Adynovate (Rurioctocog Alfa Pegol)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Adynovate Used For?
Adynovate is a specialized medication designed to help people with haemophilia A, an inherited bleeding disorder where the body lacks enough blood clotting factor VIII.
Primary Uses
Adynovate is used to control and prevent bleeding episodes, routinely prevent and reduce the frequency of bleeding episodes, and prevent or reduce bleeding before, during and after surgery in patients with congenital haemophilia A.
How It Works
Blood clotting factor VIII is essential for blood to form clots and stop bleeding. In patients with inherited haemophilia A, there is a low level of factor VIII in the blood circulation. Adynovate is similar to the blood clotting factor VIII in human blood and works as a replacement therapy so that blood can form clots at the site of bleeding. It is produced by recombinant DNA technology and has been modified chemically to prolong its duration of action.
Good to know: This medicine helps to control your condition but does not cure it. It’s designed to work as a long-term replacement therapy.
How to Take Adynovate
Adynovate is given as a slow injection directly into your vein. Treatment will be started in a hospital or Haemophilia Treatment Centre and supervised by your doctor. Some individuals may be trained to use Adynovate at home after proper training.
Dosage Instructions
Your doctor will decide how much Adynovate you use based on your body weight, the amount of factor VIII your body is able to make, how much, how often and where you are bleeding, and if your body has built up antibodies to Adynovate. The frequency of injections and how long you will use Adynovate will depend on how well it is working for you. Adynovate comes as a powder in a vial with a diluent vial that need to be mixed before use. After mixing, use the solution immediately or within 3 hours when stored at room temperature (below 30°C).
What If You Miss a Dose?
Do not inject a double dose to make up for the forgotten dose. If you are not sure what to do, ask your doctor or Haemophilia Treatment Centre.
Important: Never attempt to inject Adynovate by yourself unless you have received proper training by your doctor or Haemophilia Treatment Centre on how to use the product.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Headache (very common)
- Dizziness
- Nausea
- Diarrhoea
- Rash
- Hives
- Flushing
- Redness of the eye
- Allergic reactions
- Easy bruising or bleeding due to development of factor VIII inhibitors
- Increase in some type of white blood cells
- Skin reactions at site of injection
- Itchy rash
Seek immediate medical attention if you experience:
- Severe, sudden allergic reaction which may progress to anaphylaxis including shock
- Signs of allergic response: rash, hives, wheals, or generalised itching
- Swelling of face, lips, tongue or other parts of the body
- Shortness of breath, wheezing, difficulty in breathing
- Tightness or discomfort in the chest, chest pain
- Dizziness and fainting
Important Warnings
There are several important safety considerations before using Adynovate that you should discuss with your healthcare provider.
Who Should Not Take Adynovate
Do not use Adynovate if you have ever had an allergic reaction to Adynovate, octocog alfa (a medicine called ADVATE), or if you are allergic to mouse or hamster proteins or any of the ingredients listed in the medication information.
Medical Conditions to Discuss
Check with your doctor if you have or have had any other medical conditions, have had or are at risk of any heart problems or conditions involving the blood vessels, or are on a controlled sodium diet. Adynovate may increase the risk of abnormal blood clots forming in your body if you have risk factors for developing blood clots.
Pregnancy and Breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. There is no information on the use of Adynovate during pregnancy. Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known if Adynovate passes into your milk and if it can harm your baby. Your doctor will discuss the risks and benefits of using Adynovate if you are pregnant or breast-feeding.
Drug Interactions
It’s important to tell your healthcare provider about all medications you’re taking, even though there are no known interactions of Adynovate with other medicines.
- No known interactions with other medicines
- Tell your doctor about all medicines, vitamins or supplements you buy without a prescription
Alcohol & Driving
Adynovate is not expected to have an influence on your ability to drive and use machines, but you should be careful until you know how it affects you.
Alcohol
No specific alcohol warnings mentioned in the source material.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how Adynovate affects you. Adynovate is not expected to have an influence on your ability to drive and use machines.
Storage
Keep Adynovate in the pack until it is time to use it to protect it from light. Store in the refrigerator at 2°C to 8°C. Do not freeze. If necessary, you can keep Adynovate out of the refrigerator for a single 3-month period when stored in the original packaging in a cool dry place at room temperature (below 30°C). Record the date that the product is removed from the refrigerator on the carton. Do not return the medicine to the refrigerator after it has been stored at room temperature. Do not use any Adynovate that has been out of the refrigerator for more than 3 months. Keep out of reach of children.
Overdose Information
If you think that you have used too much Adynovate, you may need urgent medical attention. You should immediately contact your doctor or Haemophilia Treatment Centre, go to the Emergency Department at your nearest hospital, or phone the Poisons Information Centre by calling 13 11 26 (if you are in Australia), or by calling 0800 764 766 (if you are in New Zealand). You should do this even if there are no signs of discomfort or poisoning.
Frequently Asked Questions
Adynovate works as a replacement therapy to help blood form clots at the site of bleeding. It has been modified chemically to prolong its duration of action compared to regular factor VIII.
Some individuals may be trained to use Adynovate at home after starting treatment in a hospital or Haemophilia Treatment Centre. However, you should never attempt to inject Adynovate by yourself unless you have received proper training from your doctor or Haemophilia Treatment Centre.
Adynovate comes as a powder in a vial with a diluent vial that need to be mixed before use. Use only the reconstitution device provided with each pack. After mixing, the solution should be clear to colourless and free from particles. Use immediately or within 3 hours when stored at room temperature below 30°C.
Tell your doctor or Haemophilia Treatment Centre immediately if your bleeding is not controlled or worsens after using Adynovate. This could indicate that your body has developed antibodies against the medication.
The frequency of injections you receive and how long you will use Adynovate will depend on how well it is working for you. Your doctor will determine the schedule based on your individual needs. Usually, replacement therapy with Adynovate is a life-long treatment.
Adynovate must be kept refrigerated at 2°C to 8°C, but if necessary, you can keep it out of the refrigerator for a single 3-month period when stored in original packaging at room temperature below 30°C. Record the date it was removed from refrigeration and do not return it to the refrigerator afterward.
Signs of an allergic reaction include rash, hives, wheals or generalised itching, swelling of face, lips, tongue or other body parts, shortness of breath, wheezing, difficulty breathing, chest tightness or pain, and dizziness or fainting. Stop the injection immediately and seek emergency medical care if these occur.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.