Emicizumab-kxwh and Side Effects

Emicizumab-kxwh is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with or without factor 8 (factor VIII or FVIII) inhibitors.  

The safety of emicizumab-kxwh was assessed in 5 clinical studies: HAVEN 1, HAVEN 2, HAVEN 3, HAVEN 4 and a dose-finding study. The below information is from the Prescribing Information:

  • HAVEN 1 (in adults and adolescents ≥12 years of age) and HAVEN 2 (an ongoing study in children) studied the effects of emicizumab-kxwh in people with hemophilia A with factor VIII inhibitors.

  • HAVEN 3 (in adults and adolescents ≥12 years of age) studied the effects of emicizumab-kxwh in people with hemophilia A without factor VIII inhibitors.

  • HAVEN 4 and the dose-finding study (in adult and adolescents ≥12 years of age) studied the effects of emicizumab-kxwh in people with hemophilia A with or without factor VIII inhibitors.

  • Among these 5 studies, safety was looked at in 391 people who took emicizumab-kxwh.

The most common side effects (10% or more) in people who took emicizumab-kxwh were:

  • redness, tenderness, warmth, or itching where the injection  was given

  • headache

  • joint discomfort

Side effects that happened in 5% or more of people who took emicizumab-kxwh are shown in the below table:

Side Effect

Number of People (N=391)

Percentage of People (%)

Injection site reaction

85

22%

Fever

23

6%

Headache

57

15%

Diarrhea

22

6%

Joint discomfort

59

15%

These are not all of the possible side effects of emicizumab-kxwh. Call your doctor for medical advice about side effects.

Your healthcare provider should be the primary source of information about your medical condition and the safe and effective use of any medicine, including emicizumab-kxwh.

You may contact our Medical Communications department with questions specific to this site: (800) 821-8590, Monday-Friday, 5:00A – 5:00P PST.

Important Safety Information & Indication

Indication

HEMLIBRA® is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.

What is the most important information I should know about HEMLIBRA?

HEMLIBRA increases the potential for your blood to clot. Carefully follow your healthcare provider’s instructions regarding when to use an on-demand bypassing agent or factor VIII, and the dose and schedule to use for breakthrough bleed treatment. HEMLIBRA may cause the following serious side effects when used with activated prothrombin complex concentrate (aPCC; FEIBA®), including:

  • Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs. Get medical help right away if you have any of the following signs or symptoms during or after treatment with HEMLIBRA:

    • Confusion

    • Weakness

    • Swelling of arms and legs

    • Yellowing of skin and eyes

    • Stomach (abdomen) or back pain

    • Nausea or vomiting

    • Feeling sick

    • Decreased urination

  • Blood clots (thrombotic events). Blood clots may form in blood vessels in your arm, leg, lung, or head. Get medical help right away if you have any of these signs or symptoms of blood clots during or after treatment with HEMLIBRA: 

    • Swelling in arms or legs

    • Pain or redness in your arms or legs

    • Shortness of breath

    • Chest pain or tightness

    • Fast heart rate

    • Cough up blood

    • Feel faint

    • Headache

    • Numbness in your face

    • Eye pain or swelling

    • Trouble seeing

If aPCC (FEIBA®) is needed, talk to your healthcare provider in case you feel you need more than 100 U/kg of aPCC (FEIBA®) total.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555, 24 hrs/day, 7 days/week.

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