{"id":23421,"date":"2022-07-29T11:23:58","date_gmt":"2022-07-29T11:23:58","guid":{"rendered":"https:\/\/zeepedia.com\/?p=23421"},"modified":"2022-07-30T07:03:01","modified_gmt":"2022-07-30T07:03:01","slug":"somavert","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/somavert\/","title":{"rendered":"SOMAVERT &#8211; Pegvisomant uses, dose and side effects"},"content":{"rendered":"\n<p>10 mg, 15 mg, 20 mg, 25 mg, or 30 mg\u00a0powder and liquid for\u00a0injection, solution<br>pegvisomant<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What SOMAVERT is and what it is used for<\/h2>\n\n\n\n<p>SOMAVERT is used for the treatment of\u00a0acromegaly, a hormonal disorder that involves increased secretion of\u00a0growth hormone\u00a0(\u00a0GH\u00a0) and\u00a0IGF\u00a0-I (\u00a0Insulin-like growth factors), which can lead to increased bone growth, swelling in soft tissues, heart disease, and other problems.<\/p>\n\n\n\n<p>The active substance in SOMAVERT, pegvisomant, is a so-called\u00a0antagonist\u00a0against the receptor for\u00a0growth hormone.\u00a0Such substances reduce the effect of\u00a0growth hormone\u00a0(\u00a0GH\u00a0) and lower the level of\u00a0IGF\u00a0-I (\u00a0Insulin-like growth factors) circulating in the blood.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you use SOMAVERT<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use SOMAVERT<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to pegvisomant 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 precautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before using SOMAVERT.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you experience visual disturbances or headaches, contact your doctor immediately.<\/li><li>Your doctor or nurse will measure the levels of\u00a0IGF\u00a0\u20111 (\u00a0Insulin-growth factors) circulating in the blood and adjust the SOMAVERT\u00a0dose\u00a0if necessary.<\/li><li>Your doctor will also check your\u00a0adenoma\u00a0(benign\u00a0tumor\u00a0).<\/li><li>Your doctor will take blood tests to measure your liver function before and during treatment with SOMAVERT.\u00a0If the values \u200b\u200bare abnormal, your doctor will discuss with you what treatment options are available.\u00a0Once treatment is started, your doctor or nurse will measure the level of liver enzymes every 4-6 weeks for the first 6 months of treatment with SOMAVERT.\u00a0Treatment with SOMAVERT should be discontinued if there are persistent signs of liver disease.<\/li><li>If you have\u00a0diabetes, your doctor may need to adjust the amount of\u00a0insulin\u00a0or other medicine you take.<\/li><li>Fertility\u00a0in female patients may increase as the disease improves.\u00a0Use of this medicine during pregnancy is not recommended and women of childbearing potential should be advised to use contraception.\u00a0See also the sections on Pregnancy below.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and SOMAVERT<\/h2>\n\n\n\n<p>You must tell your doctor if you have previously used any other medicine for the treatment of\u00a0acromegaly\u00a0or the treatment of\u00a0diabetes.<\/p>\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>You may receive other medicines as part of your treatment.\u00a0You must take all the medicines you have been prescribed as well as SOMAVERT, unless your doctor, pharmacist, or nurse tells you otherwise.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>Use of SOMAVERT during pregnancy is not recommended.&nbsp;If you are a&nbsp;fertile&nbsp;woman, you must use contraception during treatment.<\/p>\n\n\n\n<p>It is not known whether pegvisomant passes into breast milk.\u00a0You should not breastfeed while taking SOMAVERT unless your doctor has discussed this with you.