Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Women of childbearing potential/contraception
DuoTrav must not be used in women of child-bearing age/potential unless adequate contraceptive measures are in place (see section 5.3).


Pregnancy
Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/newborn child.

There are no or limited amount of data from the use of DuoTrav or the individual components in pregnant women. Timolol should not be used during pregnancy unless clearly necessary.


Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta- blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If DuoTrav is administered until delivery, the neonate should be carefully monitored during the first days of life.


DuoTrav should not be used during pregnancy unless clearly necessary. For information on how to reduce systemic absorption, see section 4.2.

Breast-feeding
It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. Timolol is excreted in breast milk and has the potential to cause serious adverse reactions in the breast- fed infant. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. For information on how to reduce systemic absorption, see section 4.2.
The use of DuoTrav by breast-feeding women is not recommended.


DUO API DEC20 V3                                                                              EU SmPC Oct2020 Fertility
There are no data on the effects of DuoTrav on human fertility. Animal studies showed no effect of travoprost on fertility at doses up to 75 times the maximum recommended human ocular dose, whereas no relevant effect of timolol was noted at this dose level.