250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection nonacog
gamma ( recombinant human coagulation factor IX)
What RIXUBIS is and what it is used for
RIXUBIS contains the active substance nonacog gamma and is a coagulation factor IX product. Factor IX is a normal ingredient in human blood required for effective blood coagulation. RIXUBIS is used in patients with hemophilia B (Christmas disease, a hereditary bleeding disorder caused by a lack of factor IX). It works by replacing the missing factor IX so that patients’ blood can coagulate.
RIXUBIS is used for treating and preventing bleeding in patients with hemophilia B in all age groups.
What you need to know before using RIXUBIS
Do not use RIXUBIS
- if you are allergic to nonacog gamma or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to hamster proteins
Warnings and cautions
Hypersensitivity reactions of the allergy type are possible with RIXUBIS. Stop infusion one and contact your doctor immediately or seek emergency care if you get early signs of hypersensitivity / allergic reactions such as hives, skin rash, chest tightness, wheezing, low blood pressure, or anaphylactic reaction (a severe allergic reaction that may make it difficult to swallow and/or breathing and causing red or swollen face and/or hands). Your doctor may need to treat you immediately for these reactions. Your doctor may also take a blood sample to check if you have developed an antibody neutralizing the activity of the drug (inhibitors), as inhibitors can develop together with allergies. Patients with factor IX inhibitors may be at increased risk of anaphylaxis during future factor IX treatment.
Talk to your doctor immediately if your bleeding does not stop as expected or if you experience a significant increase in your use of RIXUBIS to control your bleeding. Your doctor will take a blood test to check if you have developed antibodies that neutralize the activity (inhibitors) against RIXUBIS. The risk of developing inhibitors is highest in patients who have not previously been treated with a factor IX replacement drug or who are in the early stages of treatment, ie. small children.
The production of factor IX in the body is controlled by the factor IX gene. Patients with certain mutations are on the factor IX gene, e.g. that a larger portion has been deleted, may have a higher probability of having a factor IX inhibitor and having an allergic reaction in the early period of treatment with a factor IX concentrate. Therefore, if you are known to have such a mutation, your doctor will monitor you more closely for signs of an allergic reaction.
If you suffer from liver or heart disease or have recently undergone major surgery, you should inform your doctor, as there is an increased risk of coagulation complications.
Kidney disease ( nephrotic syndrome ) has been reported after high doses of factor IX in hemophilia B patients with factor IX inhibitors and a history of allergic reactions.
If possible, record the product and batch number each time you use RIXUBIS (eg in a diary) to document which products and product sets have been used.
Other medicines and RIXUBIS
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. No interactions between RIXUBIS and other medicines are known.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Hemophilia B is very rare in women.
Driving and using machines
RIXUBIS does not affect the ability to drive and use machines.
RIXUBIS contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’. However, depending on your body weight and your dose of RIXUBIS, you may receive more than one vial. This should be taken into account if you eat a diet with limited sodium content.
How to use RIXUBIS
RIXUBIS treatment is started by a doctor who has experience in caring for patients with hemophilia B.
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Your doctor will decide which dose of RIXUBIS you should receive. Dose one and the duration depend on the severity of your factor IX deficiency, where and how extensive the bleeding is and your clinical condition, your age, and how fast your body consumes factor IX, which must be checked regularly.
RIXUBIS is administered by intravenous infusion (IV) after reconstitution of the powder in the supplied diluent by your physician or nurse. You or someone else can also administer RIXUBIS as an injection, but only after receiving proper training.
Preparation and administration
- Use only the diluent and the preparation device (BAXJECT II) provided in the package for preparation.
- The use of a Luer syringe is required for administration.
- Do not use the BAXJECT II device if the sterile protective system or packaging is damaged or shows signs of degeneration.
Preparation
Use aseptic technique
- If the product is stored in a refrigerator: remove both the RIXUBIS powder and the bottles of diluent from the refrigerator and allow them to reach room temperature (between 15 ° C and 30 ° C).
- Wash your hands thoroughly with soap and warm water.
- Remove the stoppers from the bottles with powder and diluent.
- Clean the plugs with an alcohol wipe. Place the bottles on a flat, clean surface.
- Open the package with the BaxJect II device by pulling off the paper cover without touching the inside (Fig. A). Do not remove the device from its packaging.
