Skip to Content
Reach blood sugar goals with long-acting insulin. Go >

Insulin inhalation, rapid acting Pregnancy and Breastfeeding Warnings

Insulin inhalation, rapid acting is also known as: Afrezza, Exubera

Insulin inhalation, rapid acting Pregnancy Warnings

Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. The estimated background risk of major birth defects in women with pre-gestational diabetes and a HbA1c less than 7% is 6% to 10% compared with 20% to 25% in women with a HbA1c greater than 10%. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. During pregnancy, insulin requirements may decrease during the first trimester; increase during the second and third trimesters, and rapidly decline after delivery. In pregnant rats receiving carrier particle (vehicle without insulin) subcutaneously at doses of 10, 30, and 100 mg/kg/day (14 to 21 times the expected human exposure) from gestation day 6 through 17 (organogenesis), no major malformations were observed. Pregnant rats given carrier particle subcutaneously at doses of 10, 30, and 100 mg/kg/day from gestation day 7 through lactation day 20, showed decreased epididymis and testes weight with no decrease in fertility and rat pups receiving 30 mg/kg/day or more (6 times expected human exposure) showed impaired learning. Pregnant rabbits receiving carrier particles subcutaneously at doses of 2, 10, and 100 mg/kg/day during organogenesis showed adverse maternal effects at all dose groups. 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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus US FDA pregnancy category: Not assigned Risk Summary: Insufficient to determine drug-associated risks due to limited data in pregnant women Comments: -Due to adverse effects with carrier particles (vehicle) in some animal studies, questions remain regarding the safety of carrier particles during pregnancy. -For women who are pregnant, and for women who are contemplating pregnancy, intensified blood glucose control and close monitoring of blood glucose is essential.

See references

Insulin inhalation, rapid acting Breastfeeding Warnings

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential risks on the breastfed infant Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: In rats, approximately 10% of the inhaled insulin carrier is excreted in milk; therefore it is highly likely that inhaled insulin is excreted in human milk.

Studies have not been done specifically looking at the presence of oral inhaled insulin in human milk, the effect on the breastfed infant, or effects on milk production. Carrier particles (vehicle) have been found in rat milk. Potential adverse effects related to inhalation administration of insulin are unlikely to be associated with exposure in breastmilk.

See references

References for pregnancy information

  1. "Product Information. Afrezza (insulin inhalation, rapid acting)." MannKind Corporation, Valencia, CA.

References for breastfeeding information

  1. "Product Information. Afrezza (insulin inhalation, rapid acting)." MannKind Corporation, Valencia, CA.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide