{"id":8598,"date":"2021-03-16T10:21:19","date_gmt":"2021-03-16T10:21:19","guid":{"rendered":"https:\/\/zeepedia.com\/?p=8598"},"modified":"2021-04-10T07:51:20","modified_gmt":"2021-04-10T07:51:20","slug":"fabrazyme","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/fabrazyme\/","title":{"rendered":"Fabrazyme &#8211; Agalsidas Beta uses, dose, and side effects"},"content":{"rendered":"\n<p> 5 mg&nbsp;powder for concentrate for&nbsp;solution&nbsp;for&nbsp;infusion.&nbsp;<br>agalsidas beta<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Fabrazyme is and what it is used for<\/h2>\n\n\n\n<p>Fabrazyme contains the active substance agalsidase beta and is used as enzyme replacement therapy in Fabry disease, where the enzyme activity of \u03b1-galactosidase is absent or lower than normal.&nbsp;If you suffer from Fabry&#8217;s disease, a fatty substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and instead accumulates in the blood vessel walls of your organs.<br><\/p>\n\n\n\n<p>Fabrazyme is intended as a long-term enzyme replacement therapy in patients with a diagnosis of Fabry disease.<br><\/p>\n\n\n\n<p>Fabrazyme is intended for adults, children, and adolescents 8 years of age and older.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before you use Fabrazyme<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Fabrazyme<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to agalsidase beta or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor or pharmacist before using Fabrazyme.<br><\/p>\n\n\n\n<p>If you are being treated with Fabrazyme, you may experience infusion-related reactions.&nbsp;An infusion-related reaction is a&nbsp;side effect&nbsp;that occurs during&nbsp;infusion&nbsp;one or until the end of the infusion day (see section 4).&nbsp;If you get such a reaction, you must&nbsp;<strong>contact a doctor immediately.&nbsp;<\/strong>You may need additional medicines to prevent such a reaction (eg&nbsp;antihistamines&nbsp;or&nbsp;paracetamol&nbsp;).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>No&nbsp;clinical studies&nbsp;have been performed in children 0 &#8211; 4 years of age.&nbsp;The risks and benefits of Fabrazyme in children aged 5 to 7 years have not yet been established and no&nbsp;dose&nbsp;can therefore be recommended for this age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Fabrazyme<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.&nbsp;<br>Tell your doctor if you are taking medicines containing chloroquine,&nbsp;amiodarone, benzoquinone, or gentamicin.&nbsp;There is a theoretical risk of reduced agalsidase beta activity<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>The use of Fabrazyme during pregnancy is not recommended.&nbsp;There is no experience with the use of Fabrazyme in pregnant women.&nbsp;Fabrazyme may be excreted in human milk.&nbsp;The use of Fabrazyme during breast-feeding is not recommended.&nbsp;Studies have not been performed to investigate the effect of Fabrazyme on&nbsp;fertility.<br><\/p>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Do not drive or use any tools or machines if you feel dizzy, sleepy, faint, or dizzy during or shortly after&nbsp;administering&nbsp;one of Fabrazyme (see section 4).&nbsp;Consult a doctor first.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Fabrazyme contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol&nbsp;sodium&nbsp;(23 mg) per&nbsp;vial, ie essentially &#8216;sodium-free&#8217;.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Fabrazyme<\/h2>\n\n\n\n<p>Fabrazyme is given by a drip into a vein (by&nbsp;intravenous&nbsp;infusion&nbsp;).&nbsp;It is supplied as a powder to be mixed with sterile water before administration (see Information for doctors and healthcare professionals at the end of this leaflet).&nbsp;<br>Always use this medicine exactly as your doctor has told you.&nbsp;Consult a doctor if you are unsure.<br><\/p>\n\n\n\n<p>Fabrazyme is only given under the supervision of a doctor who has experience in the treatment of Fabry&#8217;s disease.&nbsp;Your doctor may recommend that you be treated at home provided you meet certain criteria.&nbsp;Contact your doctor if you want to receive the treatment at home.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose of&nbsp;Fabrazyme for adults is 1 mg\/kg body weight, once every two weeks.&nbsp;No&nbsp;dose&nbsp;changes&nbsp;are necessary for patients with kidney disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Use for children and adolescents<\/h2>\n\n\n\n<p>The recommended&nbsp;dose of&nbsp;Fabrazyme for children and adolescents aged 8 to 16 years is 1 mg\/kg body weight, once every two weeks.&nbsp;No changes in&nbsp;dose&nbsp;one are necessary for patients with kidney disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Fabrazyme then you should&nbsp;<\/h2>\n\n\n\n<p>Doses&nbsp;of up to 3 mg\/kg body weight are harmless.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Fabrazyme<\/h2>\n\n\n\n<p>If you have missed an&nbsp;infusion&nbsp;of Fabrazyme, contact your doctor.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects,&nbsp;although not everybody gets them.<br><\/p>\n\n\n\n<p>In&nbsp;clinical trials,&nbsp;adverse reactions were&nbsp;observed mainly during or shortly thereafter, the patients received the medicine (&#8220;infusion-related reactions&#8221;).