Lorbrena Pregnancy Warnings
Animal studies have revealed evidence of malformations (e.g., gastroschisis, rotated limbs, supernumerary digits, vessel abnormalities), increased post-implantation loss, decreased fetal body weight, and abortion at maternal exposures that were equal to or less than the human exposure at the recommended dose. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
Use is not recommended.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal studies and its mechanism of action this drug can cause embryofetal harm when administered to a pregnant woman.
Comments:
-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise female patients of reproductive potential to use nonhormonal contraception during therapy and for at least 6 months after because this drug can render hormonal contraceptives ineffective.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 3 months after.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-This drug may impair male fertility.
See references
