HEMLIBRA ,FDA-Approved New Drug HEMLIBRA

                          HEMLIBRA 

(Active Ingredient: EMICIZUMAB)

                      

   

• About HEMLIBRA:

HEMLIBRA (emicizumab) It is approved by FDA as a prophylactic medicine It is used to Reduce the frequency of bleeding episodes in adults and children with hemophilia-A with factor VIII-inhibitors1 It is given once a week subcutaneously (under the skin).

1.  Its First new FDA approved Drug/Medicine to treat hemophilia-A with Resistor nearly 20 years 
2.  its First Bispecific monoclonal antibody to treat hemophilia-A with Resistor 
3.  Main Factor IXA and X in the blood clotting cascade 
4.  Its Only treatment option for hemophilia-A with Resistor that can be self-administered once weekly by injection subcutaneously Form.

• Important information to know about HEMLIBRA? 

HEMLIBRA may also cause serious side effects when used withactivated prothrombin complex concentrate (FEIBA). with including thrombotic microangiopathy and blood clots. 

The Cases of thrombotic microangiopathy & thrombotic events were reported when on average a cumulative amount of 100 U/kg/24 hours of (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis.

• About Hemophilia-A Inhibitors:

Hemophilia-A is a rare genetic blood disease where faulty blood clotting factor VIII prevents blood from clotting normally. 

It Can cause frequent bleeding, especially into joints & muscles.

• These bleeds often cause pain
• It can lead to deformity,chronic swelling, reduced mobility and long term joint damage.
• Factor VIII therapy is a standard Replacement treatment for people with hemophilia-A, but in some Case, their immune systems recognize this as a foreign Substance & generate the antibodies to attack it. These antibodies is called inhibitors. 

• Hemophilia occurs more frequently in males than females.

1. NEARLY20,000 PEOPLE IN THE U.S. HAVE HEMOPHILIA
2. ABOUT50-60% OF PEOPLE WITH HEMOPHILIA A HAVE A SEVERE FORM OF THE DISORDER.

• How HEMLIBRA Work (Mechanism of Action)

• Blood clotting factors activated In each Cell to form a blood clot, or coagulate. These processes are called as the blood coagulation. 

• HEMLIBRA is bispecific factor IXa- & factor X-directed antibodys designed to activate the natural coagulation & restore the blood clotting process.

• People who has hemophilia-A do not have enough functional natural protein factor VIII.

• By replacing the natural activated factor VIII, HEMLIBRA promotes blood clotting.

• HEMLIBRA is a different type of molecule than activated factor VIII, and is therefore not expected to induce inhibitors or be affected by inhibitors.

• HEMLIBRA has a long half-life of approximately 4 weeks, which is related to the amount of time the medicine remains active in the body.

• Efficacy1 HEMLIBRA :  
• Primary Endpoint

1. The approval from FDA of HEMLIBRA is based on positive results of Phase III clinical study in adolescents & adults 
2. In HAVEN-1 studied the total 109 adolescents & adults (12 years) of hemophilia-A with inhibitors, once weekly preventative administration of HEMLIBRA substantially reduced treated bleeds or preventative use of bypassing agents (BPAs)

• Secondary Endpoints 

Improvement in a bleed with HEMLIBRA prophylaxis compared to no prophylaxis were consistent across all secondary bleed endpoints.

                           WHAT IT TREAT'S

• HEMLIBRA?

It is a prescription medicine used for routine prophylaxis to reduce the frequency of bleeding episodes in adults & children with hemophilia-A factor VIII inhibitors.

• Most important information should know about HEMLIBRA?

HEMLIBRA is increases the potential to your blood to clot. Discontinue the prophylactic use of bypassing agents the day before starting of HEMLIBRA prophylaxis. 

Carefully follow your instructions provided by healthcare providers regarding when to use an on-demand bypassing agent. & the use of scheduled prescribed dose. 

HEMLIBRA may cause the following serious side effects when used with prothrombin complex concentrate (FEIBA).

• Thrombotic microangiopathy. This is a condition of blood clots and injury to small blood vessels it may cause harm to your brain, kidney & other organs. Get medical help if you have any of the following symptoms occur during or after treatment with HEMLIBRA.

• nausea or vomiting
• feeling sick
• swelling of arms and legs
• yellowing of skin and eyes
• decreased urination
• confusion
• weakness
• stomach (abdomen) or back pain

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

• numbness in your face
• eye pain or swelling
• trouble seeing
• chest pain or tightness
• fast heart rate
• feel faint
• swelling in arms or legs
• pain or redness in your arms or legs
• shortness of breath
• headache

How should I use HEMLIBRA?

• Instructions Use of HEMLIBRA

Information on how to prepare and inject a dose of HEMLIBRA, and how to properly dispose used needles and syringes.

HEMLIBRA interfere with laboratory tests that measure how well your blood is clotting & may cause a false reading. Talk to your healthcare provider about how this may affect your care.

• The most common side effects of HEMLIBRA include:

1. Redness, 
2. tenderness
3. warmth
4. itching at the site of injection
5. headache
6. joint pain..

• General information about use of HEMLIBRA.

1. Sometimes Medicines prescribed for purposes other than those listed in a Medication Guide. 
2. Do not use HEMLIBRA for a condition for which it was not prescribed. 
3. Do not give HEMLIBRA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about HEMLIBRA that is written for health professionals...

• Hemlibra Drug Price:

See BOXED WARNING,What is HEMLIB & Price.