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Elelyso Safe for Use While Breastfeeding, Case Study Finds

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Wednesday, February 20, 2019

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Elelyso (taliglucerase alfa) is safe for use by breastfeeding women with Gaucher disease, not representing a risk to the child, a case report shows. Researchers recommend this treatment can be given to women who are breastfeeding an infant, along with calcium supplements.

Their letter detailing the case report, "Breastfeeding in patients with Gaucher disease: Is taliglucerase alfa safe?," was published in the journal Molecular Genetics and Metabolism Reports. It complements an earlier report showing that Cerezyme (imiglucerase, by Sanofi Genzyme) is also safe while breastfeeding.

In Gaucher disease patients, the glucocerebrosidase enzyme is faulty due to mutations in its gene. This enzyme is responsible for breaking down glucocerebroside — a special fat molecule — so that the molecule accumulates in patients, particularly in their liver, spleen, bone marrow, and nervous system.

Treatment normally consists of enzyme replacement therapy, which delivers healthy copies of glucocerebrosidase to patients to reduce the amount of glucocerebroside in tissues.

Pfizer's Elelyso, a kind of glucocerebrosidase made from plant cells, is one such therapy and approved to treat adults with type 1 disease, as well as pediatric patients in the U.S., Canada, and Australia.

Two other similar treatments are also approved for the condition, including Cerezyme (imiglucerase), produced in animal cells, and VPRIV (velaglucerase alfa, by Shire), produced in human cells.

Although all are effective, whether women can safely use these medications while breastfeeding, without posing a risk to a child, was not certain.

In an earlier report, researchers in Brazil showed that glucocerebrosidase is excreted in the milk. Treatment with Cerezyme did not increase glucocerebrosidase levels in the milk, indicating the treatment was safe.

Now, they report that Elelyso treatment is also safe during breastfeeding.

The treatment was administered to a 20-year-old women with Gaucher type 1, who found that she was pregnant after the seventh Elelyso infusion. Doctors decided to continue with the therapy because no recommendations existed against continuation.

The pregnancy went without complications, and a healthy boy was born full term.

She then started exclusively breastfeeding, which was maintained for 10 months. During this period, she took calcium supplements and continued to receive regular infusions of Elelyso.

Similar to Cerezyme, Elelyso treatment did not increase the levels of glucocerebrosidase in the milk, with its levels being lower than what is normally seen in healthy breastfeeding women, the report said.

This finding suggests once more that "the levels of recombinant enzymes excreted in human breast milk is very low," the researchers wrote.

"We believe that [Elelyso] should not be contraindicated to women with Gaucher disease during breastfeeding. Actually, we advocate that ERT should be indicated to these women, together with calcium supplementation, since it is a period in which the need for calcium and the bone remodeling increases," they concluded.

Source: Pfizer
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