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UPLYSO(TM) (alfataliglicerase) Approved In Brazil By ANVISA For The Treatment Of Gaucher Disease

On November 30, 2009, Protalix entered into an agreement with Pfizer to develop and commercialize taliglucerase alfa/alfataliglicerase. Under the terms of the agreement, Protalix retained the exclusive commercialization rights in Israel, while Pfizer received exclusive licensing rights for commercialization in all other markets.

Indication for UPLYSO in Brazil

UPLYSO (alfataliglicerase) is indicated for long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease. The manifestations of Gaucher disease may include one or more of the following: splenomegaly, hepatomegaly, anemia, thrombocytopenia, bone disease.

Important Safety Information for UPLYSO in Brazil

As with any intravenous protein medicine, like enzyme replacement therapy (ERT), UPLYSO may cause infusion-related reactions (i.e., occurring during or shortly after infusion) and hypersensitivity reactions. If a severe allergic reaction occurs, immediate discontinuation of the alfataliglicerase infusion is recommended. Patients who experience reactions of hypersensitivity or related to the infusion, can however be managed successfully. The therapy can be continued by slowing the infusion rate, treating with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with decreased infusion rate. Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions.

The most commonly observed infusion reactions were headache, hypersensitivity (allergic reaction), dizziness, flushing (redness), throat irritation, nausea (qualm), pruritus (itch), erythema (redness), rash, bone pain, back pain, arthralgia (joint pain), among others.

Also, there is a possibility of developing antibodies to UPLYSO. However, it is currently unclear whether this has an impact on the clinical response or adverse reactions. Patients with an immune response to other ERTs who are switching to UPLYSO should continue to be monitored for antibodies. Patients who have developed infusion or immune reactions with UPLYSO or with another ERT should be monitored for antidrug antibodies when being treated with UPLYSO.

If you are pregnant, or plan to become pregnant, you should talk to your doctor about potential benefits and risks.

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