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Factor VIIa (activated), recombinant human: Drug information

Factor VIIa (activated), recombinant human: Drug information
(For additional information see "Factor VIIa (activated), recombinant human: Patient drug information" and see "Factor VIIa (activated), recombinant human: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Thrombosis:

Serious arterial and venous thrombotic events following administration of Factor VIIa (recombinant) have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive Factor VIIa (recombinant). Monitor patients for signs and symptoms of activation of the coagulation system and for thrombosis.

Brand Names: US
  • NovoSeven RT;
  • Sevenfact
Brand Names: Canada
  • NiaStase RT
Pharmacologic Category
  • Antihemophilic Agent
Dosing: Adult
Acquired hemophilia

Acquired hemophilia: IV:

NovoSeven RT:

Bleeding episodes: 70 to 90 mcg/kg/dose every 2 to 3 hours until hemostasis is achieved.

Perioperative management: 70 to 90 mcg/kg/dose immediately before surgery; repeat every 2 to 3 hours for the duration of surgery and until hemostasis achieved.

Congenital factor VII deficiency

Congenital factor VII deficiency: IV:

NovoSeven RT:

Bleeding episodes: 15 to 30 mcg/kg/dose every 4 to 6 hours until hemostasis is achieved. Doses as low as 10 mcg/kg have been effective.

Perioperative management: 15 to 30 mcg/kg/dose immediately before surgery; repeat every 4 to 6 hours for the duration of surgery and until hemostasis achieved. Doses as low as 10 mcg/kg have been effective.

Congenital hemophilia A or B with inhibitors

Congenital hemophilia A or B with inhibitors: IV:

NovoSeven RT:

Bleeding episodes: 90 mcg/kg/dose every 2 hours until hemostasis is achieved or until the treatment is judged ineffective (Ref). The dose, interval, and duration of therapy may be adjusted based upon the severity of bleeding and the degree of hemostasis achieved. For patients experiencing severe bleeds, dosing should be continued at 3- to 6-hour intervals post-hemostasis. The duration of any post-hemostatic dosing should be minimized (Ref).

Perioperative management: 90 mcg/kg/dose immediately before surgery (additional bolus doses may be administered for major surgery if required); repeat at 2-hour intervals for the duration of surgery. For minor surgery, continue 90 mcg/kg/dose postoperatively every 2 hours for 48 hours, then every 2 to 6 hours until healed. For major surgery, continue 90 mcg/kg/dose postoperatively every 2 hours for 5 days, then every 4 hours or by continuous infusion at 50 mcg/kg/hour until healed.

Secondary prophylaxis of bleeding events (off-label use): 90 mcg/kg once daily. In a clinical trial, male patients with frequent bleeds (mean ≥4 bleeding events per month requiring hemostatic therapy) received prophylaxis for a duration of 3 months (Ref).

SevenFact:

Note: Maximum dosage has not been established; cumulative daily dosages >900 mcg/kg, which may be associated with a greater risk of thromboembolic complications, have not been studied.

Mild to moderate bleeding (eg, joint, superficial muscle, soft tissue and mucous membranes): 75 mcg/kg every 3 hours until hemostasis is achieved OR initial dose of 225 mcg/kg and if hemostasis is not achieved within 9 hours, administer 75 mcg/kg every 3 hours as needed to achieve hemostasis. If successful control of bleeding does not occur within 24 hours of initial administration, consider alternative treatments. Continue therapy to support healing and prevent recurrent hemorrhage after hemostasis to maintain the hemostatic plug.

Severe bleeding (eg, life- or limb-threatening hemorrhage, iliopsoas and deep muscle with neurovascular injury, retroperitoneum, intracranial, or GI): Initial: 225 mcg/kg, then 6 hours later (if needed) administer 75 mcg/kg every 2 hours until hemostasis is achieved; continue therapy to support healing and prevent recurrent hemorrhage.

Glanzmann thrombasthenia

Glanzmann thrombasthenia: IV:

NovoSeven RT:

Bleeding episodes (severe, refractory to platelet transfusions): 90 mcg/kg/dose every 2 to 6 hours until hemostasis is achieved.

