Coagulation factor viia (recombinant)
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
Warning: Serious thrombotic adverse events are associated with the use of NovoSeven RT outside labeled indications Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven have been reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven RT when administered outside the current approved indications. Fatal and non-fatal thrombotic events have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven RT.
Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. See WARNINGS AND PRECAUTIONS section of prescribing information. Safety and efficacy of NovoSeven RT has not been established outside the approved indications. Warning: Serious thrombotic adverse events are associated with the use of NovoSeven RT outside labeled indications Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven have been reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven RT when administered outside the current approved indications.
Fatal and non-fatal thrombotic events have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven RT. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. See WARNINGS AND PRECAUTIONS section of prescribing information. Safety and efficacy of NovoSeven RT has not been established outside the approved indications. Hemostatic Dosing 90 micrograms/kg given every two hours by bolus infusion until hemostasis is achieved, or until the treatment has been judged to be inadequate.
Doses between 35 and 120 micrograms/kg have been used successfully in clinical trials for hemophilia A or B patients with inhibitors, and both the dose and administration interval may be adjusted based on the severity of the bleeding and degree of hemostasis achieved. 1 The minimum effective dose has not been established. For patients treated for joint or muscle bleeds, a decision on outcome was reached for a majority of patients within eight doses although more doses were required for severe bleeds. A majority of patients who reported adverse experiences received more than twelve doses. Post-hemostatic Dosing The appropriate duration of post-hemostatic dosing…
Dosing in kidney impairment
Other arterial thromboembolic events (such as retinal artery embolism, renal artery thrombosis, arterial thrombosis of limb, bowel infarction and intestinal infarction) have also been reported. 3,4,5,6,7 While venous thromboembolic events such as deep venous thrombosis, portal vein thrombosis and pulmonary embolism have been reported in clinical trials, the meta analysis of these pooled data from placebo-controlled trials performed outside the currently approved indications did not suggest an increased risk of venous thromboembolic events in patients treated with NovoSeven versus placebo (4.8% in patients treated with NovoSeven versus 4.7% in placebo-treated patients).
Preparation and administration
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Your numbers for coagulation factor viia (recombinant). Take vial strength, diluent, and limits from the label below.
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General NovoSeven RT is intended for intravenous bolus administration only. Evaluation of hemostasis should be used to determine the effectiveness of NovoSeven RT and to provide a basis for modification of the NovoSeven RT treatment schedule. Coagulation parameters do not necessarily correlate with or predict the effectiveness of NovoSeven RT.
NovoSeven RT should be administered to patients only under the supervision of a physician experienced in the treatment of bleeding disorders.
Reconstitution Calculate the NovoSeven RT dosage you will need and select the appropriate NovoSeven RT vial package. The selected package contains 1 vial of NovoSeven RT powder and 1 vial of histidine diluent required to prepare reconstituted NovoSeven RT solution. Reconstitute only with the histidine diluent provided with NovoSeven RT.
Do not reconstitute with sterile water or other diluent. Reconstitution should be performed using the following procedures: 1. Always use aseptic technique. 2. Bring NovoSeven RT (white, lyophilized powder) and the specified volume of histidine (diluent) to room temperature, but not above 37° C (98.6° F). The specified volume of diluent corresponding to the amount of NovoSeven RT is as follows: 1 mg (1000 micrograms) vial + 1.1 mL Histidine diluent 2 mg (2000 micrograms) vial + 2.1 mL Histidine diluent 5 mg (5000 micrograms) vial + 5.2 mL Histidine diluent After reconstitution with the specified volume of diluent, each vial contains approximately 1 mg/mL NovoSeven RT (1000 micrograms/mL). 3.
Remove caps from the NovoSeven RT vials to expose the central portion of the rubber stopper. Cleanse the rubber stoppers with an alcohol swab and allow to dry prior to use. 4. Draw back the plunger of a sterile syringe (attached to sterile needle) and admit air into the syringe. It is recommended to use syringe needles of gauge size 20-26. 5.
Insert the needle of the syringe into the Histidine diluent vial. Inject air into the vial and withdraw the quantity required for reconstitution. 6. Insert the syringe needle containing the diluent into the NovoSeven RT vial through the center of the rubber stopper, aiming the needle against the side so that the stream of liquid runs down the vial wall (the NovoSeven RT vial does not contain a vacuum).
Do not inject the diluent directly on the NovoSeven RT powder. 7. Gently swirl the vial until all the material is dissolved. The reconstituted solution is a clear, colorless solution which may be stored either at room temperature or refrigerated for up to 3 hours after reconstitution.
Administration NovoSeven RT is intended for intravenous bolus injection only and should not be mixed with infusion solutions. Reconstituted NovoSeven RT should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed.
Administration should take place within 3 hours after reconstitution. Any unused solution should be discarded. Do not freeze reconstituted NovoSeven RT or store it in syringes. Administration should be performed using the following procedures: Always use aseptic technique. Draw back the plunger of a sterile syringe (attached to sterile needle) and admit air into the syringe.
Insert needle into the vial of reconstituted NovoSeven RT. Inject air into the vial and then withdraw the appropriate amount of reconstituted NovoSeven RT into the syringe. Remove and discard the needle from the syringe. Administer as a slow bolus injection over 2 to 5 minutes, depending on the dose administered. If line needs to be flushed before or after NovoSeven RT administration, use 0.9% Sodium Chloride Injection, USP.
Discard any unused reconstituted NovoSeven RT after 3 hours.
Drug interactions
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Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Coagulation factor viia (recombinant)
Label text (3 paragraphs)
Avoid simultaneous use of NovoSeven RT and PCCs/aPCCs (7.1) NovoSeven RT should not be mixed with infusion solutions (7.2)
7.1 Coagulation Factor Concentrates The risk of a potential interaction between NovoSeven RT and coagulation factor concentrates has not been adequately evaluated in preclinical or clinical studies. Simultaneous use of activated prothrombin complex concentrates or prothrombin complex concentrates should be avoided.
7.2 Infusion Solutions NovoSeven RT should not be mixed with infusion solutions.
Contraindications
None None (4)
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for coagulation factor viia (recombinant). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. NovoSeven RT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Treatment of rats and rabbits with NovoSeven in reproduction studies has been associated with mortality at doses up to 6 mg/kg and 5 mg/kg. At 6 mg/kg in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg/kg, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg/kg of NovoSeven gave birth successfully, however, two of the 23 litters died during the early period of lactation.
No evidence of teratogenicity was observed after dosing with NovoSeven.
Lactation
8.3 Nursing Mothers It is not known whether NovoSeven RT is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Breastfeeding (LactMed)
No information is available on the clinical use of coagulation factor VIIa during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, coagulation factor VIIa should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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