<\/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 using this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>No studies have been performed on the ability to drive or use machines.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">SOMAVERT contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg) of\u00a0sodium\u00a0per\u00a0dose, i.e. it is almost &#8220;sodium-free&#8221;.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use SOMAVERT<\/h2>\n\n\n\n<p>Always inject this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p>Your doctor will give you an initial\u00a0subcutaneous\u00a0(under the skin)\u00a0injection\u00a0of 80 mg pegvisomant.\u00a0After that, the daily\u00a0dose\u00a0is one of pegvisomant 10 mg, taken as a\u00a0subcutaneous\u00a0(under the skin)\u00a0injection.<\/p>\n\n\n\n<p>Your doctor will change the&nbsp;dose&nbsp;every 4-6 weeks, in increments of 5 mg pegvisomant\/day, depending on your so-called&nbsp;serum&nbsp;IGF&nbsp;-I values, to maintain an optimal treatment result.<\/p>\n\n\n\n<p><strong>Mode of administration and route of administration:<\/strong><\/p>\n\n\n\n<p>SOMAVERT is injected under the skin.&nbsp;Injection 1&nbsp;can be taken on your own or given by someone else, such as your doctor or nurse.&nbsp;The detailed instructions on injection technique at the end of this leaflet should be followed.&nbsp;Continue to inject this medicine for as long as your doctor prescribes.<\/p>\n\n\n\n<p>This medicine must be dissolved before use.&nbsp;The injection fluid must not be mixed in the same&nbsp;syringe&nbsp;or bottle as any other medicine.<\/p>\n\n\n\n<p>Adipose tissue may form at the injection site.\u00a0To avoid this, you should inject in different places each time, see the description in Step 2 of &#8220;Instructions for\u00a0preparing\u00a0and giving an\u00a0injection\u00a0of SOMAVERT\u00a0<strong>&#8220;<\/strong>\u00a0in this leaflet.\u00a0It gives the skin and\u00a0tissue\u00a0under the skin an opportunity to recover after an\u00a0injection\u00a0before the next one is given in the same place.<\/p>\n\n\n\n<p>If you feel that the effect of this medicine is too strong or too weak, contact your doctor, pharmacist, or nurse.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use too much SOMAVERT&nbsp;<\/h2>\n\n\n\n<p>If you accidentally inject more SOMAVERT than your doctor prescribed, nothing serious is likely to happen, but you should contact your doctor, pharmacist, or nurse immediately.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use SOMAVERT<\/h2>\n\n\n\n<p>If you forget to give yourself an\u00a0injection, you should inject the next\u00a0dose\u00a0as soon as you remember.\u00a0Then continue injecting SOMAVERT as directed by your doctor.\u00a0Do not inject a double\u00a0dose\u00a0to make up for a missed\u00a0dose.<\/p>\n\n\n\n<p>If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.<\/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>Mild to severe allergic (anaphylactic) reactions have been reported in some patients taking SOMAVERT.&nbsp;Symptoms of a serious&nbsp;allergic reaction&nbsp;may include one or more of the following: swelling of the face, tongue, lips, or throat, wheezing or difficulty breathing (spasm of the larynx), generalized skin rash,&nbsp;hives&nbsp;(&nbsp;urticaria&nbsp;), or itching;&nbsp;or dizziness.&nbsp;Contact your doctor immediately if you develop any of these symptoms.<\/p>\n\n\n\n<p>Very common: may affect more than 1 in 10 users:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Headache.<\/li><li>Diarrhea.<\/li><li>Joint pain.<\/li><\/ul>\n\n\n\n<p>Common: may affect up to 1 in 10 users:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Shortness of breath.<\/li><li>Increased levels of substances that measure liver function, can be seen in blood test results.