First Prescription Medicine Certified Kosher by the Orthodox Union Available for Treatment of Rare Disease
Prescription Medicine Certified Kosher by the Orthodox Union Available for Treatment of Rare Disease
(BPT) – The word “kosher” is typically associated with food products. However, Pfizer Inc. has taken the next step to include prescription medicine by certifying their product, ELELYSO™ (taliglucerase alfa) for injection, an enzyme replacement therapy for adults with Type 1 Gaucher disease. The Orthodox Union (OU), the world’s most recognized and trusted kosher certification body, certified ELELYSO, as part of their efforts to support the interests of the global Jewish community.
Gaucher disease is an inherited lysosomal storage disorder, which can cause severe and debilitating symptoms and affects an estimated 10,000 patients worldwide.1,2 Type 1 Gaucher disease, which is the most common type,1 is seen in higher numbers in people of Ashkenazi Jewish heritage.3 In fact, Type 1 Gaucher disease is present in approximately 1 in 600 people of Ashkenazi Jewish ancestry, and approximately 1 in 14 Ashkenazi Jews is a carrier.4,5
Gaucher disease occurs when there is an abnormal gene, causing low levels of a particular enzyme to be produced.1 This enzyme is responsible for breaking down fatty substances, or lipids, from cells. A lack of this enzyme will cause the cells to become enlarged, called Gaucher cells.1 Gaucher cells commonly affect the spleen, liver and bone marrow.1
“Rare diseases, like Gaucher disease, can have a significant impact on both patients and their families. This certification reflects Pfizer’s commitment to all patients suffering from Type 1 Gaucher disease,” said Rory O’Connor, Senior Vice President, Head of Global Medical Affairs, Innovative Pharma Business. “We appreciate the Orthodox Union working extensively with our partners at Protalix to confirm that the ingredients and manufacturing process for ELELYSO pass strict kosher regulations.”
ELELYSO is the first prescription medication to be awarded a kosher certification by the Orthodox Union, and is made in Israel with innovative technology using carrot cells to grow the inefficient enzyme. ELELYSO was approved by the U.S. Food and Drug Administration in May 2012 as treatment option for adults with Type 1 Gaucher disease.
For more information, visit www.ELELYSO.com.
ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease.
IMPORTANT SAFETY INFORMATION
As with any intravenous protein medicine, like enzyme replacement therapy (ERT), severe allergic reactions (including anaphylaxis) have been observed in patients treated with ELELYSO. If this occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated. Patients who have experienced anaphylaxis to ELELYSO or another ERT should proceed with caution upon retreatment.
In addition, infusion reactions (including allergic reactions)—defined as a reaction occurring within 24 hours of the infusion—were the most commonly observed reactions to ELELYSO™ (taliglucerase alfa) for injection. The most commonly observed infusion reactions were headache, chest pain or discomfort, weakness, fatigue, hives, abnormal redness of the skin, increased blood pressure, back or joint pain, and flushing. Other infusion or allergic reactions included swelling of the face, mouth, and/or throat; wheezing; shortness of breath; skin color turning blue; coughing; and low blood pressure. Most of these reactions were mild and did not require treatment.
Management of infusion reactions is based on the type and severity of the reaction. Your doctor may manage infusion reactions by temporarily stopping the infusion, slowing the infusion rate, or treating with medications such as an antihistamine and/or a fever reducer. Treatment with antihistamines and/or corticosteroids prior to infusion with ELELYSO may prevent these reactions.
Other common adverse reactions observed were upper respiratory tract infections, throat infection, flu, urinary tract infection, and pain in extremities.
As with all therapeutic proteins, including ERTs, there is a possibility of developing antibodies to ELELYSO. 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 ELELYSO should continue to be monitored for antibodies. Comparison of the frequency of antibodies across ERTs may be misleading. Patients who have developed infusion or immune reactions with ELELYSO or with another ERT should be monitored for antidrug antibodies when being treated with ELELYSO.
If you are pregnant, or plan to become pregnant, you should talk to your doctor about potential benefits and risks.
You are encouraged to report negative side effect of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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1 Jmoudiak M. Gaucher disease: pathological mechanisms and modern management. Br J Haematol. 2005; 129(2):178-188. Retrieved from: http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2004.05351.x/pdf. Accessed March 24, 2014.
2 Zeller JL. Gaucher disease. JAMA. 2007; 298:11. Accessed March 24, 2014.
3 Mistry, P, et al. Consequences of diagnostic delays in type 1 Gaucher disease: The need for greater awareness among hematologists-oncologists and an opportunity for early diagnosis and intervention. Am J Hematol. 2007; 82:697-701.
4 Cox TM, Aerts JMFG, Belmatoug N, et al. Management of non-neuropathic Gaucher disease with special reference to pregnancy, splenectomy, bisphosphonate therapy, use of biomarkers and bone disease monitoring. J Inherit Metab Dis. 2008; 31:319-336.
5 Kannai R, Chertox IR. Prenatal panel screening for non-neuronopathic Gaucher disease in the Ashkenazi-Jewish population. IMAJ. 2006; 8:347-350.