Hemlibra (Emicizumab)

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

Prescription Required

Quick Facts

Generic Name
emicizumab
Drug Class
monoclonal antibody
Used For
routine prophylaxis in haemophilia A
How Taken
subcutaneous injection weekly or every 2-4 weeks

What Is Hemlibra Used For?

Hemlibra contains emicizumab, a monoclonal antibody that helps prevent bleeding in people with haemophilia A. It works by mimicking factor VIII to help your blood clot properly.

Primary Uses

Hemlibra is used for routine prophylaxis (prevention) in children, adolescents and adults with haemophilia A (congenital factor VIII deficiency). It prevents bleeding or reduces the number of bleeding episodes, whether or not you have inhibitors to factor VIII.

How It Works

Hemlibra works like factor VIII by binding to the same clotting factors, which helps your blood to clot. Because emicizumab is different to factor VIII, it works whether or not inhibitors are present. It recognizes and binds to specific targets in the body to help with blood clotting.

Good to know: This medicine is used to prevent bleeding episodes, not to treat bleeds once they occur. It’s not used ‘on-demand’ for active bleeding.

How to Take Hemlibra

Hemlibra is given by injection under the skin (subcutaneously). Your doctor will train you or your caregiver to inject this medicine at home. The dose depends on your weight and how often you inject.

Dosage Instructions

Weeks 1 to 4: 3 milligrams for every 1 kilogram you weigh, injected once a week. Week 5 and onwards: your doctor will determine if you continue weekly injections or change to once every 2 weeks or once every 4 weeks. Different concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection. Do not inject into a vein or muscle – only under the skin.

What If You Miss a Dose?

If you forget your scheduled injection, inject the forgotten dose as soon as possible before the day of the next scheduled dose. Then continue with your usual scheduled dosing day.

Important: Do not inject a double dose on the same day to make up for a missed dose. This may increase your chance of getting unwanted side effects.

Available Tablet Strengths

30 mg in 1 mL
30 mg in 1 mL Tablet Colourless to slightly yellow, Solution in vial • AUST R 293761
60 mg in 0.4 mL
60 mg in 0.4 mL Tablet Colourless to slightly yellow, Solution in vial • AUST R 293760
105 mg in 0.7 mL
105 mg in 0.7 mL Tablet Colourless to slightly yellow, Solution in vial • AUST R 293758
150 mg in 1 mL
150 mg in 1 mL Tablet Colourless to slightly yellow, Solution in vial • AUST R 293759

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:

  • Injection site reactions (redness, itching, pain)
  • Joint pain
  • Muscle aches
  • Diarrhea
  • Nausea or vomiting
  • Abdominal pain
  • Skin rash or hives
  • Flushing
  • Itchy, watery eyes
  • Headache
  • Fever
  • Fatigue or lightheadedness

Seek immediate medical attention if you experience:

  • Difficulty breathing or shortness of breath
  • Wheezing or whistling sound while breathing
  • Coughing
  • Swelling of face, lips, tongue, throat or extremities (angioedema)
  • Loss of consciousness
  • Rapid or weak pulse
  • Low blood pressure
  • Blood clots in small blood vessels (confusion, weakness, swelling, yellowing of skin/eyes)
  • Blood clot in vein near skin surface (swelling, warmth, pain, redness)
  • Blood clot behind the eye (headache, numbness around face, eye pain, vision problems)
  • Severe skin damage or blackening (skin necrosis)

Important Warnings

Hemlibra increases your blood’s potential to clot and has important interactions with other blood products. There are serious warnings about using it with certain medications.

Who Should Not Take Hemlibra

Do not use Hemlibra if you are allergic to emicizumab, any of the ingredients, or any other proteins that are of hamster origin.

Medical Conditions to Discuss

Tell your doctor if you have any other medical conditions or take any medicines for other conditions. If you have haemophilia A with inhibitors, it’s very important to discuss when and how to use bypassing agents while using Hemlibra.

Pregnancy and Breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Your doctor can discuss the risks and benefits with you. Talk to your doctor if you are breastfeeding or intend to breastfeed. Call your doctor immediately if you become pregnant while using Hemlibra.

Critical Warning: Stop prophylactic use of bypassing agents the day before starting Hemlibra. Hemlibra may cause serious side effects when used with aPCC (FEIBA-NF). Carefully follow your doctor’s instructions regarding bypassing agents.

Drug Interactions

Some medicines may interfere with Hemlibra and affect how it works. There are serious interactions with certain blood products that require careful monitoring.

FEIBA-NF Warning: Avoid using FEIBA-NF unless no other treatment options are available. If required, do not use more than 50 units/kg except under medical supervision. Stop both medicines immediately if you notice symptoms of blood clots.

  • FEIBA-NF (factor VIII inhibitor bypassing fraction/activated prothrombin complex concentrate) – serious and potentially life-threatening interactions
  • NovoSeven recombinant coagulation factor VIIa (activated factor VII or eptacog alfa)
  • Any form of factor VIII
  • Other blood products

Alcohol & Driving

Hemlibra is not expected to affect your ability to drive or operate machinery, but you should be careful until you know how it affects you.

Alcohol

No specific alcohol warnings are mentioned in the prescribing information.

Driving and Operating Machinery

This medicine is not expected to affect your ability to drive a car or operate machinery. However, be careful before you drive or use any machines or tools until you know how Hemlibra affects you.

Storage

Store Hemlibra in a refrigerator between 2°C to 8°C. Keep the vial in the box until use and protect from light. Do not shake or freeze the vial. If necessary, unopened vials may be kept at room temperature (below 30°C) for up to 7 days, but the total time at room temperature should not exceed 7 days. Take the vial out 15 minutes before use to reach room temperature. Do not refrigerate the solution once it’s in the syringe. Do not use if it has been out of the refrigerator for more than 7 days or past the expiry date.

Overdose Information

If you think you have used too much Hemlibra, you may need urgent medical attention. Immediately phone the Poisons Information Centre (13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital. Do this even if there are no signs of discomfort, as you may be at risk of developing side effects such as blood clots and may need urgent medical attention.

Frequently Asked Questions

Hemlibra begins working to prevent bleeding episodes from the first injection. The initial dosing period is weeks 1-4 with weekly injections, then the schedule may change to every 2-4 weeks from week 5 onwards.

Yes, Hemlibra is used for routine prophylaxis in children, adolescents and adults with haemophilia A. Self-injection for children below 7 years is not recommended, but older children may self-inject with proper training and healthcare provider approval.

Call your doctor immediately if you feel Hemlibra is no longer helping your condition, such as if you notice an increase in bleeds. This is uncommon but might mean you have developed antibodies to Hemlibra, and a change to your treatment may be required.

Hemlibra must be stored in a refrigerator between 2°C to 8°C, but unopened vials can be kept at room temperature (below 30°C) for up to 7 days if necessary. Always carry your Patient Card and inform any healthcare providers that you are using Hemlibra.

Tell any doctor, dentist, pharmacist or nurse you visit that you are using Hemlibra. Your doctor should be informed if you are about to have any coagulation blood tests, as Hemlibra may affect the results.

Do not stop using Hemlibra or change the dosage without checking with your doctor. Continue using your medicine for as long as your doctor tells you to maintain bleeding prevention.

Hemlibra is for prevention, not treatment of active bleeds. If you have haemophilia A with inhibitors, your doctor will give you specific instructions about when and how to use bypassing agents to treat bleeds while using Hemlibra.

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.