Jivi

Jivi is a prescription medication used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Jivi belongs to a group of drugs called, hematological agents. These help to clot blood and stop bleeding.

This medication is available as an injection form and is to be injected directly into a vein (IV) by a healthcare professional.

Common side effects of Jivi include headache, cough, nausea and fever.

Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

• Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).
• Jivi is not for use in children below 12 years of age or in previously untreated patients.
• Jivi is not used to treat von Willebrand disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The dose you doctor recommends may be based on the following:

• Severity of the bleed

• Body weight

• Lab results

• Condition being treated

The number of doses will be determined by several factors and may be adjusted accordingly.

Control of bleeding episodes and perioperative management 

• Expected recovery: one unit per kilogram body weight of Jivi will increase the Factor VIII level by 2 international units per deciliter (IU/dL). Each vial of Jivi contains the labeled amount of recombinant Factor VIII in IU.
• Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected recovery (or observed recovery, if available).
• Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg).

Routine prophylaxis 

• The recommended initial regimen is 30–40 IU/kg twice weekly.
• Based on the bleeding episodes:
  • The regimen may be adjusted to 45–60 IU/kg every 5 days.
  • A regimen may be further individually adjusted to less or more frequent dosing.

Serious side effects may occur with Jivi which include:

• Serious allergic reactions

  • Chest or throat tightness
  • Dizziness
  • Mild hypotension
  • Nausea
• If any of these symptoms occur, seek immediate medical attention because these could be the first signs of a severe allergic reaction.
• Your body may develop antibodies to this medication and therefore Jivi may not work as well as it should.

Do not use this medication if you are allergic to:

• polyethylene glycol (PEG)
• mouse or hamster protein
• any ingredient found in Jivi

Jivi may cause serious side effects. See "Drug Precautions" section.

Common side effects include:

• headache
• cough
• nausea
• fever

Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea. Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.

Your body can also make antibodies, called “inhibitors”, against Jivi, which may stop Jivi from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.

This is not a complete list of Jivi side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medications to clot your blood.

This is not a complete list of Jivi drug interactions. Ask your doctor of pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no studies that have been done in humans with Jivi. It is not known if Jivi may harm your unborn baby.

Talk to your healthcare provider about the risks and benefits of taking Jivi while pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Jivi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Jivi.