Antihemophilic Factor Recombinant

Antihemophilic Factor Recombinant is a prescription medication used to treat symptoms of congenital and acquired hemophilia A.

• Antihemophilic Factor Recombinant is available under the following different brand names: Helixate FS, Xyntha, Kogenate FS, NovoEight, Recombinant, Advate, Eloctate, Factor VIII (Recombinant), turoctocog alfa, Obizur, Nuwiq, Adynovate, Kovaltry, Afstyla, Jivi, Esperoct, Altuviiio, efanesoctocog alfa.

Common side effects of Antihemophilic Factor Recombinant include:

• Flushing of the face (warmth, redness, itching, or tingling feeling under the skin)
• Headache
• Nausea
• Vomiting, and
• Fast heartbeat which can be lessened by giving this medication more slowly.

Serious side effects of Antihemophilic Factor Recombinant include:

• Injection site reactions (burning, redness, irritation, swelling, or stinging)
• Fever
• Chills
• Sore throat
• Cough
• Runny nose
• Unusual or unpleasant taste in the mouth
• Skin itching or rash.
• Joint pain or swelling, or
• Dizziness

Rare side effects of Antihemophilic Factor Recombinant include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, of lyophilized powder for reconstitution

• Eloctate
  • 250 IU, 500 IU, 750 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU
• Kogenate FS
  • 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU
• Nuwiq
  • 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU, 4000 IU
• NovoEight
  • 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU
• Recombinant
  • 220-400 IU, 401-800 IU, 801-1240 IU, 1241-1800 IU, 1801-2400 IU
• Pegylated (Adynovate)
  • 250 IU, 500 IU, 750 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU
• Pegylated-aucl (Jivi)
  • 500 IU, 1000 IU, 2000 IU, 3000 IU
• Efanesoctocog alfa (Altuviiio)
  • 250 IU, 500 IU, 750 IU, 1000 IU, 2000 IU, 3000 IU, or 4000 IU
• Glycosylated exec (Esperoct)
  • 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU
• Single chain (Afstyla)
  • 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 2500 IU, 3000 IU
• Plasma/albumin free
  • 250 IU, 500 IU, 1000 IU, 2000 IU (Xyntha)
  • 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU (Xyntha Solofuse)
  • 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU (Kovaltry)
  • 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU, 4000 IU (Advate)
• Porcine sequence (Obizur)
  • 500 IU

Hemophilia A, Congenital

Adult dosage

• Dosage (IU) = Body Weight (kg) × Desired Factor VIII level increase (IU/dL or % normal) × 0.5 (IU/kg per IU/dL)

Bleeding episodes

Mild/moderate hemorrhage

• Eloctate: 20-30 IU/kg Intravenous to achieve factor VIII level of 40% to 60% of normal for the treatment of joint, superficial muscle/no neurovascular compromise (except iliopsoas), deep laceration and renal, superficial soft tissue, or mucous membrane bleeding; repeat every 24-48 hours until resolved.
• Advate, Helixate FS, Kogenate FS (initial): 10-20 units/kg Intravenous to achieve factor VIII level of 20-40% of normal for the treatment of early hemarthrosis and minor muscle or oral bleed; may repeat dose every 12-24 hours for 1-3 days if evidence of further bleeding.
• Recombinant, Xyntha: A dose sufficient to achieve a factor VIII level of 20-40% of normal for the treatment of early hemarthrosis, muscle bleeding, or oral bleeding episode; may repeat dose every 12-24hours for1-3 for days if evidence of further bleeding.
• Nuwiq (mild): A dose sufficient to achieve factor VIII activity of 20-40% of normal for superficial muscle or soft tissue and oral bleeds; may repeat dose every 12-24 hours for at least 1 day, until bleeding episode resolved.
• Adynovate (mild): 10-20 IU/kg intravenous to achieve factor VIII activity of 20-40% of normal for superficial muscle or soft tissue and minor oral bleeds; may repeat dose every 12-24hours for at least 1 day until bleeding episode resolved.
• Kovaltry (mild): A dose sufficient to achieve factor VIII activity of 20-40% of normal for early hemarthrosis, minor muscle bleeding, or oral bleeds; may repeat dose every 12-24 hours for at least 1 day, until bleeding episode resolved.
• Afstyla (mild): A dose sufficient to achieve factor VIII activity of 20-40% of normal for early hemarthrosis, minor muscle bleeding, or oral bleeds; may repeat dose every 12-24hours for at least 1 day, until bleeding episode resolved.
• Jivi (mild): 10-20 IU/kg IV to achieve factor VIII activity of 20-40% of normal for early hemarthrosis, superficial muscle or soft tissue, and minor oral bleeds; may repeat dose every 24-48 hours until bleeding episode resolved.
• Esperoct (mild): 40 IU/kg; 1 dose is typically sufficient.
• Altuviiio: Single dose of 50 IU/kg Intravenous; if a bleeding episode occurs within 2-3 days after the prophylactic dose, 30 IU/kg dose may be used; may consider additional doses of 30 or 50 IU/kg every 2-3 days.

