Factor IX (AlphaNine)
How does it work?
AlphaNine injection contains the active ingredient factor IX, which is a protein that is essential for the process of blood clotting (coagulation). It is found in human plasma and is produced for this medicine by extracting the factor IX from blood plasma from screened blood donors.
When bleeding occurs the body quickly seals the breaks in blood vessels by forming clots. A series of clotting proteins is involved in this process. Lack of any one of these clotting factors can lead to uncontrolled bleeding or excessive bruising following injury.
Factor IX is deficient from birth in people with haemophilia B. This deficiency causes the blood to clot very slowly and can result in prolonged bleeding following any injury or wound. People with haemophilia may also bleed spontaneously into muscles and joints.
Factor IX fraction is given to people with haemophilia B to supplement their deficient factor IX. This is necessary to help the blood clot and stop bleeding following accidents, surgery or spontaneous bleeds. In severe cases it may also be given regularly every few days to prevent bleeding.
What is it used for?
- Prevention and treatment of bleeding in haemophilia B, which is a disease where there is a deficiency from birth of a protein necessary for blood clotting called factor IX.
How is it given?
- AlphaNine is given by injection or drip (infusion) into a vein.
- Allergic reactions are possible to this medicine. If you get symptoms such as hives, tightness of the chest, wheezing, dizziness or nausea you should tell your doctor straight away. These may be early signs of hypersensitivity, or a severe allergic reaction called anaphylaxis. If you get an allergic reaction the medicine should be stopped immediately. If you have an allergic reaction it could suggest you have developed an inhibitor (see below).
- People being treated with this medicine can sometimes develop antibodies against the factor IX. These are known as inhibitors and they can stop the medicine working properly. If you experience an allergic reaction, or your bleeding is not being controlled with this medicine you should let your doctor know immediately, as you may have developed an inhibitor and your doctor may want to carry out tests to confirm this.
- When medicines prepared from human blood or plasma are administered the possibility of transmitting infections from viruses cannot be totally excluded. To reduce the risk of transmission of infective agents, stringent controls are applied to the selection of blood donors and donations. In addition, virus elimination/inactivation procedures are part of the production process. The measures taken are considered effective for removing enveloped viruses such as HIV, hepatitis B and hepatitis C. However, the measures taken may be of limited value against non-enveloped viruses such as parvovirus B19, which may be serious for pregnant women and for people with an underactive immune system or certain types of anaemia (eg sickle cell disease or haemolytic anaemia). It is recommended that people who regularly receive this medicine should have vaccinations against hepatitis A and B. You should discuss this with your doctor.
Use with caution in
- People with a risk of blood clots in the blood vessels (thrombosis or disseminated intravascular coagulation (DIC)) or who have had thromboembolic complications in the past.
- People with liver disease.
- People having surgery.
- AlphaNine injections contain sodium, and so should be used with caution in people whose intake of sodium needs be restricted.
Not to be used in
- AlphaNine is not recommended for children under six years of age, as it has not been studied in this age group.
- AlphaNine injections may contain a small amount of heparin, which may cause allergic reactions and affect the blood clotting mechanism. This medicine should not be used in people who have previously had an allergic reaction to heparin.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- Haemophilia B in women is rare, so this medicine has not been studied in women who are pregnant or breastfeeding.
- The safety of this medicine during pregnancy has not been established. It should only be used to treat pregnant women if the potential benefits outweigh any possible risks to the unborn child. Seek medical advice from your doctor.
- The safety of this medicine during breastfeeding has not been established. It should only be used to treat breastfeeding women if the potential benefits outweigh any possible risks to the nursing infant. Seek medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Burning and stinging at the infusion site.
- Nausea and vomiting.
- Allergic reactions including rashes, chills, low blood pressure, wheezing, chest tightness, swelling of lips and throat (angiodema). See the warning section above.
- An extreme allergic reaction (anaphylaxis).
- Development of neutralising antibodies (inhibitors) to factor IX. See warning section above.
- Kidney disorder called nephrotic syndrome.
- Blood clotting complications, such as disseminated intravascular coagulation, blood clot in a vein (venous thrombosis), blood clot in the lungs (pulmonary embolism) or heart attack may occur rarely.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
This medicine is not known to affect other medicines. However, before taking any other medicines or having other treatments it is important that you tell your pharmacist or the health professional that is treating you that you suffer from haemophilia B.
Other medicines containing the same active ingredient
Haemonine, Mononine and Replenine-VF are other brands of clotting factor IX that are prepared from plasma from screened blood donors.
BeneFIX contains nonacog alfa, which is a genetically engineered version of clotting factor IX.