500 IU and 1000 IU powder and solvent for solution for injection Human
coagulation factor IX
What Nanofix is and what it is used for
Nanofix belongs to a group of medicines called coagulation factors and contains coagulation factor IX from human blood. This is a special protein that increases the blood’s ability to coagulate.
Nanofix is used to treat or prevent bleeding in patients with hemophilia ( haemophilia B). This is a disease that causes you to bleed longer than you would normally expect. The disease is due to a hereditary deficiency of coagulation factor IX in the blood.
Nanofix is supplied as a powder and solvent for solution for injection . After reconstitution, the drug is administered intravenously (injected into a vein).
What you need to know before using Nanofix
Do not use Nanofix
Do not use Nanofix
– if you are allergic to human coagulation factor IX or any of the ingredients of Nanofix (listed in section 6).
if you have heparin-induced thrombocytopenia type II, which results in a decrease in the number of platelets in your blood after administration of heparin. Platelets are blood cells that help stop the bleeding. Heparin is a drug used to prevent blood clots.
Warnings and cautions
Talk to your doctor or pharmacist before using Nanofix.
- Like all medicines that are given intravenously and that contain protein , you may experience allergic hypersensitivity reactions . Nanofix also contains very small amounts of human proteins other than factor IX and heparin . Early signs of a hypersensitivity reaction are:
hives _
– skin rash
– pressure over the chest
– wheezing
– low blood pressure
acute, severe allergic reaction (anaphylactic shock, when one or all of the above symptoms develop rapidly or are severe).
If these symptoms occur, the injection should be stopped immediately and a doctor consulted. In case of anaphylactic shock, the doctor will start the recommended treatment as soon as possible.
- Your doctor may recommend that you consider vaccination against hepatitis A and B, if you are regularly / repeatedly treated with factor IX preparations prepared from human plasma .
- It is known that patients with haemophilia B may develop inhibitors (neutralizing antibodies ) against factor IX. These are formed by cells in the immune system. Inhibitors may increase the risk of anaphylactic shock (severe allergic reactions). If you get an allergic reaction , you should be tested for the presence of inhibitors. Patients with factor IX inhibitors may be at increased risk of anaphylactic shock if treated with factor IX. The doctor may therefore decide that the first injection of factor IX is given under medical supervision, where adequate medical treatment is available.
- Factor IX concentrate can cause a blockage in the blood vessels by forming a clot . This risk is greater when using preparations with a lower degree of purity. Due to this risk, you should be monitored for signs of blood clot formation after treatment with factor IX preparations if:
– you show signs of fibrinolysis (dissolved blood clot)
– you have disseminated intravascular coagulation (widespread blood clots in the blood vessels)
– you have been diagnosed with a liver disease
– you have known risk factors that affect the cardiovascular condition
– you have recently undergone an operation
– if you have an increased risk of clot formation or an increased risk of disseminated intravascular coagulation
If any of the above conditions apply to you, your doctor will only give you Nanofix if the benefit of treatment outweighs its risks.
Following repeated treatment with human factor IX preparations, patients should be monitored for the formation of neutralizing antibodies (inhibitors). Levels should be measured in Bethesda (BU) units using the appropriate biological test method.
Virus security
When medicines are made from human plasma or blood, certain measures are taken to prevent the transmission of infection to patients. This includes:
o a careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded.
o Testing of individual donations and plasma pools for signs of virus/infection.
o The manufacturers of these products also include steps in the management of blood and plasma that can inactivate or eliminate viruses.
Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C, and the non-enveloped virus and hepatitis A. The measures may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be serious in pregnant women ( fetal infection ), and in individuals with weakened immune systems or patients with certain types of anemia (eg sickle cell anemia or hemolytic anemia ).
When you receive Nanofix, it is recommended that the product name and batch number be registered to enable traceability of the product used.
Children
If Nanofix is given to neonates, signs of disseminated intravascular coagulation should be closely monitored.
Other medicines and Nanofix
- There are no known interactions between products containing human blood coagulation factor IX and other drugs.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
There is no experience with the use of factor IX during pregnancy or breastfeeding. Factor IX should therefore only be used during pregnancy and lactation if necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Nanofix does not affect the ability to operate and use machines.
