Sanofi-Aventis Releases New Ferrlecit Formulation

By Keith Chartier Comments

BRIDGEWATER, N.J.—In response to customer feedback, sanofi-aventis has started to sell its iron drug Ferrlecit in a new vial formulation, which is replacing the older ampule version in order to avoid and potential safety issues.

Ferrlecit has been used for more than 10 years to treat iron deficiency anemia in both children (6 years and above) and adults undergoing chronic hemodialysis who are receiving epoetin. The drug had previously been distributed in ampules that were entirely made of glass. There was a line at top of the pencil-like glass container where it would be broken in order to access the product.

Ferrlecit Ampule

“Based on feedback from the customers, it had the potential to cause cuts when the vial was broken open for use,” said Bhavesh Ashar, associate vice president, Sales & Marketing, Injectables, sanofi-aventis. “You could have avoided the risk of cuts with an ampule breaker, and as a safety precaution, most clinics used a filtered needle when they removed the product from the ampule itself to avoid the potential of any small glass pieces getting into the product.”

A filter within that particular needle removes any pieces of glass as the product is withdrawn from the ampule into the syringe through the needle.

“Based on the feedback, we decided to bring about this new formulation,” said Ashar, who leads the development and implementation of strategic and operational plans for the sanofi-aventis Injectables portfolio.  “It’s the same product inside the glass, but it includes a vial cover so it’s easier to insert the needle into the top where there is rubber tubing. There is no risk of healthcare professionals getting cut, and there is no need for a filtered needle.”

Ferrlecit Vial

The new packaging has a metal ring at the top, and inside is rubber tubing where healthcare workers can push the needle through the rubber tubing to get to the product.  “It’s the same product, and it’s used exactly the same way,” Ashar said. “It’s more of a packing change in response to customer feedback.”

Ashar said the new Ferrlecit packaging costs sanofi-aventis a bit more to make, but he added that the pharmaceutical company will not be passing that cost down to the customer. “We are keeping the price the same as the ampule,” he said. “In fact, customers might see a slight decrease in costs because they don’t need the filtered needle anymore. They can just use an ordinary needle. So there is a slight benefit to them. It’s marginal, but there is some savings there.”

The new formulation was approved earlier this year and is commercially available now for all clinics to order through their regular distributors.

Ferrlecit had previously been distributed in the United States by Watson Pharmaceuticals. However, the supply and distribution agreement ended in late 2009, and sanofi-aventis, the iron drug’s manufacturer, started distributing the drug in 2010.

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