Moroctocog Alfa
Pronunciation: (ZIN-tha).
- Generic name
- moroctocog alfa
- Brand names
- ReFacto AF, Xyntha, Kogenate, Recombinate
- Drug class
- Antihemophilic Factor (Recombinant), Blood Coagulation Factor VIII
Availability and supply rules vary by country
Trade names by country: Canada
Australia: · Full directory
What moroctocog alfa is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how moroctocog alfa works
Xyntha (moroctocog alfa) is a recombinant antihemophilic factor (factor VIII) that temporarily replaces the missing or deficient endogenous factor VIII in patients with hemophilia A. It acts as a cofactor for factor IXa, enabling the conversion of factor X to activated factor X, which is essential for the formation of a stable fibrin clot. (1)
What moroctocog alfa is used for
Control and prevention of bleeding episodes in patients with hemophilia A
Control and prevention of bleeding episodes in patients with hemophilia A (1)
Perioperative management of bleeding in patients with hemophilia A
Perioperative management of bleeding in patients with hemophilia A (1)
Routine prophylaxis to prevent bleeding in patients with hemophilia A
Routine prophylaxis to prevent bleeding in patients with hemophilia A (1)
Before taking moroctocog alfa
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to moroctocog alfa or excipients. (Contraindication) (1)
- Not indicated for von Willebrand disease. (Contraindication) (1)
Tell your clinician about
(1)How to take moroctocog alfa
- General Instructions: Xyntha is administered as an intravenous injection. Always use it exactly as prescribed by your healthcare provider.. Adult Dosing: The dose and frequency depend on the severity of factor VIII deficiency, the location and extent of bleeding, and individual response. Typical dosing ranges from 10-50 IU/kg, adjusted based on clinical need.. Pediatric Dosing: Children are dosed similarly to adults, based on body weight and clinical response. Close monitoring is required.. Administration: Reconstitute the powder with the provided diluent, mix gently, and inject intravenously over several minutes. Use aseptic technique and follow the instructions provided with the medication.. When To Seek Review: Continue treatment as directed. Do not stop without consulting your healthcare provider, even if you feel well.. Storage: Store Xyntha in the refrigerator (2°C–8°C/36°F–46°F) or at room temperature (up to 25°C/77°F) for up to 3 months. Protect from light. Do not freeze.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, administer it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. do not take an extra dose.
Overdose
In case of overdose, seek immediate medical attention. Overdose may increase the risk of thrombosis or other complications. Supportive care and monitoring are recommended. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Fever
Incidence: Reported in the clinician-authored database; frequency not established
Injection site reactions
Incidence: Reported in the clinician-authored database; frequency not established
Hypersensitivity reactions
Incidence: Reported in the clinician-authored database; frequency not established
Development of inhibitors
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
Serious allergic reactions, including anaphylaxis, may occur — serious
Symptoms: Serious allergic reactions, including anaphylaxis, may occur. Development of inhibitors (antibodies) to factor VIII can reduce effectiveness. Monitor for signs of thrombosis, especially in patients with risk factors. Not effective for treating von Willebrand disease. Use with caution in patients with liver disease or other coagulopathies.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with known hypersensitivity to moroctocog alfa or excipients. Use with caution in patients with a history of inhibitors, liver disease, or at risk for thrombosis. Not indicated for von Willebrand disease.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | No significant drug interactions have been reported with Xyntha. However, always inform your healthcare provider about all medicines, supplements, and herbal products you are taking. Immunomodulatory drugs or other blood products may affect bleeding risk or immune response. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
The FDA label reviewed for this page states animal reproduction studies have not been conducted with Xyntha and it is not known whether it can cause fetal harm; it should be used during pregnancy only if clearly needed, as directed by the treating physician. (1)
Breastfeeding
The FDA label reviewed for this page states it is not known whether Xyntha is excreted in human milk; caution should be exercised when Xyntha is administered to a breastfeeding parent, in consultation with the treating physician. (1)
Children
Frequency: Dosing frequency is every 12-24 hours, similar to adults.. Weight Based: 10-40 IU/kg/dose based on the severity of hemophilia A.. Max Daily Dose: Maximum daily dose is 200 IU/kg.. Max Single Dose: Maximum single dose is 100 IU/kg.. Age Restrictions: Safety not established in children under 12 years of age. (1)
Renal_impairment
Per the FDA label reviewed for this page, dosage adjustment for patients with renal or hepatic impairment has not been studied in clinical trials, so no specific renal- or hepatic-impairment dosing recommendation exists. Dosing should be individualized to clinical response (bleeding control and factor VIII levels) regardless of organ function, with more cautious, low-end initial dosing suggested for elderly patients, who more often have reduced hepatic, renal, or cardiac function. (1)
Hepatic_impairment
Per the FDA label reviewed for this page, dosage adjustment for patients with renal or hepatic impairment has not been studied in clinical trials, so no specific renal- or hepatic-impairment dosing recommendation exists. Dosing should be individualized to clinical response (bleeding control and factor VIII levels) regardless of organ function, with more cautious, low-end initial dosing suggested for elderly patients, who more often have reduced hepatic, renal, or cardiac function. (1)
Monitoring
(1)Storage
Per the FDA label, store Xyntha refrigerated at 2-8 degrees C (36-46 degrees F), or at room temperature up to 25 degrees C (77 degrees F) for a single period of up to 3 months; do not freeze, protect from light, and do not use after the stated expiration date. Once reconstituted, use promptly per the product insert's specific window.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Control and prevention of bleeding episodes in patients with hemophilia A
Dose summary: Initial dosing is based on the severity of hemophilia A and the patient's weight. A typical starting dose is 20-40 IU/kg.
