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Common Summary of Product Characteristics (QRD template version Version 3.0, 04/2013) Common SUMMARY OF PRODUCT CHARACTERISTICS for innohep® 20,000 anti-Xa IU/mL solution for injection, pre-filled syringes MRP: DK/H/0104/002 1 (00217577 v 11.0) v00217577 11.0 1. NAME OF THE MEDICINAL PRODUCT innohep 20,000 anti-Xa IU/mL solution for injection, pre-filled syringes 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tinzaparin sodium 20,000 anti-Xa IU/mL Excipients with known effect: Sodium metabisulphite (1.83 mg/mL) and sodium (in total < 23 mg/dose). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection, pre-filled syringes 1 mL syringe holding a colourless or straw-coloured liquid, free from turbidity and from matter that deposits on standing. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis and pulmonary embolus. Extended treatment of symptomatic venous thromboembolism and prevention of recurrences in patients with active cancer. Note: innohep is not indicated for the treatment of serious pulmonary embolism, i.e. high-risk patients with hemodynamic instability. 4.2 Posology and method of administration Posology Adults 175 anti-Xa IU/kg body weight given subcutaneously once daily. Oral anticoagulation should be commenced on the second day of treatment. 175 anti-Xa IU/kg body weight once daily for at least 6 days and until adequate oral anticoagulation is established. Different low molecular weight heparins are not necessarily equivalent. Therefore, specific posology and method of administration of each one should be followed. Extended treatment in cancer patients Treatment should consist of the standard 175 IU anti-Xa/kg dose given subcutaneously once daily. The recommended treatment duration is 3-6 months. Anticoagulant treatment beyond 6 months should be evaluated taking into account the possible benefit for the patient and the progression of cancer disease. Paediatric population The safety and efficacy of innohep in children below 18 years have not yet been established. 2 (00217577 v 11.0) v00217577 11.0 Patients with renal impairment If renal impairment is suspected, renal function should be assessed using a formula based on serum creatinine to estimate creatinine clearance level. Available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 mL/minute. However, caution is recommended when treating patients with severe renal impairment (creatinine clearance < 30 mL/minute). There is limited data available in patients with an estimated creatinine clearance level below 20 mL/minute. See section 4.4: Renal impairment. Elderly patients innohep should be used in the elderly in standard doses. Precaution is recommended in the treatment of elderly patients with renal impairment. If renal impairment is suspected, see section 4.2: Patients with renal impairment and section 4.4: Renal impairment. Method of administration Parenteral products should be inspected visually prior to administration. Do not use if cloudiness or precipitate is observed. The liquid may turn yellow by storage but is still suitable. The innohep 20,000 anti Xa UL/mL pre-filled syringes have a graduation of 0.05 mL which makes it possible to choose the most suitable dose for the individual patient depending on the patient’s body weight. In order to achieve the correct dosage for the individual patient the excess volume is ejected before SC injection holding the syringe in a vertical position. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Current or history of immune-mediated heparin-induced thrombocytopenia (type II) (see section 4.4). Active major haemorrhage or conditions predisposing to major haemorrhage. Major haemorrhage is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra- articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or c) leads to transfusion of two or more units of whole blood or red blood cells. Septic endocarditis. Treatment doses of innohep (175 IU/kg) are contraindicated in patients who receive neuraxial anaesthesia. If neuraxial anaesthesia is planned, innohep should be discontinued at least 24 hours before the procedure is performed. innohep should not be resumed until at least 4-6 hours after the use of spinal anaesthesia or after the catheter has been removed. Patients should be closely monitored for signs and symptoms of neurological injury. 4.4 Special warnings and precautions for use Haemorrhage Caution is advised when administering innohep to patients at risk of haemorrhage. For patients at risk of major haemorrhage see section 4.3. The combination with medicinal products affecting platelet function or the coagulation system should be avoided or carefully monitored (see section 4.5). Intramuscular injections innohep should not be administered by intramuscular injection due to the risk of haematoma. Due to the risk of haematoma, concomitant intramuscular injections should also be avoided. 3 (00217577 v 11.0) v00217577 11.0 Heparin-induced thrombocytopenia Because of the risk of immune-mediated heparin-induced thrombocytopenia (type II), platelet count should be measured before the start of treatment and periodically thereafter. innohep must be discontinued in patients who develop immune-mediated heparin-induced thrombocytopenia (type II) (see section 4.3 and 4.8). Platelet counts will usually normalise within 2 to 4 weeks after withdrawal. Cancer and its treatments such as chemotherapy may cause thrombocytopenia. Regular monitoring of platelet count also applies to extended treatment for cancer associated thrombosis. Hyperkalaemia Heparin products can suppress adrenal secretion of aldosterone, leading to hyperkalaemia. Risk factors include diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, raised plasma potassium at pre-treatment, concomitant therapy with drugs that may elevate plasma potassium, and long-term use of innohep. In patients at risk, potassium levels should be measured before starting innohep and monitored regularly thereafter. Heparin-related hyperkalaemia is usually reversible upon treatment discontinuation, though other approaches may need to be considered if innohep treatment is considered lifesaving (e.g. decreasing potassium intake, discontinuing other drugs that may affect potassium balance). Prosthetic heart valves Therapeutic failures have been reported in patients with prosthetic heart valves on full anti-coagulant doses of innohep and other low molecular weight heparins. innohep is not recommended for use in this population. Renal impairment Available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 mL/minute. Although anti-Xa monitoring is the most appropriate measure of the pharmacodynamic effects of innohep, it remains a poor predictor of haemorrhage risk, nonetheless monitoring of anti-factor Xa activity may be considered in patients with severe renal impairment (creatinine clearance < 30 mL/minute). Caution is recommended when treating patients with severe renal impairment (creatinine clearance < 30 mL/minute). There is limited data available in patients with an estimated creatinine clearance level below 20 mL/minute. Elderly Elderly are more likely to have reduced renal function (see section 4.4: Renal impairment); therefore caution should be exercised when prescribing innohep to the elderly. Excipients warnings innohep 20,000 anti-Xa IU/mL contains sodium metabisulphite. Metabisulphites may rarely cause severe hypersensitivity reactions and bronchospasm. innohep formulations containing sodium metabisulphite must be used with caution in patients with asthma. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. 4.5 Interaction with other medicinal products and other forms of interaction The anticoagulant effect of innohep may be enhanced by other drugs affecting the coagulation system, such as those inhibiting platelet function (e.g. acetylsalicylic acid and other non-steroidal anti-inflammatory drugs), thrombolytic agents, vitamin K antagonists, activated protein C, direct factor Xa and IIa inhibitors. Such combinations should be avoided or carefully monitored (see section 4.4). 4.6 Fertility, pregnancy and lactation Pregnancy Anticoagulant treatment of pregnant women requires specialist involvement. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 4 (00217577 v 11.0) v00217577 11.0 A large amount of data on pregnant women (more than 2,200 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of tinzaparin. Tinzaparin does not cross the placenta. innohep can be used during all trimesters of pregnancy if clinically needed. Epidural anaesthesia: Due to the risk of spinal haematoma, treatment doses of innohep (175 IU/kg) are contraindicated in patients who receive neuraxial anaesthesia. Therefore, epidural anaesthesia in pregnant women should always be delayed until at least 24 hours after administration of the last treatment dose of innohep. Prophylactic doses may be used as long as a minimum delay of 12 hours is allowed between the last administration of innohep and the needle or catheter
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