Perioperative management: 90 mcg/kg/dose immediately before surgery; repeat at 2-hour intervals for the duration of surgery. Continue 90 mcg/kg/dose every 2 to 6 hours to prevent postoperative bleeding. Note: Higher doses (100 to 140 mcg/kg) may be used for surgical patients who have clinical refractoriness with or without platelet-specific antibodies compared to those with neither.

Intracranial hemorrhage associated with danaparoid

Intracranial hemorrhage associated with danaparoid (off-label use):

Note: Dosing based on NovoSeven RT studies.

IV: 90 mcg/kg once (Ref).

Intracranial hemorrhage associated with low molecular weight heparin

Intracranial hemorrhage associated with low molecular weight heparin (if protamine is contraindicated) (alternative agent) (off-label use):

Note: Not for use in patients with intracranial hemorrhage receiving prophylactic low molecular weight heparin. Dosing based on NovoSeven RT studies.

IV: 90 mcg/kg once (Ref).

Refractory bleeding after cardiac surgery in nonhemophiliac patients

Refractory bleeding after cardiac surgery in nonhemophiliac patients (off-label use):

Note: Dosing not established; recommendations based on low-quality evidence (case series, observational studies using NovoSeven RT).

IV: Initial range of ~11 to 22 mcg/kg/dose (median ~17 mcg/kg) has been used (Ref); others have used a range of ~35 to 72 mcg/kg/dose (median ~49 mcg/kg) (Ref). For persistent bleeding, 1 or 2 additional doses may be required in some patients (Ref). In patients with a left ventricular assist device, a single lower dose of 10 to 20 mcg/kg may be preferred to reduce thromboembolic events (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided the in manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Factor VIIa (activated), recombinant human: Pediatric drug information")

Hemophilia A or B with inhibitors

Hemophilia A or B (congenital) with inhibitors: Note: Dose, frequency and duration of therapy should be individualized based on severity of the bleeding, need for urgent hemostasis, and prior patient response to factor VIIa bypassing agents in previous bleeding events.

NovoSeven RT:

Bleeding episodes: Infants, Children, and Adolescents: IV: 90 mcg/kg/dose every 2 hours until hemostasis is achieved or until the treatment is judged ineffective. Doses between 35 to 90 mcg/kg have been used successfully in clinical trials. The dose, frequency, and duration of therapy should be adjusted based on severity of bleeding and the degree of hemostasis achieved. For patients experiencing severe bleeds to maintain the hemostatic plug, dosing should be continued at 3- to 6-hour intervals; the duration of post-hemostatic dosing has not been studied. Monitor and minimize the duration of post-hemostatic dosing.

Perioperative management: Infants, Children, and Adolescents: IV: 90 mcg/kg immediately before surgery (additional bolus doses may be administered for major surgery if required); repeat at 2-hour intervals for the duration of surgery. For minor surgery, continue 90 mcg/kg/dose every 2 hours for 48 hours, then every 2 to 6 hours until healing achieved. For major surgery, continue 90 mcg/kg/dose every 2 hours for 5 days, then every 4 hours or by continuous infusion at 50 mcg/kg/hour until healing achieved.

Secondary prophylaxis of bleeding events: Very limited data available: Children ≥5 years and Adolescents: IV: 90 mcg/kg/dose OR 270 mcg/kg/dose once daily (Ref). Dosing based on a trial which enrolled 22 male patients, including 16 pediatric patients (age: 5 to <18 years), with severe congenital hemophilia with high inhibitor titers, a need for treatment with bypassing agents, and who had experienced at least 4 bleeds requiring hemostatic therapy the previous month. Patients were randomized to receive either 90 mcg/kg/dose or 270 mcg/kg/dose IV daily as prophylaxis for 3 months. The overall bleeding frequency was reduced by 45% and 59% in the 90 mcg/kg group and the 270 mcg/kg group, respectively, with the most significant decrease was seen in joint bleeds. No thromboembolic events were reported (Ref).

