RimabotulinumtoxinB Pregnancy and Breastfeeding Warnings
Brand names: Myobloc
Medically reviewed by Drugs.com. Last updated on Jul 19, 2023.
RimabotulinumtoxinB Pregnancy Warnings
IM administration to rats and rabbits throughout gestation showed no adverse effects on embryofetal development. It is not known if this drug can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. There are no controlled data in human pregnancy.
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 unless clearly needed
US FDA pregnancy category: Not assigned
Risk Summary: There are no adequate data on the developmental risks associated with use in pregnant women; development toxicity was not observed in animal studies.
RimabotulinumtoxinB Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
No data exists on the medical use of this drug during breastfeeding. Medical use is not expected to produce measurable blood levels and therefore it would not be expected to be available for secretion into breast milk.
There is a report of a mother who contracted botulism and successfully breastfed her infant. On admission to the hospital, type A botulinum toxin was detected in her blood and stools; none was detected in the infant's stools. The mother was treated with 2 vials of trivalent botulism antitoxin (IV and IM). A milk sample obtained 4 hours after administration of the antitoxin had no detectable botulinum toxin or botulism organisms.
See also
References for pregnancy information
- Product Information. Myobloc (rimabotulinumtoxinB). Elan Pharmaceuticals. PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
References for breastfeeding information
- Product Information. Myobloc (rimabotulinumtoxinB). Elan Pharmaceuticals. PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
