Fondaparinux Sodium Injection - Consumer Medicine Information
|Manufacture:||Dr. Reddy's Laboratories, Inc.|
|Condition:||Deep Vein Thrombosis, Deep Vein Thrombosis Prophylaxis after Abdominal Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis, Prophylaxis, Pulmonary Embolism|
|Class:||Factor Xa inhibitors|
|Form:||Liquid solution, Subcutaneous (SC), Intravenous (IV)|
|Ingredients:||fondaparinux sodium, sodium hydroxide or hydrochloric acid for pH adjustment|
2.5 mg/0.5 mL, 5.0 mg/0.4 mL, 7.5 mg/0.6 mL, and 10.0 mg/0.8 mL
About This Medication
What the Medication is Used For
Fondaparinux Sodium Injection is a synthetic antithrombotic agent (against blood clotting). An antithrombotic drug helps prevent clots from forming in the blood. Fondaparinux Sodium Injection sodium is used:
- to prevent the occurrence of venous thromboembolic events (blood clots in the blood vessels of the legs or lungs) for up to one month post-surgery in patients undergoing orthopedic surgery of the lower limbs (hip fracture, knee surgery or hip replacement surgery);
- to prevent the occurrence of venous thromboembolic events (blood clots in the blood vessels of the legs or lungs) in patients undergoing abdominal surgery;
- to treat acute deep vein thrombosis (blood clots in a deep vein of the legs) and acute pulmonary embolism (blood clots in the blood vessels of the lungs);
- for the management ST segment elevation myocardial infarction (severe heart attack).
What It Does
Fondaparinux Sodium Injection contains fondaparinux sodium, a synthetic compound,that inhibits specifically a clotting factor and plays an important role in blood coagulation. It helps to prevent the development of unwanted blood clots (thrombosis) in blood vessels and is useful in dissolving existing blood clots.
When It Should not be Used
Do not take Fondaparinux Sodium Injection if:
- You are allergic to fondaparinux sodium or to any non-medicinal ingredient in the formulation;
- You have thrombocytopenia (an abnormally small number of platelets in the circulating blood) associated with a positive lab test for anti-platelet protective protein in the presence of fondaparinux sodium (see your doctor);
- You are bleeding excessively;
- You suffer from bacterial infection of the heart.
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Isotonic solution of sodium chloride and water for injection. Also contain sodium hydroxide or hydrochloric acid for pH adjustment (pH 5.5–8).
What Dosage Form It Comes In
Fondaparinux Sodium Injection is a solution for injection supplied in a sterile prefilled syringe affixed with an active needle protection to help prevent needle injuries after use.
Package of 10:
Single-dose, prefilled syringes containing either 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL or 10 mg/0.8 mL of fondaparinux.
Warnings and Precautions
It is important that you provide your doctor with an accurate history of any serious illnesses you may have had in the past or any current medical conditions, as these may influence the action of Fondaparinux Sodium Injection.
BEFORE you use Fondaparinux Sodium Injection, talk to your doctor or pharmacist if:
- You weigh less than 50 kg or are 65 years of age or older
- You have had or currently suffer from any of the following conditions listed below, it is necessary that you inform your doctor before starting treatment.
- You suffer from bacterial infection of the heart;
- You are bleeding excessively;
- You have a risk of hemorrhage (uncontrolled bleeding), such as:
- stomach ulcer;
- bleeding disorders;
- recent intracranial bleeding;
- You have had recent brain, spinal column or eye surgery;
- You have liver disease;
- You have kidney disease.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, you should tell your doctor so that the possible risks to you and your child can be assessed.
The safety and effectiveness of Fondaparinux Sodium Injection in children under the age of 17 has not been established.
It is necessary that you follow the instructions of your doctor or nurse carefully. Only give yourself the injections prescribed and do so the entire time period specified by your doctor.
Interactions With This Medication
Some other medicines may affect the way Fondaparinux Sodium Injection works or vice versa. Please tell your doctor or pharmacist what medicine you have recently taken, are taking or intend to take since these medicines might affect blood clotting, even those available without prescription such as acetylsalicylic acid (i.e. ASPIRIN). If you should see another doctor or a dentist while you are using Fondaparinux Sodium Injection, you should inform/tell them that you are using Fondaparinux Sodium Injection.
Proper Use of This Medication
Fondaparinux Sodium Injection is a prescription drug and must be used as directed. Fondaparinux Sodium Injection is given by injection under the skin (subcutaneously) into a skin fold of the lower stomach area. For a step-by-step ‘Instructions for use’ please see below. Do not inject Fondaparinux Sodium Injection into muscle (intramuscularly).
While you are in the hospital, your doctor or a nurse will give your first injection. It is possible that after you go home, you may need to continue your injections of Fondaparinux Sodium Injection for a few days.
For prevention of blood clots following orthopedic or abdominal Surgery
The usual dose of Fondaparinux Sodium Injection is 2.5 mg once a day.
For treatment of blood Clots:
The usual dose of Fondaparinux Sodium Injection is 5 mg (body weight < 50 kg), 7.5 mg (body weight 50–100 kg) or 10 mg (body weight > 100 kg) once daily.
In the management of heart attacks or severe Angina
The usual dose of Fondaparinux Sodium Injection is 2.5 mg once daily.
You should continue Fondaparinux Sodium Injection treatment for as long as your doctor has told you, since Fondaparinux Sodium Injection decreases the risk of developing more serious conditions.
