Generic Name: Coagulation Factor Viia Recomb Brand Name(s): Coagulation Factor Viia Recomb.

Uses

What is Coagulation Factor Viia Recomb used for?

Coagulation Factor Viia Recomb is commonly 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 therefore stop bleeding.

How should I take Coagulation Factor Viia Recomb?

This medication is given by injection into a vein usually over several minutes. The dose is usually repeated every 2 to 6 hours or as directed by your doctor. 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.

How do I store Coagulation Factor Viia Recomb?

Medication is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store medication in the bathroom or the freezer. There may be different brands of medication that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush medication down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Coagulation Factor Viia Recomb?

Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or to animal proteins (e.g., mouse, hamster, cow); 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 (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., 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. Because of the possible risk to the infant, consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Coagulation Factor Viia Recomb during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Coagulation Factor Viia Recomb. Coagulation Factor Viia Recomb is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Coagulation Factor Viia Recomb?

Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Coagulation Factor Viia Recomb?

This product should not be given at the same time as certain other clotting factor products (activated and non-activated prothrombin complex concentrates).

Coagulation Factor Viia Recomb may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Coagulation Factor Viia Recomb?

Coagulation Factor Viia Recomb may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Coagulation Factor Viia Recomb?

Coagulation Factor Viia Recomb may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Coagulation Factor Viia Recomb.

What is the dose of Coagulation Factor Viia Recomb for an adult?

Usual Adult Dose for Hemophilia A

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:

Hemostatic:

90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:

90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:

Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).

Post-surgical:

-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.

-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:

Non-perioperative Management:

70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:

70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.

Usual Adult Dose for Hemophilia B

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:

Hemostatic:

90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:

90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:

Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).

Post-surgical:

-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.

-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:

Non-perioperative Management:

70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:

70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.

Usual Adult Dose for Factor VII Deficiency

15 to 30 mcg/kg IV bolus injection once every 4 to 6 hours until hemostasis is achieved

Comments: Doses as low as 10 mcg/kg have been effective.

Usual Adult Dose for Glanzmann’s Thrombasthenia

Non-perioperative Management:

90 mcg/kg IV bolus injection once every 2 to 6 hours until hemostasis is achieved in severe bleeding episodes requiring systemic hemostatic therapy

Perioperative Management:

Initial: 90 mcg/kg IV bolus injection immediately before surgery; repeat every 2 hours for procedure duration.

Post-surgical: 90 mcg/kg IV bolus injection once every 2 to 6 hours

Other Comments

Administration advice:

-For IV bolus injection only.

-Administer as soon as possible following bleeding onset or immediately before scheduled procedure.

-The manufacturer product information should be consulted.

Storage requirements:

-Prior to reconstitution: Store powder and histidine diluent between 2 and 25C (36 to 77F); do not freeze; protect from light.

-After reconstitution: Store at room temperature or refrigerated up to 3 hours; do not freeze or store in syringes.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: Do not mix with other infusion solutions.

General:

-Coagulation parameters do not necessarily correlate with or predict effectiveness of this drug; use hemostasis evaluation to determine effectiveness.

-Congenital hemophilia A or B with inhibitors: Outcome decision was made for a majority of patients treated for joint or muscle bleeds within 8 doses; more doses were required for severe bleeds. A majority of patients who reported adverse experiences received more than 12 doses.

Monitoring:

-Monitor for signs or symptoms of activation of the coagulation system or thrombosis.

-Monitor and minimize the duration of any post-hemostatic dosing.

-Monitor prothrombin time (PT) and factor VII coagulant activity in factor VII deficient patients before and after administering this drug.

-Monitor for factor VII antibodies in factor VII deficient patients treated with this drug.

Patient advice:

-Inform patients to seek immediate medical attention if early signs of hypersensitivity occur (e.g., hives, urticaria, chest tightness, wheezing, hypotension, and anaphylaxis).

-Advise patients to seek immediate medical attention if signs of thrombosis occur (e.g., new onset swelling and pain in the limbs or abdomen, new onset chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech).

What is the dose of Coagulation Factor Viia Recomb for a child?

Usual Pediatric Dose for Hemophilia A

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:

Hemostatic:

90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:

90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:

Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).

Post-surgical:

-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.

-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:

Non-perioperative Management:

70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:

70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.

Usual Pediatric Dose for Hemophilia B

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS:

Hemostatic:

90 mcg/kg IV bolus injection once every 2 hours (adjustable based on bleeding severity) until hemostasis is achieved or treatment is deemed inadequate

Post-hemostatic:

90 mcg/kg IV bolus injection once every 3 to 6 hours for severe bleeds

Perioperative Management:

Initial: 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 hours for surgery duration (additional bolus doses may be required with major surgery).

Post-surgical:

-Minor surgery: 90 mcg/kg IV bolus injection once every 2 hours for 48 hours, then every 2 to 6 hours until healing occurs.

-Major surgery: 90 mcg/kg IV bolus injection once every 2 hours for 5 days, then every 4 hours until healing occurs.

ACQUIRED HEMOPHILIA:

Non-perioperative Management:

70 to 90 mcg/kg IV bolus injection once every 2 to 3 hours until hemostasis is achieved

Perioperative Management:

70 to 90 mcg/kg IV bolus injection once immediately before surgery; repeat every 2 to 3 hours for surgery duration and until hemostasis is achieved.

Usual Pediatric Dose for Factor VII Deficiency

15 to 30 mcg/kg IV bolus injection once every 4 to 6 hours until hemostasis is achieved

Comments: Doses as low as 10 mcg/kg have been effective.

Usual Pediatric Dose for Glanzmann’s Thrombasthenia

Non-perioperative Management:

90 mcg/kg IV bolus injection once every 2 to 6 hours until hemostasis is achieved in severe bleeding episodes requiring systemic hemostatic therapy

Perioperative Management:

Initial: 90 mcg/kg IV bolus injection immediately before surgery; repeat every 2 hours for procedure duration.

Post-surgical: 90 mcg/kg IV bolus injection once every 2 to 6 hours

How is Coagulation Factor Viia Recomb available?

Coagulation Factor Viia Recomb is available in the following dosage forms and strengths:

  • Intravenous powder for injection

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Coagulation Factor Viia Recomb, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 30, 2018 | Last Modified: January 30, 2018

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