SevenFact: Note: Maximum dosage has not been established; cumulative daily dosages >900 mcg/kg, which may be associated with a greater risk of thromboembolic complications, have not been studied. The dose, frequency, and duration of therapy should be adjusted based on patient's response to therapy and the degree of hemostasis achieved.

Children ≥12 years and Adolescents:

Mild to moderate bleeding (eg, joint, superficial muscle, soft tissue and mucous membranes): IV: 75 mcg/kg/dose every 3 hours until hemostasis is achieved OR initial dose of 225 mcg/kg and if hemostasis is not achieved within 9 hours, administer 75 mcg/kg/dose every 3 hours as needed to achieve hemostasis. If successful control of bleeding does not occur within 24 hours of initial administration, consider alternative treatments. Continue therapy to support healing and prevent recurrent hemorrhage after hemostasis to maintain the hemostatic plug. Duration of therapy should be individualized by site and severity of bleeding.

Severe bleeding (eg, life- or limb-threatening hemorrhage, iliopsoas and deep muscle with neurovascular injury, retroperitoneum, intracranial, or GI): IV: Initial: 225 mcg/kg/dose, then 6 hours later (if needed) administer 75 mcg/kg/dose every 2 hours until hemostasis is achieved; continue therapy to support healing and prevent recurrent hemorrhage. Duration of therapy should be individualized based on site and severity of bleeding and use of other procoagulant therapies. Consider the risk of thrombosis with subsequent dosing after hemostasis achieved.

Congenital factor VII deficiency

Congenital factor VII deficiency:

NovoSeven RT: Infants, Children, and Adolescents: IV:

Bleeding episodes: 15 to 30 mcg/kg/dose every 4 to 6 hours until hemostasis is achieved. Doses as low as 10 mcg/kg/dose have been effective. Adjust dose and frequency to each individual patient.

Perioperative management: 15 to 30 mcg/kg immediately before surgery; repeat every 4 to 6 hours for the duration of surgery and until hemostasis achieved. Doses as low as 10 mcg/kg/dose have been effective. Adjust dose and frequency to each individual patient.

Glanzmann thrombasthenia

Glanzmann thrombasthenia:

NovoSeven RT: Infants, Children, and Adolescents: IV:

Bleeding episodes, severe (refractory to platelet transfusions): 90 mcg/kg/dose every 2 to 6 hours until hemostasis is achieved.

Perioperative management: 90 mcg/kg immediately before surgery; repeat at 2-hour intervals for the duration of surgery. Continue 90 mcg/kg/dose every 2 to 6 hours to prevent postoperative bleeding. Note: Higher doses of 100 to 140 mcg/kg can be used for surgical patients who have clinical refractoriness with or without platelet-specific antibodies.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Hypertension (2%), thrombosis (≤4%; including internal jugular thrombosis)

Endocrine & metabolic: Decreased serum fibrinogen (2%)

Immunologic: Antibody development

Local: Discomfort at injection site, hematoma at injection site, infusion site reaction

Nervous system: Dizziness, headache (1%), intracranial hypertension (1%)

Neuromuscular & skeletal: Hemarthrosis (acute, postoperative: 2%)

Miscellaneous: Fever (1% to 4%)

<1%:

Cardiovascular: Acute myocardial infarction, angina pectoris, cerebral ischemia, cerebrovascular accident, deep vein thrombosis, localized phlebitis, occlusion of cerebral arteries, pulmonary embolism, shock

Gastrointestinal: Nausea

Respiratory: Dyspnea

Frequency not defined:

Cardiovascular: Arterial thrombosis, deep vein thrombophlebitis, venous thrombosis

Hematologic & oncologic: Disseminated intravascular coagulation

Hepatic: Abnormal liver function

Hypersensitivity: Anaphylactic shock

Nervous system: Cerebrovascular disease, pain

Contraindications

NovoSeven RT: There are no contraindications listed in the manufacturer's labeling.

