentrate derived from human plasma. It is used to treat and prevent (prophylaxis) bleeding episodes in patients with congenital hemophilia B (Christmas disease), a hereditary bleeding disorder caused by deficient or dysfunctional factor IX.

Hemophilia B, also known as Christmas disease, is an X-linked hereditary bleeding disorder that results from reduced levels or impaired function of coagulation factor IX. Factor IX is an essential component of the intrinsic coagulation pathway, and its deficiency leads to a significantly increased bleeding tendency. Patients with hemophilia B can experience severe bleeding into joints (hemarthrosis), muscles, and internal organs, either spontaneously or following trauma, surgery, or dental procedures.

Immunine provides exogenous human coagulation factor IX that temporarily replaces the missing or dysfunctional endogenous factor. When administered intravenously, it restores the patient's factor IX activity level toward normal, correcting the coagulation defect and reducing the bleeding tendency. The degree and duration of correction depend on the dose administered, the severity of the factor IX deficiency, and the individual patient's pharmacokinetic response.

According to the World Federation of Hemophilia (WFH) guidelines, factor IX replacement therapy is the cornerstone of hemophilia B management. Treatment can be given as on-demand therapy to treat active bleeding episodes, or as regular prophylaxis to prevent bleeding before it occurs. Prophylactic treatment has been shown to reduce the frequency of spontaneous joint bleeds, prevent the progressive joint damage (hemophilic arthropathy) that is a major cause of disability in hemophilia patients, and improve quality of life.

Immunine is approved for use in patients from 6 years of age through to adulthood. There is currently insufficient clinical data to recommend its use in children younger than 6 years. For this younger age group, alternative factor IX products with established pediatric data should be considered in consultation with a specialist hematologist.

Good to know:

Hemophilia B affects approximately 1 in 25,000 to 30,000 male births worldwide. It accounts for roughly 15–20% of all hemophilia cases, with hemophilia A (factor VIII deficiency) being more common. Despite being rarer, hemophilia B is managed using the same fundamental principles of factor replacement therapy, and patients benefit from treatment at specialized hemophilia treatment centers.

What Should You Know Before Using Immunine?

Before using Immunine, inform your doctor about all your medical conditions, especially liver or heart disease, history of thrombosis, and any allergies. Immunine must not be used in patients with a known allergy to heparin or a history of heparin-induced thrombocytopenia, except in life-threatening situations.

Contraindications

You should not use Immunine if any of the following apply to you:

  • Allergy to human coagulation factor IX or any of the other ingredients in Immunine
  • Known allergy to heparin or a history of heparin-induced thrombocytopenia (HIT) – a condition where heparin exposure causes a dangerous drop in platelet count. Immunine contains trace amounts of heparin from the manufacturing process

After treatment for either of these conditions, Immunine should only be used in the event of life-threatening bleeding when no alternative factor IX product is available.

Warnings and Precautions

Talk to your doctor before using Immunine if you have or have had any of the following conditions:

Allergic reactions – seek immediate emergency medical attention:

There is a risk of severe, sudden allergic reactions (anaphylaxis) with Immunine. Stop the infusion immediately and contact your doctor or emergency services if you experience any of the following symptoms:

  • Skin flushing, rash, or hives (urticaria)
  • Itching over the entire body
  • Swelling of the lips, tongue, or face (angioedema)
  • Difficulty breathing, wheezing, or chest tightness
  • Dizziness, low blood pressure, or loss of consciousness
  • General feeling of being unwell

Your doctor will monitor you carefully during treatment with Immunine, particularly in the following situations:

  • High-dose treatment: Your doctor will check your blood regularly to ensure appropriate dosing and adequate factor IX levels
  • Thrombosis risk: If you have a tendency toward blood clot formation (thrombophilia), you may receive a lower dose. There is a risk of thrombotic complications, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, and heart attack, particularly at high doses or in patients with underlying risk factors
  • Persistent bleeding: If your bleeding cannot be controlled with Immunine, you may have developed factor IX inhibitors – antibodies in the blood that neutralize the factor IX you receive. Your doctor will perform appropriate laboratory tests to confirm this. Patients with inhibitors may be at increased risk for anaphylaxis
  • Liver or heart disease: Inform your doctor if you have liver disease, heart disease, or have recently undergone major surgery, as these conditions increase the risk of coagulation complications

Viral Safety Information

When medicines are manufactured from human blood or plasma, special measures are taken to prevent the transmission of infections to patients. These include careful selection and screening of blood and plasma donors, testing of individual donations and plasma pools for signs of virus or infection, and viral inactivation and removal steps during manufacture.