Nanofix contains sodium
This medicine contains up to 69 mg of sodium (the main component of table salt) in a vial of Nanofix 500 IU, equivalent to 3.45% of the maximum recommended sodium intake for an adult.
and up to 138 mg sodium in a Vial Nanofix 1000 IU equivalent to 6.9% of the maximum recommended sodium intake for an adult. You should take this into account if you have been prescribed a low-sodium diet.
How to use Nanofix
Always take Nanofix exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Nanofix is given intravenously (injected into a vein) after reconstitution with the supplied solution for injection.
Use only the infusion aids provided. The use of other injection/infusion aids may increase the risk and lead to unsuccessful treatment.
Treatment should be initiated under the supervision of a physician well versed in the treatment of hemophilia. How much Nanofix you should take and how long a substitution treatment should last depends on the severity of your factor IX deficiency. It also depends on where it is bleeding and how severe the bleeding is and your clinical condition.
Calculation of the dose:
Your doctor will tell you how often and how much Nanofix to inject.
Factor IX dose is expressed in international units (IU). Factor IX activity in plasma refers to the amount of factor IX in plasma. It is expressed either as a percentage (compared to normal human plasma) or as international units (compared to an international standard for factor IX in plasma ).
An international unit (IU) of factor IX activity corresponds to the amount of factor IX in one milliliter of normal human blood plasma. Calculation of the required factor IX dose is based on observations showing that 1 IU factor IX per kg body weight increases plasma factor IX activity by 1%. To calculate the dose you need, the factor IX activity in your blood plasma is measured. It shows how much the activity needs to be increased.
The required dose is calculated according to the following formula:
Units required = body weight (kg) x desired increase of factor IX (%) (IU / dl) x 0.8
The size of the dose and how often it should be given depends on how you respond to the medicine and is determined by your doctor. Coagulation factor IX rarely needs to be given more than once a day.
Because your response to factor IX may vary, the dose and how often it is given should be based on measuring your factor IX levels during treatment. Especially during surgeries, the doctor uses blood tests (the activity of factor IX in plasma ) for close monitoring of substitution treatment.
Prevention of bleeding:
If you have severe hemophilia B, inject 20-40 IU factor IX per kg body weight. For long-term prophylaxis, inject this dose twice a week. Dose one should be adjusted according to your response to treatment. In some cases, especially in younger patients, shorter dosing intervals and higher doses may be necessary.
Use for children:
In a study in children under 6 years of age, the dose per treatment day was on average 40 IU / kg body weight.
If bleeding cannot be stopped due to inhibitors :
Tell your doctor if expected factor IX activity is not achieved after injection, or if the bleeding does not stop after the correct dose. Your doctor will examine your blood plasma to see if you have developed inhibitors ( antibodies ) against the factor IX protein. These inhibitors may reduce factor IX activity. In that case, it may be necessary to choose another treatment. Your doctor will discuss this with you and, if necessary, recommend further treatment.
If you take more Nanofix than you should
No overdose symptoms have been reported for human coagulation factor IX. However, the recommended dose should not be exceeded.
For instructions for treatment at home, see the box with injection aids.
Possible side effects
Like all medicines, Nanofix can cause side effects, although not everybody gets them.
- Hypersensitivity reactions or allergic reactions have been reported rarely in patients treated with factor IX-containing products. These can mean:
- involuntary blood vessel contractions (cramps), which are associated with swelling of the face, mouth and throat
- burning sensation and burning at the infusion site
- frostbite
- feeling of warmth
- rash
- headache
- hives
- low blood pressure
- drowsiness
- nausea
- concern
- palpitation
- pressure over the chest
- knitting
- vomiting
- hissing breathing
In some cases, these allergic reactions can lead to a serious reaction called anaphylaxis, which can be associated with shock. These reactions occur mainly in connection with the formation of factor IX inhibitors. If you have any of the symptoms mentioned above, consult your doctor.
• If you have hemophilia B, you may develop neutralizing antibodies (inhibitors) to factor IX. These inhibitors can prevent the drug from working properly. This condition is called the immune response. Your doctor will discuss this with you and, if necessary, recommend further treatment.
