Konyne

DRUG DESCRIPTION

Factor IX Complex, Konyne (factor ix complex) ® 80, heat-treated at 80°C for 72 hours, is a sterile, dried, plasma fraction comprising coagulation factors II, IX, X and low levels of factor VII.

 

                                     Nomenclature

Factor:                         Synonyms:

II                                   prothrombin

VII                                proconvertin

IX                                 plasma thromboplastin component, PTC, Christmas factor

X                                   Stuart-Prower factor

Konyne (factor ix complex) 80 is standardized in terms of factor IX content and each vial of Konyne (factor ix complex) 80 is labeled for factor IX. One international unit (IU) of factor IX as defined by the World Health Organization standard for blood coagulation factor IX is approximately equal to the level of factor IX found in 1.0 mL of fresh, normal plasma.

The factor IX content is approximately 50 times purified over whole plasma, and when reconstituted as directed, Konyne (factor ix complex) 80 contains 25 times as much factor IX as an equal volume of fresh plasma. Konyne 80, containing approximately 1000 IU of factor IX administered in 40 mL, contains the factor IX content of 1 liter of fresh plasma. Konyne (factor ix complex) 80 must be administered intravenously.

What are the possible side effects of factor IX complex?

Factor IX complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although factor IX complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using factor IX complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from factor IX complex. Parovovirus B19 may more seriously affect pregnant...

Read All Potential Side Effects and See Pictures of Konyne »

What are the precautions when taking factor ix complex (Konyne)?

Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; 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 clotting disorders (e.g., disseminated intravascular coagulation-DIC), heart disease (e.g., coronary artery disease), immune system problems, recent surgery/procedure, liver disease.

Before having surgery, tell your doctor or dentist that you are using this medication.

Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral...

Read All Potential Precautions of Konyne »


Konyne Consumer (continued)

SIDE EFFECTS: Pain at injection site, chills, tingling, flushing, headache, 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 at injection site, fast heartbeat, shortness of breath, change in the amount of urine, swelling of the ankles/feet, pain/redness/swelling of arms or legs, new or increased bleeding/bruising.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, trouble breathing, bluish fingers.

This medication is made from human blood. Even though donors are carefully screened and this medication goes through a special manufacturing process, there is a very small chance that you may get infections from the medication (e.g., viral infections such as hepatitis). Tell your doctor immediately if you develop any signs of hepatitis/another infection, including fever, persistent sore throat, unusual tiredness, persistent nausea/vomiting, yellowing eyes/skin, dark 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.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; 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 clotting disorders (e.g., disseminated intravascular coagulation-DIC), heart disease (e.g., coronary artery disease), immune system problems, recent surgery/procedure, liver disease.

Before having surgery, tell your doctor or dentist that you are using this medication.

Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral infections such as hepatitis). It is recommended that you get the appropriate vaccinations (e.g., for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent viral infections. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.


Konyne Patient Information Including Side Effects

Brand Names: Bebulin VH, Konyne 80, Profilnine SD, Proplex T

Generic Name: factor IX complex (Pronunciation: FAK tor NINE KOM plex)

  • What is factor IX complex (Konyne)?
  • What are the possible side effects of factor IX complex (Konyne)?
  • What is the most important information I should know about factor IX complex (Konyne)?
  • What should I discuss with my healthcare provider before using factor IX complex (Konyne)?
  • How should I use factor IX complex (Konyne)?
  • What happens if I miss a dose (Konyne)?
  • What happens if I overdose (Konyne)?
  • What should I avoid while using factor IX complex (Konyne)?
  • What other drugs will affect factor IX complex (Konyne)?
  • Where can I get more information?

What is factor IX complex (Konyne)?

Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.

Factor IX complex is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.

Factor IX complex is used to treat or prevent bleeding episodes in people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.

Factor IX may also be used for other purposes not listed in this medication guide.

What are the possible side effects of factor IX complex (Konyne)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • cough, chest pain;
  • weak or shallow breathing;
  • feeling short of breath;
  • headache, feeling like you might pass out;
  • fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • mild nausea or stomach pain; or
  • mild tingly or jittery feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about factor IX complex (Konyne)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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