Despite these measures, the risk of transmitting infection cannot be completely eliminated when products derived from human blood or plasma are administered. This also applies to previously unknown or emerging viruses and other types of infections. The measures taken are considered effective against enveloped viruses such as HIV, hepatitis B virus, and hepatitis C virus, as well as the non-enveloped hepatitis A virus. The measures may be of limited value against non-enveloped viruses such as parvovirus B19.

Parvovirus B19 infection can be serious for pregnant women (fetal infection), individuals with weakened immune systems, and patients with certain types of anemia such as sickle cell disease or hemolytic anemia. Your doctor may recommend hepatitis A and B vaccination if you regularly receive plasma-derived products.

Traceability:

When you receive Immunine, it is strongly recommended that the product name and batch number are recorded to maintain traceability between you and the specific product batch used. This is important for safety monitoring purposes.

Use in Children

There is insufficient clinical data to recommend the use of Immunine in children under 6 years of age. For children aged 6 to 12 years, available clinical data is limited, and dosing recommendations are based on the same principles as for adults (1 IU/kg raises plasma factor IX activity by approximately 1.1%). Observational studies have shown that the safety profile in children is similar to that observed in adults. Your child's hematologist will determine the most appropriate factor IX product and dosing regimen.

Pregnancy and Breastfeeding

Hemophilia B is extremely rare in women due to its X-linked inheritance pattern. Consequently, there is no clinical experience with the use of Immunine during pregnancy or breastfeeding. If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before using Immunine. Your doctor will assess whether the potential benefits of treatment outweigh any possible risks.

Driving and Operating Machinery

No effects on the ability to drive or operate machinery have been observed with Immunine. However, if you experience dizziness or any other side effects that could impair your ability to concentrate, you should refrain from driving or operating machinery until the symptoms resolve.

Sodium Content

Immunine 600 IU contains 20 mg sodium (the main component of table salt) per vial, equivalent to 1% of the WHO-recommended maximum daily sodium intake for adults. Immunine 1200 IU contains 41 mg sodium per vial, equivalent to 2% of the recommended maximum. This should be taken into account by patients on a sodium-restricted diet.

How Does Immunine Interact with Other Drugs?

No known interactions between Immunine and other medicines have been reported. However, Immunine must not be mixed with other medicinal products during administration. Always inform your doctor about all medications you are taking.

Based on available clinical data, Immunine is not known to interact with other medications. Unlike many small-molecule drugs, Immunine is a biological product (a coagulation factor protein) that is not metabolized by liver enzymes such as cytochrome P450. Therefore, the typical drug–drug interactions seen with conventional medicines do not apply.

However, there are several important practical considerations regarding Immunine use in combination with other treatments:

Practical Considerations for Immunine Administration
Consideration Detail Recommendation
No mixing with other drugs Immunine must not be mixed with other medicinal products before or during administration, as this may affect its efficacy and safety Always administer Immunine separately through a dedicated IV line or flush the line with saline before and after
Heparin-containing products Immunine contains trace amounts of heparin from manufacture. Patients with heparin allergy or HIT must avoid Immunine except in life-threatening situations Use an alternative factor IX product if the patient has a history of HIT
Antifibrinolytic agents Tranexamic acid or aminocaproic acid may be used alongside factor IX to help stabilize clots, especially for oral or mucosal bleeding Use under specialist guidance; antifibrinolytics are generally compatible with factor IX products
IV line flushing If other medications are administered through the same venous access, the line must be flushed with an appropriate solution (e.g., normal saline) before and after Immunine Always flush with physiological saline solution before and after administration
Infusion set compatibility Immunine may adsorb to the inner surface of some infusion sets, resulting in under-dosing Use only the supplied infusion set to ensure accurate dosing

If you are using other treatments for hemophilia B, such as bypassing agents (for patients with inhibitors) or emicizumab (for hemophilia A with inhibitors – not typically used in hemophilia B), your hematologist will provide specific guidance on how to coordinate these therapies. Always tell your doctor about all medicines, supplements, and herbal products you are using or plan to use.