<\/li><li>Blood in the urine.<\/li><li>Increased\u00a0blood pressure.<\/li><li>Constipation, feeling sick, vomiting, feeling bloated, indigestion, flatulence.<\/li><li>Dizziness, sleepiness, involuntary tremors, decreased sensitivity to touch.<\/li><li>Bruising, bleeding, tenderness, or swelling at the injection site.\u00a0Fat formation under the skin at the injection site, swollen arms and legs, feeling weak, fever.<\/li><li>Sweating,\u00a0itching, rash, increased tendency to bruise.<\/li><li>Muscle pain,\u00a0arthritis.<\/li><li>Increase in cholesterol in the blood, weight gain, increase in blood glucose, and decreased blood glucose.<\/li><li>Flu-like symptoms, feeling tired.<\/li><li>Abnormal dreams.<\/li><li>Pain in the eyes.<\/li><\/ul>\n\n\n\n<p>Uncommon: may affect up to 1 in 100 users:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic reaction\u00a0after drug administration (fever, skin rash,\u00a0itching,\u00a0and, in severe cases, breathing difficulties, rapid swelling of the skin, which requires immediate medical attention).\u00a0May occur immediately or several days after drug administration.<\/li><li>Protein\u00a0in the urine, increased urine volume, kidney problems<\/li><li>Indifference, confusion, increased sex drive, panic attacks, memory loss, and sleep problems.<\/li><li>Decreased amount of\u00a0platelets, increased or decreased amount of\u00a0white blood cells, tendency to bleed<\/li><li>Feeling of being abnormal, impaired healing.<\/li><li>Strained eyes, problems with the inner ear.<\/li><li>Facial swelling, dry skin, night sweats, skin redness (\u00a0erythema\u00a0), raised itchy nodules on the skin (\u00a0hives\u00a0).<\/li><li>Elevated blood fats, increased appetite.<\/li><li>Dry mouth, increased salivation, dental problems,\u00a0hemorrhoids.<\/li><li>Altered sense of taste,\u00a0migraine.<\/li><\/ul>\n\n\n\n<p>Has been reported: occurring in an unknown number of users:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Anger.<\/li><li>Severe shortness of breath (&nbsp;laryngospasm&nbsp;).<\/li><li>Rapid swelling of the skin and underlying&nbsp;tissue&nbsp;and mucous membranes in the organs (&nbsp;angioedema&nbsp;).<\/li><\/ul>\n\n\n\n<p>Approximately 17% of patients will develop&nbsp;antibodies&nbsp;to&nbsp;growth hormone&nbsp;during treatment.&nbsp;Antibodies&nbsp;do not seem to counteract the effect of this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How SOMAVERT should be stored<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Use before the expiry date which is stated on the vial and packaging after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store the vials of powder in the carton in a refrigerator (2 \u00b0C \u2013 8 \u00b0C).&nbsp;Light sensitive.&nbsp;Do not freeze.<\/p>\n\n\n\n<p>Carton containing SOMAVERT vials of powder can be stored at room temperature at a maximum of 25 \u00b0C for a period of a maximum of 30 days.&nbsp;Use by date must be indicated on the carton with day\/month\/year (no more than 30 days from the date it was taken out of the refrigerator).&nbsp;The vials must be protected from light.&nbsp;This medicine must not be put back in the refrigerator.<\/p>\n\n\n\n<p>Discard this medicine if it has not been used by the new use-by date or expiry date printed on the carton, whichever comes first.<\/p>\n\n\n\n<p>Store pre-filled syringe(s) at a maximum of 30 \u00b0C or in a refrigerator (2 \u00b0C \u2013 8 \u00b0C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>After\u00a0preparation\u00a0of the SOMAVERT solution, it must be used immediately.<\/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 must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Contents declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is pegvisomant.