{"id":22058,"date":"2022-06-17T05:14:47","date_gmt":"2022-06-17T05:14:47","guid":{"rendered":"https:\/\/zeepedia.com\/?p=22058"},"modified":"2022-06-18T12:24:36","modified_gmt":"2022-06-18T12:24:36","slug":"revestive","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/revestive\/","title":{"rendered":"Revestive &#8211; Teduglutide uses, dose and side effects"},"content":{"rendered":"\n<p>1.25 mg powder and solvent for solution for injection<br>teduglutide.&nbsp;For children and young people<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Revestive is and what it is used for<\/h2>\n\n\n\n<p>Revive contains the active substance teduglutide.\u00a0It improves the uptake of nutrients and fluid from the remaining gastrointestinal tract (gut).<\/p>\n\n\n\n<p>Revive is used to treat children and adolescents (aged 1 year and older) with short bowel syndrome.\u00a0Short bowel syndrome is a disease in which the intestine is unable to absorb nutrients and fluid.\u00a0It often occurs when all or part of the small intestine has been operated on.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Revestive<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Revestive<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if your child is allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or to tetracycline residues.<\/li><li>if your child has or if he or she is suspected of having cancer.<\/li><li>if your child has had cancer of the gastrointestinal tract, including the liver, gallbladder or bile ducts, and pancreas within the last five years.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor before your child uses Revestive:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if your child has severe hepatic impairment.\u00a0Your doctor will take this into account when prescribing this medicine.<\/li><li>if your child has certain cardiovascular diseases (affecting the heart and\/or blood vessels), such as high\u00a0blood pressure\u00a0(\u00a0hypertension\u00a0) or weak heart (\u00a0heart failure\u00a0).\u00a0Signs and symptoms include sudden weight gain, swollen face, swollen ankles, and\/or shortness of breath.<\/li><li>if your child has other serious illnesses that are not well controlled.\u00a0Your doctor will take this into account when prescribing this medicine.<\/li><li>if your child has impaired kidney function.\u00a0Your doctor may then need to\u00a0prescribe\u00a0a lower\u00a0dose\u00a0of this medicine.<\/li><\/ul>\n\n\n\n<p>When your child starts treatment with Revestive and during treatment, your doctor may need to adjust the amount of&nbsp;intravenous&nbsp;fluid or nutrition that your child is receiving.<\/p>\n\n\n\n<p><em>Medical check-ups before and during treatment with Revestive<\/em><\/p>\n\n\n\n<p>Before starting your child with this medicine, a test must be taken to check for blood in the stool.\u00a0Your child will also be examined with a\u00a0colonoscopy\u00a0(an examination where the inside of the colon and rectum is examined to check for\u00a0polyps\u00a0[small abnormal growths] and if so, have them removed) if the child has blood in the stool without knowing why.\u00a0About\u00a0polyp, before your child starts treatment with Revestive, your child&#8217;s doctor will decide if your child should use the medicine or not.\u00a0Revive should not be used if cancer is found during a colonoscopy.\u00a0Your child will undergo further colonoscopy examinations if they continue treatment with Revestive.\u00a0Your doctor will monitor your baby&#8217;s body fluids and\u00a0electrolytes\u00a0as an imbalance may cause dehydration or dehydration.<\/p>\n\n\n\n<p>The doctor will be especially careful when it comes to monitoring small bowel function as well as monitoring for signs and symptoms that indicate problems with the gallbladder, bile ducts, and pancreas.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p><em>Children under 1 year<\/em><\/p>\n\n\n\n<p>This medicine should not be used in children under 1 year of age.&nbsp;This is because there is limited experience using Revestive in this age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other drugs and Revestive<\/h2>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse if your child is taking, has recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>Revive can affect how other drugs are absorbed in the gut and thus also affect how well they work.