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ARIXTRA- fondaparinux sodium injection, solution


  1. Arixtra May Cause Serious Side Effects, Including:
  2. Because The Risk Of Bleeding May Be Higher, Tell Your Doctor Before Taking Arixtra If You:
  3. Arixtra Is A Prescription Medicine That Is Used To:
  4. Do Not Take Arixtra If You:
  5. Before Taking Arixtra, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  6. How Should I Take Arixtra?
  7. The Most Common Side Effects Of Arixtra Include:
  8. How Should I Store Arixtra?
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Do Not Use Arixtra If:
  12. The Different Parts Of Arixtra Safety Syringe Are:
  13. Disposing Of Used Arixtra Needles And Syringes:
  14. Patient Information
  15. If Patients Must Self-administer Arixtra (e.g., If Arixtra Is Used At Home), They Should Be Advised Of The Following:

Arixtra May Cause Serious Side Effects, Including: 

Spinal or epidural blood clots (hematoma).People who take a blood thinner medicine (anticoagulant) like ARIXTRA, 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 ARIXTRA 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 Arixtra 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

Arixtra 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 ARIXTRA is safe and effective for use in children younger than 18 years of age.

Do Not Take Arixtra 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 ARIXTRA
weigh less than 110 pounds (50kg) to prevent blood clots from surgery.
had a serious allergic reaction to ARIXTRA

Before Taking Arixtra, 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 ARIXTRA contains dry natural latex rubber.
are pregnant or plan to become pregnant. ARIXTRA 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 ARIXTRA passes into breast milk. You and your doctor should decide if you will breastfeed during treatment with ARIXTRA.

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

Do not start taking any new medicines without first talking to your doctor.

Tell all your doctors and dentist that you take ARIXTRA, 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 Arixtra? 

ARIXTRA can cause serious side effects.

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 ARIXTRA. Your doctor may check your kidney function during your treatment with ARIXTRA.
Increased bleeding risk in people undergoing certain surgeries who weigh less than 110 pounds (50kg).
Low blood platelets (thrombocytopenia).Low blood platelets can happen when you take ARIXTRA. Platelets are blood cells that help your blood to clot normally. Your doctor may check your platelet counts during your treatment with ARIXTRA.
You may bruise or bleed more easily during your treatment with ARIXTRA, 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 ARIXTRA.

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 Arixtra 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 ARIXTRA. 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 Arixtra? 

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

Keep ARIXTRA and all medicines out of the reach of children.

General information about the safe and effective use of ARIXTRA

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use ARIXTRA for a condition for which it was not prescribed. Do not give ARIXTRA 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 ARIXTRA that is written for healthcare professionals.

Active Ingredient: 

fondaparinux sodium

Inactive Ingredients: 

sodium chloride and water for injection

For more information about ARIXTRA, contact Mylan Pharmaceuticals Inc. 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: 8/2017

INSTRUCTIONS FOR USE
ARIXTRA
(Ah-RIX-trah)
(fondaparinux sodium injection)
solution, 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 ARIXTRA 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 Arixtra If: 

the solution appears discolored (the solution should normally appear clear)
you

ARIXTRA is injected into a skin fold of the lower stomach area (abdomen). Do not inject ARIXTRA 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 Arixtra Safety Syringe Are: 

1. Rigid needle guard

arixtra-syringe-1

2. Plunger

3. Finger-grip

4. Security sleeve

Syringe BEFORE USE

arixtra-syringe-2

Syringe AFTER USE

arixtra-syringe-3

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 ARIXTRA syringe. See, Disposing of used ARIXTRA needles and syringes below.

arixtra-figure-fFigure F.

Disposing Of Used Arixtra Needles And Syringes: 

Put your used ARIXTRA needles and syringes in a FDA-cleared sharps disposal container right away after use.Do notthrow 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: 8/2017

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

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

Revised: 8/2017
PL:MI:ARXTIJ:R4p

Patient Information 

SeeFDA-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 ARIXTRA therapy whenever possible; if co-administration is essential, the patient s clinical and laboratory status should be closely monitored.[SeeDrug Interactions (7).]

If Patients Must Self-administer Arixtra (e.g., If Arixtra Is Used At Home), They Should Be Advised Of The Following: 

ARIXTRA should be given by subcutaneous injection. Patients must be instructed in the proper technique for administration.
The most important risk with ARIXTRA 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 ARIXTRA.
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 ARIXTRA and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken[seeWarnings 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.[SeeDrug 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
Rockford, IL 61103 U.S.A.

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

Revised: 8/2017
MI:ARXTIJ:R4p



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