1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU), 8 mg (400 KIU) – powder and solvent for solution for injection eptacog
alfa (activated)
What NovoSeven® is and what it is used for
NovoSeven is a blood clotting factor. It works by causing the blood to coagulate at the bleeding site when the body’s coagulation factor is not working.
NovoSeven is used to treat bleeding and to prevent heavy bleeding after surgery or other important treatments. Early treatment with NovoSeven reduces how much you bleed and for how long. It works for all types of bleeding, even for bleeding in joints. This reduces the need for hospital care and the number of days off from work and school.
It is used for certain groups:
- If you have congenital haemophilia and do not normally respond to factor VIII or IX treatment
- If you have acquired hemophilia
- If you are deficient in factor VII
- If you have Glanzmann’s thrombasthenia (bleeding disorder) and your condition cannot be effectively treated with platelet transfusion , or platelets are not available.
What you need to know before using NovoSeven®
Do not use NovoSeven
- if you are allergic to eptacog alfa (the active substance of NovoSeven) or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to protein from mice, hamsters or cattle (such as cow’s milk).
If any of these apply to you, do not use NovoSeven. Talk to a doctor.
Warnings and cautions
Before treatment with NovoSeven, make sure your doctor knows:
- if you have recently had surgery
- if you have recently suffered a crush or crush injury
- if you have narrowing of the arteries due to illness (atherosclerosis)
- if you have an increased risk of blood clots ( thrombosis )
- if you have severe liver disease
- if you have blood poisoning
- if you have an increased risk of disseminated intravascular coagulation ( DIC , a condition in which blood clots form throughout the bloodstream), you should be closely monitored.
If any of these conditions apply to you, talk to your doctor before using the injection.
Other medicines and NovoSeven
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use NovoSeven at the same time as prothrombin complex concentrate or rFXIII. You should talk to your doctor before using NovoSeven if you are also taking factor VIII or IX drugs.
There is limited experience with the use of NovoSeven in combination with antifibrinolytics (such as aminocaproic acid or tranexamic acid ) which are also used to control bleeding. You should talk to your doctor before using NovoSeven with these medicines.
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 NovoSeven.
Driving and using machines
There are no studies on the effect of NovoSeven on the ability to drive and use machines. However, there is no medical basis to believe that it would affect the ability.
NovoSeven contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per injection, ie essentially ‘sodium-free’.
How to use NovoSeven®
The powder for NovoSeven should be dissolved in the diluent and injected into a vein. See the page below for detailed instructions.
When to treat yourself
Start treatment for bleeding as early as possible, preferably within 2 hours.
- In case of mild or moderate bleeding, you should treat yourself as early as possible, preferably at home.
- In case of severe bleeding, consult a doctor. Severe bleeding is usually treated in a hospital and you can give yourself the first dose of NovoSeven on the way there.
Do not treat yourself for more than 24 hours without consulting your doctor.
- Every time you use NovoSeven, tell your doctor or hospital as soon as possible.
- If the bleeding is not under control within 24 hours, contact a doctor immediately. Then you usually need hospital care.
Dose
The first dose should be given as early as possible after the bleeding has started. Talk to your doctor about when to use the injections and how long to use them.
Dose one is calculated by your doctor based on your body weight, condition, and blood type. For best results, follow the prescribed dose carefully. Your doctor may change the dose one.
If you have hemophilia:
The usual dose is 90 micrograms for every kilogram you weigh. You can repeat injection one at 2-3 hour intervals until the bleeding is under control.
Your doctor may recommend a single-dose injection of 270 micrograms for every kilogram you weigh. There is no clinical experience in the treatment of patients over 65 years of age with this single dose.
If you have a factor VII deficiency:
The usual dose range, for each injection, is 15 to 30 micrograms for each kilogram you weigh.
If you have Glanzmann’s thrombasthenia:
The usual dose for each injection is 90 micrograms (80 to 120 micrograms) for each kilogram you weigh.
If you take more NovoSeven than you should
If you inject too much NovoSeven, contact your healthcare provider immediately for advice.
If you forget to take NovoSeven
If you forget to take an injection or if you want to stop treatment, consult a doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Rare (may affect up to 1 in 1,000 people )
- Allergic, hypersensitive or anaphylactic reactions. Symptoms may include rash, itching , redness and hives; wheezing or difficulty breathing; feeling faint or dizzy as well as severe swelling of the lips or throat or at the injection site.
- Blood clots in the artery in the heart (which can lead to heart attack or angina), in the brain (which can lead to stroke ) or in the intestines or kidneys. Symptoms may include severe chest pain, shortness of breath, confusion, difficulty speaking or moving (paralysis) or abdominal pain.
Uncommon (may affect up to 1 in 100 people )
- Blood clots in the veins of the lungs, bones, liver, kidneys or at the injection site. Symptoms may include difficulty breathing, red and painful swelling in the legs and abdominal pain.
- Lack of effect or reduced response to treatment.
If you notice any of these serious side effects, contact your healthcare provider immediately. Explain that you have used NovoSeven.
Remind your doctor if you have previously had allergic reactions as you may need to be monitored more closely. In most cases of blood clots, patients had an increased risk of blood clots.
Other rare side effects ar
(may occur in up to 1 in 1000 treatments )
- Nausea
- Headache
- Changes in some liver and blood tests.
Other less common side effects are
(may occur in up to 1 in 100 treatment cases)
- Allergic skin reactions that include rash, itching and hives
- Fever.
How to store NovoSeven®
- Keep this medicine out of the sight and reach of children.
- Use this medicine before the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- Store powder and diluent at a maximum of 25 ° C.
- Store powder and diluent in light protection.
- Do not freeze.
- Use NovoSeven immediately after mixing the powder with the diluent to avoid infection . If you can not use the solution immediately after reconstitution, store it in the vial, with the adapter and syringe still in place, in a refrigerator at 2 ° C-8 ° C for a maximum of 24 hours. Do not freeze the NovoSeven solution and protect it from light. Do not store injection solution without consulting a doctor or nurse.
- 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 package and other information
Content declaration
- The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
- The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid , sodium hydroxide. The diluent contains histidine, hydrochloric acid , sodium hydroxide, water for injections.
Powder for solution for injection contains:
1 mg / vial (equivalent to 50 KIU / vial), 2 mg / vial (equivalent to 100 KIU / vial), 5 mg / vial (equivalent to 250 KIU / vial) or 8 mg / vial (equivalent to 400 KIU / vial).
After reconstitution , 1 ml solution contains 1 mg eptacog alfa (activated).
1 KIU corresponds to 1,000 IU (international units).
What the medicine looks like and contents of the pack
The vial contains a white powder and the pre-filled syringe a clear, colorless solution. The reconstituted solution is colorless. Do not use the reconstituted solution if you see particles in it or if it is discolored.
Each NovoSeven package contains:
- 1 vial of white powder for solution for injection
- 1 vial adapter
- 1 pre- filled syringe with diluent for reconstitution
- 1 piston rod
Pack sizes: 1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU) and 8 mg (400 KIU).
The current package size is stated on the outer packaging.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd, Denmark