Fondaparinux Sodium (Page 12 of 13)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fondaparinux Sodium Injection, USP is available in the following strengths:

2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.

NDC 67457-582-10

10 Single Unit Syringes

5 mg fondaparinux sodium in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.

NDC 67457-583-04

10 Single Unit Syringes

7.5 mg fondaparinux sodium in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.

NDC 67457-584-06

10 Single Unit Syringes

10 mg fondaparinux sodium in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod.

NDC 67457-585-08

10 Single Unit Syringes

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Discard unused portion.

PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (17.2)

17.1 Patient Advice

If the patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDS, platelet inhibitors, or other anticoagulants, they should be informed to watch for signs and symptoms of spinal or epidural hematomas, such as back pain, tingling, numbness (especially in the lower limbs), muscular weakness, and stool or urine incontinence. If any of these symptoms occur, the patients should contact his or her physician immediately.

The use of aspirin and other NSAIDS may enhance the risk of hemorrhage. Their use should be discontinued prior to fondaparinux sodium therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored [see Drug Interactions (7)].

If patients must self-administer fondaparinux sodium (e.g., if fondaparinux sodium is used at home), they should be advised of the following:

Fondaparinux sodium should be given by subcutaneous injection. Patients must be instructed in the proper technique for administration.
The most important risk with fondaparinux sodium administration is bleeding. Patients should be counseled on signs and symptoms of possible bleeding.
It may take them longer than usual to stop bleeding.
They may bruise and/or bleed more easily when they are treated with fondaparinux sodium.
They should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions (5.2, 5.5)].
To tell their physicians and dentists they are taking fondaparinux sodium and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.2)].
To tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs [see Drug Interactions (7)].

Keep out of the reach of children.

17.2 FDA-Approved Patient Labeling

Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Aspen Notre Dame de Bondeville Notre Dame de Bondeville, France

MI:FONDIJ:R5p

PATIENT INFORMATION

Fondaparinux Sodium Injection, USP(fon″ da par′ in ux soe′ dee um)

for subcutaneous use

What is the most important information I should know about fondaparinux sodium injection?

Fondaparinux sodium injection may cause serious side effects, including:

Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like fondaparinux sodium injection, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
o
a thin tube called an epidural catheter is placed in your back to give you certain medicine
o
you take NSAIDs or a medicine to prevent blood from clotting
o
you have a history of difficult or repeated epidural or spinal punctures
o
you have a history of problems with your spine or have had surgery on your spine
If you take fondaparinux sodium injection and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).
Because the risk of bleeding may be higher, tell your doctor before taking fondaparinux sodium injection if you:
o
are also taking certain other medicines that affect blood clotting such as aspirin, an NSAID (for example, ibuprofen or naproxen), clopidogrel, or warfarin sodium
o
have bleeding problems
o
had problems in the past with pain medication given through the spine
o
have had surgery to your spine
o
have a spinal deformity

What is fondaparinux sodium injection?

Fondaparinux sodium injection is a prescription medicine that is used to:

help prevent blood clots from forming in people who have had certain surgeries of the hip, knee, or the stomach area (abdominal surgery)
treat people who have blood clots in their legs or blood clots that travel to their lungs, along with the blood thinner medicine warfarin.

It is not known if fondaparinux sodium injection is safe and effective for use in children younger than 18 years of age.

Who should not take fondaparinux sodium injection?

Do not take fondaparinux sodium injection if you:

have certain kidney problems
have active bleeding problems
have an infection in your heart
have low platelet counts and if you test positive for a certain antibody while you are taking fondaparinux sodium injection
weigh less than 110 pounds (50 kg) to prevent blood clots from surgery. See, “What are the possible side effects of fondaparinux sodium injection?”
had a serious allergic reaction to fondaparinux sodium injection

What should I tell my doctor before taking fondaparinux sodium injection?

Before taking fondaparinux sodium injection, tell your doctor about all of your medical conditions, including if you:

have had any bleeding problems (such as stomach ulcers)
have had a stroke
have had recent surgeries, including eye surgery
have diabetic eye disease
have kidney or liver problems
have uncontrolled high blood pressure
have a latex allergy. The packaging (needle guard) for fondaparinux sodium injection contains dry natural latex rubber.
are pregnant or plan to become pregnant. Fondaparinux sodium injection may harm your unborn baby. If you are pregnant, talk to your doctor about the best way for you to prevent or treat blood clots.
are breastfeeding or plan to breastfeed. It is not known if fondaparinux sodium passes into breast milk. You and your doctor should decide if you will breastfeed during treatment with fondaparinux sodium injection.

Tell your doctor about all the medicines you take including prescriptions and over-the-counter medicines, vitamins, and herbal supplements. Some medicines can increase your risk of bleeding.

See “What is the most important information I should know about fondaparinux sodium injection?” Do not start taking any new medicines without first talking to your doctor.

Tell all your doctors and dentist that you take fondaparinux sodium injection, especially if you need to have any kind of surgery or a dental procedure. Keep a list of your medicines and show it to all your doctors and pharmacist before you start a new medicine.

How should I take fondaparinux sodium injection?

See the detailed Instructions for Use that comes with fondaparinux sodium injection for information about how to give a fondaparinux sodium injection.
If your doctor tells you that you may give yourself injections of fondaparinux sodium at home, you will be shown how to give the injections first before you do them on your own.
Take fondaparinux sodium injection exactly as your doctor tells you to.
Fondaparinux sodium is given by injection under the skin (subcutaneous injection).
If you miss a dose of fondaparinux sodium injection, take your dose as soon as you remember. Do not take 2 doses at the same time.
If you take too much fondaparinux sodium injection, call your doctor right away.

