Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of miltefosine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Impavido is contraindicated in pregnancy (see section 4.3). Women of childbearing age have to use effective contraception during and up to 5 months after treatment.
Vomiting and diarrhea are very common side effects of therapy with Impavido and can compromise the efficacy of oral contraception. The patient must be informed by her physician accordingly. If necessary, suitable alternative methods of contraception must be used.
During pregnancy, visceral leishmaniasis may be life-threatening for the mother and may result in adverse fetal outcomes, including spontaneous abortion, congenital disease due to vertical transmission, small for gestational age newborn, and severe anemia. During pregnancy, cutaneous leishmaniasis may manifest with larger and 
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atypical appearing lesions and may be associated with increased risk for adverse fetal outcomes, including preterm births and stillbirths.

The patient has to be advised to immediately contact her physician for pregnancy testing as soon as there is any suspicion of pregnancy. If the test is positive, the physician and patient must discuss the risks associated with this pregnancy.

Breast Feeding
It is not known whether miltefosine is excreted in the milk. Impavido must not be used during lactation; Breastfeeding should be avoided for 5 months after Impavido therapy.

Fertility
Studies in rats revealed testicular atrophies and an impairment of fertility after the treatment with miltefosine. These results were reversible after a recovery period of 10 weeks. Data with regard to the impact of miltefosine to the fertility in men are not available.

Advise women and men of the animal fertility findings, and that the potential for impaired fertility with Impavido therapy has not been adequately evaluated.