Moderate hemorrhage

• Advate: 15-30 units/kg intravenous to achieve factor VIII level of 30-60% of normal for the treatment of moderate bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma; may repeat dose every 12-24 hours for 1-3 days if evidence of further bleeding.
• Eloctate: 20-30 IU/kg intravenous to achieve a factor VIII level of 40-60% of normal for the treatment of joint, superficial muscle/no neurovascular compromise (except iliopsoas), deep laceration and renal, superficial soft tissue, or mucous membrane bleeding; repeat every 24-48 hours until resolved.
• Helixate FS, Kogenate FS (initial): 15-20 units/kg Intravenous to achieve factor VIII level of 30-60% of normal for the treatment of moderate bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma; may repeat dose every 12-24 hours for 1-3 days if evidence of further bleeding.
• Recombinant: A dose sufficient to achieve a factor VIII level of 30-60% of normal for the treatment of more extensive hemarthrosis, muscle bleeding, or hematoma; repeat every 12-24 hours per 3 days or more
• Xyntha: A dose sufficient to achieve a factor VIII level of 30-60% of normal for the treatment of hemorrhages into muscles, mild head trauma, and hemorrhages into the oral cavity; repeat every 12-24 hours per 3-4 days or until adequate local hemostasis is achieved.
• Nuwiq: A dose sufficient to achieve factor VIII activity of 30-60% of normal for hemorrhage into muscles, into the oral cavity, hemarthrosis, or known trauma; may repeat dose every 12-24 hours for at least 3-4 days, until bleeding episode resolved.
• Adynovate: 15-30 IU/kg IV to achieve factor VIII activity of 30-60% of normal for moderate hemorrhage in the oral cavity, definite hemarthroses, and known trauma; may repeat dose every 12-24 hours until bleeding episode resolved.
• Kovaltry: A dose sufficient to achieve factor VIII activity of 30-60% of normal for more extensive hemarthrosis, muscle bleeding, or hematoma; may repeat dose every 12-24 hours for at least 3-4 days, until bleeding episode resolved.
• Afstyla: A dose sufficient to achieve factor VIII activity of 30-60% of normal for more extensive hemarthrosis, muscle bleeding, or hematoma; may repeat dose every 12-24 hours for at least 3-4daysy, until bleeding episode resolved.
• Jivi: 15-30 IU/kg IV to achieve factor VIII activity of 30-60% of normal for more extensive hemarthrosis, muscle bleeding, or hematoma; may repeat dose every 24-48 hours until bleeding episode resolved.
• Esperoct: 40 IU/kg; an additional dose may be administered after 24 hours.

