In the U.S.—

Other commonly used names are coagulation factor VIIa (recombinant); eptacog alfa; factor 7; proconvertin; recombinant activated factor VIIa; recombinant coagulation factor VIIa; recombinant factor VIIa; rFVIIa.

• Antihemorrhagic

Factor VIIa is a man-made protein produced to replicate the naturally occurring activated factor VII (factor VIIa) in the body. Factor VIIa is used to stop bleeding of injuries for patients with hemophilia by helping the blood to clot. This man-made protein, factor VIIa, is used in people who have Hemophilia A or Hemophilia B, who have also formed antibodies against other clotting proteins that help bleeding to stop. Patients using factor VIIa are usually male.

Factor VIIa is to be administered only by or under the supervision of your doctor or other health care professional. It is available in the following dosage form(s):

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For factor VIIa, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to factor VIIa or to any products that contain mouse, hamster, or cow proteins. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in humans.

Breast-feeding—It is not known whether factor VIIa passes into breast milk. However, because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—This medicine has been tested in children and no side effects or problems were found that were different from those seen in adults.

Older adults—No information is available about the use of factor VIIa in older adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking factor VIIa, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Activated prothrombin complex concentrates (ie, FEIBA, Autoplex T) or
• Prothrombin complex concentrates (ie, AlphaNine, BeneFix)—May increase the risk of side effects

• Blood clots or a history of medical problems caused by blood clots or
• Heart disease or
• Infection or
• Injury (crush)—These conditions may increase the risk of bleeding

This medicine is to be used in a medical setting under the direct supervision of a doctor.

Dosing—

The dose of factor VIIa will be different for different patients. The dose you receive will be based on:

• Your body weight.
• How much, how often, and where in your body you are bleeding.

If you notice early signs of a hypersensitivity reaction such as hives, skin rash, tightness of the chest or wheezing, lightheadedness or dizziness, notify your physician immediately.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Bleeding problems;  fever;  high blood pressure;  joint or muscle pain and/or stiffness 
  
  

• Less common or rare
  • Bloating or swelling of face, hands, lower legs, and/or feet ;  bluish color hands or feet;  blurred vision;  changes in facial color;  chest pain;  chills;  cold sweats;  confusion;  continuing thirst;  cough;  dizziness;  excessive sweating;  faintness;  fast heartbeat;  hives and/or itching;  large flat blue or purplish patches on the skin;  lightheadedness when getting up from a lying or sitting position;  persistent bleeding or oozing from puncture sites or mucous membranes [bowel, mouth, nose, or urinary bladder];  puffiness or swelling of eyelids or around the eyes;  shakiness;  slurred speech;  shortness of breath;  skin rash;  slow or irregular heartbeat [less than 50 beats per minute];  sneezing;  sore throat;  sudden decrease in the amount urine;  swelling of face, fingers, feet, and/or lower legs;  troubled breathing, tightness in chest, and/or wheezing;  unusual tiredness or weakness;  weight gain (unusual).  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common or rare
  • Burning or stinging at the injection site;  changes in blood pressure or pulse rate;  drowsiness ;  flushing [redness of face];  headache;  pinpoint red or purple spots on skin;  nausea or vomiting 
  
  

. Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, factor VIIa is used in certain patients with the following medical conditions:

• Factor VII deficiency

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.