Source: Web Search Revision Year: 2020 Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, 72 Steel Road, Spartan, Kempton Park, 1619 1 Company Reg. No.: 1990/001979/07
NOXFIBRA is indicated:
Do not administer by intramuscular route.
In orthopaedic surgery, 40 mg (0,4 ml) once daily by subcutaneous injection. The first injection should be given 12 hours pre-operatively.
Treatment is continued for as long as the risk of thromboembolism persists; in general, from 7 to 10 days after surgery or as long as there is a risk of venous thromboembolism until the patient is ambulatory. Continued therapy with 40 mg once daily for 3 weeks following the initial therapy has been proven to be beneficial in total hip replacement.
In general surgery, 20 mg (0,2 ml) once daily by subcutaneous injection. The first injection should be given 2 hours pre-operatively. Treatment is continued for as long as the risk of thromboembolism persists; in general, from 7 to 10 days after surgery as long as there is a risk of venous thromboembolism and until the patient is ambulatory. For special recommendations concerning dosing intervals for spinal/epidural anaesthesia and percutaneous coronary revascularisation procedures (see “WARNINGS AND SPECIAL PRECAUTIONS”).
The recommended dose of NOXFIBRA is 40 mg once daily by subcutaneous injection. NOXFIBRA treatment is prescribed for a minimum of 6 days and continued until the return of full ambulation, for a maximum of 14 days. Treatment of deep vein thrombosis with or without pulmonary embolism: A dose of 1 mg/kg should be given subcutaneously every 12 hours. Oral anticoagulant therapy should be initiated when appropriate and NOXFIBRA should be continued until a therapeutic anticoagulant effect has been achieved (International Normalised Ratio 2 to 3). NOXFIBRA treatment is usually prescribed for between 5 and 10 days.
The recommended dose of NOXFIBRA is 1 mg/kg every 12 hours by subcutaneous injection, administered concurrently with aspirin (100 to 325 mg once daily).
Treatment with NOXFIBRA in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days.
The recommended dose is 1 mg/kg of NOXFIBRA.
For patients with a high risk of haemorrhage, the dose should be reduced to 0,5 mg/kg for double vascular access or 0,75 mg/kg for single vascular access.
During haemodialysis, NOXFIBRA should be introduced into the arterial line of the circuit at the beginning of the dialysis session. The effect of this dose is usually sufficient for a 4 hour session; however, if fibrin rings are found, for example after a longer than normal session, a further dose of 0,5 to 1 mg/kg may be given.
The recommended dose of NOXFIBRA is a single IV bolus of 30 mg plus a 1 mg/kg subcutaneous dose, followed by 1 mg/kg administered subcutaneously every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses).
For dosage in patients > 75 years of age, refer to the section on the Elderly, in this section. When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific), NOXFIBRA should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive aspirin as soon as they are identified as having STEMI and maintained on an appropriate dose once daily, unless contraindicated.
The recommended duration of NOXFIBRA treatment is 8 days or until hospital discharge, whichever comes first.
If the last NOXFIBRA subcutaneous administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last subcutaneous administration was given more than 8 hours before balloon inflation, an IV bolus of 0,3 mg/kg of NOXFIBRA should be administered.
For treatment of acute ST-segment Elevation Myocardial Infarction in the elderly patient >75 years of age, do not use an initial IV bolus. Initiate dosing with 0,75 mg/kg subcutaneous every 12 hours (maximum 75 mg for the first two doses only, followed by 0,75 mg/kg dosing for the remaining doses).
For other indications, no dose reduction is necessary in the elderly, unless kidney function is impaired (see “WARNINGS AND SPECIAL PRECAUTIONS” – Haemorrhage in the elderly, “PHARMACOLOGICAL ACTION” – Elderly and “DOSAGE AND DIRECTIONS FOR USE” – Renal impairment).
The efficacy of NOXFIBRA injection in the elderly (>65 years) was similar to that seen in younger patients (<65 years). The incidence of bleeding complications was similar between elderly and younger patients when 30 mg every 12 hours of 40 mg once a day doses of NOXFIBRA injection was employed. The incidence of bleeding complications was higher in elderly patients as compared to younger patients when NOXFIBRA injection was administered at doses of 1,5 mg/kg once a day or 1 mg/kg every 12 hours. The risk of NOXFIBRA injection-associated bleeding increased with age.
Serious adverse events increased with age for patients receiving NOXFIBRA injection. Other clinical experience (including post-marketing surveillance and literature reports) has not revealed additional differences in the safety of NOXFIBRA injection between elderly and younger patients.
Careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. Monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered (see “PHARMACOLOGICAL ACTION” and “WARNINGS AND SPECIAL PRECAUTIONS”).
In the absence of safety data on dosages more than 80 mg daily and delayed elimination in patients with severe renal impairment, dosages of more than 60 mg daily should be used with caution. Special safety vigilance is warranted in patients with severe renal impairment, as there may be an increased bleeding tendency due to renal failure.
