Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 1mg (NovoSeven RT, Sevenfact)
- 2mg (NovoSeven RT)
- 5mg (NovoSeven RT, Sevenfact)
- 8mg (NovoSeven RT)
Hemophilia A or B
Indicated for treatment of bleeding episodes in hemophilia A or B with inhibitors
Bleeding episodes (NovoSeven RT)
- 90 mcg/kg IV bolus q2hr until hemostasis achieved
- Range: 35-120 mcg/kg q2hr until hemostasis
- Post-hemostatic doses for severe bleeds: Continue with dosing q3-6hr after hemostasis achieved as per clinical judgment
Bleeding episodes (Sevenfact)
-
Mild or moderate
-
Severe
- 225 mcg/kg IV initially; followed if necessary 6 hr later with 75 mcg/kg IV q2hr until hemostasis achieved
- Subsequent dosing: After achieving hemostasis, base decision for dosing on clinical assessment and bleeding type; consider thrombosis risk with subsequent dosing after achieving hemostatic efficacy
Surgical intervention (NovoSeven RT)
- Indicated for prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B with inhibitors and in acquired hemophilia
- 90 mcg/kg IV immediately before intervention, THEN q2hr for surgery duration
- Postsurgical dosing for minor surgery: 90 mcg/kg IV bolus q2h for 48 hr, THEN q2-6 hr until healing has occurred
- Postsurgical dosing for major surgery: 90 mcg/kg IV bolus q2hr for 5 days, THEN q4hr until healing has occurred
Congenital Factor VII Deficiency
NovoSeven RT only
Bleeding episodes or surgery: 15-30 mcg/kg IV bolus q4-6hr until hemostasis achieved
Doses as low as 10 mcg/kg shown to be effective
Acquired Hemophilia
NovoSeven RT only
Bleeding episodes or surgery: 70-90 mcg/kg IV bolus q2-3hr until hemostasis achieved
Glanzmann Thrombasthenia
NovoSeven RT only
Perioperative management of bleeding episodes in patients with Glanzmann's thrombasthenia with refractoriness to platelet transfusions with or without antibodies to platelets
Bleeding episodes: 90 mcg/kg q2-6hr until hemostasis achieved
Peri-operative management
- 90 mcg/kg immediately before surgery and repeat q2hr for duration of procedure
- 90 mcg/kg q2-6hr to prevent post-operative bleeding
Intracranial Hemorrhage (Orphan)
Orphan designation for treatment of bleeding in patients experiencing intracranial hemorrhage
Orphan sponsor
- Novo Nordisk, Inc; 100 College Road West; Princeton, NJ 08540
Alveolar Hemorrhage (Orphan)
Orphan designation for treatment of diffuse alveolar hemorrhage
Orphan sponsor
- PharmaOrigin ApS; Cobis Building, 2200 Copenhagen; Denmark
Long-acting Factor VIIa-CTP (Orphan)
Orphan designation for hemophilia A or B with inhibitors to Factor VIII or Factor IX
This product may be administered SC or IV; SC administration has a longer duration of action and allows for self-administration for prophylaxis
Sponsor: OPKO Health, Inc
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 1mg (NovoSeven RT, Sevenfact)
- 2mg (NovoSeven RT)
- 5mg (NovoSeven RT, Sevenfact)
- 8mg (NovoSeven RT)
Hemophilia A or B
Indicated for treatment of bleeding episodes in hemophilia A or B with inhibitors
NovoSeven RT is approved for all ages of children, whereas Sevenfact is approved for adolescents aged >12 yr
Bleeding episodes (NovoSeven RT)
- As for adults; dosing based on body weight, not age 90 mcg/kg IV bolus q2hr until hemostasis achieved
- Range: 35-120 mcg/kg q2hr until hemostasis
- Post-hemostatic doses for severe bleeds: Continue with dosing q3-6hr after hemostasis achieved as per clinical judgment
Bleeding episodes (Sevenfact)
-
Mild or moderate
-
Severe
- 225 mcg/kg IV initially; followed if necessary 6 hr later with 75 mcg/kg IV q2hr until hemostasis achievedSubsequent dosing: After achieving hemostasis, base decision for dosing on clinical assessment and bleeding type; consider thrombosis risk with subsequent dosing after achieving hemostatic efficacy
Surgical intervention
- NovoSeven RT only
- Indicated for prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B with inhibitors and in acquired hemophilia
- As for adults; dosing based on body weight, not age 90 mcg/kg IV immediately before intervention, THEN q2hr for surgery duration
- Postsurgical dosing for minor surgery: 90 mcg/kg IV bolus q2h for 48 hr, THEN q2-6 hr until healing has occurred
- Postsurgical dosing for major surgery: 90 mcg/kg IV bolus q2hr for 5 days, THEN q4hr until healing has occurred
Congenital Factor VII Deficiency
NovoSeven RT only
As for adults; dosing based on body weight, not age
Bleeding episodes or surgery: 15-30 mcg/kg IV bolus q4-6hr until hemostasis achieved
Doses as low as 10 mcg/kg shown to be effective
Acquired Hemophilia (Off-label)
As for adults; dosing based on body weight, not age
Bleeding episodes or surgery: 70-90 mcg/kg IV bolus q2-3hr until hemostasis achieved
Adverse Effects
1-10%
>1%
- Headache
- Dizziness
- Infusion-site discomfort
- Infusion-site hematoma
- Infusion-related reaction
- Fever
Frequency Not Defined
Plasma fibrinogen decreased
Hypertension
Warnings
Black Box Warnings
Serious arterial and venous thrombotic and thromboembolic events following administration reported
Discuss risks and explain signs and symptoms of thromboembolic events with patients
Monitor for signs or symptoms of activation of the coagulation system and for thrombosis
Contraindications
Sevenfact
- Known allergy to rabbits, rabbit proteins, or any product components; exposure can result in severe hypersensitivity reaction
Cautions
NovoSeven RT: Hypersensitivity to mouse, hamster, bovine protein, or any components of the product
Neutralizing antibodies may develop; if inadequate hemostasis occurs after dosing, suspect development of antibodies and perform testing as clinically indicated
Thromboembolism