\u00a0Your doctor may need to change the\u00a0dose\u00a0of one of the other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Revive is not recommended if your baby is pregnant or breastfeeding.<\/p>\n\n\n\n<p>If your baby is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability, cycling, and use of machines<\/h2>\n\n\n\n<p>This medicine may make your child feel dizzy.&nbsp;If this happens, your child should not drive, cycle or use machines until he or she feels better.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Important information about the ingredients of Revestive<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0dose, ie essentially &#8216;sodium-free&#8217;.\u00a0it is next to &#8220;sodium-free&#8221;.<\/p>\n\n\n\n<p>Caution is required if your child is hypersensitive to&nbsp;tetracycline&nbsp;(see section \u201c&nbsp;<strong>Do not use Revestive<\/strong>&nbsp;\u201d).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Revestive<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor has told you.\u00a0If you are not sure, talk to your child&#8217;s doctor, pharmacist, or nurse.<\/p>\n\n\n\n<p><em>Dose<\/em><\/p>\n\n\n\n<p>The recommended daily\u00a0dose\u00a0for your child is 0.05 mg\/kg body weight.\u00a0The dose\u00a0is given in milliliters (ml) of solution.<\/p>\n\n\n\n<p>The doctor chooses the\u00a0dose\u00a0that is best for your child about the child&#8217;s body weight.\u00a0Your doctor will tell you which\u00a0dose\u00a0to inject.\u00a0If you are not sure, talk to your doctor, pharmacist, or nurse.<\/p>\n\n\n\n<p><em>How to use Revestive<\/em><\/p>\n\n\n\n<p>Revive is injected under the skin (\u00a0subcutaneously\u00a0) once daily.\u00a0You can inject the medicine yourself or get help from another person, such as your child&#8217;s doctor, their assistant, or home nurse.\u00a0If you, or the caregiver, inject the medicine, you or the caregiver must first be given detailed instructions by your doctor or nurse.\u00a0At the end of this information, there are detailed instructions on how to\u00a0inject\u00a0one.<\/p>\n\n\n\n<p>It is strongly recommended that each time your child receives a&nbsp;dose&nbsp;of Revestive, the name and lot number of the medicine should be recorded to maintain a list of the lot numbers used.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Revestive than you should &nbsp;<\/h2>\n\n\n\n<p>If you have injected more Revestive than your child&#8217;s doctor prescribed, contact your doctor, pharmacist, or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Revestive<\/h2>\n\n\n\n<p>If you forget to inject this medicine (or can not inject it at the time you usually use it), inject it as soon as possible on that day.\u00a0Never inject more than one\u00a0injection\u00a0in one day.\u00a0Do not inject a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Revestive<\/h2>\n\n\n\n<p>Continue to use this medicine for as long as your child&#8217;s doctor has prescribed it for your child.\u00a0Do not stop using this medicine without consulting your doctor, as sudden discontinuation of treatment may lead to altered fluid balance.<\/p>\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><strong>Contact a doctor immediately if you get any of the following side effects:<\/strong><\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Chronic\u00a0heart failure.\u00a0Contact a doctor if your child experiences fatigue, shortness of breath or swollen ankles or legs, or swollen face.<\/li><li>Inflammation\u00a0of the pancreas (\u00a0pancreatitis\u00a0).\u00a0Contact a doctor or emergency room if your child experiences severe abdominal pain and fever.<\/li><li>Intestinal obstruction (blockage in the intestines).\u00a0Contact a doctor or emergency room if your child experiences severe abdominal pain, vomiting, and constipation.<\/li><li>Decreased bile flow from the gallbladder and\/or\u00a0inflammation\u00a0of the gallbladder.\u00a0Contact a doctor or emergency room if your child experiences yellow tones on the skin and whites of the eyes,\u00a0itching, dark urine, and light stools, or pain in the upper right side or the middle of the abdomen.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Fainting.&nbsp;If your heart rate and breathing are normal and your child wakes up quickly, talk to your doctor.&nbsp;In other cases, seek help as soon as possible.