Refer to “WARNINGS AND SPECIAL PRECAUTIONS” – Renal impairment and “PHARMACOLOGICAL ACTION” – Renal impairment.
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance <30 ml/min), according to the following tables, since NOXFIBRA exposure is significantly increased in this patient population.
Table 1. The following dosage adjustments are recommended for therapeutic dosage ranges:
| Standard dosing | Severe renal impairment |
|---|---|
| 1 mg/kg SC twice daily 1,5 mg/kg SC once daily 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg SC twice daily | 1 mg/kg SC once daily 1 mg/kg SC once daily 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg SC once daily |
Table 2. Elderly patients >75 years of age (for acute STEMI indication only):
| Standard dosing | Severe renal impairment |
|---|---|
| 0,75 mg/kg SC twice daily without initial bolus | 1 mg/kg SC once daily without initial bolus |
Table 3. The following dosage adjustments are recommended for prophylactic dosage ranges:
| Standard dosage | Severe renal impairment |
|---|---|
| 40 mg SC once daily 20 mg SC once daily | 20 mg SC once daily 20 mg SC once daily |
The recommended dosage adjustments do not apply to the haemodialysis indication.
Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30 to 50 ml/min) and mild (creatinine clearance 50 to 80 ml/min) renal impairment, careful clinical monitoring is advised.
NOXFIBRA is administered by subcutaneous injection for the prevention of venous thromboembolic disease; treatment of deep vein thrombosis; treatment of unstable angina and non-Q-wave myocardial infarction and treatment of acute ST-segment Elevation Myocardial Infarction.
For acute ST-segment Elevation Myocardial Infarction, treatment is to be initiated with a single IV bolus injection immediately followed by a subcutaneous injection.
It is administered through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during haemodialysis.
NOXFIBRA must never be injected intramuscularly.
The pre-filled disposable syringe is ready for immediate use. When using NOXFIBRA vials, the volume to be injected should be measured precisely with a graduated syringe fitted with an appropriate needle for subcutaneous injection.
Injections should be made preferably when the patient is lying down. NOXFIBRA is administered by deep subcutaneous injection. Do not expel the air bubble from the syringe before injecting to avoid the loss of medicine, when using the 20 mg and 40 mg pre-filled syringes. The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
The pre-filled syringes fitted with an automatic safety device avoid accidental needle pricks after injecting. When the protective cap is removed off the needle, a drop may appear at the end of the needle. If so, remove it before injecting the medicine by lightly tapping the body of the syringe with the needle pointing down. The pre-filled syringe is ready to use. Do not press on the plunger to expel any air bubbles before administering the injection. The injection must be given with the patient preferably lying down. The whole length of the needle should be introduced perpendicularly, not from the side, into a skin fold held between the thumb and index finger. The skin fold should be held throughout the injection. Do not rub the injection site after administration. The safety device is automatically activated once the plunger is fully depressed, thus completely protecting the used needle and without causing discomfort to the patient. Activation of the safety device is only possible if the plunger is fully depressed.
The safety device can only be activated once the syringe is completely empty.
For intravenous injection, the multiple-dose vial should be used. NOXFIBRA should be administered through an intravenous line. It should not be mixed or co-administered with other medicines. To avoid the possible mixture of NEXFIBRA with other medicines, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of NOXFIBRA to clear the port of medicine. NOXFIBRA may be safely administered with normal saline solution (0,9%) or 5% dextrose in water. Do not use the multidose vial for more than 28 days after the first use.
Severe bleeding with NOXFIBRA, usually caused by accidental overdosage, may be reduced by slow intravenous administration of protamine sulphate.
1 mg of protamine sulphate is stated to inhibit the effects of 1 mg (100 units) of NOXFIBRA. Such doses of protamine sulphate should completely neutralise the anti-thrombin effect of NOXFIBRA but not the anti-Factor Xa effect (maximum of 60% anti-Factor Xa activity is neutralised). Not more than 50 mg of protamine sulphate should be injected for any one dose. Further treatment is symptomatic and supportive.
Store at or below 25°C.
Do not freeze.
For single, one-time use only. Any unused solution should be discarded.
KEEP OUT OF THE REACH OF CHILDREN.
Noxfibra 20: is a 0,2 ml (20 mg/0,2 ml) solution for injection, packed in 0,5 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is white in colour.
Noxfibra 40: is a 0,4 ml (40 mg/0,4 ml) solution for injection, packed in a 0,5 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is yellow in colour.
Noxfibra 60: is a 0,6 ml (60 mg/0,6 ml) solution for injection, packed in a 1 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is orange in colour.
Noxfibra 80: is a 0,8 ml (80 mg/0,8 ml) solution for injection, packed in a 1 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is brown in colour.
Noxfibra 100: is a 1 ml (100 mg/ml) solution for injection, packed in a 1 ml clear and colourless type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and an automatic safety device. The plunger rod is black in colour.
The pre-filled syringes are packed into an outer cardboard carton.
NOXFIBRA pre-filled syringes are packed in 10’s.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
