葛兰素史克公司（GlaxoSmithKline）2005年5月27日宣布抗血栓药戊聚糖钠（fondaparinux sodium，ARIXTRA）用于行腹部外科手术患者预防术后静脉血栓（VTE）获得美国FDA批准。
　　
　　“由于许多接受腹部外科手术的患者罹发静脉血栓，FDA批准该补充新药申请(sNDA)代表了一个重要并且激动人心的医学进步。”葛兰素史克公司肿瘤与急性治疗部门副总裁Kevin Lokay称。据报道，美国每年有200万例的静脉血栓患者。
　　
　　ARIXTRA是第一个选择性抑制Xa的抗血栓因子，已批准用于经髋骨折、膝或髋关节置换术患者静脉血栓，包括深静脉血栓（DVT）和肺栓塞(PE)的预防。另外，ARIXTRA与华法林钠（warfarin sodium）联用可用于急性深静脉血栓，与急性肺栓塞的医院起始治疗。
　　
　　一项双盲非劣效性戊糖外科手术研究（PEGASUS）验证了ARIXTRA对腹部外科手术患者的疗效，研究显示ARIXTRA在降低VTE风险方面至少与达肝素（dalteparin）具有相同效果。接受ARIXTRA治疗的患者VTE发生率为4.6%，使用达肝素为6.1%。研究中69%为因患癌症而接受腹部治疗的患者，接受ARIXTRA治疗后VTE发生率为4.7%，达肝素组为7.7%。在对非癌症外科手术患者研究中，接受ARIXTRA治疗的VTE发生率4.2%，达肝素组为2.3%。

Fondaparinux

Fondaparinux Sodium Solution for injection

What is this medicine?

FONDAPARINUX is used after knee, hip, or abdominal surgeries to prevent blood clotting. It is also used to treat existing blood clots in the lungs or in the veins.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•bleeding disorders, hemorrhage, or hemophilia
•infection of the heart or heart valves
•kidney or liver disease
•previous stroke
•recent surgery or child birth
•ulcer in the stomach or intestine, diverticulitis, or other bowel disease
•an unusual or allergic reaction to fondaparinux, heparin, low molecular weight heparins, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Missing a dose is probably not harmful. If you miss a dose, simply resume taking it on your previous schedule. Do not take double doses to catch up, however.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
•aspirin and aspirin-like medicines
•heparin
•mifepristone
•warfarin

This medicine may also interact with the following medications:
•antiinflammatory drugs like ibuprofen
•cilostazol
•clopidogrel
•dipyridamole
•sulfinpyrazone
•ticlopidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Your condition will be monitored carefully while you are receiving this medicine. Contact your doctor or health care professional and seek emergency treatment if you develop increased difficulty in breathing, chest pain, dizziness, shortness of breath, swelling in the legs or arms, abdominal pain, decreased vision, pain when walking, or pain and warmth of the arms or legs. These can be signs that your condition has gotten worse.

Monitor your skin closely for easy bruising or red spots, which can be signs of bleeding. If you notice easy bruising or minor bleeding from the nose, gums/teeth, in your urine, or stool, contact your doctor or health care professional right away. The dose of your medicine may need to be changed.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

Try to avoid injury while you are using this medicine. Be careful when brushing or flossing your teeth, shaving, cutting your fingernails or toenails, or when using sharp objects. Report any injuries to your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•bleeding from the injection site
•difficulty breathing
•dizziness or fainting spells
•fever
•heavy menstrual bleeding
•signs and symptoms of bleeding such as back or stomach pain, black, tarry stools, blood in the urine, or coughing up blood
•unusual bruising or bleeding: bleeding gums, red spots on the skin, nosebleeds

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•pain or irritation at the injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

Last updated: 7/1/2002

Fondaparinux sodium review

Fondaparinux sodium belongs to the group of drugs called heparinoids or blood thinner. It helps in preventing the development of blood clots after a knee or hip surgery.

This medicine is popularly known as Arixtra. It is given to individuals who have undergone surgeries such as knee replacement and hip fracture and abdominal operations to reduce the risks of blood clots. Blood clots can go to the heart, lungs, and brain when left untreated which can result to severe cases of breathing difficulties, stroke, and heart attack.

Fondaparinux sodium is administered intravenously. Before injecting a dose, the area to be injected should be cleaned with rubbing alcohol. It is also recommended that the site of the injection is changed daily to avoid problematic areas under the skin.

Before using Fondaparinux sodium, users should check the product for any discoloration. It should not be used if there is any discoloration, nor mixed with any drug in similar type of injection.

Fondaparinux sodium is usually injected in the skin just below the stomach or abdomen area. It should never be injected into a muscle group.

The initial dosage of Fondaparinux sodium is 2.5 milligrams taken once a day. The dosage is increased thrice a day once hemostasis is established. This usually lasts 9 days after the therapy. For those who have undergone hip fracture operation, the treatment can take up to 32 days.

The dosage and duration of the treatment may vary according to the condition of the patient and his or her response to the medication. It can also vary according to the patient’s weight.

To help patients remember taking Fondaparinux sodium, it is recommended that they take the drug at the same time every day.

Some of the more common side effects that users of Fondaparinux sodium experience are pain, redness, bruising and swelling at the area of injection. Users may also experience nausea, headache, vomiting, swollen feet and hands, or fever. In case any of these side effects persist, users should immediately inform their physicians.

Users should immediately tell their doctors in case any of these severe side effects appear- unexplained bruising and bleeding, difficulty in breathing, chest pains, coughing up of blood, unexplained dizziness, irregular heart beat, pain in the joint and muscles, black stool, pinkish urine, and changes in mood.

It is very rare for users of Fondaparinux sodium to experience any symptom of allergic reaction. However in case any of these symptoms occur- rashes, swelling, and itching- persist, users should immediately seek medical help.

Patients should inform their doctor or pharmacist if they are allergic to blood thinners, NSAIDs, and sulfinpyrazone before agreeing to take Fondaparinux sodium.

Those who have blood or bleeding problems like low blood count; blood clotting ailment due to heparin; eye problems; kidney disease; high blood pressure; seizures; and intestinal problems are also cautioned into taking Fondaparinux sodium. The same goes for those who have had stroke, recent surgery on the brain, spine, and eye, and body weight of less than 110 pounds.

Fondaparinux sodium has the following structural formula:

• Molecular formula of fondaparinux sodium is C31H43N3Na10O49S8
• Chemical IUPAC Name is decasodium (2R,3S,4S,5R,6R)-3-[(2R,3R,4R,5S,6R)-5-[(2R,3R,4S,5S,6S)-6- carboxylato-5-[(2R,3R,4R,5S,6R)- 4,5-dihydroxy-3- (sulfonatoamino)-6-(sulfonatooxymethyl)oxan-2-yl]oxy-3,4- dihydroxy-oxan-2-yl]oxy-3-(sulfonatoamino)-4- sulfonatooxy-6-(sulfonatooxymethyl)oxan-2-yl]oxy- 4-hydroxy-6-[(2R,3S,4R,5R,6S)-4-hydroxy-6- methoxy-5-(sulfonatoamino)-2-(sulfonatooxymethyl) oxan-3-yl]oxy-5-sulfonatooxy-oxane-2-carboxylate
• Molecular weight is 1726.77 g/mol
Brand name(s): Arixtra, Fondaparinux