SevenFact: Severe hypersensitivity to factor VIIa (recombinant)-jncw or any component of the formulation; known allergy to rabbits or rabbit proteins.

Canadian labeling: Additional contraindications (not in the US labeling): Known hypersensitivity to eptacog alfa (activated), any component of the formulation, or to mouse, hamster, or bovine protein.

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: If factor VIIa activity does not reach the expected level, prothrombin time is not corrected, or bleeding is uncontrolled (with recommended doses), suspect antibody formation and perform antibody analysis. Prothrombin time and factor VII coagulant activity should be measured before and after administration in patients with factor VII deficiency.

• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have been reported with use. Patients with known hypersensitivity to rabbit, mouse, hamster, or bovine proteins, or IgE-based hypersensitivity to casein may be at higher risk. If hypersensitivity reaction occurs, discontinue use and administer appropriate treatment.

• Thromboembolic events: [US Boxed Warning]: Serious arterial and venous thrombotic events following administration of Factor VIIa (recombinant) have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive factor VIIa (recombinant). Monitor patients for signs and symptoms of activation of the coagulation system and for thrombosis. All patients receiving factor VIIa should be monitored for signs and symptoms of activation of the coagulation system or thrombosis; thrombotic events may be increased in patients with history of congenital or acquired hemophilia receiving concomitant treatment with activated or nonactivated prothrombin complex or other hemostatic agents, older patients with acquired hemophilia receiving other hemostatic agents, or patients with a history of atherosclerotic or coronary artery disease, cerebrovascular disease, crush injury, septicemia, or thromboembolism. Decreased dosage or discontinuation is warranted with confirmed intravascular coagulation or presence of clinical thrombosis.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Reduced efficacy: A number of factors influence the efficacy of factor VIIa, including hypothermia, thrombocytopenia, acidosis, and the amount of blood products transfused prior to administration (Dunkley 2008).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Sevenfact: Factor VIIa, recombinant-jncw 1 mg (1 ea); Factor VIIa, recombinant-jncw 5 mg (1 ea) [contains polysorbate 80]

Solution Reconstituted, Intravenous [preservative free]:

NovoSeven RT: 1 mg (1 ea); 2 mg (1 ea); 5 mg (1 ea); 8 mg (1 ea) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (NovoSeven RT Intravenous)

1 mg (0 Price provided is per microgram): $3.22

2 mg (0 Price provided is per microgram): $3.22

5 mg (0 Price provided is per microgram): $3.22

8 mg (0 Price provided is per microgram): $3.22

Solution (reconstituted) (Sevenfact Intravenous)

1 mg (0 Price provided is per microgram): $3.07

5 mg (0 Price provided is per microgram): $3.07

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

NiaStase RT: 1 mg (1 ea); 2 mg (1 ea); 5 mg (1 ea) [contains polysorbate 80]

Administration: Adult

NovoSeven RT:

IV bolus: Administer over 2 to 5 minutes (depending on the dose). Use NS to flush line (if necessary) before and after administration.

IV infusion: May be infused as a continuous IV infusion for perioperative management of major bleeding in patients with congenital hemophilia A or B. Continuous infusions should be infused via an infusion pump.

SevenFact:

IV bolus: Administer over ≤2 minutes.

Administration: Pediatric

Parenteral: IV administration only:

NovoSeven RT: Use NS to flush line (if necessary) before and after administration.

Intermittent IV: Administer as a slow bolus over 2 to 5 minutes. Do not mix with other infusion solutions.

Continuous IV infusion: May be infused as a continuous IV infusion for perioperative management of major bleeding in patients with congenital hemophilia A or B. Continuous infusions should be infused via an infusion pump.

SevenFact: Intermittent IV: Administer over ≤2 minutes Do not mix with other infusion solutions.

Use: Labeled Indications

Bleeding episodes and perioperative management (NovoSeven RT): Treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital factor VII deficiency, and Glanzmann thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets; treatment of bleeding episodes and perioperative management in adults with acquired hemophilia.

Bleeding episodes (SevenFact): Treatment and control of bleeding episodes in adults and adolescents ≥12 years of age with hemophilia A or B with inhibitors.

Limitation of use: SevenFact is not indicated for the treatment of patients with congenital factor VII deficiency.

Use: Off-Label: Adult

Intracranial hemorrhage associated with danaparoid; Intracranial hemorrhage associated with low molecular weight heparin (if protamine is contraindicated); Refractory bleeding after cardiac surgery in nonhemophiliac patients; Secondary prophylaxis of bleeding events in congenital hemophilia A or B with inhibitors

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Anti-inhibitor Coagulant Complex (Human): May enhance the thrombogenic effect of Factor VIIa (Recombinant). Management: Consider avoiding concomitant use of factor VIIa (recombinant) and activated prothrombin concentrates, such as anti-inhibitor coagulant complex (human), due to an increased risk of developing thrombotic events. Risk D: Consider therapy modification

Concizumab: Factor VIIa (Recombinant) may enhance the thrombogenic effect of Concizumab. Management: Discontinue treatment with recombinant factor VIIa (rFVIIa) at least 12 hours before starting concizumab. If rFVIIa is required as a bypassing agent in a patient receiving concizumab prophylaxis, use the lowest possible effective rFVIIa dose. Risk D: Consider therapy modification

Factor XIII A-Subunit (Recombinant): May enhance the thrombogenic effect of Factor VIIa (Recombinant). Risk C: Monitor therapy

Pregnancy Considerations

Pregnant patients with inherited bleeding disorders, including factor VII deficiency and Glanzmann’s thrombasthenia, may have an increased risk of bleeding following abortion, antenatal procedures, delivery, and miscarriage; close surveillance is recommended. Patients with factor VII deficiency and severe or abnormal bleeding should be treated with recombinant factor VIIa. Patients with Glanzmann’s thrombasthenia and a history of bleeding can be treated prophylactically with recombinant factor VIIa at delivery (RCOG [Pavord 2017).

Breastfeeding Considerations

It is not known if factor VIIa (recombinant) is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Dietary Considerations

Some products may contain sodium.

Monitoring Parameters

Hemoglobin and hematocrit; evidence of hemostasis; blood loss; signs/symptoms of thrombosis. Note: There are no reliable laboratory tests to measure recombinant factor VIIa efficacy. Tests used to monitor hemostatic efficacy, such as PT/INR, aPTT, factor activity assays, and thromboelastography, are not useful. In factor VII deficient patients, monitor for factor VII antibodies if the expected clinical response is not achieved with recommended doses.

Mechanism of Action

Recombinant factor VIIa, a vitamin K-dependent glycoprotein, promotes hemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation factor VII, which complexes with tissue factor and may activate coagulation factor X to Xa and factor IX to IXa. When complexed with other factors, coagulation factor Xa converts prothrombin to thrombin, a key step in the formation of a fibrin-platelet hemostatic plug.

Pharmacokinetics (Adult Data Unless Noted)

Hemophilia:

Distribution: Vss:

NovoSeven RT: Hemophilia A with inhibitors:

Children:

≤5 years: 145 ± 1 mL/kg.

6 to 12 years: 149 ± 22 mL/kg.

Adults: 130 ± 37 mL/kg.

SevenFact: 11.9 to 19.9 L.

Half-life, terminal:

NovoSeven RT: Hemophilia A with inhibitors:

Children:

≤5 years: 1.9 ± 0.6 hours.

6 to 12 years: 3 ± 0.5 hours.

Adults: 3.2 ± 0.3 hours.

SevenFact: 1.4 to 1.7 hours.

Excretion: Clearance:

NovoSeven RT: Hemophilia A with inhibitors:

Children:

≤5 years: 61 ± 9 mL/hour/kg.

6 to 12 years: 52 ± 12 mL/hour/kg.

Adults: 43 ± 15 mL/hour/kg.

SevenFact: 5.8 to 8 L/hour.

