Hemlibra, illustration of injection vial form (not a photo of the actual pack)

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Hemlibra

Emicizumab

Prescription required

$3625.00

30mg/1ml · 1 vial

BrandBranded medicine· By Roche

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30mg/1ml

60mg/0.4ml

105mg/0.7ml

150mg/1ml

FDA boxed warningThrombotic microangiopathy and thromboembolism

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

Read this with the rest of the clinical information

About Hemlibra

Overview

Hemlibra (emicizumab) is an antibody medicine supplied in single-dose vials for injection under the skin. It is used to prevent or reduce bleeding episodes in adults and children, including newborns, with hemophilia A, with or without factor VIII inhibitors. It works by bringing together two blood-clotting proteins to take over the role of missing activated factor VIII, helping blood to clot.

What it treats

Routine prevention or reduction of bleeding episodes in adults and children, including newborns, with hemophilia A (congenital factor VIII deficiency), with or without factor VIII inhibitors.

Safety information

Side effects

Common side effects include injection-site reactions, headache and joint pain. Serious side effects include thrombotic microangiopathy (damage and blood clots in small blood vessels) and thromboembolism (blood clots that block blood vessels), associated with Hemlibra used with activated prothrombin complex concentrate (aPCC). Contact a doctor immediately if a blood clot is suspected. Antibodies against emicizumab can develop and may reduce its effectiveness. Contact your doctor promptly if Hemlibra seems to be working less well. Hemlibra can interfere with certain blood-clotting tests and make their results unreliable. Tell the healthcare professional arranging these tests that you use Hemlibra.

FDA boxed warning

Thrombotic microangiopathy and thromboembolism

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek immediate medical attention if you suspect blood clots, including clots in small blood vessels, particularly if you also receive activated prothrombin complex concentrate (aPCC). - Contact your doctor promptly if Hemlibra seems to be working less well. Antibodies against the medicine may reduce its effect.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

The FDA label lists no contraindications for Hemlibra. Some patients develop antibodies against emicizumab, including antibodies that can reduce its effect. If there are signs that treatment is becoming less effective, the prescriber should promptly assess the cause and consider changing treatment if neutralizing antibodies are suspected. Hemlibra interferes with certain blood-clotting tests, including activated clotting time (ACT), activated partial thromboplastin time (aPTT), and tests based on aPTT. These include some tests for clotting factors and factor VIII inhibitors. Intrinsic pathway clotting-based laboratory tests should not be used. Tell the healthcare team that you use Hemlibra before having clotting tests.

Using Hemlibra

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label HEMLIBRA (EMICIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] (DailyMed, retrieved 19 September 2026).

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