What Is the Correct Dosage of Immunine?

The dose of Immunine is calculated individually based on body weight, the severity of the bleeding, and the desired factor IX level. As a general guide, 1 IU of factor IX per kg body weight raises plasma factor IX activity by approximately 1.1% of normal in patients 12 years or older. Treatment should be initiated and monitored by a physician experienced in hemophilia care.

Your doctor will determine the appropriate dose for you based on your specific clinical needs. The dose is calculated using the following formula:

Dosing Formula

Required units = Body weight (kg) × Desired factor IX increase (%) × 0.9

For example, a 70 kg patient requiring a 40% increase in factor IX activity would need: 70 × 40 × 0.9 = 2,520 IU

On-Demand Treatment (Bleeding Episodes)

The following table provides dosing guidance based on the type and severity of bleeding:

Immunine Dosing Guide for Bleeding Episodes
Bleeding Type Target Factor IX Level Dosing Frequency
Early joint bleed, muscle bleed, or oral bleed 20–40% of normal Repeat every 24 hours for at least 1 day until bleeding resolves or healing is achieved
More extensive joint bleed, muscle bleed, or hematoma 30–60% of normal Repeat every 24 hours for 3–4 days or longer until pain and acute impairment resolve
Life-threatening bleeding 60–100% of normal Repeat every 8–24 hours until the life-threatening condition has resolved

Surgical Coverage

Immunine Dosing Guide for Surgery
Surgery Type Target Factor IX Level Dosing Frequency
Minor surgery (including dental extraction) 30–60% of normal Every 24 hours for at least 1 day, until healing is achieved
Major surgery 80–100% (pre- and post-operatively) Every 8–24 hours until adequate wound healing, then continue for at least 7 days to maintain FIX activity at 30–60%

Long-Term Prophylaxis

Prophylactic Dosing

Usual dose: 20–40 IU of factor IX per kg body weight

Frequency: Every 3–4 days

In some patients, particularly younger patients, shorter dosing intervals or higher doses may be required to maintain adequate trough levels and prevent breakthrough bleeding. Your doctor will individualize the regimen based on your factor IX levels and bleeding history.

Children and Adolescents

Dosing recommendations for patients aged 12 to 18 years follow the same principles as for adults (1 IU/kg raises plasma factor IX by approximately 1.1%). For children aged 6 to 12 years, the available clinical data is limited, and your specialist will determine the appropriate dose. Immunine is not recommended for children under 6 years due to insufficient data.

How to Administer Immunine

Immunine is administered by slow intravenous injection or infusion after reconstitution. The key steps are:

  1. Warm the solvent vial (sterile water for injection) to room temperature (maximum 37°C) before use
  2. Remove the protective caps from both vials and clean the rubber stoppers
  3. Use the supplied transfer needle to transfer the solvent into the powder vial, utilizing the vacuum in the powder vial
  4. Gently swirl the powder vial until the powder is completely dissolved – do not shake vigorously
  5. Insert the supplied venting needle to allow any foam to dissipate, then remove it
  6. Attach the supplied filter needle to a sterile disposable syringe and draw up the solution
  7. Replace the filter needle with the supplied infusion set or disposable needle
  8. Administer slowly intravenously at a rate not exceeding 2 mL per minute
Important administration notes:

Reconstitute Immunine immediately before use. The solution contains no preservatives and must be used within 3 hours of preparation. The reconstituted solution should be clear or slightly opalescent. Do not use if the solution is cloudy or contains visible particles. Use only the supplied infusion set, as other sets may cause the product to adsorb to the inner surface, resulting in inaccurate dosing. Discard any unused reconstituted solution.

