Nuwiq 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 2500 IU, 3000 IU, and 4000 IU powder and solvent for solution for injection
simoctocog alfa ( recombinant human coagulation factor VIII)
What Nuwiq is and what it is used for
Nuwiq contains the active substance recombinant human coagulation factor VIII (simoctocog alfa). Factor VIII is needed for the blood to coagulate and stop bleeding. In patients with hemophilia A (congenital factor VIII deficiency), factor VIII is missing or does not function normally.
Nuwiq ® replaces the missing factor VIII and is used to treat and prevent bleeding in patients with hemophilia A and is suitable for use by all age groups.
What you need to know before using Nuwiq
Do not use Nuwiq
- if you are allergic to the active substance simoctocog alfa or any of the other ingredients of this medicine (listed in section 6).
Contact your doctor for questions about the above.
Warnings and cautions
Talk to your doctor before using Nuwiq.
In very rare cases, an anaphylactic reaction to Nuwiq ® may occur (a severe, sudden allergic reaction ). You should be aware of these early signs of allergic reactions, which are listed in section 4 “Allergic reactions”. Discontinue injection immediately and consult a physician if you notice any of the following symptoms.
The development of inhibitors ( antibodies ) is a known complication that can occur during treatment with any factor VIII drug. The inhibitors prevent, especially at high levels, that the treatment works properly. You or your child will be closely monitored for the development of such inhibitors. If you or your child suffer from bleeding that cannot be controlled with Nuwiq, tell your doctor immediately.
Cardiovascular disease
In patients who have risk factors for cardiovascular disease, treatment with FVIII may increase the risk of cardiovascular disease.
Catheter-related complications
If you need a central venous access device (CVAD), the risk of CVAD-related complications, including local infections, the presence of bacteria in the blood, and thrombosis at the catheter site should be considered.
It is important to keep a record of Nuwiq’s batch number.
Each time you receive a new package of Nuwiq, you should therefore note the date and batch number (indicated on the package after Lot ) and keep this information in a safe place.
Other medicines and Nuwiq
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
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.
Driving and using machines
Nuwiq does not affect the ability to drive or use machines.
Nuwiq contains sodium
This medicine contains 18.4 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 0.92% of the maximum recommended daily intake of sodium for adults.
3. How to use Nuwiq
Treatment with Nuwiq is started by a doctor who has experience in treating patients with hemophilia A. Always use this medicine exactly as your doctor or nurse has told you. If you are not sure, talk to your doctor or nurse.
Nuwiq is usually injected into a vein ( intravenously ) by a doctor or nurse experienced in the care of patients with hemophilia A. You or someone else can also give your Nuwiq as an injection, but only after receiving adequate training.
Your doctor will calculate your dose of Nuwiq (in international units = IU) depending on your health condition and body weight, and depending on whether it is used as a preventative or as a treatment for bleeding. How often you need an injection depends on how well Nuwiq works for you. Usually, the treatment of hemophilia A is a lifelong treatment.
Prevention of bleeding
The usual dose of Nuwiq is 20 to 40 IU per kg body weight, given every two to three days. In some cases, more frequent injections or higher doses may be needed, especially for younger patients.
Bleeding treatment
Dose one of Nuwiq is calculated depending on your body weight and the levels of factor VIII to be achieved. The desired level of factor VIII depends on the severity and location of the bleeding.
Contact your doctor if you experience that Nuwiq has an insufficient effect. Your doctor will perform appropriate laboratory tests to ensure you have adequate levels of factor VIII. This is especially important if you are having major surgery.
Patients developing factor VIII inhibitors
If your factor VIII plasma level does not reach the expected level with Nuwiq or if your bleeding is not adequately controlled, it may be due to the development of factor VIII inhibitors. Your doctor will check this. You may need a higher dose of Nuwiq or another medicine to control your bleeding. Do not increase the total dose of Nuwiq to control your bleeding without consulting your doctor.