Always use Fondaparinux Sodium Injection exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The different parts of Fondaparinux Sodium Injection safety syringe are:
- Rigid needle Shield
- Security sleeve
Syringe BEFORE USE
Syringe AFTER USE
|1. Wash your hands thoroughly with soap and water. Towel dry. When at home, there is nothing for you to prepare. The syringe is pre-filled with the exact amount of drug required. Do not press on the plunger prior to injection.
2. Sit or lie down in a comfortable position. Choose a spot on the lower stomach area (abdomen), at least 5 centimeters below your belly button (Figure A). Change (alternate) between using the left and right side of the lower abdomen for each injection. If injecting in the stomach area is not possible or you have any questions, consult your nurse or doctor for instruction.
|3. Clean the injection area with an alcohol swab.|
|4. Remove the needle shield by pulling it straight off the syringe (Figure B). Discard the rigid needle shield.
To prevent infection, do not touch the needle or let it come in contact with any surface before the injection. A small air bubble in the syringe is normal. To be sure that you do not lose any medicine from the syringe, do not try to remove air bubbles from the syringe before giving the injection.
|5. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger of one hand during the entire injection (Figure C).|
|6. Hold the syringe firmly in your other hand using the finger-grip. Insert the full length of the needle directly up and down (at an angle of 90°) into the skin fold (Figure D).|
|7. Inject all of the medicine in the syringe by pressing down on the plunger as far as it goes. (Figure E).|
|8. Remove the syringe from the injection site keeping your finger on the plunger.|
|9. Orient the needle away from you and others, and activate the safety shield by firmly pushing the plunger. The protective sleeve will automatically cover the needle and an audible "click" will be heard to confirm shield activation.|
Discard the used syringe into a sharps container as your nurse or doctor has instructed you.
Follow the instructions given to you by your nurse or doctor about the right way to throw away used syringes and needles. There may be laws about the right way to dispose of used syringes, needles, and disposal containers.
- The safety system can only be activated once the syringe has been emptied.
- Activation of the safety system must be done only after removing the needle from the patient’s skin.
- Do not replace the needle shield after injection.
- The safety system should not be sterilized.
- Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
|If you think you have taken too much Fondaparinux Sodium Injection, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
NEVER inject a double dose to make up for forgotten individual doses. If you are not sure what to do, ask your doctor or pharmacist before you take any action.
If you stop treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or in the lung. Contact your doctor or pharmacist before stopping treatment if for any reason you feel you need to stop the treatment.
Side Effects and What to Do About Them
Fondaparinux Sodium Injection helps most people in the prevention of blood clots. However, like all medicines it may have unwanted effects on some people.
The most common side effect that may occur in up to one in every 10 people is bleeding. Any bleeding can be serious, if this occurs you should contact your doctor urgently. Other common side effects are edema (swelling) and insomnia (trouble sleeping).
Uncommon side effects that may occur in up to one in every 100 people are: Headache, nausea (feeling sick), vomiting, rash, itchy skin, wound secretion (oozing) blood coagulation disorders, low platelet count and fever.
Rare side effects that may occur in up to one in every 1,000 people are: Anxiety, confusion, dizziness, coughing, indigestion, stomach pain, constipation, diarrhea, skin reactions at injection site (mild irritation, pain, bruising and redness), tiredness, flushing, somnolence (drowsiness), vertigo (feeling of spinning), dyspnea (shortness of breath), fatigue, and syncope (loss of consciousness).
If you notice any unwanted effects not mentioned, please inform your doctor or pharmacist.
|Symptom / effect||Talk with your
|Common||A low number of red blood cells which can cause tiredness, weakness, shortness of breath and feeling generally unwell||✓|
|Bleeding from various sites (i.e., from an operation site, bruising, blood in urine and stool, an existing stomach ulcer, nosebleed, etc.)||✓|
|Bruises that are joining together||✓|
|Urinary tract infection (pain or burning sensation during urination, frequent urge to urinate)||✓|
|Uncommon||Liver problems (symptoms include nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark urine and unusual tiredness)||✓|
|Rare||Wound infection at site of surgery (oozing of fluid, swelling aroun the wound)||✓|
|Allergic reactions such as rash or itching, swelling (usually of the face, lips, tongue or throat) which may cause difficulty breathing or swallowing or collapse||✓
|Reduction of potassium in the blood (hypokalemia) hich can cause muscular weakness and cramping||✓|
|Low blood pressure (if measured) which can result in lightheadedness, dizziness or fainting||✓|
Additionally, Fondaparinux Sodium Injection may also cause some side effects which can only be diagnosed by your health care provider and may require blood tests, for example: reduction or increase in the number of platelets (blood cells necessary for blood clotting), abnormal blood clotting (coagulation disorder) or bleeding around the brain or internal organs.
This is not a complete list of side effects. For any unexpected effects while taking Fondaparinux Sodium Injection, contact your doctor or pharmacist.
How to Store It
Fondaparinux Sodium Injection should be stored at 15°C - 30°C. Do not freeze.
Keep out of the reach and sight of children.
Do not use Fondaparinux Sodium Injection under the following conditions:
- after the expiry date stated on the label and carton;
- if you notice that particulate matter or discoloration is present in the solution;
- if you notice that the syringe is damaged;
- if you have opened a syringe and do not intend to use it straight away.
Any unused syringe should be disposed of in a safe manner.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at:
Dr. Reddy's Laboratories Limited
Bachupally — 500 090 INDIA
Innomar Strategies Inc.
3470 Superior Court
Oakville, Ontario L6L 0C4