Fondaparinux sodium parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of fondaparinux sodium
Drugs List
Therapeutic Indications
Uses
Anticoagulant for prophylaxis and treatment of venous thrombosis
Deep vein thrombosis - treatment
Non ST-segment elevation MI where urgent PCI not indicated
Pulmonary embolism - treatment
ST segment elevation MI where no other initial reperfusion indicated
ST segment elevation MI: treatment adjunctive to thrombolytics
Superficial thrombophlebitis
Treatment of unstable angina pectoris
Dosage
Adults
VTE prophylaxis following major orthopaedic or abdominal surgery:
The recommended dose is 2.5 mg once daily administered post-operatively by subcutaneous injection.
The initial dose should be given 6 hours following surgical closure provided that haemostasis has been established.
Treatment should be continued until the risk of VTE has diminished usually when patient is ambulatory at least 5 to 9 days after surgery. Patients undergoing hip fracture surgery are at risk of VTE beyond 9 days after surgery and should be considered for treatment with VTE prophylaxis for up to an additional 24 days.
Thromboembolic complication prophylaxis for high risk patients:
The recommended dose is 2.5 mg once daily via subcutaneous injection. Treatment should last 6 to 14 days. No data available on treatment durations longer than this.
DVT/PE treatment:
Body weight less than 50 kg: 5 mg once daily via subcutaneous injection
Body weight 50 to 100 kg: 7.5 mg once daily via subcutaneous injection
Body weight over 100 kg: 10 mg once daily via subcutaneous injection
Treatment should last at least 5 days until adequate oral anticoagulation is established (INR 2 to 3). Oral therapy should be initiated as soon as possible (within 72 hours). The average duration of treatment is 7 days. There is limited experience with treatment beyond 10 days.
Unstable angina/Non-ST segment elevation MI:
The recommended dose is 2.5 mg fondaparinux given via subcutaneous injection once daily for up to a maximum of 8 days or until hospital discharge if that occurs earlier. Treatment should be initiated as soon as possible following diagnosis.
If the patient is to undergo percutaneous coronary intervention, any unfractionated heparin administered according to local practice should be given after consideration of the time the last dose of fondaparinux and after taking into account the patient's potential risk for bleeding.
The timing regarding the re-introduction of fondaparinux following the removal of the sheath should be based on clinical judgement but should not be attempted less that 2 hours after sheath removal.
Fondaparinux should not be given (where possible) during the 24 hours before or for 48 hours following coronary artery bypass graft surgery.
ST segment elevation MI:
The recommended dose is 2.5 mg fondaparinux given once daily for up to a maximum of 8 days or until hospital discharge if that occurs earlier. The initial dose should be administered intravenously and subsequent doses via subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis.
If the patient is to undergo non-primary percutaneous coronary intervention, any unfractionated heparin administered according to local practice should be given after consideration of the time the last dose of fondaparinux and after taking into account the patient's potential risk for bleeding.
The timing regarding the re-introduction of fondaparinux following the removal of the sheath should be based on clinical judgement but should not be attempted less that 3 hours after sheath removal.
Fondaparinux should not be given (where possible) during the 24 hours before or for 48 hours following coronary artery bypass graft surgery.
Treatment of superficial vein thrombosis:
The recommended dose is 2.5 mg fondaparinux given via subcutaneous injection once daily. Treatment should be initiated a soon as possible after diagnosis and continued for a minimum of 30 days and up to a maximum of 45 days in patients at high risk of thromboembolic complications.
Elderly
(See Dosage; Adult).
The timing of the first injection in patients undergoing major orthopaedic surgery requires strict adherence in patients aged 75 years and over.
Patients with Renal Impairment
Creatinine clearance 20 to 30 ml/minute
Doses over 1.5 mg are not recommended.
VTE prophylaxis:
Creatinine clearance 20 to 50 ml/minute: 1.5 mg dose daily.
DVT/PE treatment:
Creatinine clearance 30 to 50 ml/minute and high body weight ( above 100 kg): Initial dose 10 mg. A maintenance dose of 7.5 mg daily should be considered.
The use of this drug in patients with creatinine clearance below 30 ml/minute is contraindicated when treating DVT or PE
Treatment of superficial vein thrombosis:
Creatinine clearance 20 to 50 ml/minute: The dose should be reduced to 1.5 mg once daily.
Patients with Hepatic Impairment
Treatment of superficial vein thrombosis
The safety and efficiency of fondaparinux in patients with severe hepatic impairment has not been studied, there fondaparinux is not recommended.
Additional Dosage Information
Timing of the first injection in patients undergoing major orthopaedic surgery requires strict adherence in patients aged 75 years and over, and/or with body weight below 50 kg and/or with moderate renal impairment (creatinine clearance 20 to 50 ml/minute).
The first injection should not be given earlier than 6 hours following surgical closure. The injection should not be given unless haemostasis has been established.
Treatment of superficial vein thrombosis
The safety and efficiency of fondaparinux in patients with a body weight less than 50 kg has not been studied, and is therefore not recommended.
Administration
For deep subcutaneous injection (or intravenous injection in the case of the initial dose when treating STEMI).