Severe hemorrhage

• Advate: 30-50 units/kg IV to achieve factor VIII plasma level of 60-100% of normal for treatment of significant GI bleeding; intracranial, intra-abdominal, or intrathoracic bleeding; CNS bleeding; bleeding in the retropharyngeal or retroperitoneal spaces; or iliopsoas sheath, fractures, and head trauma; repeat every 8-24 hours until bleeding episode resolved.
• Eloctate: 40-50 IU/kg intravenous to achieve factor VIII level of 80-100% of normal for the treatment of life or limb-threatening hemorrhage, iliopsoas and deep muscle with neurovascular injury, and retroperitoneum, intracranial, or GI bleeding; repeat every 12-24 hours until bleeding resolved (typically 7-10 days)
• Helixate FS, Kogenate FS: 40-50 units/kg intravenous to achieve factor VIII level of 80-100% of normal for the treatment of intracranial, intra-abdominal, or intrathoracic bleeding; GI bleeding; CNS bleeding; bleeding in the retroperitoneal or retropharyngeal spaces or iliopsoas sheath; fractures; and head trauma; repeat with 20-25 units/kg every 8-12 hours until bleeding episode resolved.
• Recombinant: A dose sufficient to achieve a factor VIII level of 60-100% of normal for the treatment of life-threatening bleeding episodes, such as head injury, throat bleeding, or severe abdominal pain; repeat every 8-24 hours until the bleeding episode is resolved.
• Xyntha: A dose sufficient to achieve factor VIII level of 60-100% of normal for GI bleeding; intracranial, intra-abdominal, or intrathoracic hemorrhages; and fractures; repeat every 8-24 hours until bleeding episode resolved.
• Nuwiq: A dose sufficient to achieve factor VIII activity of 60-100% of normal for Intracranial, intraabdominal, GI, or intrathoracic bleeds, central nervous system bleeds, bleeding in retropharyngeal spaces or iliopsoas sheath, eyes/retina, fractures, or head trauma; may repeat dose 8-24 hours until bleeding risk resolved.
• Adynovate: 30-50 IU/kg intravenous to achieve factor VIII activity of 60-100% of normal for severe hemorrhage including GI bleeding, intracranial, intraabdominal, or intrathoracic, CNS, bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, fractures, head trauma; may repeat dose every 8-24 hours until bleeding episode resolved.
• Kovaltry: A dose sufficient to achieve factor VIII activity of 60-100% of normal for intracranial, intraabdominal, GI, or intrathoracic bleeds, central nervous system bleeds, bleeding in retropharyngeal spaces or iliopsoas sheath, life, or limb-threatening hemorrhage; may repeat dose 8-24 hours until bleeding risk resolved.
• Afstyla: A dose sufficient to achieve factor VIII activity of 60-100% of normal for intracranial, intraabdominal, GI, or intrathoracic bleeds, central nervous system bleeds, bleeding in retropharyngeal spaces or iliopsoas sheath, life, or limb-threatening hemorrhage; may repeat dose 8-24 hours until bleeding risk resolved.
• Jivi: 30-50 IU/kg Intravenous to achieve factor VIII activity of 60-100% of normal for major hemorrhage including GI bleeding, intracranial, intraabdominal, or intrathoracic, CNS, bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, live- or limb-threatening hemorrhage; may repeat dose every 8-24 hours until bleeding episode resolved.
• Esperoct: 50 IU/kg; additional doses may be administered approximately 24 hours.
• Altuviiio: Single dose of 50 IU/kg intravenous; may consider additional doses of 30 or 50 IU/kg every 2-3 days.

Perioperative management

Minor surgery

• Advate: 30-50 units/kg intravenous as a single intravenous bolus infusion beginning within 1 hour of the operation to achieve a factor VIII level of 60-100% of normal for minor surgery, including tooth extraction; may repeat dosage every 12-24 hours as needed to control bleeding (for dental procedures, adjunctive therapy may be considered)
• Eloctate: 25-40 units/kg intravenous to achieve factor VIII level of 50-80% of normal for minor surgery, including tooth extraction; may repeat dosage every 24 hours for at least 1 day until healing is achieved.
• Helixate FS, Kogenate FS: 15-30 units/kg intravenous to achieve factor VIII level of 30-60% of normal for minor surgery, including tooth extraction; may repeat dosage every 12-24 hours until bleeding is resolved.
• Recombinant: 60-80 units/kg intravenous to achieve adequate factor VIII level for minor surgery, including tooth extraction; a single infusion plus oral antifibrinolytic therapy within 1 hour is sufficient in approximately 70% of cases
• Xyntha: An intravenous dose sufficient to achieve Factor VIII activity within 30-60% of normal every 12-24 hours for 3-4 days or until adequate local hemostasis is achieved; for tooth extraction, a single infusion plus oral antifibrinolytic therapy within 1 hour may be sufficient.
• Nuwiq: An Intravenous dose sufficient to achieve Factor VIII activity within 80-100% of normal pre- and postoperatively; may repeat every 24 hours for at least 1 day until healing is achieved.
• Kovaltry: An intravenous dose sufficient to achieve Factor VIII activity within 30-60% of normal pre- and postoperatively; may repeat every 24 hours for at least 1 day until healing is achieved.
• Afstyla: An intravenous dose sufficient to achieve Factor VIII activity within 30-60% of normal pre- and postoperatively; may repeat every 24 hours for at least 1 day until healing is achieved.
• Jivi: 15-30 IU/kg intravenous to achieve factor VIII level of 30-60% of normal for minor surgery (. g, tooth extraction); may repeat dosage every 24 hours for at least 1 day until healing is achieved.
• Esperoct: 50 IU/kg; additional dose(s) may be administered after 24 hours if necessary.
• Altuviiio: Single dose of 50 IU/kg intravenous; may consider an additional dose of 30 or 50 IU/kg after 2-3 days.