In a study of 25 children with hemophilia B, six of whom had not been treated before, no inhibitors were found. The tolerability of the injections was considered to be “very good” or “good”.
• Some patients with hemophilia B who had factor IX inhibitors and who were treated with immune response therapy and who had an allergic reaction developed nephrotic syndrome (a severe kidney disease).
Fever may occur in rare cases.
• Factor IX products with low purity can in rare cases cause clot formation in a blood vessel. This can lead to any of the following complications:
- myocardial infarction
- widespread coagulation of blood vessels (disseminated intravascular coagulation )
- blood clots in the veins ( venous thrombosis )
- blood clots in the lungs ( pulmonary embolism )
These side effects are more common if you use factor IX products with low purity, and they only occur rarely if you use high-purity products, such as Nanofix.
• The product contains heparin, which may cause a sudden decrease in platelet counts below 100,000 / microliters or below 50% of the original number. This allergic reaction is called “heparin-induced thrombocytopenia type II”. In rare cases, this reduction in platelet count may occur 6-14 days after the start of treatment in patients who have not previously been hypersensitive to heparin. In patients with previous heparin hypersensitivity, the change may develop within a few hours after starting treatment.
This severe decrease in the number of blood cells may be associated with or result in:
- blood clots in the arteries and veins
- clogging of blood vessels due to a clot formed elsewhere
- severe disturbance of blood coagulation (consumption coagulopathy)
- skin necrosis at the injection site
- bleeding similar to flea bites
- purple bruises
- tar-like feces
If you notice these allergic reactions, stop using Nanofix immediately and do not continue to use heparin-containing medicines . Due to this rare effect on platelets, your doctor should monitor your platelet count, especially at the beginning of treatment.
For information on virus security, see section 2.
How to store Nanofix
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not freeze.
Store the vials in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the label and carton (month/year). The expiration date is the last day of the specified month.
The reconstituted product should be used immediately, or at least within 8 hours with storage at room temperature (25 ° C).
Use dissolved Nanofix only once. Do not use this medicine if the solution is cloudy or if the powder has not completely dissolved.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is human coagulation factor IX.
The other ingredients are heparin, sodium chloride, sodium citrate, arginine hydrochloride, and lysine hydrochloride.
What the medicine looks like and contents of the pack
Nanofix is available in two pack sizes with the following strength:
- Nanofix 500 IU is supplied as a powder and solvent for solution for injection . One vial contains a nominal 500 IU human coagulation factor IX. The product contains approximately 100 IU / ml human coagulation factor IX after reconstitution with 5 ml of water for injection .
- Nanofix 1000 IU is supplied as a powder and solvent for solution for injection; one vial contains nominally 1000 IU human coagulation factor IX.The product contains approximately 100 IU / ml human coagulation factor IX after dissolution with 10 ml of water for injection .
Nanofix is made from human blood plasma.
The potency (IU) is determined by a one-step coagulation test according to the European Pharmacopoeia compared with the World Health Organization (WHO) international standard. The specific activity of Nanofix is approximately 100 IU / mg protein.
Description of packaging:
Nanofix is supplied as a combination package, consisting of two cartons held together with plastic film:
A carton contains a vial of powder for solution for injection and a package leaflet.
The second carton contains a vial of solvent (water for injections):
5 ml for Nanofix 500 IU and 10 ml for Nanofix 1000 IU.
The package also contains the following aids:
- 1 pack of intravenous injection equipment (1 transfer set, 1 infusion set, 1 disposable syringe)
- 2 disinfectant dryers
Marketing Authorization Holder
Octapharma AB
112 75 Stockholm
Tel: 08-566 43000
Customer contact: 020-311020
Manufacturer
Octapharma Pharmazeutika Produktionsges.mbH
Oberlaaer Strasse 235
A-1100 Vienna
Austria
Octapharma SAS
70-72 Rue du Maréchal Foch
67380 Lingolsheim
France
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Octapharma AB
112 75 Stockholm
Tel: 08-566 43000
Customer contact: 020-311020