<\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;are:<\/strong><\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(may affect more than 1 user in 10):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Respiratory tract infections (\u00a0infection\u00a0of the sinuses, throat, respiratory tract, or lungs)<\/li><li>Headache<\/li><li>Abdominal pain, bloating, nausea, swollen\u00a0stoma\u00a0(an artificial opening for stool removal), vomiting<\/li><li>Redness, pain, or swelling at the injection site<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people):&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Influenza\u00a0or\u00a0flu-like symptoms<\/li><li>Decreased appetite<\/li><li>Swollen hands and\/or feet<\/li><li>Sleep problems, anxiety<\/li><li>Cough, shortness of breath<\/li><li>Polyps\u00a0(small abnormal growths) in the colon<\/li><li>Gases<\/li><li>Narrowing or blockage of the pancreatic duct can cause\u00a0inflammation\u00a0of the pancreas<\/li><li>Inflammation\u00a0of the gallbladder<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Polyps&nbsp;(small abnormal growths) in the small intestine<\/li><\/ul>\n\n\n\n<p><strong>Has been reported<\/strong>&nbsp;(occurs in an unknown number of users):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic reaction&nbsp;(hypersensitivity)<\/li><li>Fluid accumulation<\/li><li>Polyps&nbsp;(small abnormal growths) in the stomach<\/li><\/ul>\n\n\n\n<p><strong>Use in children and adolescents<\/strong><\/p>\n\n\n\n<p>In general, the&nbsp;side effects&nbsp;in children and adolescents are similar to those seen in adults.<\/p>\n\n\n\n<p>There is a limited experience for children under 1 year of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Revestive<\/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 carton, vial, and prefilled syringe after EXP.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>From a\u00a0microbiological\u00a0point of view, the solution should be used immediately after\u00a0reconstitution.\u00a0However, chemical and physical in-use stability has been demonstrated for 24 hours at 25 \u00b0 C.<\/p>\n\n\n\n<p>Do not use this medicine if the solution is cloudy or contains 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.&nbsp;Throw needles and syringes in containers for stinging and cutting waste.<\/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<ul class=\"wp-block-list\"><li>The active substance is teduglutide.\u00a0One\u00a0vial\u00a0contains 1.25 mg of teduglutide.\u00a0After\u00a0reconstitution, each\u00a0vial\u00a0contains 1.25 mg of teduglutide in 0.5 ml solution, corresponding to a concentration of 2.5 mg\/ml.<\/li><li>The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, and disodium phosphate heptahydrate.<\/li><li>The liquid contains water for injections<\/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>Revertive consists of a powder and solvent for solution for\u00a0injection\u00a0(\u00a0vial\u00a0with 1.25 mg teduglutide, pre-filled\u00a0syringe\u00a0with 0.5 ml liquid).<\/p>\n\n\n\n<p>The powder is white and the liquid is clear and colorless.<\/p>\n\n\n\n<p>Revive is available in pack sizes of 28 powder vials and 28 pre-filled syringes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\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\n\n\n<p>Tel: +44 (0) 1256 894 959<\/p>\n\n\n\n<p>Email: medinfoEMEA@shire.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Revestive contains the active substance teduglutide. It improves the uptake of nutrients and fluid from the remaining gastrointestinal tract (gut).<\/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":[22963,22958,22959,22962,22954,22957,22960,22955,22961,22956],"class_list":["post-22058","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-revestive","tag-benefits-of-teduglutide","tag-revestive","tag-revestive-side-effects","tag-teduglutide","tag-teduglutide-side-effects","tag-what-is-revestive","tag-what-is-teduglutide","tag-what-revestive-is-used-for","tag-what-teduglutide-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22058","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=22058"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22058\/revisions"}],"predecessor-version":[{"id":22141,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22058\/revisions\/22141"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22058"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22058"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22058"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}