Major surgery

• Advate: 40-60 units/kg intravenous preoperatively to achieve factor VIII level of 80-120% of normal pre- and postoperatively for major surgery, including intracranial, intra-abdominal, or intrathoracic surgery, and joint replacement surgery; repeat every 8-24hours, depending on the desired level of factor VIII and state of wound healing.
• Eloctate: 40-60 units/kg intravenous preoperatively to achieve factor VIII level of 80-120% of normal pre- and postoperatively for major surgery, including intracranial, intra-abdominal, and joint replacement surgery; repeat dose of 40-50 units/kg after 8-24hours and then every 24hours until adequate wound healing, then continue therapy for at least 7 days to maintain a Factor VIII activity within the target range.
• Helixate FS, Kogenate FS: 50 units/kg intravenous preoperatively to achieve factor VIII level of 100% of normal perioperatively for major surgery, including tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, trauma; repeat dose every 6-12 hours to maintain a Factor VIII activity within the target range until healing is complete.
• Recombinant: 80-100 units/kg intravenous preoperatively and postoperatively for major surgery; repeat dose every 8-24 hours depending on the state of healing.
• Xyntha: An intravenous dose sufficient to achieve Factor VIII activity within 60-100% of normal every 8-24 hours until the threat is resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.
• Nuwiq: An intravenous dose sufficient to achieve Factor VIII activity within 30-60% of normal pre- and postoperatively for major surgery including intracranial, intraabdominal, or joint replacement therapy; may repeat every 8-24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a Factor VIII activity of 30-60% (IU/dL)
• Kovaltry: An intravenous dose sufficient to achieve Factor VIII activity within 80-100% of normal pre- and postoperatively for major surgery including intracranial, intraabdominal, intrathoracic, or joint replacement therapy; may repeat q8-24hr until adequate wound healing, then continue therapy for at least another 7 days to maintain a Factor VIII activity of 30-60% (IU/dL)
• Afstyla: An intravenous dose sufficient to achieve Factor VIII activity within 80-100% of normal pre- and postoperatively for major surgery including intracranial, intraabdominal, intrathoracic, or joint replacement therapy; may repeat every 8-24hr until adequate wound healing, then continue therapy for at least another 7 days to maintain a Factor VIII activity of 30-60% (IU/dL)
• Jivi: 40-50 IU/kg intravenous to achieve factor VIII level of 80-100% of normal for major surgery (. g, intracranial, intra-abdominal, or joint replacement); may repeat dosage every 12-24 hours for at least 1 day until adequate wound healing complete, then continue therapy for at least another 7 days to maintain Factor VIII activity of 30-60% (IU/dL)
• Esperoct: 50 IU/kg; additional doses can be administered approximately 24 hours for the first week and then approximately every 48 hours until wound healing has occurred.
• Altuviiio: Single dose of 50 IU/kg intravenous; additional doses of 30 or 50 IU/kg every 2-3 days may be administered as clinically needed.

Routine prophylaxis dose

• NovoEight: 20-50 IU/kg intravenous 3 per week, OR 20-4 IU/kg intravenous every other day
• Kogenate FS: 25 IU/kg intravenous 3 per week
• Advate: 20-50 IU/kg intravenous every other day, OR every 3rd day dosing targeted to maintain FVIII trough levels above 1%
• Eloctate: 50 IU/kg intravenous every 4 days; adjust based on patient response (range: 24-65 IU/kg at 3–5-day intervals)
• Nuwiq: 30-40 IU/kg intravenous every other day
• Adynovate: 40-50 IU/kg intravenous 2 per week; adjust dose based on clinical response.
• Kovaltry (adults and adolescents): 20-40 IU/kg intravenous 2-3 per week
• Afstyla (adults and adolescents): 20-50 IU/kg intravenous 2-3 times per week
• Jivi: 30-40 IU/kg intravenous 2 per week; based on bleeding episodes, may adjust to 45-60 IU/kg every 5 days; may further individually adjust to less or more frequent dosing.
• Esperoct: 50 IU/kg intravenous every 4 days; may further individually adjust to less or more frequent dosing.
• Xyntha: 30 IU/kg intravenous 3 per week; adjust dose based on clinical response
• Altuviiio: 50 IU/kg intravenous once weekly; allow at least 72 hours between the last 50 IU/kg dose for treatment of a bleed and resuming prophylaxis dosing.

