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Canagliflozin / metformin Pregnancy and Breastfeeding Warnings

Canagliflozin / metformin is also known as: Invokamet, Invokamet XR

Medically reviewed on Aug 30, 2018

Canagliflozin / metformin Pregnancy Warnings

Co-administration of canagliflozin and metformin in animals demonstrated that neither was embryolethal nor teratogenic, but minor skeletal abnormalities (delayed-ossification) in fetuses; however, in animal studies, canagliflozin exposure during periods of animal development corresponding to the late second and third trimesters of human development showed increased kidney weights and renal pelvic and tubular dilation at doses expected during human exposure. There are no adequate and well-controlled studies in pregnant women.

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.

Not recommended during the second and third trimester

US FDA pregnancy category: Not Assigned

Risk Summary: Based on animal data, there are potential risks to the fetus during the second and third trimester.

Comments:
-There are risk to mother and fetus associated with poorly controlled diabetes in pregnancy.

See references

Canagliflozin / metformin Breastfeeding Warnings

Not recommended

Excreted into human milk: Unknown (canagliflozin); Yes, in small amounts (metformin)
Excreted into animal milk: Yes (canagliflozin, metformin)

Comments:
-Because of the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended while taking this drug.

Upon administering radiolabeled canagliflozin to lactating rats, a milk to plasma ratio of 1.4 was found indicating that canagliflozin may be transferred into milk at a concentration comparable to that in plasma. Since human kidney maturation occurs in utero and during the first 2 years of life (when lactational exposure may occur), there may be a risk to the developing human kidney. A risk to the developing rat kidney (renal pelvic and tubular dilations) was observed when juvenile rats were exposed to canagliflozin during maturation.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Invokamet (canagliflozin-metFORMIN)." Janssen Pharmaceuticals, Titusville, NJ.

References for breastfeeding information

  1. "Product Information. Invokamet (canagliflozin-metFORMIN)." Janssen Pharmaceuticals, Titusville, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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