ARIXTRA (Page 10 of 10)

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 tingling, numbness (especially in the lower limbs) and muscular weakness. 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. [See Drug 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.
  • As with all anticoagulants, 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 (5.1, 5.4)].
  • 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 [see Warnings and Precautions (5.1)].
  • 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.

ARIXTRA is a registered trademark of GlaxoSmithKline.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2011, GlaxoSmithKline. All rights reserved.

February 2011

ARX:9PI

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

————————————————————————————————————-

PATIENT INFORMATION

ARIXTRA® (Ah-RIX-trah)

fondaparinux sodium injection

Read the Patient Information that comes with ARIXTRA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about ARIXTRA, ask your doctor or pharmacist.

What is the most important information I should know about ARIXTRA?

Certain medical procedures involving the spine, such as an epidural (pain medication given through the spine), spinal anesthesia, or spinal puncture, may be used during your hospital stay. If you need any of these procedures while receiving ARIXTRA, heparins, heparinoids, or low-molecular weight heparins (anticoagulants), you may be at risk for having a blood clot (hematoma) in or around your spine. This type of clot is very serious, as it can cause long-term and possibly permanent paralysis (loss of the ability to move).

If you receive ARIXTRA after an epidural or spinal anesthetic is used, as the anesthesia for your surgery, your doctor will watch you closely for problems with feeling (sensation) and being able to move. Tell your doctor right away if you have any of these signs and symptoms, especially in your legs and feet:

  • tingling
  • numbness
  • muscle weakness

Because the risk of bleeding may be higher, tell your doctor before taking ARIXTRA if you:

  • are also taking certain other medicines that affect blood clotting such as aspirin, an NSAID (for example, ibuprofen or naproxen), clopidogrel, or warfarin sodium.
  • have bleeding problems.
  • had problems in the past with pain medication given through the spine.
  • have had surgery to your spine.
  • have a spinal deformity.

What is ARIXTRA?

ARIXTRA is a prescription medicine that “thins your blood” (also known as an anticoagulant). ARIXTRA is used to:

  • help prevent blood clots from forming in patients 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

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

Who should not take ARIXTRA?

Do not take ARIXTRA if you have:

  • certain kidney problems
  • active bleeding problems
  • an infection in your heart
  • low platelet counts and if you test positive for a certain antibody while you are taking ARIXTRA.

People who weigh less than 110 pounds (50 kg) should not use ARIXTRA to prevent blood clots from forming after surgery.

What should I tell my doctor 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 problems
  • have uncontrolled high blood pressure
  • have a latex allergy. The packaging (needle guard) for ARIXTRA contains dry natural rubber.
  • are pregnant. It is not known if ARIXTRA will 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 breast-feeding. It is not known if ARIXTRA passes into breast milk.

Tell your doctor about all the medicines you take including prescriptions and non-prescription medicines, vitamins, and herbal supplements. Some medicines can increase your risk of bleeding. Especially tell your doctor if you take:

  • aspirin
  • NSAIDS (such as ibuprofen or naproxen)
  • other blood thinner medicines, such as clopidogrel or warfarin

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

Know the medicines you take. 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?

  • Take ARIXTRA exactly as prescribed by your doctor.
  • ARIXTRA is given by injection under the skin (subcutaneous injection). See “How should I give an injection of ARIXTRA?”
  • If your doctor tells you that you may give yourself injections of ARIXTRA at home, you will be shown how to give the injections first before you do them on your own.
  • Tell your doctor if you have any bleeding or bruising while taking ARIXTRA.
  • If you miss a dose of ARIXTRA, take your dose as soon as you remember. Do not take 2 doses at the same time.
  • If you take too much ARIXTRA, call your doctor right away.
  • Do not use ARIXTRA if:
    • the solution appears discolored (the solution should normally appear clear),
    • you see any particles in the solution, or
    • the syringe is damaged.

What are possible side effects of ARIXTRA?

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

  • Severe bleeding
    Certain conditions can increase your risk for severe bleeding, including:
    -some bleeding problems
    -some gastrointestinal problems including ulcers
    -some types of strokes
    -uncontrolled high blood pressure
    -diabetic eye disease
    -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 while you are taking ARIXTRA.
    • People undergoing surgery who weigh less than 110 pounds. See “Who should not take ARIXTRA?”
    • Low blood platelets. 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 while you take ARIXTRA.
      You may bruise or bleed more easily while taking ARIXTRA, and it may take longer than usual for bleeding to stop.
      Tell your doctor if you have any of these signs or symptoms of bleeding while taking ARIXTRA.
      -any bleeding
      -bruising-rash of dark red spots under the skin
  • Allergic reactions. See “What should I tell my doctor before taking ARIXTRA?”

