ALTUVOCT
Generic Name/API: efanesoctocog alfa
Manufacturer: Swedish Orphan Biovitrum AB
Dosage Forms & Strength & Pack Size:
ALTUVOCT 250 IU powder and solvent for solution for injection
ALTUVOCT 500 IU powder and solvent for solution for injection
ALTUVOCT 750 IU powder and solvent for solution for injection
ALTUVOCT 1 000 IU powder and solvent for solution for injection
ALTUVOCT 2 000 IU powder and solvent for solution for injection
ALTUVOCT 3 000 IU powder and solvent for solution for injection
ALTUVOCT 4 000 IU powder and solvent for solution for injection
Storage:
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 on the vial after
‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Before ALTUVOCT powder is reconstituted it may be kept at room temperature (≤ 30 °C) for a single period no longer than 6 months. The date that the product is removed from refrigeration should be recorded on the carton. After storage at room temperature, the product must not be put back in the refrigerator.
Do not use beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, whichever is earlier.
ALTUVOCT contains the active substance efanesoctocog alfa, a replacement factor VIII protein.
ALTUVOCT is used to treat and prevent bleeding episodes in patients with haemophilia A (an inherited bleeding disorder caused by factor VIII deficiency) and can be used in patients of all age groups.
Factor VIII is a protein naturally found in the body and is necessary for the blood to form clots and stop bleeding. In patients with haemophilia A, factor VIII is missing or not working properly.
ALTUVOCT replaces the deficient or missing factor VIII. ALTUVOCT increases factor VIII levels in the blood, helping blood to form clots at the site of bleeding which temporarily corrects the bleeding tendency.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ALTUVOCT.
• There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ALTUVOCT. Signs of allergic reactions may include generalised itching,
hives, tightness of the chest, difficulty in breathing, and low blood pressure. If any of these symptoms occur, stop the injection immediately and contact your doctor.
• Talk to your doctor if you think that your or your child’s bleeding is not being controlled with the dose you receive, as there can be several reasons for this. Some people using this medicine can develop antibodies to factor VIII (also known as factor VIII inhibitors). The formation of factor VIII inhibitors is a known complication that can occur during treatment with all factor VIII medicines. These inhibitors, especially at high levels, stop the treatment from working properly and you or your child will be monitored carefully for the development of these inhibitors.
Cardiovascular events
If you have heart disease or are at risk for heart disease, take special care when using factor VIII
medicines and talk to your doctor.
Catheter-related complications
If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.
Other medicines and ALTUVOCT
Tell your doctor if you are using, have recently used or might use any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think that you may be pregnant or are planning to have a baby,
ask your doctor for advice before using this medicine.
Driving and using machines
ALTUVOCT has no or negligible influence on your ability to drive and use machines.
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
