Factor ix (intravenous, injection)

Factor ix (intravenous, injection)

Factor ix (intravenous, injection)

Used for factor ix

Factor IX is a protein produced by the body. It helps the blood form clots to stop bleeding. Factor IX injections are used to treat hemophilia B, sometimes called Christmas disease. This is a condition in which the body does not produce enough factor IX. If you are deficient in factor IX and you injure yourself, your blood will not form clots as it should and bleeding and damage to muscles and joints may occur.

The factor IX product that your doctor will prescribe for you is obtained naturally from human blood or artificially through an artificial process. Factor IX obtained from human blood has been treated and is unlikely to contain harmful viruses such as hepatitis B virus, hepatitis C virus (not A, not B), or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The artificially produced factor IX product does not contain these viruses.

Factor IX is only available with a doctor's prescription.

Before using factor ix

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Blood clots may be particularly likely to occur in premature and newborn babies, who are usually more sensitive to the effects of factor IX injections than adults.

geriatrics

This medicine has been tested and has not been shown to cause any different side effects or problems in older people than in younger adults.

Breastfeeding

Coagulation factor IX recombinant, glycoPEGylated factor IX Fc fusion protein recombinantCoagulation factor IX recombinantFactor IX albumin fusion protein recombinant

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Factor IX

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your doctor if you are taking other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Blutgerinnsel oder eine Vorgeschichte von medizinischen Problemen, die durch Blutgerinnsel verursacht wurden oder
• Lebererkrankung – Das Risiko von Blutungen oder der Bildung von Blutgerinnseln kann erhöht sein

Proper use of factor ix

Some medicines given by injection can sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. You will have the opportunity to practice preparation and injection. Make sure you understand exactly how the medicine is prepared and injected.

To prepare this medicine:

• Nehmen Sie das trockene Arzneimittel und die Flüssigkeit (Verdünnungsmittel) aus dem Kühlschrank und bringen Sie sie gemäß den Anweisungen Ihres Arztes auf Raumtemperatur.
• Wenn Sie die Flüssigkeit (Verdünnungsmittel) in das Trockenarzneimittel injizieren, richten Sie den Flüssigkeitsstrahl (Verdünnungsmittel) gegen die Wand des Behälters mit dem Trockenarzneimittel, um Schaumbildung zu verhindern.
• Schwenken Sie den Behälter vorsichtig, um das Arzneimittel aufzulösen. Schütteln Sie den Behälter nicht.

Use this medicine immediately. It should not be kept for more than 3 hours after preparation.

This medicine requires the use of a disposable syringe and a plastic filter needle. The medicine may stick to the inside of a glass syringe and you may not get the full dose.

Do not reuse syringes and needles. Place used syringes and needles in a disposable puncture-proof container or dispose of them according to your doctor's instructions.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Die Erkrankung, gegen die Sie dieses Arzneimittel anwenden.
• Ihr Körpergewicht.
• Die Menge an Faktor IX, die Ihr Körper herstellen kann.
• Wie viel, wie oft und an welcher Stelle Ihres Körpers bluten Sie?
• Ob Ihr Körper eine Abwehr (Antikörper) gegen dieses Arzneimittel aufgebaut hat oder nicht.

Missed dose

Call your doctor or pharmacist for instructions.

storage

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Some factor IX products need to be kept in the refrigerator, but others can be kept at room temperature for short periods of time. Store this medication as directed by your doctor or the manufacturer.

Precautions when using factor ix

If you have recently been diagnosed with hemophilia B, you should get vaccinated against hepatitis A and hepatitis B to further reduce your risk of contracting hepatitis A or hepatitis B from factor IX products.

After a while, your body may build up a defense (antibodies) against this medicine. Tell your doctor if this medicine seems to be less effective than usual.

It is recommended that you carry ID proving that you have hemophilia A or hemophilia B. If you have questions about what type of identification you need to carry, contact your doctor.

Side effects of factor ix

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

Less common or rare

• Veränderungen der Gesichtshautfarbe
• schnelles oder unregelmäßiges Atmen
• Schwellungen oder Schwellungen der Augenlider oder um die Augen herum
• Kurzatmigkeit, Atembeschwerden, Engegefühl in der Brust und/oder pfeifende Atmung
• Hautausschlag, Nesselsucht und/oder Juckreiz

Consult your doctor immediately if any of the following side effects occur:

More common

• Bläuliche Verfärbung (vor allem der Hände und Füße)
• Krämpfe
• Schwindel oder Benommenheit beim Aufstehen aus liegender oder sitzender Position
• erhöhter Puls
• große blaue oder violette Flecken auf der Haut (an Injektionsstellen)
• Übelkeit oder Erbrechen
• Schmerzen in Brust, Leistengegend oder Beinen (insbesondere Waden)
• anhaltende Blutungen aus Einstichstellen, Zahnfleisch oder der inneren Auskleidung von Nase und/oder Mund oder Blut im Stuhl oder Urin
• starke Schmerzen oder Druck in der Brust und/oder im Nacken, Rücken oder linken Arm
• starke, plötzliche Kopfschmerzen
• Kurzatmigkeit oder schnelles Atmen
• Plötzlicher Verlust der Koordination
• Plötzliche und unerklärliche undeutliche Sprache, Sehstörungen und/oder Schwäche oder Taubheitsgefühl in Arm oder Bein

Consult your doctor immediately if any of the following side effects occur:

Less common

• Brennen oder Stechen an der Injektionsstelle
• Veränderungen des Blutdrucks oder der Pulsfrequenz
• Schüttelfrost
• Schläfrigkeit
• Fieber
• Kopfschmerzen
• Übelkeit oder Erbrechen
• Rötung des Gesichts
• Kurzatmigkeit

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

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

Commonly used brand names

In the USA

• Alphanin SD
• Alprolix
• Bebulin
• Bebulin VH
• Benefix
• Idelvion
• Ixinity
• Mononin
• Profilnine SD
• Proplex T
• Rebinyn
• Rixubis

Available dosage forms:

• Pulver zur Lösung

Therapeutic class: Antihemophilic agent

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