{"id":21967,"date":"2022-06-15T07:34:01","date_gmt":"2022-06-15T07:34:01","guid":{"rendered":"https:\/\/zeepedia.com\/?p=21967"},"modified":"2022-06-15T10:48:56","modified_gmt":"2022-06-15T10:48:56","slug":"replagal","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/replagal\/","title":{"rendered":"Replagal &#8211; Agalsidas alfa uses, dose and side effects"},"content":{"rendered":"\n<p>1 mg \/ ml&nbsp;concentrate for solution for&nbsp;infusion&nbsp;.<br>agalsidas alfa<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Replagal is and what it is used for<\/h2>\n\n\n\n<p>The active substance in Replagal is agalsidase alfa (1 mg\/ml).\u00a0An agalsidase alfa is a form of the\u00a0enzyme\u00a0\u03b1-galactosidase found in humans.\u00a0It has been made by activating the \u03b1-galactosidase A gene in cells.\u00a0The enzyme\u00a0is then removed from the cells and converted to a sterile concentrate for solution for\u00a0infusion.<\/p>\n\n\n\n<p>Replagal is used to treat both adult patients and adolescents and children from the age of 7 with a confirmed diagnosis of Fabry&#8217;s disease.&nbsp;It is used as a long-term enzyme replacement therapy when the&nbsp;enzyme&nbsp;is missing in the body or its level is lower than normal, which is the case with Fabry&#8217;s disease.<\/p>\n\n\n\n<p>After 6 months of treatment, Replagal&nbsp;significantly&nbsp;reduced patients&#8217; pain compared to placebo-treated patients.&nbsp;Replagal decreased left ventricular mass in treated patients compared with placebo-treated patients.&nbsp;These results indicate that the disease symptoms improve or that the disease becomes stable.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you get Replagal<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">You must not be given Replagal<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to agalsidase alfa 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 Replagal.<\/p>\n\n\n\n<p>If you notice any of these effects during or after an\u00a0infusion, tell your doctor immediately:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>high fever, chills, sweating, fast heart rate<\/li><li>vomiting<\/li><li>feeling drunk<\/li><li>hives<\/li><li>swollen hands, feet, ankles, face, lips, mouth, or throat that may make it difficult to swallow or breathe<\/li><\/ul>\n\n\n\n<p>Your doctor may temporarily stop the&nbsp;infusion&nbsp;(5-10 minutes) until the symptoms go away and then start the&nbsp;infusion&nbsp;again.<\/p>\n\n\n\n<p>Your doctor may also treat the symptoms with other medicines (&nbsp;antihistamines&nbsp;or&nbsp;corticosteroids&nbsp;).&nbsp;For the most part, you can continue with Replagal even if these symptoms occur.<\/p>\n\n\n\n<p>If you get severe allergic reactions (anaphylactic reactions), the&nbsp;administration&nbsp;of one of Replagal must be stopped immediately and appropriate treatment initiated by your doctor.<\/p>\n\n\n\n<p>If treatment with Replagal causes your body to make\u00a0antibodies, this will not stop the action of Replagal and the\u00a0antibodies\u00a0may disappear over time.<\/p>\n\n\n\n<p>If you have advanced kidney disease, you may notice that Replagal treatment may affect your kidneys to a limited extent.&nbsp;Talk to your doctor or pharmacist before using Replagal.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children<\/h2>\n\n\n\n<p>The experience for children aged 0-6 years is limited, and therefore no&nbsp;dosage&nbsp;can be recommended for this age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Replagal<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>Tell your doctor if you are taking any medicines that contain chloroquine,\u00a0amiodarone, booking, or gentamicin.\u00a0There is a theoretical risk of decreased alpha activity of agalsida.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Very limited clinical data on pregnancies in which Replagal has been exposed have not shown any\u00a0adverse effects\u00a0on the mother or the newborn.<\/p>\n\n\n\n<p>If you are pregnant or breastfeeding, 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>You can drive and use machines during treatment with Replagal.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Replagal contains sodium<\/h2>\n\n\n\n<p>This medicine contains 14.2 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per\u00a0vial.