Tapcom/Tapcom-S Use In Pregnancy & Lactation

Tapcom: This product should be used for pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits are judged to outweigh the possible risks associated with the treatment. [The safety of this product for use during pregnancy has not been established. In animal studies, when Tafluprost solution was administered intravenously to pregnant rats at a dose of 30 mcg/kg/day (2000 times the clinical dose*), teratogenicity and post-implantation embryonic mortality rate increased; at 10 mcg/kg/day (about 670 times the clinical dose*) adverse effects on fetal development (low body weight and unossification of breast bone in fetuses) was observed. In intravenous administration in pregnant rabbits at 0.1 mcg/kg/day (about 6.7 times the clinical dose*), the miscarriage and mortality rate after implantation increased, and luteal body and implantation decreased; at 0.03 mcg/kg/day (2 times the clinical dose*) teratogenicity was observed. In an intravenous administration study in pregnant and lactating rats at a dose level of 1 mcg/kg/day (about 67 times the clinical dose*), mal-nursing of dams was observed and the 4-day survival rate of new born baby decreased. On the other hand, in the study using uteri isolated from rats, uterine contraction was observed at about 3.3 times the plasma concentration of Tafluprost (less than 30 pg/mL), or about 420 times the plasma concentration of unbound Tafluprost (less than 0.24 pg/mL), calculated based on the protein binding ratio, estimated after ocular administration of the clinical dosage.]
*Dosage (0.015 mcg/kg/day) when one drop (30 mcL) of tafluprost ophthalmic solution 0.0015% is instilled into both eyes at a time for a 60 kg patient.
Avoid administration to nursing mothers. If administration is judged to be essential, the patients should be instructed to stop breast-feeding during the treatment. [A study in rats has shown excretion of Tafluprost in breast milk after ocular instillation in rats. Timolol maleate may be excreted in human breast milk.]
Tapcom-S: Use in Pregnancy: There are no or limited amount of data from the use of TAPCOM-S in pregnant women.
Women of childbearing potential have to use effective contraception during TAPCOM-S treatment.
TAPCOM-S should not be used during pregnancy unless clearly necessary (in case no other treatment options are available).
Tafluprost: There are no adequate data for the use of Tafluprost in pregnant women. Tafluprost can have harmful pharmacologic effects on pregnancy and/or the fetus/newborn child. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Timolol: There are no adequate data for the use of Timolol in pregnant women. Timolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see Dosage & Administration.
Epidemiological studies have not revealed malformative effects but show a risk for intra uterine 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 TAPCOM-S is administered until delivery, the neonate should be carefully monitored during the first days of life.
Use in Lactation: Beta-blockers are excreted in breast milk. 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. To reduce the systemic absorption, see Dosage & Administration.
It is unknown whether Tafluprost and/or its metabolites are excreted in human milk. Available toxicological data in animals have shown excretion of Tafluprost and/or its metabolites in milk.
However, at therapeutic doses of Tafluprost in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms in the infant.
As a precautionary measure lactation is not recommended if treatment with TAPCOM-S is required.
Fertility: There are no data on the effects of TAPCOM-S on human fertility.