Hemabate

Hemabate does not directly affect the fetoplacental unit. The possibility that the previable fetus aborted by Hemabate could exhibit transient life signs. Hemabate is not indicated if the fetus in utero has reached the stage of viability. Hemabate should not be considered a feticidal agent.

This product contains benzyl alcohol. Benzyl alcohol may be associated with a fatal "Gasping Syndrome" in premature infants.

General

• Animal studies at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone.
• These effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment.
• No evidence that short term use of Hemabate can cause similar bone effects.
• Use Hemabate cautiously in patients with a history of asthma, hypo- or hypertension, cardiovascular, renal, or hepatic disease, anemia, jaundice, diabetes, epilepsy, or in those with compromised (scarred) uteri.

Abortion

• Abortion induced by Hemabate may be expected to be incomplete in about 20% of cases.
• Always examine the cervix carefully and immediately post-abortion for possible cervical trauma.
• Use of Hemabate is associated with transient pyrexia that may be due to its effect on hypothalamic thermoregulation.
• Temperature elevations >2° F (1.1° C) were seen in approximately 1/8th of the patients who were given the recommended dosage regimen; however, returned to normal after therapy completion.

Postpartum Hemorrhage

• Increased blood pressure.
  • In the postpartum hemorrhage series, 5/115 (4%) of patients had an increase of blood pressure reported as a side effect.
  • The degree of hypertension was moderate and it is not certain as to whether this was in fact due to a direct effect of Hemabate or a return to a status of pregnancy associated hypertension manifest by the correction of hypovolemic shock.
  • Cases reported did not require specific therapy for the elevated blood pressure.
• Caution in those with chorioamnionitis.
  • In clinical trials with Hemabate, chorioamnionitis was identified as a complication contributing to postpartum uterine atony and hemorrhage in 8/115 (7%) of cases, 3 of which failed to respond to Hemabate.
  • This complication during labor may have an inhibitory effect on the uterine response to Hemabate similar to what has been reported for other oxytocic agents.