DIVITI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 2.5MG/0.5ML [SIN16809P]

Product Info

DIVITI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 2.5MG/0.5ML

[SIN16809P]

Indications:

• Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopedic surgery of the lower limbs such as:

  1. hip fracture,

  2. major knee surgery,

  3. hip replacement surgery.

• Prevention of venous thromboembolic events (VTE) in patients undergoing abdominal surgery who are at risk of thromboembolic complications.

• Treatment of deep vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE) except in hemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

• Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) acute coronary syndrome for the prevention of death, myocardial infarction and refractory ischemia (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Treatment of ST segment elevation myocardial infarction (STEMI) acute coronary syndrome for the prevention of death and myocardial reinfarction in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Recommended Dosage:
Adults
Prevention of VTE
The recommended dose of DIVITI is 2.5 mg once daily, administered postoperatively by subcutaneous injection. The timing of the first dose should be no earlier than 6 hours following surgical closure, and only after hemostasis has been established (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Treatment should be continued until the risk of venous thromboembolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery. Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery. In these patients the use of prolonged prophylaxis with DIVITI should be considered for up to an additional 24 days.

Treatment of DVT and PE
The recommended dose of DIVITI to be administered by subcutaneous injection once daily is:

• 5 mg for body weight less than 50 kg;

• 7.5 mg for body weight 50 to 100 kg;

• 10 mg for body weight greater than 100 kg.

Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (international normalized ratio 2 to 3). Concomitant treatment with vitamin K antagonists should be initiated as soon as possible, usually within 72 hours. The usual duration of DIVITI treatment is 5 to 9 days.

Treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI)
The recommended dose of DIVITI is 2.5 mg once daily, administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to 8 days or until hospital discharge. If a patient is to undergo percutaneous coronary intervention (PCI) while on DIVITI, unfractionated heparin (UFH) as per standard practice should be administered during PCI, taking into account the patient’s potential risk of bleeding, including the time since the last dose of DIVITI (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The timing of restarting subcutaneous DIVITI after sheath removal should be based on clinical judgment. In the UA/NSTEMI clinical trial treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.

In patients who are to undergo coronary artery bypass graft (CABG) surgery, DIVITI where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours postoperatively.

Treatment of ST segment elevation myocardial infarction (STEMI)
The recommended dose of DIVITI is 2.5 mg once daily. The first dose of DIVITI is administered intravenously and subsequent doses are administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to 8 days or until hospital discharge. If a patient is to undergo non-primary percutaneous coronary intervention (PCI) while on DIVITI, unfractionated heparin (UFH) as per standard practice should be administered during PCI, taking into account the patient’s potential risk of bleeding, including the time since the last dose of DIVITI (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The timing of restarting subcutaneous DIVITI after sheath removal should be based on clinical judgment. In the STEMI clinical trial treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.

In patients who are to undergo coronary artery bypass graft (CABG) surgery, DIVITI where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours postoperatively.

Special Populations
The first DIVITI administration should be given not earlier than 6 hours following surgical closure. The injection should not be given unless hemostasis has been established.

• Children
  The safety and efficacy of DIVITI in patients under the age of 17 has not been established.

• Elderly (from 75 years)
  DIVITI should be used with caution in elderly patients as renal function decreases with age (see Renal impairment, Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients undergoing surgery, the timing of the first dose of DIVITI requires strict adherence (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients with body weight less than 50 kg
  Patients with body weight below 50 kg are at increased risk of bleeding (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients undergoing surgery, the timing of the first dose of DIVITI requires strict adherence (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Renal impairment

  1. Prevention and treatment of VTE
     In patients undergoing surgery, the timing of the first dose of DIVITI requires strict adherence. DIVITI should be used with caution in patients with moderate renal impairment (creatinine clearance 30–50 ml/minute). DIVITI should not be used in patients with severe (creatinine clearance less than 30 ml/minute) renal impairment (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  2. Treatment of UA/NSTEMI and STEMI
     DIVITI is not recommended for use in patients with a creatinine clearance of less than 20 ml/minute (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No dosage reduction is required for patients with a creatinine clearance greater than or equal to 20 ml/minute.

• Hepatic impairment
  No dosing adjustment of DIVITI is necessary (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients with severe hepatic impairment, DIVITI should be used with caution (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications:

• Known hypersensitivity to fondaparinux or any of the excipients.

• Active clinically significant bleeding.

• Acute bacterial endocarditis.

• Severe renal impairment defined by creatinine clearance <30 ml/minute.