\u00a0This corresponds to 0.7% of the highest recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n<p><strong>Documentation<\/strong><\/p>\n\n\n\n<p>To facilitate the traceability of biological drugs, the name and manufacturing batch number of the drug must be documented by your healthcare provider.&nbsp;Talk to your healthcare provider if you are unsure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to get Replagal<\/h2>\n\n\n\n<p>This medicine should be administered and supervised by staff with&nbsp;adequate&nbsp;training, who will also calculate the&nbsp;dose&nbsp;you should receive.<\/p>\n\n\n\n<p>The recommended\u00a0dose\u00a0for\u00a0infusion\u00a0is 0.2 mg\/kg body weight.\u00a0This means about 14 mg or 4 vials of Replagal for a person with average body weight (70 kg).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Use for children and adolescents<\/h2>\n\n\n\n<p>For children and adolescents aged 7-18 years, a\u00a0dose\u00a0of 0.2 mg\/kg every two weeks can be used.<\/p>\n\n\n\n<p>Children and adolescents may be more likely to have an infusion-related reaction than adults.\u00a0Tell your doctor if you get any\u00a0side effects\u00a0while you are receiving\u00a0an infusion.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Method of administration<\/h2>\n\n\n\n<p>Replagal must be diluted with\u00a0sterile\u00a09 mg\/ml (0.9%) sodium chloride solution before use.\u00a0After dilution, Replagal is given into a vein.\u00a0This happens mostly in the arm.<\/p>\n\n\n\n<p>The infusions&nbsp;are given every two weeks.<\/p>\n\n\n\n<p>At each treatment, one&nbsp;infusion&nbsp;of Replagal takes at least 40 minutes.&nbsp;Your treatment is monitored by a doctor who specializes in treating Fabry&#8217;s disease.<\/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\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>If you get a severe&nbsp;allergic reaction&nbsp;(of the anaphylactic type), the administration of Replagal will be stopped immediately, and&nbsp;adequate&nbsp;treatment must be instituted by your doctor.<\/p>\n\n\n\n<p>Most\u00a0side effects\u00a0are mild to moderate.\u00a0More than 1 in 10 people (frequency \u201cvery common\u201d) may experience a reaction during or after a Replagal\u00a0infusion\u00a0(infusion-related reaction).\u00a0These reactions include chills, headache, nausea, fever, fatigue, instability, difficulty breathing, shaking, coughing, and vomiting.\u00a0However, some reactions can be severe and require treatment.\u00a0Infusion-related reactions involving the heart, such as myocardial ischemia (lack of blood supply to the heart muscle) and\u00a0heart failure, may occur in patients with Fabry disease affecting the structures of the heart (&#8220;no known frequency&#8221; (can not be calculated from available data)).\u00a0Your doctor may stop the\u00a0infusion one temporarily (5 10 min) until the symptoms have disappeared and then start\u00a0infusion\u00a0one again.\u00a0Your doctor may also treat the symptoms with other medicines (\u00a0antihistamines\u00a0or\u00a0corticosteroids\u00a0).\u00a0In most cases, you can still get Replagal even if these symptoms occur.<\/p>\n\n\n\n<p>List of other side effects:<\/p>\n\n\n\n<p>Very common: may affect more than 1 in 10 people<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>swelling in&nbsp;tissue&nbsp;one (eg bone, arm)<\/li><li>tingling or numbness or pain in fingers or toes<\/li><li>ringing in the ears<\/li><li>palpitation<\/li><li>sore throat<\/li><li>abdominal pain, diarrhea<\/li><li>rash at the infusion site<\/li><li>back or&nbsp;extremity&nbsp;pain, muscle aches, joint pain<\/li><li>chest pain, cold symptoms, fever, nausea<\/li><\/ul>\n\n\n\n<p>Common: may affect up to 1 in 10 people:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>changes in how the food tastes, prolonged sleep<\/li><li>the increased amount of tear fluid<\/li><li>increased ringing in the ears<\/li><li>increased heart rate, problems with heart rhythm<\/li><li>high\u00a0blood pressure, low\u00a0blood pressure, flushing<\/li><li>hoarseness or congestion in the throat, runny nose<\/li><li>the feeling of discomfort in the abdomen<\/li><li>acne, red, itchy or flammable