Other side effects include:

  • Injection site reactions. Bleeding, rash, and itching can happen at the place where you inject ARIXTRA.
  • Low red blood cell counts (anemia). Your doctor may check your red blood cell counts while you are taking ARIXTRA.
  • Increased liver enzyme test results. Your doctor may check your liver function while you are taking ARIXTRA.
  • Sleep problems (insomnia).

These are not all the possible side effects of ARIXTRA. Call your doctor if you have any side effects that bother you or don’t go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store ARIXTRA?

Store ARIXTRA at room temperature 59°F to 86°F (15°C to 30°C). Do not freeze.

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 ARIXTRA

Medicines are sometimes prescribed for purposes other than those described in patient information leaflets. Do not use ARIXTRA for a condition for which it was not prescribed. Do not give ARIXTRA to other people. It may harm them.

This leaflet summarizes the most important information about ARIXTRA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ARIXTRA that is written for healthcare professionals. For more information about ARIXTRA, go to www.ARIXTRA.com or call 1-888-825-5249.

What are the ingredients in ARIXTRA?

Active Ingredient: fondaparinux sodium

Inactive Ingredients: sodium chloride and water for injection

How should I give an injection of ARIXTRA?

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. Be sure that you read, understand, and follow the step-by-step instructions in this leaflet, on how to give yourself an injection of ARIXTRA.

Instructions for self-administration
The different parts of ARIXTRA safety syringe are:
1. Rigid needle guardArixtra safety syringe
2. Plunger
3. Finger-grip
4. Security sleeve

Syringe BEFORE USE

Syringe before use
(click image for full-size original)

Syringe AFTER USE

Syringe after use
(click image for full-size original)
1. Wash your hands thoroughly with soap and water. 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.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 the needle guard.

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.
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).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).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).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).

Figure FFigure F.
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 state laws about the right way to dispose of used syringes, needles, and disposal containers.

ARIXTRA is a registered trademark of GlaxoSmithKline.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2011, GlaxoSmithKline. All rights reserved.

Revised: February 2011

ARX:5PIL

Principal Display Panel

NDC 54868-5652-0

Arixtra®

(fondaparinux sodium) Injection

5 mg/0.4 mL

image of No Label Available
(click image for full-size original)

Principal Display Panel

NDC 54868-5501-0

Arixtra®

(fondaparinux sodium) Injection

7.5 mg/0.6 mL

10 x 0.6 mL

Contains 10 Single Dose, Prefilled Syringes

Rx only

Single Dose, Prefilled Syringes

Affixed with an Automatic Needle Protection System

For Subcutaneous Injection

Contents: Each single dose prefilled syringe contains 7.5 mg of fondaparinux sodium in 0.6 mL of an isotonic solution of sodium chloride and water for injection.

The needle guard of the prefilled syringe of ARIXTRA contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

Recommended Dose: 7.5 mg subcutaneous injection, once daily. See package insert.

Storage: Store at 25o C (77o F); excursions permitted to 15o C – 30o C (59o F -86o F), (see USP Controlled Room Temperature).

Arixtra 7.5 mg/0.6 mL package label
(click image for full-size original)
ARIXTRA fondaparinux sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5652(NDC:0007-3232)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM (FONDAPARINUX) FONDAPARINUX SODIUM 5 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5652-0 10 SYRINGE (SYRINGE) in 1 CARTON contains a SYRINGE
1 0.4 mL in 1 SYRINGE This package is contained within the CARTON (54868-5652-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021345 12/07/2001 06/30/2011
ARIXTRA fondaparinux sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5501(NDC:0007-3234)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FONDAPARINUX SODIUM (FONDAPARINUX) FONDAPARINUX SODIUM 7.5 mg in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (clear and colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5501-0 10 SYRINGE (SYRINGE) in 1 CARTON contains a SYRINGE
1 0.6 mL in 1 SYRINGE This package is contained within the CARTON (54868-5501-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021345 11/17/2004
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2012 Physicians Total Care, Inc.

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