BICOMLIC

Thrombosis

Mechanism of action

Prescribing information

Patient information

Bicomlic in the world

:: Thrombosis ::
Data Statistic and Facts
Thrombosis is a condition which often leads to cardiovacular and cerebrovascular diseases.
In 2010, 18, 1 million people died from Cardiovascular diseases (CVD) which means 30.8% of all deaths. About 10% were due to stroke with a higher rate in women. Smokers and people with diabetes have a higher risk level than others (10 % of the CVD deaths were due to cigarette smoking).1

What is Thrombosis?
Thrombosis is the presence of a blood clot within arteries (blood vessels that carry oxygenated blood away from the heart to the body) or veins (blood vessels that carry blood from the body back into the heart).  This blood clot has the potential to break away from an artery or vein and either partially or completely block the flow of blood to a particular area of the body. Diseases arising from clots in blood vessels are mainly heart attacks and strokes. Fibrinogen fiber is the main component of protein in blood clots. These blood clots can be destroyed by the fibrinolytic enzymes.  Therefore, the use of these enzymes in the clinical history is an effective method for the treatment of thrombosis diseases. 2
Causes of thrombosis depend on the type of thrombosis that occurred, whether venous or arterial thrombosis. Venous thrombosis may occur because of:

  • disease or injury to the veins in the legs
  • immobility for any reason
  • fracture
  • certain medications
  • obesity
  • inherited disorders or inherited predisposition

Pooling (stasis) of blood in the legs and subsequent clotting can result in varicose veins. Clots in the legs may break loose and travel to the lungs, causing pulmonary clots that can result in respiratory distress, pain, and in extreme cases, death.
Arterial thrombosis may be the result of arteriosclerosis (hardening of the arteries where fatty or calcium deposits cause the arterial walls to thicken) of blood vessels (clots form on abnormal blood vessel surfaces). When arterial thrombosis occurs in the coronary arteries (the two arteries that come from the aorta to provide blood to the heart muscle), it can lead to heart attacks. When it occurs in the cerebral (brain) circulation, it can lead to strokes or lack of oxygen to other organs. 3, 4

What are the symptoms of Thrombosis?
The following are the most common symptoms of thrombosis. However, each individual may experience symptoms differently. Symptoms may include:

  • Increased blood clots in arteries and veins
  • Pain in your arm or leg
  • Swelling in the extremity in your arm or leg
  • Varicose veins
  • Skin redness

You must call your doctor immediately, if you think you have a blood clot. 5, 6

How to detect Thrombosis?
Blood clots are difficult to detect, because sometimes they do not cause any symptoms. To detect and diagnose thrombosis, the doctor will order:

  • A complete medical history and physical examination, which diagnostic procedures for thrombosis may include additional blood tests including hypercoagulability panels.
  • To diagnose the presence of arterial and venous thrombosis, the doctor will also use dye injection and catheterization.
  • Doppler Ultrasound
  • Angiography
  • Computed Topography (CT) Scan, especially if a clot in the lungs is suspected . 3, 5

What are the risks and complications of Thrombosis?
The presence of a blood clot within an artery will cause heart attack, stroke (cardiovascular disease) and myocardial infarction, among others, while the presence of a blood clot within veins can cause deep vein thrombosis, portal vein thrombosis, renal vein thrombosis, jugular vein thrombosis, budd-chiari syndrome, paget-schroetter disease, cerebral venous sinus thrombosis. However, thrombosis can lead to serious complications or death if it is not recognized or treated effectively.

How to prevent Thrombosis?
According to Agency for Healthcare Research and Quality (2009), there are several ways to prevent thrombosis, among others: 6

  • Staying active and always moving around.
  • Wear loose-fitting clothes, socks, or stockings.
  • Raise your legs six inches above your heart from time to time.
  • Change your position often, especially during a long trip.
  • Do not stand or sit for more than one hour at a time.
  • Eat less salt.
  • Try not to bump or hurt your legs and try not to cross them.
  • Do not use pillows under your knees
  • Raise the bottom of your bed four to six inches with blocks or books.

How to treat Thrombosis?

  • People with thrombosis will be treated with several medications may include 3, 5:
  • Anticoagulant medications to weaken blood clots and prevent them from expanding in size.
  • Catheters (to expand the width, or lumen, of involved vessels).
  • Thrombolytic agents to dissolve blood clots, and these are generally prescribed for larger, more dangerous clots. Thrombolytic agents such as tissue plasminogen activator (t-PA) and/or enzymes, such as streptokinase.
  • Antiplatelet agents are preventive drugs, and work to avoid new clot formation.

Bicomlic
Bicomlic (DLBS1033) is an antithrombotic and thrombolytic agent which can be used as safe and effective oral thrombolytic drug in order to help cardiovascular and cerebrovascular risk patients. 7

Source:
1. CVD Atlas. The future of CVD. http://www.who.int/cardiovascular_diseases/resources/atlas/en/
2. American Society of Haematology, 2011
3. Sutter Health.With You For Live. Thrombosis (Blood Clot). http://www.cardiac.sutterhealth.org/health/conditions/thrombosis.html
4. NewYork-Presbyterian.Thrombosis. http://nyp.org/health/blood-thrombosis.html
5. San Diego’s Health Care Leader. Thrombosis. http://www.sharp.com/healthinfo/content.cfm?pageid=P00105
6. Agency for Healthcare Research and Quality. U.S. Department of Health & Human Service. Your Guide to Preventing and Treating Blood Clots. http://www.ahrq.gov/consumer/bloodclots.htm
7. Trisina J. Sunardi F. Suhartono M.T. and Raymond R. Tjandrawinata. DLBS1033, A protein extract form Lumbricus rubellus, possesses Antithrombotic and Thrombolytic activities. Journal of Biomedicine and Biotechnology. 2011;  10:8. Published October 15,2010:7.