Missed Dose

If you miss a scheduled dose, administer it as soon as possible and then continue with your regular dosing schedule as instructed by your doctor. Do not administer a double dose to compensate for the missed one.

Overdose

Overdose Information:

No specific symptoms of overdose with factor IX have been reported. However, excessive doses may theoretically increase the risk of thromboembolic complications, particularly in patients with predisposing risk factors. If you suspect you have received more Immunine than intended, contact your doctor, hospital, or local emergency services immediately for assessment and advice.

Stopping Treatment

Hemophilia B typically requires lifelong treatment with factor IX replacement. Do not stop using Immunine without consulting your hematologist. Discontinuing factor IX replacement therapy can leave you unprotected against bleeding episodes, which may be spontaneous and potentially life-threatening. If you have any questions or concerns about your treatment, speak with your doctor.

What Are the Side Effects of Immunine?

Like all medicines, Immunine can cause side effects, although not everybody gets them. The most serious potential side effect is anaphylaxis (severe allergic reaction), which is rare but requires immediate emergency treatment. Other side effects include throat irritation, rash, fever, headache, nausea, and injection site reactions.

If you experience any side effects that concern you, consult your doctor. Particular vigilance is needed if your doctor has detected factor IX inhibitors in your blood, as this may increase the risk of allergic reactions. The following side effects have been reported with Immunine:

Seek immediate emergency medical attention if you experience:
  • Skin flushing, rash, or hives (urticaria) spreading over the body
  • Swelling of the lips, tongue, face, or throat (angioedema)
  • Difficulty breathing, wheezing, or chest tightness
  • Dizziness, low blood pressure, or loss of consciousness
  • Signs of blood clots: sudden chest pain, leg swelling, shortness of breath, severe headache, or visual changes
  • Signs of serum sickness (if inhibitors present): rash, joint pain, fever, swollen lymph nodes

Uncommon

May affect up to 1 in 100 people

  • Throat irritation, sore throat, and dry cough
  • Rash and itching (pruritus)
  • Fever (pyrexia)

Frequency Not Known

Cannot be estimated from available data

  • Headache
  • Restlessness
  • Tingling or numbness (paraesthesia)
  • Nausea and vomiting
  • Hives (urticaria)
  • Chills
  • Hypersensitivity reactions
  • Burning and stinging at the injection site
  • Lethargy
  • Hot flushes
  • Chest tightness

Serious Side Effects Reported with Factor IX Products

The following serious side effects have been reported with Immunine or similar factor IX products and require immediate medical attention:

  • Anaphylactic reactions: Severe, life-threatening allergic reactions that can include cardiovascular collapse, low blood pressure, and loss of consciousness. Patients with factor IX inhibitors may be at higher risk
  • Thromboembolic events: Blood clots in veins (venous thrombosis), lungs (pulmonary embolism), arteries, or brain (cerebral arterial thrombosis). This risk is higher with high doses or in patients with predisposing risk factors
  • Disseminated intravascular coagulation (DIC): A condition involving widespread clotting in small blood vessels throughout the body
  • Heart attack (myocardial infarction): Reported rarely with factor IX products
  • Nephrotic syndrome: A kidney condition with symptoms including swelling of the eyelids, face, and lower legs, weight gain, and protein loss in urine
  • Inhibitor development: Formation of antibodies against factor IX that reduce or eliminate the therapeutic effect. This is more common in previously untreated patients

Reporting suspected side effects after a medicine has been authorized is important, as it allows continued monitoring of the medicine's benefit–risk balance. You can report side effects to your national pharmacovigilance authority or directly to your healthcare provider.

How Should You Store Immunine?

Store Immunine in a refrigerator at 2–8°C. Do not freeze. Keep the vial in the outer carton to protect from light. Within its shelf life, Immunine may be stored at room temperature (up to 25°C) for a maximum of 3 months.

Keep Immunine out of the sight and reach of children. Do not use after the expiry date printed on the label and carton. The expiry date refers to the last day of the stated month.

