| Fondaparinux Sodium side effects and warning (marketed as Arixtra) zhion@zhion.com November 2005 |
Arixtra Injection
Brand Name: Arixtra
Active Ingredient: fondaparinux sodium
Strength(s): 2.5 mg/0.5 mL
Dosage Form(s): Sucutaneous Injection
Company Name: Fonda BV
Availability: Prescription only, professional use only
*Date Approved by the FDA: December 7, 2001
--------------------------------------------------------------------------------
What is Arixtra used for?
Arixtra is used to reduce the risk of blood clots in the deep veins
of the legs and thighs. These clots may break off and travel to
the lungs (pulmonary embolism). Patients at risk for these
complications include those undergoing:
hip fracture surgery,
hip replacement surgery,
knee replacement surgery,
abdominal surgery who are already at risk of blood clot
complications
Arixtra also is used with warfarin to treat:
· blood clots in the veins
· blood clots that have broken off and traveled to the lungs
(pulmonary embolism) when the patient is first treated in the
hospital
Who should not be given Arixtra?
Arixtra should not be given to patients who:
have severe kidney problems
weigh less than 110 pounds (50kg)
have bleeding anywhere
have a heart infection (bacterial endocarditis)
have a history of Arixtra causing the blood to have low platelets
(thrombocytopenia)
are allergic to Arixtra or to any of the ingredients in Arixtra
Tell your healthcare provider if you have any of these conditions.
Special Warning(s) with Arixtra:
Arixtra and other medicines like it can cause bleeding into the
spine when used in patients who have received epidural or spinal
anesthesia, or any spinal injection. Bleeding in the spine can
cause long term or permanent paralysis.
Arixtra, like other medicines that prevent the blood from clotting,
is given with extreme caution to people who have conditions that
have an increased risk of bleeding, such as:
bleeding disorders
ulcerative colitis and other bleeding disorders in the stomach and
intestines
bleeding into the brain (hemorrhagic stroke)
recent brain, spinal, or eye surgery
taking other medicines that prevent the blood from clotting
General Precautions with Arixtra:
Certain other medicines can increase the risk of bleeding with
Arixtra. Tell your healthcare provider about all the medicines you
take, including prescription and non-prescription medicines,
vitamins, and herbal supplements. Especially, tell your health care
provider if you are taking:
blood thinners
aspirin
non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin)
or naproxen sodium (Naprosyn or Aleve)
What should I tell my doctor or healthcare provider?
Tell your healthcare provider if you have:
bleeding problems, any recent bleeding, or if you bleed easily
high blood pressure
a recent stomach ulcer
eye problems due to diabetes
kidney problems
had a stroke
What are some possible side effects of Arixtra? (This list is NOT
a complete list of side effects reported with Arixtra. Your
healthcare provider can discuss with you a more complete list of
side effects.)
The most common side effect with Arixtra is bleeding.
For more detailed information about Arixtra, ask your
healthcare provider.
Brand Name: Arixtra
Active Ingredient: fondaparinux sodium
Strength(s): 2.5 mg/0.5 mL
Dosage Form(s): Sucutaneous Injection
Company Name: Fonda BV
Availability: Prescription only, professional use only
*Date Approved by the FDA: December 7, 2001
--------------------------------------------------------------------------------
What is Arixtra used for?
Arixtra is used to reduce the risk of blood clots in the deep veins
of the legs and thighs. These clots may break off and travel to
the lungs (pulmonary embolism). Patients at risk for these
complications include those undergoing:
hip fracture surgery,
hip replacement surgery,
knee replacement surgery,
abdominal surgery who are already at risk of blood clot
complications
Arixtra also is used with warfarin to treat:
· blood clots in the veins
· blood clots that have broken off and traveled to the lungs
(pulmonary embolism) when the patient is first treated in the
hospital
Who should not be given Arixtra?
Arixtra should not be given to patients who:
have severe kidney problems
weigh less than 110 pounds (50kg)
have bleeding anywhere
have a heart infection (bacterial endocarditis)
have a history of Arixtra causing the blood to have low platelets
(thrombocytopenia)
are allergic to Arixtra or to any of the ingredients in Arixtra
Tell your healthcare provider if you have any of these conditions.
Special Warning(s) with Arixtra:
Arixtra and other medicines like it can cause bleeding into the
spine when used in patients who have received epidural or spinal
anesthesia, or any spinal injection. Bleeding in the spine can
cause long term or permanent paralysis.
Arixtra, like other medicines that prevent the blood from clotting,
is given with extreme caution to people who have conditions that
have an increased risk of bleeding, such as:
bleeding disorders
ulcerative colitis and other bleeding disorders in the stomach and
intestines
bleeding into the brain (hemorrhagic stroke)
recent brain, spinal, or eye surgery
taking other medicines that prevent the blood from clotting
General Precautions with Arixtra:
Certain other medicines can increase the risk of bleeding with
Arixtra. Tell your healthcare provider about all the medicines you
take, including prescription and non-prescription medicines,
vitamins, and herbal supplements. Especially, tell your health care
provider if you are taking:
blood thinners
aspirin
non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin)
or naproxen sodium (Naprosyn or Aleve)
What should I tell my doctor or healthcare provider?
Tell your healthcare provider if you have:
bleeding problems, any recent bleeding, or if you bleed easily
high blood pressure
a recent stomach ulcer
eye problems due to diabetes
kidney problems
had a stroke
What are some possible side effects of Arixtra? (This list is NOT
a complete list of side effects reported with Arixtra. Your
healthcare provider can discuss with you a more complete list of
side effects.)
The most common side effect with Arixtra is bleeding.
For more detailed information about Arixtra, ask your
healthcare provider.
PHARMCEUTICAL
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-loweri
ng
Drug-Terminologi
es
Packaging
Materials
Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market
Novo Norkdisk
R&D
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-loweri
ng
Drug-Terminologi
es
Packaging
Materials
Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market
Novo Norkdisk
R&D
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study
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