Introduction
Fonidel is an anticoagulant medicine used in the treatment of deep vein thrombosis (clot in veins of leg) and pulmonary embolism (clot in artery of lungs). It helps to prevent formation of harmful blood clots in blood vessels.
Fonidel also reduces the risk of getting clots in people who have undergone knee or hip replacement surgeries, or who have been bedridden for long. It is administered under the supervision of a doctor. Your doctor will decide the dose and duration of the medicine for you. You should continue all your other medicines that are advised by the doctor for your long-term treatment even after this injection.
Use of this medicine may increase your risk of bleeding. Let your doctor know immediately if you see pinpoint rash or blood in your vomits, urine, or stool. Before taking it, you must inform the doctor if you are suffering from any bleeding disorder, kidney or liver disease. Also, let your doctor know if you are pregnant or breastfeeding and about all the other medications that you are taking regularly.
Uses of Fonidel
- Deep vein thrombosis
- Pulmonary embolism
Side effects of Fonidel
Common
- Bleeding
- Anemia (low number of red blood cells)
How to use Fonidel
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How Fonidel works
Fonidel is an anticoagulant. It stops the action of a substance (clotting factor Xa) from working in the blood. This prevents the formation of unwanted blood clots (thrombosis) in the blood vessels.
What if you forget to take Fonidel?
If you miss a dose of Fonidel, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Indication
Venous thromboembolic events, acute DVT, pulmonary embolism (PE), unstable angina, non-ST segment elevation MI
Administration
Administration
Administer initial dose 6-8 hours after surgery, once hemostasis has been established
SC administration is deep, alternating right and left anterior and posterior abdominal walls
Adult Dose
Deep Vein Thrombosis/Acute Pulmonary Embolism
Treatment
<50 kg: 5 mg SC once daily
50-100 kg: 7.5 mg SC once daily
>100 kg: 10 mg SC once daily
Administer for 5-9 days; up to 26 days administered in clinical trials
Prophylaxis
>50 kg: 2.5 mg SC once daily for 5-9 days or up to 10 days following abdomonal surgery; for hip replacement, 11 days recommended and a minimum 10-14 days recommended for patients undergoing total hip or knee arthroplasty, or hip fracture surgery; administered for up to 35 days in some instances
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
<20 Contraindicated.
20-50 1.5 mg once daily.
Contraindication
Hypersensitivity. Active clinically significant bleeding, acute bacterial endocarditis.
Mode of Action
Fondaparinux, a synthetic pentasaccharide, acts as a selective inhibitor of activated factor X. It works by binding selectively to ATIII, and potentiates the neutralisation of Factor Xa. This will interrupt the blood coagulation cascade and inhibit both thrombin formation and thrombus development. At the recommended dosage, fondaparinux does not affect fibrinolytic activity or platelet function. It cannot lyse established thrombi and does not affect clotting function tests (e.g. aPPT, INR).
Precaution
Patient w/ increased risk of haemorrhage (e.g. congenital or acquired bleeding disorders, history or active GI ulceration, intracranial haemorrhage, recent brain, spinal or ophth surgery); body wt <50 kg. Increased risk of spinal or epidural haematomas in patient undergoing neuraxial (spinal/epidural) anaesth or spinal puncture esp w/ post-op use of indwelling epidural catheters and concurrent use of medications affecting haemostasis. Moderate renal and severe hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor CBC, platelet count, serum creatinine and stool occult blood regularly.
Lactation: Unknown whether drug is excreted in milk; use with caution
Side Effect
>10%
Anemia (1-20%),Fever (4-14%),Nausea (3-11%)
1-10%
Rash (7.5%),Dizziness (4%),Confusion (3%),Constipation (5-9%),Diarrhea (2-3%),Edema (9%),Headache (2-5%),Hypokalemia (1-4%),Hypotension (4%),Insomnia (4-5%),Purpura (4%),Thrombocytopenia (3%),Urinary retention (3%),Urinary tract infection (2-4%),Vomiting (1-6%)
Pregnancy Category Note
Pregnancy
Available data from published literature and postmarketing reports have not reported clear association with adverse developmental outcomes; fondaparinux sodium plasma concentrations obtained from four women treated during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium; there are risks to mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with use of anticoagulants
Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions; published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy
Fetal/neonatal adverse reactions
Drug has been demonstrated to cross placenta in humans; use of anticoagulants, may increase risk of bleeding in the fetus and neonate; monitor neonates for bleeding
Labor or delivery
All patients receiving anticoagulants, including pregnant women, are at risk for bleeding; use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas; pregnant women receiving therapy should be carefully monitored for evidence of bleeding or unexpected changes in coagulation parameters; consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches
Lactation
There are no data on presence in human milk, or effects on milk production; limited clinical data during lactation preclude a clear determination of risk of therapy to an infant during lactation; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interaction
Increased risk of bleeding w/ (e.g. desirudin, fibrinolytic drugs, glycoprotein IIb/IIIa-receptor antagonists, heparin, heparinoids or LMWH).