Hemlibra 105mg Injection is used for:

• Haemophilia A: To prevent or reduce the frequency of bleeding episodes in people with congenital factor VIII deficiency, with or without factor VIII inhibitors. It can be used across age groups.

Hemlibra 105mg Injection contains Emicizumab, which binds to activated factor IX (FIXa) and factor X (FX). This brings these clotting proteins together and helps restore the function normally provided by activated factor VIII (FVIIIa), supporting the blood-clotting process.

Because Emicizumab has a different structure from factor VIII, it can continue to work in people who have developed factor VIII inhibitors.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• Activated prothrombin complex concentrate (aPCC): Using aPCC with Hemlibra can increase the risk of blood clots and thrombotic microangiopathy (TMA), particularly with higher cumulative doses. Avoid aPCC unless no suitable alternative is available, and use it only under medical supervision.

• Recombinant factor VIIa (rFVIIa) and factor VIII: Hemlibra increases the body's clotting potential, so the dose of these medicines needed to control bleeding may be lower than before starting Hemlibra. Their use should be guided by your haemophilia specialist.

• Other medicines given under the skin: If you need another subcutaneous medicine, it is preferable to use a different injection site.

• Blood-clotting tests: Hemlibra can interfere with certain laboratory tests, including activated partial thromboplastin time (aPTT), activated clotting time (ACT) and some aPTT-based factor VIII tests. Tell your healthcare provider that you are receiving Hemlibra before having blood-clotting tests or procedures. These effects may continue for up to 6 months after the last dose.

• Store Hemlibra 105mg Injection in a refrigerator at 2°C to 8°C.

• Do not freeze.

• Do not shake the vial.

• Keep the vial in its outer carton to protect it from light.

• Once removed from the refrigerator, an unopened vial may be stored at room temperature below 30°C for up to 7 days. The total time kept at room temperature should not exceed 7 days.

• Keep Hemlibra out of the reach of children.

• Do not use the medicine after the expiry date.

Hemlibra 105mg Injection is given under the skin (subcutaneously). Your doctor or healthcare professional will determine your dose based on your body weight and treatment plan.

The usual treatment starts with 3 mg/kg once weekly for the first 4 weeks. From week 5 onwards, the maintenance dose may be 1.5 mg/kg once weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks, as prescribed by your doctor. The 105 mg/0.7 mL vial is one of the available strengths used to make up the prescribed dose.

Hemlibra can be injected into the abdomen, thighs or upper outer arms. An injection into the upper outer arm should be given by a caregiver or healthcare professional. Rotate injection sites and do not inject into skin that is red, bruised, tender or hard, or into areas with moles or scars.

After proper training, you or your caregiver may administer Hemlibra at home if your doctor considers this appropriate. Self-administration is not recommended for children below 7 years of age.

If you miss a scheduled dose, administer it as soon as possible before the day of your next scheduled dose, then continue with your usual schedule. Do not take two doses on the same day to make up for a missed dose.

Hemlibra 105 mg injection can cause side effects, although not everyone experiences them.

Common side effects:

• Injection-site reactions, such as redness, pain, itching or swelling

• Headache

• Joint pain

• Diarrhoea

• Fever

• Muscle pain

• Rash

• Hives (urticaria)

Serious side effects:

• Thrombotic microangiopathy (TMA): A serious condition involving small blood-vessel clots, which may cause low platelet levels, destruction of red blood cells and acute kidney injury. The risk is particularly associated with the use of aPCC during Hemlibra treatment.

• Thromboembolic events: Blood clots can develop in blood vessels, including uncommon events such as cavernous sinus thrombosis and superficial vein thrombosis associated with skin necrosis.

• Severe allergic reactions: Hypersensitivity, angioedema or other serious allergic reactions can occur.

• Loss of treatment effect: Rarely, neutralising antibodies against Emicizumab may reduce its effectiveness and lead to an increase in breakthrough bleeding.

Seek immediate medical attention if you develop symptoms suggesting a serious blood clot, TMA, severe allergic reaction or unexpected increase in bleeding.

• Use Hemlibra exactly as prescribed and do not change the dose or injection schedule without medical advice.

• Tell every healthcare professional involved in your care that you are receiving Hemlibra, especially before blood tests, surgery or other medical procedures.

• Do not use aPCC with Hemlibra unless your haemophilia specialist specifically advises it.

• If a bypassing agent is required, follow the exact dose and schedule given by your haemophilia treatment team. The interaction with aPCC can persist for up to 6 months after the last Hemlibra dose.

• Rotate injection sites and avoid injecting into bruised, red, tender, hard or damaged skin.

• Use a new needle and syringe for each injection and dispose of used sharps safely.

• Keep a record of your Hemlibra treatment, including the product name and batch number where applicable.

• Contact your doctor promptly if breakthrough bleeding becomes more frequent or your usual bleeding control changes.