Alprolix (Eftrenonacog Alfa (Recombinant Coagulation Factor Ix Fusion Protein))

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
eftrenonacog alfa (recombinant coagulation factor IX fusion protein)
Drug Class
Coagulation factor replacement therapy
Used For
Management of haemophilia B (congenital factor IX deficiency)
How Taken
Slow injection directly into veins as prescribed by doctor

What Is Alprolix Used For?

Alprolix is a specialized medication designed to help people with haemophilia B, a condition where the body doesn’t produce enough factor IX protein needed for proper blood clotting.

Primary Uses

Alprolix is used to control and prevent bleeding episodes, routinely prevent and reduce the frequency of bleeding episodes, and reduce bleeding before, during, and after surgery in people with haemophilia B.

How It Works

People with haemophilia B lack sufficient factor IX to control bleeding. Alprolix works by replacing the missing factor IX protein to enable blood to clot properly.

Good to know: This medicine helps to control your condition but does not cure it.

How to Take Alprolix

Alprolix is given as a slow injection directly into your veins. Your doctor will determine the exact dose based on your individual needs for factor IX replacement therapy.

Dosage Instructions

Your doctor will decide how much Alprolix you use based on your individual need for replacement factor IX therapy. Your doctor may change the dose during your treatment. Alprolix comes as a sterile powder that must be mixed with the provided diluent before use. It’s important not to shake the medicine when mixing as this can damage it. The mixed product can be kept for a maximum of 6 hours at room temperature (below 30°C) if needed.

What If You Miss a Dose?

Use your dose of Alprolix as soon as you remember and resume your normal dosing schedule. Do not take a double dose to make up for the missed dose as this may increase the chance of unwanted side effects.

Important: Never double dose to make up for a missed dose – this may increase the chance of getting unwanted side effects.

Available Tablet Strengths

250 IU
250 IU Tablet White to off-white powder, Vial • AUST R 209227
500 IU
500 IU Tablet White to off-white powder, Vial • AUST R 209223
1000 IU
1000 IU Tablet White to off-white powder, Vial • AUST R 209224
2000 IU
2000 IU Tablet White to off-white powder, Vial • AUST R 209225
3000 IU
3000 IU Tablet White to off-white powder, Vial • AUST R 209226
4000 IU
4000 IU Tablet White to off-white powder, Vial • AUST R 315497

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
  • Tingling or numbness in your mouth (paraesthesia)
  • Breath odour
  • Fatigue
  • Dizziness
  • Taste disturbance or loss of taste (dysgeusia)
  • Pain or redness at injection site
  • Low blood pressure (symptoms include dizziness or feeling lightheaded)
  • Fast or irregular heartbeats (palpitations)
  • Pain in your side with blood in your urine (obstructive uropathy)

Seek immediate medical attention if you experience:

  • Factor IX inhibition – easily bruising or bleeding due to factor IX inhibition
  • Allergic reactions with symptoms of shortness of breath, wheezing or difficulty breathing
  • Chest pain or discomfort
  • Swelling of the face, lips, tongue or other parts of the body
  • Rash or hives

Important Warnings

Before using Alprolix, it’s important to understand who should not use this medication and what conditions need special consideration.

Who Should Not Take Alprolix

Do not use Alprolix if you are allergic to eftrenonacog alfa, other factor IX replacement factors, or any of the ingredients listed in the medication guide.

Medical Conditions to Discuss

Tell your doctor if you have any other medical conditions or take any medicines for other conditions. Your doctor needs to know about all your health conditions before prescribing Alprolix.

Pregnancy and Breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. There is no information on the use of Alprolix during pregnancy. Talk to your doctor if you are breastfeeding or intend to breastfeed, as it is not known whether Alprolix passes into breast milk. Your doctor will discuss the risks and benefits in both situations.

Blood Clot Risk: Alprolix may increase the risk of formation of abnormal blood clots in your body if you have risk factors for developing blood clots.

Drug Interactions

It’s important to tell your doctor or Haemophilia Treatment Centre about all medications you’re taking to avoid potential interactions.

  • Any prescription medicines
  • Vitamins or supplements bought without prescription
  • Medicines from pharmacy, supermarket or health food shop

Alcohol & Driving

Be careful about activities that require alertness until you know how Alprolix 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 Alprolix affects you.

Storage

Keep Alprolix in the pack until it’s time to use it. Store in the refrigerator at 2°C to 8°C and protect from light. Do not freeze. If necessary, you can keep Alprolix out of the refrigerator for a single 6-month period at temperatures below 30°C. Once mixed, keep at room temperature (below 30°C) for up to 6 hours and protect from direct sunlight.

Overdose Information

If you think you have used too much Alprolix, you may need urgent medical attention. Immediately contact your doctor, go to the Emergency Department at your nearest hospital, or phone the Poisons Information Centre (13 11 26 in Australia or 0800 764 766 in New Zealand). Do this even if there are no signs of discomfort or poisoning.

Frequently Asked Questions

Once you mix the powder with the diluent, you can keep the mixed product for a maximum of 6 hours when stored at room temperature (below 30°C). Do not put it in the freezer.

Tell your doctor immediately if bleeding is not controlled after using Alprolix. This is important information your healthcare team needs to know right away.

You can keep Alprolix out of the refrigerator for a single 6-month period at temperatures below 30°C. Record the date you removed it from the refrigerator on the carton. Do not use any Alprolix that has been out of the refrigerator for more than 6 months.

Your body can make antibodies called ‘inhibitors’ against Alprolix, which may stop Alprolix from working properly. Tell your doctor or Haemophilia Treatment Centre if you notice any changes in how well the medication is working.

Do not stop using Alprolix or change the dosage without checking with your doctor unless you have an allergic reaction. Continue taking your medicine for as long as your doctor tells you.

The medicine should be clear to slightly opalescent and colourless. Do not inject if the solution is discoloured, cloudy, or contains particles. Always inspect Alprolix before use and after it has been mixed.

Tell any other doctors, dentists, and pharmacists who treat you that you are using Alprolix. Also inform your doctor if you are about to have any blood tests.

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.