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Ixazomib Pregnancy and Breastfeeding Warnings

Ixazomib is also known as: Ninlaro

Medically reviewed on Dec 8, 2016

Ixazomib Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Females of reproductive potential should be advised to avoid becoming pregnant while being treated with this drug.
-Male and female patients of reproductive potential should use effective contraceptive measures during and for 90 days following therapy with this drug.
-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 hazard to the fetus.
-When this drug is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP450 3A4 as well as other enzymes and transporters, the risk for reduced efficacy of oral contraceptives should to be considered; therefore, women using oral hormonal contraceptives should also use a barrier method of contraception.

This drug caused embryofetal toxicity in animal studies at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose. 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.

See references

Ixazomib Breastfeeding Warnings

No information is available on the use of this drug during breastfeeding. Because its half-life is about 9.5 days, it is likely to accumulate in the infant. It is also given in combination with leflunomide and dexamethasone, which may increase the risk to the infant.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No data are available regarding the presence of this drug or its metabolites in human milk, the effects on the breast fed infant, or the effects on milk production.
-Nursing women should be advised not to breastfeed during therapy with this drug and for 90 days after the last dose.

See references

References for pregnancy information

  1. "Product Information. Ninlaro (ixazomib)." Takeda Pharmaceuticals America, Lincolnshire, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Ninlaro (ixazomib)." Takeda Pharmaceuticals America, Lincolnshire, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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