Pediatric dosage

• Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) for  0.5 (IU/kg per IU/dL)
• Bleeding episodes, FVIII level required.
• Mild hemorrhage: 20-40 IU/dL peak (700-1400 IU for 70 kg); begin infusions every 12-24 hours for 1-3 days until resolved.
• Moderate hemorrhage: 30-60 IU/dL peak (1050-2100 IU for 70 kg); repeat infusions every 12-24 hours for 3 days or more until resolved.
• Severe/life-threatening hemorrhage: 60-100 IU/dL peak (2100-3500 IU for 70 kg); repeat infusions every 8-24 hours until resolved.

Bleeding episodes (Eloctate)

• Mild/moderate hemorrhage: 20-30 IU/kg Intravenous; repeat every 24-48 hours (age below 6 years give every 12-24 hours) until resolved; 40-60 IU/dL FVIII level required.
• Severe hemorrhage: 40-50 IU/kg Intravenous; repeat every 12-24 hours (age below 6 years give every 8-24 hours) until resolved (approximately7-10 days); 80-100 IU/dL FVIII level required.

Bleeding episodes (Nuwiq)

• Aged 2-17 years.
  • Mild hemorrhage: A dose sufficient to achieve factor VIII activity of 20-40% of normal for superficial muscle or soft tissue and oral bleeds; may repeat dose every 12-24 hours for at least 1 day until bleeding episode resolved.
  • Moderate hemorrhage: A dose sufficient to achieve factor VIII activity of 30-60% of normal for hemorrhage into muscles, into the oral cavity, hemarthrosis, or known trauma; may repeat dose every 12-24 hours for at least 3-4 days until bleeding episode resolved.
  • Severe hemorrhage: A dose sufficient to achieve factor VIII activity of 60-100% of normal for Intracranial, intraabdominal, GI, or intrathoracic bleeds, central nervous system bleeds, bleeding in retropharyngeal spaces or iliopsoas sheath, eyes/retina, fractures or head trauma; may repeat dose 8-24 hours until bleeding risk resolved

Bleeding episodes (Adynovate)

• Children (below 12 years) have demonstrated higher clearance, a shorter half-life, and lower incremental recovery of factor VIII compared to adults; dose adjustment or more frequent dosing based on per kg body weight may be needed in this population.
• Mild hemorrhage: 10-20 IU/kg to achieve factor VIII activity of 20-40% of normal for superficial muscle or soft tissue and minor oral bleeds; may repeat dose every 12-24 hours for at least 1 day, until bleeding episode resolved
• Moderate hemorrhage: 15-30 IU/kg to achieve factor VIII activity of 30-60% of normal for moderate hemorrhage in the oral cavity, definite hemarthroses, and known trauma; may repeat dose every 12-24hr until bleeding episode resolved.
• Severe hemorrhage: 30-50 IU/kg to achieve factor VIII activity of 60-100% of normal for severe hemorrhage including GI bleeding, intracranial, intraabdominal or intrathoracic, CNS, bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, fractures, head trauma; may repeat dose every 8-24hours until bleeding episode resolved

Bleeding episodes (Kovaltry)

• Aged below 12 years.
  • Mild hemorrhage: A dose sufficient to achieve factor VIII activity of 20-40% of normal for early hemarthrosis, minor muscle bleeding, or oral bleeds; may repeat dose every 12-24 hours for at least 1 day, until bleeding episode resolved.
  • Moderate hemorrhage: A dose sufficient to achieve factor VIII activity of 30-60% of normal for more extensive hemarthrosis, muscle bleeding, or hematoma; may repeat dose every 12-24 hours for at least 3-4 days until bleeding episode resolved.
  • Severe hemorrhage: A dose sufficient to achieve factor VIII activity of 60-100% of normal for intracranial, intraabdominal, GI, or intrathoracic bleeds, central nervous system bleeds, bleeding in retropharyngeal spaces or iliopsoas sheath, life or limb-threatening hemorrhage; may repeat dose 8-24 hours until bleeding risk resolved.