skin, heavy sweating<\/li><li>feeling discomfort in muscles or bones, swelling in\u00a0extremities\u00a0or joints<\/li><li>hypersensitivity<\/li><li>the feeling of tightness in the chest, increased lack of energy, feeling of heat or cold,\u00a0flu-like symptoms, feeling of discomfort<\/li><\/ul>\n\n\n\n<p>Uncommon: may affect up to 1 in 100 people:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>severe\u00a0allergic reaction\u00a0(of anaphylactic type)<\/li><li>abnormal blink reflex<\/li><li>increased heart rate<\/li><li>low oxygen level in the blood and tough mucus in the throat<\/li><li>altered sense of smell<\/li><li>accumulation of fluid under the skin which can lead to swelling of body parts, net-like discoloration of the skin e.g.\u00a0benet<\/li><li>feeling of heaviness<\/li><li>rash at the injection site<\/li><\/ul>\n\n\n\n<p><strong>Children and young people<\/strong><\/p>\n\n\n\n<p>The adverse reactions&nbsp;reported in children were generally similar to those reported in adults.&nbsp;However, infusion-related reactions (fever, difficulty breathing, chest pain) and aggravated pain were more common.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Replagal<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the label and carton after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C-8 \u00b0 C).<\/p>\n\n\n\n<p>Do not use this medicine if the liquid is discolored or contains foreign particles.<\/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\">Contents of the pack and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<p>&#8211; The active substance is alpha agalsidase.\u00a0Each ml of Replagal contains 1 mg of agalsidase alfa.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>&#8211; The other ingredients are:<\/td><td>monobasic sodium phosphate, monohydrate<\/td><\/tr><tr><td>&nbsp;<\/td><td>polysorbate 20<\/td><\/tr><tr><td>&nbsp;<\/td><td>sodium chloride<\/td><\/tr><tr><td>&nbsp;<\/td><td>sodium hydroxide<\/td><\/tr><tr><td>&nbsp;<\/td><td>water for injections<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Replagal contains\u00a0sodium.\u00a0See section 2.<\/p>\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>Replagal is a concentrated solution for\u00a0infusion.\u00a0Your medicine is available in vials containing 3.5 mg \/ 3.5 ml agalsidase alfa.\u00a0Pack sizes of 1, 4, or 10 vials are available.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Takeda Pharmaceuticals International AG Ireland Branch<\/p>\n\n\n\n<p>Block 3 Miesian Plaza<\/p>\n\n\n\n<p>50 &#8211; 58 Baggot Street Lower<\/p>\n\n\n\n<p>Dublin 2<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p>Tel: +800 66838470<\/p>\n\n\n\n<p>Email: medinfoEMEA@takeda.com<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Shire Pharmaceuticals Ireland Limited<\/p>\n\n\n\n<p>Block 2 &amp; 3 Miesian Plaza<\/p>\n\n\n\n<p>50 &#8211; 58 Baggot Street Lower<\/p>\n\n\n\n<p>Dublin 2<\/p>\n\n\n\n<p>Ireland<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The active substance in Replagal is agalsidase alfa (1 mg \/ ml). Agalsidase alfa is a form of the enzyme \u03b1-galactosidase found in humans. It has been made by activating the \u03b1-galactosidase A gene in cells. Enzyme is then removed from the cells and converted to a sterile concentrate for solution for infusion .<\/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":[2200,18529],"tags":[22766,22769,22771,22775,22774,22770,22768,22767,22772,22773],"class_list":["post-21967","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-agalsidas-alfa","tag-agalsidas-alfa-tablet","tag-replagal","tag-replagal-side-effects","tag-replagal-tablet","tag-side-effects-of-agalsidas-alfa","tag-what-agalsidas-alfa-is-used-for","tag-what-is-agalsidas-alfa","tag-what-is-replagal","tag-what-replagal-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21967","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=21967"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21967\/revisions"}],"predecessor-version":[{"id":21998,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21967\/revisions\/21998"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21967"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21967"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}