:: Mechanism of action ::
DLBS1033 bioactive protein fraction of Lumbricus rubellus ( Contains Lumbrokinase ) has been recently characterized to possess thrombolytic as well anti-thrombosis activities. Specifically, the fibrinogen degradation, antiplatelet aggregation, and ex vivo antithrombotic assay using human blood were performed to study antithrombotic activity.

Fibrin plate and clot lysis assays were also done to examine thrombolytic properties. DLBS1033 was found to possess fibrinogenolytic activity on α-, β-, and γ-chain of fibrinogen. It also induced antiplatelet aggregation and prolonged blood clotting time, which further confirmed its antithrombotic properties. Thrombolytic properties of DLBS1033 were shown with its fast and long-acting fibrinolytic activity, as well as its effective blood clot lysis activities. In addition, DLBS1033 was seen to play an important role in downing regulating inflammatory markers such as JAK1, STAT1, TNF-α, NF-κβ as well as reducing oxidative stress.

Moreover, DLBS1033 was also found to down regulate MMP-9 which promotes plaque stabilization. An animal pharmacology study in Wistar rats, with thrombus formed by common carotid artery (CCA) ligation, was carried out. DLBS1033 was shown to dissolve the thrombus formed by ligation, and to change the rats’ behavior in which they became more active as evidenced by the increasing speed and distance during walking challenge tests. In conclusion, DLBS1033 conferred antithrombotic and thrombolytic action, potentially becoming one of the therapies of cardiovascular and cerebrovascular diseases.  

:: Prescribing information ::
 

Composition:

Each tablet contains:

Bioactive protein fraction DLBS1033 Lumbricus rubellus 490 mg
 

Usage:

Helps to improve blood circulation
 

Dosage and administration:

For adults: 1-2 tablet, 3 times daily, ½ - 1 hours before meals

For children: Safety and efficacy have not been proved

Warnings and precautions

  • Stop consuming the BICOMLIC enteric-coated tablet minimum 2 weeks before/ after surgery or follow the physician’s instructions.
  • Caution for use in patients with deep bleeding, ulcers, intracranial or intraspinal post-surgery, post-trauma, and other bleeding disorder conditions.
  • Not recommended for pregnant and breastfeeding women
  • Only use on doctor's recommendation - During treatment, consult your doctor regularly

Contraindication
- Patients with blood clotting disorders
- Patients with allergic history of any components from bioactive protein fraction

Drug interaction
Caution for concomitant use with strong anti platelet drugs.

Adverse reaction
No side effects have been reported. Considered safe if taken in the recommended dosage

Presentation and registration number
Box, 5 strips @ 6 tablets; POM  HT. 142. 500. 471 

:: Patient information ::
 

What is Bicomlic?
Bicomlic is a bioactive protein fraction derived from Lumbricus rubellus through a patented technology. It works as an antithrombotic and thrombolytic agent. From the studies, Bicomlic was shown to reduce the thrombus (clots), by reducing blood viscosity, platelet aggregation, blood coagulation, and increase clot lysis and fibrinolysis.
Bicomlic is an effective option to treat people with thrombotic symptoms, especially those which lead to heart attacks and strokes.

Contraindication to take Bicomlic
Bicomlic is contraindicated for people:

  • Who have blood coagulation abnormality
  • Who have a known allergy to any of its components

Bicomlic is not recommended for pregnant and lactating  women.
Bicomlic must be used carefully in patients with internal bleeding, ulcers, post-intracranial or intraspinal surgery, post-trauma, bleeding disorders and other conditions.

How should I take Bicomlic?
You should take 1-2 enteric coated tablets, 3 times daily, 30 minutes - 1 hour before meals.
Always refer to your doctor's prescription.
The safety and effectiveness in children have not been established.

What happen if I miss a dose?
If you miss taking a dose of Bicomlic, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I do while taking Bicomlic?
Discontinue administration at minimum 2 weeks before/after surgery or follow the physician’s instructions.
Having a healthy life will help treating your cardiovascular disease and the efficacity of Bicomlic.
Try to have a healthy and balanced diet and do some regular exercise.
Avoid smoking and drinking alcohol.

Side effects of Bicomlic
No side effects have been reported. Considered as safe if taken at the recommended dosage.
If you experience any side effect that might be caused by Bicomlic, call your doctor as soon as possible.

Interaction of Bicomlic with other drugs
Caution for concomitant use with strong anti-platelet drugs.

What should I tell my doctor/pharmacist?
Always tell your doctor / pharmacist

  • If you are taking any other medicines or food supplements;
  • If you have any allergy.
  • Women should tell their doctor / pharmacist if they are pregnant or planning to get pregnant

What storage conditions are needed for Bicomlic?
Bicomlic must be stored at a temperature below 30°C.
It must be kept from light and out of reach of children.

:: Bicomlic in the world ::
Bicomlic is marketed in Indonesia and currently under review in other countries. If you are interested in partnering with us, please see the partnership page in this website or contact us directly.