Use for children and adolescents
Nuwiq is given to children and adolescents in the same way as to adults. Because factor VIII products may need to be given more often to children and adolescents, a central venous catheter (CVK) may need to be applied. A CVK is an external connection that allows access to the bloodstream through a catheter without injection through the skin.
If you use more Nuwiq than you should
No symptoms of overdose have been reported. If you have been given more Nuwiq than you should, tell your doctor.
If you forget to use Nuwiq
Do not take a double dose to make up for a forgotten dose. Continue immediately with the next dose, and proceed as directed by your doctor.
If you stop using Nuwiq
Do not stop using Nuwiq without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Additional side effects in children and adolescents
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this medicine and seek medical advice immediately if:
- you notice symptoms of allergic reactions
Allergic reactions may include skin rash, hives, urticaria (itchy rash), including generalized urticaria, swelling of the lips and tongue, shortness of breath, wheezing, chest tightness, vomiting, restlessness, low blood pressure, and dizziness. These symptoms may be early symptoms of anaphylactic shock. If severe, sudden allergic reactions (anaphylactic) occur (very rare; may affect up to 1 in 10,000 people), the injection should be stopped immediately and you should contact a doctor immediately. Severe symptoms require immediate emergency treatment.
- you notice that the medicine stops working properly (bleeding does not stop or occurs often)
Among children and adolescents not previously treated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients).
However, for patients who have previously been treated with factor VIII (treatment for more than 150 days), the risk is less common (occurs in less than 1 in 100 patients). If this happens, your or your child’s medication may stop working properly, and you or your child may experience persistent bleeding. If this happens, consult a doctor immediately.
Common side effects may affect up to 1 in 10 people
Hypersensitivity, fever
Uncommon side effects may affect up to 1 in 100 people
Tingling or numbness ( paresthesia ), headache, dizziness, dizziness, dyspnoea, dry mouth, back pain, inflammation at the injection site, pain at the injection site, vague feeling of physical discomfort (feeling sick), bleeding anemia, positive for non-neutralizing antibody (in previously treated patients).
By reporting side effects, you can help increase drug safety information.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Nuwiq
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 vial label after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Keep the vial in the original package. Sensitive to light.
Before preparation , the Nuwiq powder can be stored at room temperature (up to a maximum of 25 ° C) for up to 1 month. Make a note of the date on the outer carton when you start storing Nuwiq at room temperature. Do not store Nuwiq in the refrigerator again after storing it at room temperature.
Use the reconstituted solution immediately.
Do not use this medicine if you notice visible signs of damage to the tamper-evident packaging of the package, especially concerning the syringe and/or vial.
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
Powder:
– The active substance is recombinant human coagulation factor VIII (simoctocog alfa). Each vial of powder contains
250, 500, 1000, 1500, 2000, 2500, 3000 and 4000 IU simoctocog alfa. Each reconstituted solution contains approximately 100, 200, 400, 600, 800, 1000, 1200 or 1600 IU / ml simoctocog alfa.
The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, and poloxamer 188. See section 2, “Nuwiq contains sodium”.
Liquid:
Water for injections
What the medicine looks like and contents of the pack
Nuwiq is available as a powder and solvent for solution for injection. The powder is white to off-white crumbly powder in a glass vial. The liquid is water for injections and is available in a pre-filled glass syringe.
After reconstitution, the solution is clear, colorless, and free of foreign particles.
Each pack of Nuwiq contains:
– 1 vial of powder with 250, 500, 1000, 2000, 2500, 3000, or 4000 IU simoctocog alfa
– 1 pre-filled syringe with 2.5 ml of water for injections
– 1 adapter for the vial
– 1 butterfly needle
– 2 alcohol swabs
Marketing Authorization Holder and Manufacturer
Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm
Contact the representative of the marketing authorization holder to find out more about this medicine:
Octapharma Nordic AB
Tel. 08-566 430 00