Bleeding episodes (Afstyla)

All ages

1. Mild hemorrhage: A dose sufficient to achieve factor VIII activity of 20-40% of normal for early hemarthrosis, minor muscle bleeding, or oral bleeds; may repeat dose every 12-24 hours for at least 1 day, until bleeding episode resolved.
2. Moderate hemorrhage: A dose sufficient to achieve factor VIII activity of 30-60% of normal for more extensive hemarthrosis, muscle bleeding, or hematoma; may repeat dose every 12-24hr for at least 3-4 days until bleeding episode resolved.
3. Severe hemorrhage: A dose sufficient to achieve factor VIII activity of 60-100% of normal for intracranial, intraabdominal, GI, or intrathoracic bleeds, central nervous system bleeds, bleeding in retropharyngeal spaces or iliopsoas sheath, life or limb-threatening hemorrhage; may repeat dose 8-24 hours until bleeding risk resolved

Bleeding episodes (Jivi)

• Below 12 years: Safety and efficacy not established.
  • There is a higher rate of hypersensitivity in children aged below 12 years owing to the immune response to PEG
• Above 12 years
  • Mild hemorrhage: 10-20 IU/kg intravenous to achieve factor VIII activity of 20-40% of normal for early hemarthrosis, superficial muscle or soft tissue, and minor oral bleeds; may repeat dose every 24-48hours until bleeding episode resolved.
  • Moderate hemorrhage: 15-30 IU/kg intravenous to achieve factor VIII activity of 30-60% of normal for more extensive hemarthrosis, muscle bleeding, or hematoma; may repeat dose every 24-48hours until bleeding episode resolved.
  • Severe hemorrhage: 30-50 IU/kg intravenous to achieve factor VIII activity of 60-100% of normal for major hemorrhage including GI bleeding, intracranial, intraabdominal or intrathoracic, CNS, bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, live- or limb-threatening hemorrhage; may repeat dose every 8-24hours until bleeding episode resolved

Bleeding episodes (Esperoct)

• Aged above 12 years:
  • Mild hemorrhage: 40 IU/kg; 1 dose is typically sufficient.
  • Moderate hemorrhage: 40 IU/kg; an additional dose may be administered after 24 hours.
  • Severe hemorrhage: 50 IU/kg; additional doses may be administered approximately every 24 hours.
• Aged below 12 years.
  • Mild hemorrhage: 65 IU/kg; 1 dose is typically sufficient.
  • Moderate hemorrhage: 65 IU/kg; an additional dose may be administered after 24 hours.
  • Severe hemorrhage: 65 IU/kg; additional doses may be administered approximately 24 hours.

Bleeding episodes (Altuviiio)

All ages

• Mild/moderate hemorrhage: Single dose of 50 IU/kg intravenous; if a bleeding episode occurs within 2-3 days after the prophylactic dose, 30 IU/kg dose may be used; may consider additional doses of 30 or 50 IU/kg every 2-3 days.
• Severe hemorrhage: Single dose of 50 IU/kg intravenous; may consider additional doses of 30 or 50 IU/kg every 2-3 days.
• Perioperative management, FVIII level required.
• Minor surgery: Target of 60-100 IU/dL peak (2100-3500 IU for 70 kg); single bolus within 1 hour of operation; additional dosing every 12-24hours PRN for bleeding
• Major surgery: Target of 80-100 IU/dL peak (2800-4200 IU for 70 kg) preop and postop; repeat infusion every 6-12hours PRN for wound healing

Perioperative management (Eloctate)

• Minor surgery: 25-40 IU/kg intravenous; repeat every 24 hours (age below 6 years every 12-24 hours) for at least 1 day until healing is achieved; 50-80 IU/dL FVIII level required.
• Major surgery: 40-60 IU/kg intravenous preop; repeat 40-50 IU/kg after 8-24 hours (age below 6 years every 6-24hours), and then once a day until adequate wound healing, then continue for at least 7 days; 80-120 IU/dL FVIII level required.