What are possible side effects of fondaparinux sodium injection?

Fondaparinux sodium injection can cause serious side effects. See “What is the most important information I should know about fondaparinux sodium injection?”

Severe bleeding. Certain conditions can increase your risk for severe bleeding, including:
o
some bleeding problems
o
some gastrointestinal problems including ulcers
o
some types of strokes
o
uncontrolled high blood pressure
o
diabetic eye disease
o
soon after brain, spine, or eye surgery
Certain kidney problems can also increase your risk of bleeding with fondaparinux sodium injection. Your doctor may check your kidney function during your treatment with fondaparinux sodium injection.
Increased bleeding risk in people undergoing certain surgeries who weigh less than 110 pounds (50 kg).
Low blood platelets (thrombocytopenia). Low blood platelets can happen when you take fondaparinux sodium injection. Platelets are blood cells that help your blood to clot normally. Your doctor may check your platelet counts during your treatment with fondaparinux sodium injection.You may bruise or bleed more easily during your treatment with fondaparinux sodium injection, and it may take longer than usual for bleeding to stop. Tell your doctor if you have any signs or symptoms of bleeding, bruising or rash of dark red spots under the skin during your treatment with fondaparinux sodium injection.

Tell your doctor if you have any bleeding, bruising, or a rash of dark spots under the skin (thrombocytopenia).

The most common side effects of fondaparinux sodium injection include:

bleeding problems
bleeding, rash, and itching at the injection site (injection site reactions)
sleep problems (insomnia)
low red blood cell count (anemia)
increased wound drainage
low potassium in your blood (hypokalemia)
dizziness
purplish spots on skin (purpura)
low blood pressure (hypotension)
confusion
fluid-filled blisters (bullous eruption)
blood clots (hematoma)
severe bleeding after surgery (post-operative hemorrhage)

These are not all the possible side effects of fondaparinux sodium injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store fondaparinux sodium injection?

Store fondaparinux sodium injection at 68° to 77°F (20° to 25°C).
Safely throw away fondaparinux sodium injection that is out of date or no longer needed.

Keep fondaparinux sodium injection and all medicines out of the reach of children.

General information about the safe and effective use of fondaparinux sodium injection

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use fondaparinux sodium injection for a condition for which it was not prescribed. Do not give fondaparinux sodium injection to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about fondaparinux sodium injection that is written for healthcare professionals.

What are the ingredients in fondaparinux sodium injection?

Active ingredient: fondaparinux sodium

Inactive ingredients: sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters.

For more information about fondaparinux sodium injection, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 8/2020

INSTRUCTIONS FOR USE
Fondaparinux Sodium Injection, USP
(fon″ da par′ in ux soe′ dee um)for subcutaneous use

Be sure that you read, understand, and follow the step-by-step Instructions for Use, before you try to give yourself an injection of fondaparinux sodium injection for the first time and each time you get a new prescription. There may be new information. Talk to your doctor or pharmacist if you have any questions.

Do not use fondaparinux sodium injection if:

the solution appears discolored (the solution should normally appear clear)
you see any particles in the solution
the syringe is damaged

How should I give an injection of fondaparinux sodium injection?

Fondaparinux sodium injection is injected into a skin fold of the lower stomach area (abdomen). Do not inject fondaparinux sodium injection into muscle. Usually a doctor or nurse will give this injection to you. In some cases you may be taught how to do this yourself.

Instructions for self-administration

The different parts of fondaparinux sodium injection safety syringe are:

1. Rigid needle guard

arixtra-syringe-1

2. Plunger

3. Finger-grip

4. Security sleeve

Syringe BEFORE USE

arixtra-syringe-2
(click image for full-size original)

Syringe AFTER USE

arixtra-syringe-3
(click image for full-size original)

1. Wash your hands well with soap and water, rinse, and towel dry.

2. Sit or lie down in a comfortable position. Choose a spot on the lower stomach area (abdomen), at least 2 inches below your belly button (Figure A). Change (alternate) between using the left and right side of the lower abdomen for each injection. If you have any questions talk to your nurse or doctor.

arixtra-figure-aFigure A.

3. Clean the injection area with an alcohol swab.

4. Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (Figure B). Discard (throw away) the needle guard.

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.

arixtra-figure-bFigure B.

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).

arixtra-figure-cFigure 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).

arixtra-figure-dFigure D.

7. Inject all of the medicine in the syringe by pressing down on the plunger as far as it goes. This will activate the automatic needle protection system (Figure E).

arixtra-figure-eFigure E.

8. Release the plunger. The needle will withdraw automatically from the skin, and pull back (retract) into the security sleeve where it will be locked (Figure F). Throw away the used fondaparinux sodium injection syringe. See, “Disposing of used fondaparinux sodium injection needles and syringes” below.

arixtra-figure-fFigure F.

Disposing of used fondaparinux sodium injection needles and syringes:

Put your used fondaparinux sodium injection needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
o
made of a heavy-duty plastic,
o
can be closed with a tight-fitting, puncture- resistant lid, without sharps being able to come out,
o
upright and stable during use,
o
leak- resistant, and
o
properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 8/2020

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Aspen Notre Dame de Bondeville
Notre Dame de Bondeville, France

PL:MI:FONDIJ:R5p

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