The standard storage conditions are:

  • Refrigerated storage: 2–8°C (36–46°F). Do not freeze
  • Light protection: Keep the vial in its outer carton at all times
  • Room temperature option: Within the stated shelf life, Immunine may be stored at room temperature (up to 25°C / 77°F) for a single continuous period of up to 3 months. Record the date when you begin room temperature storage on the product packaging. After this 3-month period, the product must not be returned to the refrigerator – it must either be used immediately or discarded

Do not dispose of unused medicines via wastewater or household waste. Return any unused or expired product to your pharmacy for safe disposal. These measures help protect the environment.

What Does Immunine Contain?

Immunine contains human coagulation factor IX as its active substance. The 600 IU presentation provides 120 IU/mL after reconstitution with 5 mL sterile water; the 1200 IU presentation also provides 120 IU/mL after reconstitution with 10 mL sterile water.

Active Ingredient

The active substance is human coagulation factor IX. Each vial contains either 600 IU or 1200 IU of human coagulation factor IX. After reconstitution with the supplied sterile water for injection (5 mL for the 600 IU vial; 10 mL for the 1200 IU vial), the resulting solution contains 120 IU of human coagulation factor IX per milliliter.

Inactive Ingredients (Excipients)

The other ingredients in the powder are sodium chloride and sodium citrate. The solvent is sterile water for injection. These excipients are standard pharmaceutical ingredients used to ensure product stability, appropriate pH, and tonicity of the reconstituted solution.

Appearance and Packaging

Immunine powder is a white to pale yellow powder. After reconstitution with the supplied sterile water for injection, the solution is clear or slightly opalescent (milky). Do not use the solution if it is noticeably cloudy, discolored, or contains visible particles.

Each pack contains:

  • 1 vial of Immunine powder (600 IU or 1200 IU)
  • 1 vial of sterile water for injection (5 mL or 10 mL)
  • 1 transfer needle
  • 1 venting needle
  • 1 filter needle
  • 1 disposable needle
  • 1 disposable syringe (5 mL or 10 mL)
  • 1 infusion set with butterfly needle

Marketing Authorization Holder and Manufacturer

Marketing authorization holder: Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna, Austria

Manufacturer: Takeda Manufacturing Austria AG, Industriestrasse 67, 1221 Vienna, Austria

How Does Immunine Work in the Body?

Immunine provides exogenous human coagulation factor IX that integrates into the patient's coagulation cascade, replacing the deficient factor and restoring the ability to form stable blood clots. Factor IX is activated in both the intrinsic and extrinsic coagulation pathways and is essential for normal hemostasis.

Factor IX is a vitamin K–dependent glycoprotein that plays a critical role in the coagulation cascade – the complex series of biochemical reactions that leads to blood clot formation. In the intrinsic pathway, factor IX is activated to factor IXa by factor XIa. In the extrinsic pathway, factor IX can also be activated by the tissue factor/factor VIIa complex.

Once activated, factor IXa forms a complex with activated factor VIII (factor VIIIa), phospholipids, and calcium ions on the surface of activated platelets. This complex, known as the tenase complex, is responsible for activating factor X to factor Xa. Activated factor X then converts prothrombin (factor II) to thrombin, which in turn converts fibrinogen to fibrin, forming the structural framework of a blood clot.

In patients with hemophilia B, factor IX is either absent or present at significantly reduced levels, resulting in impaired thrombin generation and defective clot formation. Intravenous administration of Immunine provides functional factor IX that integrates into the patient's coagulation cascade, temporarily restoring normal hemostatic function. The degree of factor IX activity correction depends on the dose administered and the individual patient's recovery (the amount by which 1 IU/kg raises plasma levels).

Pharmacokinetic Profile

After intravenous administration, Immunine provides an immediate increase in circulating factor IX activity. Based on empirical data, 1 IU of factor IX per kg body weight raises plasma factor IX activity by approximately 1.1% of normal (1.1 IU/dL) in patients aged 12 years and older. The in vivo half-life of factor IX from Immunine is approximately 18–24 hours, though individual patients may show different recovery levels and half-lives. Factor IX products generally need to be administered no more than once per day for most bleeding situations.