Contraindications
Children under 17 years
Haemorrhage
Acute bacterial endocarditis
Renal impairment - creatinine clearance < 30ml/min - if treating VTE
Renal impairment - creatinine clearance below 20ml/minute
Spinal/epidural anaesthesia - if treating VTE
Precautions and Warnings
Lumbar puncture
Patients over 75 years
Predisposition to haemorrhage
Spinal/epidural anaesthesia
Weight below 50kg
Breastfeeding
Gastrointestinal ulcer
History of heparin-induced thrombocytopenia
Pregnancy
Recent central nervous system surgery
Recent intracranial haemorrhage
Recent ocular surgery
Renal impairment - creatinine clearance 20-50ml/minute
Severe hepatic impairment
Not for use as sole anticoagulant during non-primary PCI
Not recommended prior to or following primary PCI
Not all available strengths are licensed for all indications
Presentation (e.g. syringe, needle cap) may contain a derivative of latex
Do not administer earlier than 6 hours following surgical closure
Do not use if solution is discoloured or particulates are apparent
Ensure haemostasis established before administration
For single use only
Increased risk of spinal haematoma with post-op insitu epidural catheter
Increased risk of guiding catheter thrombus during PCI
Advise patient not to take NSAIDs unless advised by clinician
This medication should be used with caution in patients with a history of Heparin Induced Thrombocytopenia (HIT) - type II. Fondaparinux does not bind to platelet factor 4 and does not cross react with sera from patients with Heparin Induced Thrombocytopenia - type II. However, there have been spontaneous reports of HIT in patients receiving fondaparinux.
Presence of superficial vein thrombosis greater than 3cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment of fondaparinux. There are no data regarding the use of fondaparinux 2.5 mg in superficial vein thrombosis patients with concomitant DVT or with superficial vein thrombosis within 3 cm of the sapheno-femoral junction.
The safety and efficiency of fondaparinux 2.5 mg has not been studied in the following groups: patients with superficial vein thrombosis following sclerotherapy or resulting as a complication of an intravenous line, patients with history of superficial vein thrombosis within the previous 3 months, patients with a history of venous thromboembolic disease within the previous 6 months, or patients with active cancer.
If prophylactic treatment is to be continued with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection. If follow-up treatment with a vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.
Pregnancy and Lactation
Pregnancy
Use fondaparinux with caution in pregnancy.
No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. However, based on evidence that the drug does not cross the human placenta and the absence of foetal harm in animal experiments, the risk in humans appears to be low and if the maternal condition requires the drug it should not be withheld because of pregnancy.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use fondaparinux with caution in breastfeeding.
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk, although this should be expected. The potential effects of this exposure on a nursing infant are unknown but appear to be clinically insignificant (Briggs, 2011).
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal pain
Allergic reaction
Anaemia
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anxiety
Atrial fibrillation
Bilirubinuria
Bruising
Changes in hepatic function
Chest pain
Coagulation disorders
Confusion
Constipation
Cough
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Epistaxis
Fatigue
Fever
Flushing
Gastritis
Gastro-intestinal disturbances
Gastro-intestinal haemorrhage
Genital oedema
Gingival bleeding
Haemarthrosis
Haematoma
Haematuria
Haemoptysis
Haemorrhage
Headache
Hepatic haemorrhage
Hot flushes
Hyperbilirubinaemia
Hypokalaemia
Hypotension
Impaired platelet function
Increased non-protein nitrogen
Increases in hepatic enzymes
Injection site reactions
Intracranial bleeding
Leg pain
Nausea
Ocular haemorrhage
Oedema
Pain
Peripheral oedema
Post operative wound infection
Pruritus
Purpura
Rash
Retroperitoneal bleeding
Somnolence
Syncope
Tachycardia
Thrombocythaemia
Thrombocytopenia
Utero-vaginal haemorrhage
Ventricular tachycardia
Vertigo
Vomiting
Wound secretion
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2016
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia. Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 21 April 2016.
Summary of Product Characteristics: Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe. Aspen. Revised August 2014.
Summary of Product Characteristics: Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe. Aspen. Revised August 2014.
Summary of Product Characteristics: Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe. Aspen. Revised August 2014.
Summary of Product Characteristics: Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe. Aspen. Revised August 2014.
Summary of Product Characteristics: Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe. Aspen. Revised August 2014.
Fondaparinux sodium Dr. Reddy's 2.5 mg/0.5 ml solution for infection in pre-filled syringe. Dr. Reddy's Laboratories (UK) Ltd. December 2015.
Fondaparinux sodium Dr. Reddy's 7.5 mg/0.6 ml solution for infection in pre-filled syringe. Dr. Reddy's Laboratories (UK) Ltd. December 2015.
Fondaparinux sodium Dr. Reddy's 10 mg/0.8 ml solution for infection in pre-filled syringe. Dr. Reddy's Laboratories (UK) Ltd. December 2015.
Fondaparinux sodium Dr. Reddy's 10 mg/0.8 ml solution for infection in pre-filled syringe. Dr. Reddy's Laboratories (UK) Ltd. December 2015.
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