Perioperative management (Nuwiq)

• Aged 2-17 years:
  • Minor surgery: An intravenous dose sufficient to achieve Factor VIII activity within 80-100% of normal pre- and postoperatively; may repeat q24hr for least 1 day until healing is achieved.
  • Major surgery: An IV dose sufficient to achieve Factor VIII activity within 30-60% of normal pre- and postoperatively for major surgery including intracranial, intraabdominal, or joint replacement therapy; may repeat every 8-24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a Factor VIII activity of 30-60% (IU/dL)

Perioperative management (Adynovate)

• Children (below 12 years) have demonstrated higher clearance, a shorter half-life, and lower incremental recovery of factor VIII compared to adults; dose adjustment or more frequent dosing based on per kg body weight may be needed in this population
• Minor surgery: An Intravenous dose of 30-50 IU/kg sufficient to achieve Factor VIII activity within 60-100% of normal pre- and postoperatively; may repeat every 24 hours for at least 1 day until healing is achieved.
• Major surgery: An Intravenous dose of 40-60 IU/kg sufficient to achieve Factor VIII activity within 80-120% of normal pre- and postoperatively within 1 hour before the operation for major surgery including intracranial, intraabdominal, or joint replacement therapy; may repeat every 8-24 hours (every 6-24 hours for children below 12 years) until adequate wound healing

Perioperative management (Kovaltry)

• Aged below 12 years:
  • Minor surgery: An Intravenous dose sufficient to achieve Factor VIII activity within 30-60% of normal pre- and postoperatively; may repeat every 24 hours for at least 1 day until healing is achieved.
  • Major surgery: An IV dose sufficient to achieve Factor VIII activity within 80-100% of normal pre- and postoperatively for major surgery including intracranial, intraabdominal, intrathoracic, or joint replacement therapy; may repeat every 8-24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a Factor VIII activity of 30-60% (IU/dL)

Perioperative management (Afstyla)

Any age

• Minor surgery: An IV dose sufficient to achieve Factor VIII activity within 30-60% of normal pre- and postoperatively; may repeat every 24 hours for at least 1 day until healing is achieved.
• Major surgery: An IV dose sufficient to achieve Factor VIII activity within 80-100% of normal pre- and postoperatively for major surgery including intracranial, intraabdominal, intrathoracic, or joint replacement therapy; may repeat every 8-24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a Factor VIII activity of 30-60% (IU/dL)

Perioperative management (Jivi)

• Below 12 years: Safety and efficacy not established.
  • There is a higher rate of hypersensitivity in children aged below 12 years owing to the immune response to PEG.
• Below 12 years
  • Minor surgery: 15-30 IU/kg intravenous to achieve factor VIII level of 30-60% of normal for minor surgery (. g, tooth extraction); may repeat dosage every 24 hours for at least 1 day until healing is achieved.
  • Major surgery: 40-50 IU/kg intravenous to achieve factor VIII level of 80-100% of normal for major surgery (. g, intracranial, intra-abdominal, or joint replacement); may repeat dosage q12-24hr for at least 1 day until adequate wound healing complete, then continue therapy for at least another 7 days to maintain Factor VIII activity of 30-60% (IU/dL)

Perioperative management (Esperoct)

• Aged above 12 years:
  • Minor surgery: 50 IU/kg; additional dose(s) may be administered after 24 hours if necessary.
  • Major surgery: 50 IU/kg; additional doses can be administered approximately every 24 hours for the first week and then approximately every 48 hours until wound healing has occurred.
• Aged below 12 years:
  • Minor surgery: 65 IU/kg; additional dose(s) may be administered after 24 hours if necessary.
  • Major surgery: 65 IU/kg; additional doses can be administered approximately 24 hours for the first week and then approximately 48 hours until wound healing has occurred.

Perioperative management (Altuviiio)

All ages

• Minor surgery: Single dose of 50 IU/kg intravenous; may consider an additional dose of 30 or 50 IU/kg after 2-3 days.
• Major surgery: Single dose of 50 IU/kg intravenous; additional doses of 30 or 50 IU/kg every 2-3 days may be administered as clinically needed.