Renal context: Per the FDA label, dosage adjustment for renal impairment has not been studied in clinical trials; there is no specific renal-impairment dosing recommendation. Dosing is individualized to bleeding severity, factor VIII level, and clinical response rather than adjusted by a fixed organ-function-based formula. (1)
Frequently asked questions
What is Xyntha used for?
Xyntha is used to prevent and control bleeding episodes in people with hemophilia A, and to manage bleeding during surgery in these patients.
How is Xyntha administered?
Xyntha is given as an intravenous injection after reconstitution with a special diluent. It is usually administered by a healthcare provider or by patients/caregivers trained in home infusion.
Can Xyntha be used for von Willebrand disease?
No, Xyntha is not indicated for the treatment of von Willebrand disease.
What should I do if I develop an allergic reaction?
ask the prescriber about stopping $1 immediately and seek emergency medical attention if you experience symptoms such as hives, swelling, or difficulty breathing.
How should I store Xyntha?
Store Xyntha in the refrigerator or at room temperature (up to 25°C/77°F) for up to 3 months. Protect from light and do not freeze.
What are inhibitors and why are they important?
Inhibitors are antibodies that can develop against factor VIII, reducing the effectiveness of Xyntha. Regular monitoring is needed to detect inhibitors early.
Can children use Xyntha?
Yes, Xyntha is approved for use in children with hemophilia A. Dosing is based on body weight and clinical response.
What happens if I take too much Xyntha?
Taking too much Xyntha may increase the risk of thrombotic events or other adverse reactions. While specific overdose symptoms are not extensively documented for Factor VIII, it is crucial to seek immediate emergency medical attention if an overdose is suspected. Your healthcare provider can assess the situation and recommend appropriate management to mitigate potential risks.
Can I drink alcohol while taking Xyntha?
There are no specific known direct interactions between Xyntha and alcohol. However, alcohol consumption can impair liver function, which plays a role in clotting factor production, and may increase the risk of bleeding or complicate the management of hemophilia. It is always best to discuss alcohol use with your healthcare provider to ensure it does not interfere with your treatment plan or overall health.
Is Xyntha safe during pregnancy?
The safety of Xyntha during pregnancy has not been established in controlled human studies. It is categorized as a pregnancy category C medication, meaning animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. Therefore, it is crucial to consult your doctor to weigh the potential benefits against the risks before using Xyntha if you are pregnant or planning to become pregnant.
What is the mechanism of action of moroctocog alfa?
Xyntha (moroctocog alfa) is a recombinant antihemophilic factor (factor VIII) that temporarily replaces the missing or deficient endogenous factor VIII in patients with hemophilia A. It acts as a cofactor for factor IXa, enabling the conversion of factor X to activated factor X, which is essential for the formation of a stable fibrin clot. (1)
What is the generic name of Moroctocog Alfa?
The generic name is moroctocog alfa. It is sold under brand names including ReFacto AF, Xyntha, Kogenate, Recombinate.
What class of drug is moroctocog alfa?
Moroctocog Alfa is classed as: Antihemophilic Factor (Recombinant), Blood Coagulation Factor VIII.
References
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Brand names by country
Single-ingredient moroctocog alfa names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
Canada
- XYNTHA
- XYNTHA SOLOFUSE