Fraxiparine

Uses

What is Fraxiparine® (nadroparin) used for?

Fraxiparine® belongs to a class of medications known as anticoagulants or antithrombotic agents. It is commonly used for preventing and treating deep vein thrombosis (DVT).

How should I take Fraxiparine® (nadroparin)?

To use the medication:

• Before injecting nadroparin, wash your hands and the area of skin you will inject. Only use the injection if the solution appears clear and particle-free.
• Lie down and gently pinch a fold of skin (usually in the lower abdomen) between your finger and thumb. Choose alternate places on the lower abdomen for each injection (e.g., right side one day, left side the next day).
• Push the entire needle vertically into the skin and then press down on the syringe plunger to inject the medication. Make sure you are holding the skin the entire time you are injecting the needle and pressing down on the syringe plunger.
• After giving the injection, remove the needle from the skin. Use the safety shield to prevent the needle from injuring others.
• Use an alcohol swab to apply light pressure to the injection area for several seconds. Do not rub the site afterwards.
• Dispose of the syringe and needle safely (using a sharps container). Each syringe is for a single use only.

How do I store Fraxiparine® (nadroparin)?

Fraxiparine® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Fraxiparine® in the bathroom or the freezer. There may be different brands of Fraxiparine® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.       You should not flush Fraxiparine® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Fraxiparine® (nadroparin)?

Before using Fraxiparine®, tell your doctor if you have:

• Allergic reaction to excipients using for dosage form containing Fraxiparine®.
• Allergic reaction to any other medicines, foods, dyes, preservatives, or animals.
• Used any other health conditions, drugs that have a risk of interaction with Fraxiparine®.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Fraxiparine® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Fraxiparine®. Fraxiparine® is pregnancy risk category B, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Fraxiparine® (nadroparin)?

Side effects are:

• Allergic reaction
• Anaphylactoid reaction
• Bleeding
• Unexpected bruising
• Cutaneous necrosis
• Epistaxis
• Hematuria
• Intraspinal hematoma
• Melena
• Purpura
• Skin rash
• Thrombocytopenia.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Fraxiparine® (nadroparin)?

Fraxiparine® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products may interact with this drug, including:

• Nonsteroidal anti-inflammatory drugs (NSAIDS) 
• Platelet aggregation inhibitors
• Salicylates

Does food or alcohol interact with Fraxiparine® (nadroparin)?

Fraxiparine® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Fraxiparine® (nadroparin)?

Fraxiparine® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Fraxiparine® (nadroparin).

What is the dose of Fraxiparine® (nadroparin) for an adult?

Angina, unstable and myocardial infarction, non–Q wave 

Subcutaneous, initially 86 anti-factor Xa International Units (IU) per kg of body weight followed by 86 anti-factor Xa IU per kg of body weight every twelve hours for six days.

Thromboembolism, pulmonary (prophylaxis) and thrombosis, deep venous (prophylaxis)

General surgery: Subcutaneous, 2850 anti-factor Xa IU per day beginning two to four hours before surgery and continuing for at least seven days and until the patient is actively ambulant.

Hip replacement surgery: Subcutaneous, 38 anti-factor Xa IU per kg of body weight twelve hours before surgery, twelve hours after surgery, and once a day for the first three postoperative days. Then, 57 anti-factor Xa IU per kg of body weight beginning on postoperative day 4 and continuing at least through postoperative day 10 and until the patient is actively ambulant.

Thrombosis, deep venous (treatment)

Patients weighing less than 40 kg or more than 100 kg: Specific dosing guidelines have not been established. Dosing must be individualized based upon clinical and laboratory parameters.

Patients weighing 40 to 100 kg: Subcutaneous, 171 anti-factor Xa IU per kg of body weight once a day; or, 86 anti-factor Xa IU per kg of body weight two times a day in patients who have an increased risk of bleeding.

Therapy should continue until the International Normalized Ratio (INR) is within the therapeutic range, which usually occurs after five days.

Thrombosis during hemodialysis (prophylaxis)

Intra-arterial, 65 anti-factor Xa IU per kg of body weight beginning at the start of each session that is expected to last four hours or less. An additional, smaller dose may be given during sessions lasting longer than four hours. The dose should be halved in patients who have an increased risk of bleeding.

What is the dose of Fraxiparine® (nadroparin) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Fraxiparine® (nadroparin) available?

Fraxiparine® (is available in the following dosage forms and strengths:

• 9,500 anti-Xa IU per 1 ml
• 19,000 anti-Xa IU per 1 ml

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, contact your doctor or pharmacist. Do not inject a double dose to make up for a missed one.