- Turn the package over and insert the clear plastic tip through the stopper in the diluent bottle. Grasp the package at the edge and pull the package away from the BaxJect II (Fig. B). Do not remove the blue cover from the BAXJECT II device.
- Turn the system with Baxject II connected to the diluent bottle so that the diluent bottle ends up on top of the device. Insert the white plastic tip through the RIXUBIS plug. The vacuum draws diluent into the RIXUBIS bottle (Fig. C).
- Gently swirl the bottle until all the powder has dissolved. The product dissolves quickly (within 2 minutes). Make sure that RIXUBIS dissolves completely, otherwise not all the prepared solutions can pass through the filter. Prepared drug products should be inspected visually for particulate matter and discoloration before administration. The solution should be clear or slightly opalescent. Do not use a solution that is cloudy or has precipitated.
The solution must not be stored in the refrigerator after reconstitution.
Use it immediately.
Administration
Use aseptic technique
- Remove the blue cover from the BAXJECT II. Do not draw air into the syringe. Connect the syringe to BAXJECT II (Fig. D).
- Turn the system over (the bottle with the reconstituted solution should be on top). Withdraw the reconstituted solution into the syringe by slowly withdrawing the plunger (Fig. E).
- Remove the syringe.
- Connect a butterfly needle to the syringe. Inject intravenously. The solution should be administered slowly, at a rate determined by the patient’s comfort level but not exceeding 10 ml per minute.
If possible, record the product and batch number each time you use RIXUBIS (eg in a diary) to document which products and product sets have been used.
Any unused product or waste material should be disposed of by local requirements.
If you use more RIXUBIS than you should
Always use RIXUBIS exactly as your doctor has told you. Ask your doctor if you are unsure. If you have injected more RIXUBIS than recommended, talk to your doctor as soon as possible.
If you forget to use RIXUBIS
Do not take a double dose to make up for a forgotten dose. Continue with the next injection according to the schedule and proceed according to the doctor’s instructions.
If you stop using RIXUBIS
Do not stop using RIXUBIS without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions of the allergy type are possible with RIXUBIS. Such reactions may include a burning and stinging sensation at the infusion site, chills, hot flashes, lethargy, restlessness, tingling, hives, itching and rash, low blood pressure, rapid heart rate, chest tightness, wheezing, swelling of the throat, anaphylaxis (a severe allergic reaction ), headache, nausea, and vomiting. Contact a doctor immediately if you experience such signs. Your doctor may need to treat you immediately for these reactions (see section 2 “Warnings and precautions”).
The following side effects have been reported with RIXUBIS:
Common side effects ( may affect up to 1 in 10 people)
- altered sense of taste
- pain in the extremity.
Side effects with unknown frequency (can not be calculated from the available data)
- allergic reactions (hypersensitivity).
Problems with excessive blood clotting (thromboembolic episodes) have not been observed with this product, but may occur with all factor IX products. This may include heart attack and blood clots in veins or lungs.
How to store RIXUBIS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiration date is the last day of the specified month.
Store below 30 ° C.
Do not freeze.
A prepared solution should be used immediately.
Do not use RIXUBIS if the solution is not clear and colorless.
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 nonacog gamma ( recombinant human coagulation factor IX). Each vial of powder nominally contains 250, 500, 1000, 2000, or 3000 IU, corresponding to a concentration of 50, 100, 200, 400, or 600 IU / ml after reconstitution with 5 ml of diluent.
- The other ingredients in the powder are sucrose, mannitol, sodium chloride, calcium chloride, L ‑ histidine, and polysorbate 80.
Bottle of diluent: 5 ml sterile water for injections.
What the medicine looks like and the contents of the pack
RIXUBIS is supplied as a powder and solvent for solution for injection.
Package contents and other information:
- one vial of RIXUBIS 250, 500, 1000, 2000, or 3000 IU powder in a glass bottle with a rubber stopper
- a vial of 5 ml of sterile water for injection into a glass vial with a rubber stopper
- a BAXJECT II (needle-free preparation device)
Marketing Authorization Holder and Manufacturer
Baxalta Innovations GmbH
Industriestrasse 67
A ‑ 1221 Vienna
Austria
Tel .: +44 800 66838470
Email: medinfoEMEA@shire.com
Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
B ‑ 7860 Lessines
Belgium