innohep Use In Pregnancy & Lactation

Anticoagulant treatment of pregnant women requires specialist involvement.
Data on a limited number (637) of exposed pregnancies indicate no additional risk of tinzaparin on pregnancy or on the health of the foetus/new-born child. To date, no other relevant epidemiological data are available. No transplacental passage was demonstrated in two clinical studies. Animal data do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing tinzaparin to pregnant women.
There are no data available concerning lactation.
Pregnant patients with prosthetic heart valves: Therapeutic failures have been reported in pregnant women with prosthetic heart valves on full anticoagulant doses of tinzaparin and other LMWHs. Tinzaparin is not recommended for use in pregnant women with prosthetic heart valves.
In the absence of clear dosing, efficacy and safety information in this circumstance, any attempt to anti-coagulate such patients must only be undertaken by medical practitioners with expertise and experience in this clinical area, and only if no safer alternative is available.
The use of Tinzaparin sodium (innohep) in women with abortus imminens is contraindicated.
An epidural anaesthesia during birth in pregnant women treated with LMW-heparin is contraindicated.
For vials only: Cases of "Gasping Syndrome" have occurred in premature infants when large amounts of benzyl alcohol have been administered (99-404 mg/Kg/day). Therefore the use of this formulation in newborns especially in preterm babies is contraindicated.
The 2 mL vial of Tinzaparin sodium (innohep) 20,000 IU/mL contains 20mg of benzyl alcohol (10mg of benzyl alcohol per mL). As benzyl alcohol may cross the placenta, the use of Tinzaparin sodium (innohep) formulations containing benzyl alcohol is not recommended during pregnancy.