Tinzaparin interacts in the following cases:
Use in patients with a creatinine clearance level <30 ml/minute is not recommended, as dosage in this population has not been established. Available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 ml/minute. When required in these patients, tinzaparin administration can be used cautiously with anti-Xa monitoring, if the benefit outweighs the risk. Although anti-Xa monitoring remains a poor predictor of haemorrhage risk, it is the most appropriate measure of the pharmacodynamic effects of tinzaparin.
The anticoagulant effect of tinzaparin 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.
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 tinzaparin. In patients at risk, potassium levels should be measured before starting tinzaparin and monitored regularly thereafter. Heparin-related hyperkalaemia is usually reversible upon treatment discontinuation, though other approaches may need to be considered if tinzaparin treatment is considered lifesaving (e.g. decreasing potassium intake, discontinuing other drugs that may affect potassium balance).
Anticoagulant treatment of pregnant women requires specialist involvement.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
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.
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 placement.
Therapeutic failures and maternal death have been reported in pregnant women with prosthetic heart valves on full anticoagulant doses of innohep and other low molecular weight heparins. In the absence of clear dosing, efficacy and safety information in this circumstance, innohep is not recommended for use in pregnant women with prosthetic heart valves.
innohep vials contain benzyl alcohol. As this preservative may cross the placenta, innohep formulations without benzyl alcohol (syringes) should be used during pregnancy.
Animal data indicate that innohep excretion into breast milk is minimal.
It is unknown whether tinzaparin is excreted into human milk. Although oral absorption of low molecular weight heparins is unlikely, a risk to newborns/infants cannot be excluded.
In patients at risk, the incidence of venous thromboembolism is particularly high during the first 6 weeks after child birth.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from innohep therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
There are no clinical studies with innohep regarding fertility.
Tinzaparin has no or negligible influence on the ability to drive or use machines.
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