Lemtrada

Question 1

What is the risk of using LEMTRADA in pregnant women?

Accepted Answer

There are no adequate data on the developmental risk associated with the use of LEMTRADA in pregnant women. LEMTRADA was embryolethal in pregnant huCD52 transgenic mice when administered during organogenesis. Auto-antibodies may develop after administration of LEMTRADA. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves’ disease has been reported.

Question 2

What is the background risk of birth defects and miscarriage with LEMTRADA?

Accepted Answer

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Question 3

Is there a pregnancy surveillance program for LEMTRADA?

Accepted Answer

Yes, there is a pregnancy surveillance program for LEMTRADA. If LEMTRADA exposure occurs during pregnancy, healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2.

Question 4

What are the clinical considerations for pregnant women using LEMTRADA?

Accepted Answer

LEMTRADA induces persistent thyroid disorders. Untreated hypothyroidism in pregnant women increases the risk for miscarriage and may have effects on the fetus including mental retardation and dwarfism. In mothers with Graves’ disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing fetus and can cause neonatal Graves’ disease.

Question 5

Is alemtuzumab present in human milk?

Accepted Answer

There are no data on the presence of alemtuzumab in human milk, but alemtuzumab was detected in the milk of lactating huCD52 transgenic mice administered LEMTRADA.

Question 6

What are the developmental and health benefits of breastfeeding when using LEMTRADA?

Accepted Answer

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEMTRADA and any potential adverse effects on the breastfed child from LEMTRADA or from the underlying maternal conditions.

Question 7

Is LEMTRADA safe and effective for pediatric patients?

Accepted Answer

No, safety and effectiveness of LEMTRADA have not been established in pediatric patients under the age of 17. Due to the risks of autoimmunity, infusion reactions, stroke, and increased risk of malignancies (thyroid, melanoma, lymphoproliferative disorders, and lymphoma), the use of LEMTRADA is not recommended in pediatric patients. Please see Warnings and Precautions (5.1, 5.2, 5.3, 5.4) for more information.

Question 8

Is LEMTRADA safe and effective for geriatric patients?

Accepted Answer

There is not enough clinical data to determine if LEMTRADA is safe and effective for patients aged 65 and over. Further studies are needed to evaluate whether geriatric patients respond differently than younger patients.