- Serious arterial and venous thrombotic reactions can occur with FVIIa
- Risk may be further increased with history of congenital or acquired hemophilia receiving concomitant treatment with aPCC/PCC (activated or non-activated prothrombin complex) or other hemostatic agents; history of atherosclerotic disease, coronary artery disease, cerebrovascular disease, crush injury, septicemia, or thromboembolic event
- Monitor for signs and symptoms
- Consider dose reduction when laboratory confirmation is available of intravascular coagulation or presence of clinical thrombosis
Drug interaction overview
- Simultaneous use with activated prothrombin complex concentrates or coagulation factor XIII increases risk of serious thrombotic events
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women to determine whether there is a drug-associated risk
Lactation
Data are not available regarding presence in human milk, effect on breastfed infants, and effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Activates conversion of Factor X to Factor Xa, which initiates the common pathway of the coagulation cascade; prothrombin is activated to thrombin, which then converts fibrinogen to fibrin to form a hemostatic plug, thereby achieving clot formation at the site of hemorrhage (hemostasis)
Pharmacokinetics
NovoSeven RT
- Half-Life: 2.3 hr
- Clearance: 33 mL/kg/hr
- Vd: 103 mL/kg
- Excretion: 33 mL/kg/hr body clearance
Sevenfact
-
Peak plasma concentration
- 75 mcg/kg: 566.2 ng/mL
- 225 mcg/kg: 2440.6 ng/mL
-
Clearance
- 75 mcg/kg: 8 L/hr
- 225 mcg/kg: 5.8 L/hr
-
AUC
- 75 mcg/kg: 589.1 ng⋅hr/mL
- 225 mcg/kg: 2841.2 ng⋅hr/mL
-
Half-life
- 75 mcg/kg: 1.7 hr
- 225 mcg/kg: 1.4 hr
Administration
IV Administration
NovoSeven RT
- Administer as slow IV bolus over 2-5 minutes depending on the dose administered
- For perioperative management: 50 mcg/kg/hr by continuous infusion
- May flush IV before or after with 0.9% NaCl
Sevenfact
- Infuse over <2 minutes as an IV bolus
- Do not mix with other infusion solutions
Storage
NovoSeven RT
- Store vials of lyophilized powder under refrigeration before reconstitution
- Reconstituted solutions may be stored at room temp or under refrigeration, but must be infused within 3 hr
Sevenfact
- Unopened vials: Store room temperature, but can be stored between 36-86F (2-30C); protect from light and do not freeze
- Reconstituted solution may be stored at room temperature or refrigerated, but must be infused within 4 hr; do not freeze or store in syringes
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Novoseven RT intravenous - | 8 mg (8,000 mcg) vial |  | |
| Novoseven RT intravenous - | 5 mg (5,000 mcg) vial |  | |
| Novoseven RT intravenous - | 1 mg (1,000 mcg) vial |  | |
| Novoseven RT intravenous - | 2 mg (2,000 mcg) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
coagulation factor VIIa recombinant intravenous
FACTOR VIIA, RECOMBINANT - INJECTION
(factor VIIA,ree-KOM-bin-unt)
COMMON BRAND NAME(S): Novoseven
WARNING: This medication has caused very serious blood clots (such as heart attack, stroke, pulmonary embolus-PE, deep vein thrombosis-DVT). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, liver disease, or if you are immobile (such as being bedridden after surgery). Talk with your doctor about the risks and benefits of this medication. Get medical help right away if you develop symptoms of a blood clot, such as pain/swelling/redness/weakness of the arms or legs, calf pain/swelling that is warm to the touch, shortness of breath, coughing up blood, chest/jaw/left arm pain, sudden vision changes, weakness on one side of the body, trouble speaking, or confusion.
USES: This medication is used to treat and prevent bleeding in people with certain conditions (such as hemophilia type A or B, low levels of factor VII, Glanzmann's thrombasthenia). People with these conditions are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIIa, which is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and stop bleeding.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor, usually every 2 to 6 hours until no longer needed. The dosage is based on your medical condition, weight, and response to treatment.Do not inject the mixing solution directly into the medication powder because this may cause the medication to become ineffective. Aim the syringe so that the water flows gently down the side of the vial. Do not shake the vial. Gently swirl the mixture until all the powder has dissolved. Do not mix this medication with any other drugs.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also Warning Section.Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, new or worsening bleeding/bruising, new or worsening joint pain/swelling, fast/slow heartbeat, signs of kidney problems (such as change in the amount of urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bleeding/clotting problems (such as disseminated intravascular coagulation-DIC), blood vessel problems (such as atherosclerosis), recent serious infection in the blood, recent serious injury.Newborns may be at greater risk for blood clots while using this drug.Older adults may be at greater risk for blood clots while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This product should not be given at the same time as certain other clotting factor products (activated and non-activated prothrombin complex concentrates).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as clotting time tests, factor VII activity) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised July 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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