For US Healthcare Professionals

Glossary

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    A
    All bleeds

    Any bleeding episode whether treated or untreated.

    aPCC

    Activated prothrombin complex concentrate (aPCC) is a scientific term for the bypassing therapy Feiba®.

    B
    Bypassing agent

    A type of treatment developed for people with inhibitors; bypassing treatments go around (or bypass) the factors that are blocked by the inhibitor to help the body form a normal clot.

    F
    Factor replacement therapy

    A treatment that replaces the low or missing factor in people with hemophilia so that blood will clot if you have an injury.

    I
    Intravenous injection

    A method to deliver medicine into the body that involves inserting a needle directly into the vein.

    P
    Pharmacokinetics

    The movement of a drug into, through, and out of the body.

    Prophylactic

    The regular use of a medicine to prevent something from occurring. In hemophilia, prophylaxis is intended to prevent or reduce bleeding.

    S
    Subcutaneous

    A method to deliver medicine into the body that involves inserting a needle into the fatty tissue just beneath the skin.

    T
    Therapeutic antibody

    Therapeutic antibodies, often referred to as monoclonal antibodies, are designed to have the same ability as natural antibodies to bind to specific molecules. They are laboratory-produced molecules that are designed to recognize and attach to specific proteins to help treat a disease.

    Treated bleed

    A bleed that requires treatment as determined by the individual or their healthcare provider.

Important Safety Information & Indication

What is HEMLIBRA?

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. People who use activated prothrombin complex concentrate (aPCC; Feiba®) to treat breakthrough bleeds while taking HEMLIBRA may be at risk of serious side effects related to blood clots.

These serious side effects include: 

  • Thrombotic microangiopathy (TMA), a condition involving blood clots and injury to small blood  vessels that may cause harm to your kidneys, brain, and other organs 
  • Blood clots (thrombotic events), which may form in blood vessels in your arm, leg, lung, or head  

Talk to your doctor about the signs and symptoms of these serious side effects, which can include: 

  • Confusion
  • Stomach, chest, or back pain
  • Weakness
  • Nausea or vomiting
  • Swelling, pain, or redness
  • Feeling sick or faint
  • Decreased urination
  • Swelling of arms and legs
  • Yellowing of skin and eyes
  • Eye pain, swelling, or trouble seeing
  • Fast heart rate
  • Numbness in your face
  • Headache
  • Shortness of breath
  • Coughing up blood

If you experience any of these symptoms during or after treatment with HEMLIBRA, get medical help right away. 

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. 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. 

Your body may make antibodies against HEMLIBRA, which may stop HEMLIBRA from working properly. Contact your healthcare provider immediately if you notice that HEMLIBRA has stopped working for you (eg, increase in bleeds).

The most common side effects of HEMLIBRA include: injection site reactions (redness, tenderness, warmth, or itching at the site of injection), headache, and joint pain. These are not all of the possible side effects of HEMLIBRA. You can speak with your healthcare provider for more information.

What else should I know about HEMLIBRA?

See the detailed “Instructions for Use” that comes with your HEMLIBRA for information on how to prepare and inject a dose of HEMLIBRA, and how to properly throw away (dispose of) used needles and syringes.

  • Stop taking your prophylactic bypassing therapy the day before you start HEMLIBRA
  • You may continue taking your prophylactic factor VIII for the first week of HEMLIBRA

HEMLIBRA may interfere with laboratory tests that measure how well your blood is clotting and create an inaccurate result. Speak with your healthcare provider about how this may affect your care. 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Only use HEMLIBRA for the condition it was prescribed. Do not give HEMLIBRA to other people, even if they have the same symptoms that you have. It may harm them.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Keep a list of them to show your healthcare provider and pharmacist.

Before using HEMLIBRA, tell your healthcare provider about all of your medical conditions, including if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Since HEMLIBRA was tested in males, there is no information on whether HEMLIBRA may impact your unborn baby or breast milk. Females who are able to become pregnant should use birth control during treatment.

Side effects may be reported to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the HEMLIBRA full Prescribing Information and Medication Guide.