Factor VIIa (Recombinant)

• Factor VIIa (recombinant), a hemostatic agent, is structurally nearly identical to human plasma-derived coagulation factor VIIa.1 29

• Promotes hemostasis through activation of the extrinsic blood coagulation pathway.1

• Following injury to vessel wall, tissue factor (TF) is exposed to circulating blood; TF-FVIIa complexes are formed on TF-bearing cells, where they activate factor X to factor Xa and factor IX to factor IXa.1 25 26 29

• Factor Xa, in complex with factor V, calcium, and phospholipids, converts prothrombin to thrombin and subsequently activates fibrinogen to fibrin to form a hemostatic plug that provides local hemostasis.1 29 This process also may occur on the surface of activated platelets.1 26 29

• Produces hemostasis in the absence of factor VIII or factor IX by binding to activated platelets and directly activating factor X to generate thrombin independently of TF.1 11 22 25 26 27 29

• Produces circulating concentrations of factor VIIa that are approximately 1000-fold higher than physiologic levels.25 26 32

• If you have an allergy to this medicine or any part of factor VIIa.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take factor VIIa. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic side effects may rarely happen.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Call the doctor right away if the normal dose does not work as well.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in newborns. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using factor VIIa while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Antihemophilic Agent

Refer to adult dosing.

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

Some products may contain sodium.

NovoSeven RT: Prior to reconstitution, store between 2°C to 25°C (36°F to 77°F); do not freeze. Protect from light. Reconstituted solutions may be stored at room temperature or under refrigeration, but must be infused within 3 hours of reconstitution. Do not freeze reconstituted solutions. Do not store reconstituted solutions in syringes.

Concerns related to adverse effects:

• Antibody formation: In patients with factor VII deficiency, 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. Use with caution in patients with known hypersensitivity to mouse, hamster, or bovine proteins, or factor VIIa, or any components of the product. If hypersensitivity reaction occurs, discontinue use and administer appropriate treatment; carefully consider the benefits versus the risk of continued treatment with factor VIIa.

• 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 due to circulating tissue factor or predisposing coagulopathy in patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, septicemia, crush injury, concomitant treatment with activated or nonactivated prothrombin complex concentrates, or uncontrolled postpartum hemorrhage. Use with caution in patients with an increased risk of thromboembolic complications (eg, coronary heart disease, liver disease, DIC, postoperative immobilization, elderly patients, and neonates). 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).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), angina, shortness of breath, coughing up blood, jaw pain, neck pain, back pain, arm pain, severe dizziness, passing out, abdominal pain, or abdominal edema (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.