Routine prophylaxis dose

• Children have higher factor VIII clearance compared with adults and may require larger or more frequent dosing
• NovoEight (below 12 years): 25-60 IU/kg intravenous 3 per week, OR 25-50 IU/kg intravenous every other day
• NovoEight (above 12 years): 20-50 IU/kg intravenous 3 per week, OR 20-40 IU/kg Intravenous every other day
• Kogenate FS, Helixate FS: 25 IU/kg intravenous every other day
• Advate: 20-50 IU/kg intravenous every other day
• Eloctate: 50 IU/kg Intravenous every 4 days; adjust based on patient response (range: 24-65 IU/kg at 3–5-day intervals); more frequent or higher doses up to 80 IU/kg may be required for children aged below 6 years.
• Nuwiq (2-11 years): 30-50 IU/kg intravenous every other day or 3 per week
• Nuwiq (12-17 years): 30-40 IU/kg intravenous every other day
• Adynovate (above 12 years): 40-50 IU/kg intravenous 2 per week; adjust dose based on clinical response.
• Adynovate (below 12 years): 55 IU/kg intravenous 2 per week; adjust dose based on clinical response, not to exceed 70 IU/kg.
• Kovaltry (below 12 years): 25-50 IU/kg intravenous 2-3 per week or every other day according to individual requirements
• Afstyla (below 12 years): 30-50 IU/kg intravenous 2-3 times per week Afstyla (above 12 years): 20-50 IU/kg intravenous 2-3 times per week
• Jivi above 12 years): 30-40 IU/kg intravenous 2 per week; based on bleeding episodes, may adjust to 45-60 IU/kg every 5 days; may further individually adjust to less or more frequent dosing.
• Esperoct (below 12 years): 65 IU/kg intravenous 2 per week; may further individually adjust to less or more frequent dosing.
• Esperoct (above 12 years): 50 IU/kg intravenous every 4 days; may further individually adjust to less or more frequent dosing.
• Xyntha (above 12 years): 30 IU/kg intravenous 3 per week; adjust dose based on clinical response.
• Xyntha (below 12 years): 25 IU/kg intravenous every other day; adjust dose based on clinical response.
• Altuviiio (all ages): 50 IU/kg IV once weekly; allow at least 72 hours between the last 50 IU/kg dose for treatment of a bleed and resuming prophylaxis dosing.

Hemophilia A, Acquired

Adult dosage

• Obizur: Porcine sequence product indicated for the treatment of bleeding episodes in adults with acquired hemophilia.
• Initial: 200 units/kg; infuse intravenously at a rate of 1-2 mL/min

Subsequent dosing

• May repeat every 4-12 hours.
• Titrate dose and frequency of administration based on factor VIII recovery levels and individual clinical response.
• Maintain the factor VIII activity within the target range; plasma levels of factor VIII should not exceed 200% of normal or 200 units/dL.
• FVIII level required:
  • Minor/moderate, superficial muscle, no neurovascular compromise, and joint: 50-100 U/dL
  • Major, moderate to severe IM bleeding, retroperitoneal, GI, intracranial:
  • Acute major bleed: 100-200 U/dL
  • After acute major bleed controlled (if required): 50-100 U/dL
• Limitations of use
  • Safety and efficacy are not established in patients with a baseline anti-porcine factor VIII inhibitor titer above 20 BU.
  • Not indicated for the treatment of congenital hemophilia A or von Willebrand disease

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Antihemophilic Factor Recombinant has no noted severe interactions with any other drugs.
• Antihemophilic Factor Recombinant has no noted serious interactions with any other drugs.
• Antihemophilic Factor Recombinant has no noted moderate interactions with any other drugs.
• Antihemophilic Factor Recombinant has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to mouse or hamster protein, or intolerance or allergic reaction to any components, including hamster proteins.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Antihemophilic Factor Recombinant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Antihemophilic Factor Recombinant?”

Cautions

• Use serial Factor VIII assays during treatment whenever possible to assure adequate Factor VIII levels are achieved and maintained.
• Some products may contain the Willebrand factor for stabilization; efficacy is not established for the treatment of Willebrand disease.
• Clinical response to antihemophilic factor administration may vary; dosage must be individualized based on clinical response and coagulation studies, performed before treatment and at regular intervals during treatment.
• May form antibodies to mouse or hamster protein.
• Monitoring laboratory tests
• Use individual factor VIII values for recovery and, if clinically indicated, other pharmacokinetic characteristics to guide dosing and administration
• Monitor plasma factor VIII activity levels by the one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and are maintained when clinically indicated.
• Monitor for development of factor VIII inhibitors; perform an assay to determine if factor VIII inhibitor is present when expected factor VIII activity plasma levels are not attained, or when bleeding is not controlled with the expected dose.
• Use Bethesda Units (BU) to titer inhibitors.

Pregnancy and Lactation

• No data are available on pregnant women.
• Lactation
  • No data are available regarding the presence of human milk, the effects on the breastfed infant, or the effects on milk production.