&nbsp;Severe life-threatening allergic reactions (&#8220;anaphylactic reactions&#8221;) have been reported in some patients.&nbsp;If you experience any serious&nbsp;side effects,&nbsp;talk&nbsp;to your&nbsp;<strong>doctor immediately.<\/strong><br><\/p>\n\n\n\n<p>Very common symptoms (may affect 1 in 10) include chills, fever, chills, nausea, vomiting, headache, and sensations in the skin such as burning or stinging sensation.&nbsp;Your doctor may decide to slow down the infusion rate or give you additional medicines to prevent such reactions from happening.<br><\/p>\n\n\n\n<p>List of other side effects:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>chest pain breathing difficultiespalloritchingabnormal tear secretionfeeling weaktinnitus&nbsp;(ringing in the ears)nasal congestiondiarrhearednessmuscle pain high&nbsp;blood pressure sudden swelling of the face or throat edema&nbsp;(swelling) in arms and legs feeling dizzy stomach upset muscle cramps<\/td><td>somnolence increased heart rate abdominal pain back pain as low heart rate extreme fatiguefainting attackscoughdiscomfort in the abdomen swollen face joint pain lowered&nbsp;blood pressure chest discomfortfacial edema aggravated difficulty in breathing muscle tension<\/td><td>fatigue flare&nbsp;rednesspainfeeling of tightness in the throatdizzinesspalpitationdecreased pain sensitivityburning sensationalizing breathinghivespain in arms and less inflammation&nbsp;of the nose and throat heatwave feeling of warmthhyperthermiaincreased sensitivity in the mouthmusculoskeletal stiffness<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>tremorRed eyewear pain sore throat rapid breathingitchy rash feeling of heat and cold difficulty swallowing pain at the infusion site reaction at the infusion site<\/td><td>itching&nbsp;in the eyes swollen ears bronchospasm&nbsp;(spasm of the trachea)Runny nose heartburn discomfort from the skinmusculoskeletal painrhinitis&nbsp;(&nbsp;inflammation of the nose)flu-like illness general malaise<\/td><td>low heart rate due to disturbances in the heart&#8217;s conduction system increased pain sensitivityblocked upper respiratory tract rash(mottled bluish-red) skin discoloration could arm and less blood clotting at the injection site skin discoloration edema&nbsp;(swelling)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>decreased oxygen level in the blood<\/td><td>severe&nbsp;inflammation of the blood vessels<\/td><td>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>For some patients who started treatment with the recommended&nbsp;dose&nbsp;and who then received a&nbsp;reduced&nbsp;dose&nbsp;for a longer period of time, some symptoms of Fabry&#8217;s disease were reported more frequently.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Fabrazyme<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the label after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p><em><strong>Unopened bottles<\/strong><\/em>&nbsp;<br>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C)<br><\/p>\n\n\n\n<p><em><strong>Prepared and diluted solutions<\/strong><\/em>&nbsp;<br>The reconstituted solution cannot be stored but must be diluted immediately.&nbsp;The diluted solution can be stored for up to 24 hours at 2 \u00b0 C -8 \u00b0 C.<br><\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is agalsidase beta, one bottle contains 5 mg.<\/li><li>The other ingredients are:<ul><li>Mannitol<\/li><li>Sodium hydrogen phosphate monohydrate<\/li><li>Sodium dihydrogen phosphate heptahydrate<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Fabrazyme is supplied as a white to off-white powder.&nbsp;After dilution, it is a clear, colorless liquid, free from foreign particles.&nbsp;The reconstituted solution must be further diluted.&nbsp;<br>Pack sizes: 1, 5, and 10 bottles per carton.&nbsp;Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorization Holder<\/strong>&nbsp;<br>Genzyme Europe BV, Paasheuvelweg 25, 1105 BC Amsterdam, The Netherlands.<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Genzyme Ireland Limited IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland<br><\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<br><\/p>\n\n\n\n<p>Sanofi AB<\/p>\n\n\n\n<p>Tel: +46 (0) 8 634 50 00<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>5 mg powder for concentrate for solution for infusion.<br \/>\nagalsidas beta<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2206,2200],"tags":[3216,3218,3219,3217,3220,3222,3223,3221,2212,2328],"class_list":["post-8598","post","type-post","status-publish","format-standard","hentry","category-f","category-medicines","tag-agalsidas-beta","tag-agalsidas-beta-dose","tag-agalsidas-beta-side-effects","tag-agalsidas-beta-uses","tag-fabrazyme","tag-fabrazyme-dose","tag-fabrazyme-side-effects","tag-fabrazyme-uses","tag-medicine","tag-powder"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8598","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=8598"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8598\/revisions"}],"predecessor-version":[{"id":9845,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8598\/revisions\/9845"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8598"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8598"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8598"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}