During treatment, regular monitoring of factor IX activity levels is recommended to guide dosing, particularly during major surgical procedures and life-threatening bleeding episodes. Individual patient response may vary, and dose adjustments should be based on clinical response and laboratory monitoring rather than formulaic calculations alone.

Frequently Asked Questions About Immunine

Immunine is a plasma-derived factor IX concentrate used to treat and prevent bleeding episodes in patients with hemophilia B (Christmas disease). Hemophilia B is a hereditary bleeding disorder caused by deficient or absent factor IX. Immunine temporarily replaces the missing factor IX, correcting the coagulation defect and reducing bleeding tendency. It can be used for on-demand treatment of acute bleeds and for regular prophylaxis to prevent bleeding.

Immunine is given as a slow intravenous injection or infusion after reconstitution with the supplied sterile water for injection. The reconstituted solution must be used within 3 hours. The injection rate should not exceed 2 mL per minute. Only the supplied infusion set should be used, as other sets may cause the product to adsorb to the inner surface, leading to inaccurate dosing. Treatment should be initiated under the supervision of a physician experienced in hemophilia care, though many patients can be trained to self-administer at home.

If your bleeding cannot be controlled with Immunine despite adequate dosing, contact your doctor immediately. You may have developed factor IX inhibitors – antibodies in your blood that neutralize the factor IX you receive. Your doctor will perform blood tests to check for inhibitors. If inhibitors are confirmed, you may need higher doses of Immunine or a different type of treatment (such as a bypassing agent). Do not increase your Immunine dose on your own without medical supervision.

Immunine is manufactured from human plasma, and special measures are taken to minimize the risk of infection transmission, including careful donor screening, testing of plasma pools for viruses, and viral inactivation and removal steps during manufacture. These measures are considered effective against enveloped viruses such as HIV, hepatitis B, and hepatitis C, as well as hepatitis A. However, the risk of transmitting infections, including previously unknown viruses, cannot be completely eliminated. Your doctor may recommend hepatitis A and B vaccination if you regularly receive plasma-derived products.

Store Immunine in a refrigerator at 2–8°C. Do not freeze. Keep the vial in the outer carton to protect from light. Within its shelf life, Immunine may be stored at room temperature (up to 25°C) for a single continuous period of up to 3 months. Note the start and end dates of room temperature storage on the packaging. After this 3-month period, the product must not be returned to the refrigerator and should be used immediately or discarded.

Immunine is approved for patients aged 6 years and older. There is insufficient data to recommend its use in children under 6 years. Observational studies have shown that the safety profile in children over 6 years is similar to that in adults. However, younger children may have different pharmacokinetic responses and may require dosing adjustments. Your child's hematologist will determine the most appropriate factor IX product and dosing regimen based on your child's age, weight, and clinical needs.

References

This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.

  1. Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020;26(Suppl 6):1–158. doi:10.1111/hae.14046
  2. World Federation of Hemophilia (WFH). Guidelines for the Management of Hemophilia – Updated 2024. WFH, Montreal, Canada.
  3. European Medicines Agency (EMA). Immunine – Summary of Product Characteristics. EMA product information database. Accessed January 2026.
  4. World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
  5. Mannucci PM, Tuddenham EG. The hemophilias – from royal genes to gene therapy. New England Journal of Medicine. 2001;344(23):1773–1779.
  6. Berntorp E, Shapiro AD. Modern haemophilia care. The Lancet. 2012;379(9824):1447–1456. doi:10.1016/S0140-6736(11)61139-2
  7. International Society on Thrombosis and Haemostasis (ISTH). Definitions in hemophilia: Recommendations from the Scientific and Standardization Committee. Journal of Thrombosis and Haemostasis. 2012;10(7):1336–1339.
  8. British National Formulary (BNF). Factor IX fraction, dried. NICE BNF monograph. Accessed January 2026.

Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in hematology, clinical pharmacology, and internal medicine.

Medical Writers

Board-certified physicians specialising in hematology, coagulation disorders, and clinical pharmacology with documented academic and clinical experience.

Medical Reviewers

Independent review board ensuring clinical accuracy, adherence to international guidelines (WFH, ISTH, WHO, EMA), and evidence level 1A standards.

Editorial Standards:

All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.