Factor VII deficiency: NovoSeven RT:

Distribution: Vss: 230 ± 70 mL/kg.

Half-life, terminal: 2.62 ± 0.63 hours.

Excretion: Clearance: 67.7 ± 17.9 mL/kg/hour.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Novoseven;
  • (AR) Argentina: Novoseven | Novoseven mixpro | Novoseven rt;
  • (AT) Austria: Novoseven;
  • (AU) Australia: Novoseven;
  • (BE) Belgium: Novoseven;
  • (BG) Bulgaria: Novoseven;
  • (BR) Brazil: Novoseven;
  • (CH) Switzerland: Novoseven;
  • (CL) Chile: Novoseven rt;
  • (CN) China: Novoseven;
  • (CO) Colombia: Novoseven | Novoseven rt;
  • (CZ) Czech Republic: Novoseven;
  • (DE) Germany: Novoseven;
  • (EC) Ecuador: Novoseven rt;
  • (EE) Estonia: Novoseven;
  • (EG) Egypt: Novoseven;
  • (ES) Spain: Novoseven;
  • (FI) Finland: Novoseven;
  • (FR) France: Novoseven;
  • (GB) United Kingdom: Novoseven;
  • (GR) Greece: Novoseven;
  • (HK) Hong Kong: Novoseven;
  • (HR) Croatia: Novoseven;
  • (HU) Hungary: Novoseven;
  • (ID) Indonesia: Novoseven;
  • (IL) Israel: Novoseven;
  • (IS) Iceland: Novoseven;
  • (IT) Italy: Novoseven;
  • (JO) Jordan: Novoseven;
  • (JP) Japan: Novoseven;
  • (KE) Kenya: Novoseven;
  • (KR) Korea, Republic of: Novoseven | Novoseven rt;
  • (KW) Kuwait: Novoseven;
  • (LB) Lebanon: Novoseven | Recofact vii;
  • (LT) Lithuania: Novoseven;
  • (LV) Latvia: Novoseven;
  • (MA) Morocco: Novoseven rt;
  • (MX) Mexico: Novoseven | Novoseven rt;
  • (MY) Malaysia: Novoseven;
  • (NL) Netherlands: Novoseven;
  • (NO) Norway: Novoseven;
  • (NZ) New Zealand: Novoseven;
  • (PE) Peru: Novoseven;
  • (PH) Philippines: Novoseven;
  • (PL) Poland: Novoseven;
  • (PR) Puerto Rico: Novoseven;
  • (PT) Portugal: Novoseven;
  • (PY) Paraguay: Novoseven rt;
  • (QA) Qatar: Novoseven;
  • (RU) Russian Federation: Arioseven | Coagil vii;
  • (SA) Saudi Arabia: Novoseven;
  • (SE) Sweden: Novoseven;
  • (SG) Singapore: Novoseven | Novoseven rt;
  • (SI) Slovenia: Novoseven;
  • (SK) Slovakia: Novoseven;
  • (TH) Thailand: Novoseven;
  • (TN) Tunisia: Novoseven;
  • (TR) Turkey: Aryoseven | Novoseven;
  • (TW) Taiwan: Novoseven | Novoseven rt;
  • (UA) Ukraine: Novoseven;
  • (ZA) South Africa: Novoseven
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  22. Pavord S, Rayment R, Madan B, et al; for the Royal College of Obstetricians and Gynaecologists. Management of inherited bleeding disorders in pregnancy: Green-top Guideline No. 71 (joint with UKHCDO). BJOG. 2017;124(8):e193–e263. doi: 10.1111/1471-0528.14592. [PubMed 28447403]
  23. Refer to manufacturer's labeling.
  24. Romagnoli S, Bevilacqua S, Gelsomino S, et al. Small-dose recombinant activated factor VII (NovoSeven) in cardiac surgery. Anesth Analg. 2006;102(5):1320-1326. [PubMed 16632803]
  25. SevenFact (factor VIIa [recombinant]-jncw) [prescribing information]. Louisville, KY: HEMA Biologics; November 2022.
  26. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
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