<\/li><li>SOMAVERT 10 mg: One\u00a0vial\u00a0of powder contains 10 mg pegvisomant.\u00a0After reconstitution with 1 ml\u00a0diluent, 1 ml\u00a0solution for injection\u00a0contains 10 mg pegvisomant.<\/li><li>SOMAVERT 15 mg: One\u00a0vial\u00a0of powder contains 15 mg pegvisomant.\u00a0After reconstitution with 1 ml\u00a0diluent, 1 ml\u00a0solution for injection\u00a0contains 15 mg pegvisomant.<\/li><li>SOMAVERT 20 mg: One\u00a0vial\u00a0of powder contains 20 mg pegvisomant.\u00a0After reconstitution with 1 ml\u00a0diluent, 1 ml\u00a0solution for injection\u00a0contains 20 mg pegvisomant.<\/li><li>SOMAVERT 25 mg: One\u00a0vial\u00a0of powder contains 25 mg pegvisomant.\u00a0After reconstitution with 1 ml\u00a0diluent, 1 ml\u00a0solution for injection\u00a0contains 25 mg pegvisomant.<\/li><li>SOMAVERT 30 mg: One\u00a0vial\u00a0of powder contains 30 mg pegvisomant.\u00a0After reconstitution with 1 ml\u00a0diluent, 1 ml\u00a0solution for injection\u00a0contains 30 mg pegvisomant.<\/li><li>Other ingredients are\u00a0glycine, mannitol (E421), anhydrous disodium phosphate, and sodium dihydrogen phosphate monohydrate (see section 2 &#8220;SOMAVERT contains sodium&#8221;)<\/li><li>The diluent is water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>SOMAVERT consists of powder and liquid for\u00a0injection\u00a0(10 mg, 15 mg, 20 mg, 25 mg, or 30 mg pegvisomant in a\u00a0vial\u00a0and 1 ml of liquid in a pre-filled\u00a0syringe\u00a0).\u00a0Packaging sizes 1 and\/or 30 pcs.\u00a0Not all pack sizes will be marketed.<\/p>\n\n\n\n<p>The powder is white and the diluent is clear and colorless.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing authorization holder and manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder:<\/strong><\/p>\n\n\n\n<p>Pfizer Europe MA EEIG<\/p>\n\n\n\n<p>Boulevard de la Plaine 17<\/p>\n\n\n\n<p>1050 Brussels<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<p><strong>Manufacturer:<\/strong><\/p>\n\n\n\n<p>Pfizer Manufacturing Belgium NV<\/p>\n\n\n\n<p>Rijksweg 12<\/p>\n\n\n\n<p>2870 Puurs<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder if you want to know more about this medicine.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgi\u00eb\/Belgique\/Belgien<\/strong><strong>Luxembourg\/Luxembourg<\/strong>Pfizer NV\/SATel\/Tel: +32 (0)2 554 62 11<\/td><td><strong>Lithuania<\/strong>Pfizer Luxembourg SARL branches in LithuaniaTel.&nbsp;+3705 2514000<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>Pfizer Luxembourg \u0421\u0410\u0420\u041b, \u041a\u043b\u043e\u043d \u0411\u0443\u043b\u0433\u0430\u0440\u0438\u044fTel.: +359 2 970 4333<\/td><td><strong>Magyarorsz\u00e1g<\/strong>Pfizer Kft.Tel.: + 36 1 488 37 00<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Pfizer, coil.\u00a0s iPhone: +420 283 004 111<\/td><td><strong>Malta<\/strong>Vivian Corporation Ltd.Phone: +356 21344610<\/td><\/tr><tr><td><strong>Denmark<\/strong>Pfizer ApSPhone: +45 44 20 11 00<\/td><td><strong>The Netherlands<\/strong>Pfizer by phone: +31 (0)10 406 43 01<\/td><\/tr><tr><td><strong>Deutschland<\/strong>Pfizer Pharma GmbHPhone: +49 (0)30 550055 51000<\/td><td><strong>Norway<\/strong>Pfizer iPhone: +47 67 52 61 00<\/td><\/tr><tr><td><strong>Estonia<\/strong>Pfizer Luxembourg SARL Eesti branch phone: +372 666 7500<\/td><td><strong>Austria<\/strong>Pfizer Corporation Austria Ges.mbHPhone: +43 (0)1 521 15-0<\/td><\/tr><tr><td><strong>Greece<\/strong>PFIZER \u0395\u039b\u039b\u0391\u03a3 \u0391.\u0395.Tel.: +30 210 6785800<\/td><td><strong>Polish<\/strong>Pfizer Polska Sp.&nbsp;z o. oTel.: +48 22 3356100<\/td><\/tr><tr><td><strong>Spain<\/strong>Pfizer SLPhone: +34 91 490 99 00<\/td><td><strong>Portugal<\/strong>Laborat\u00f3rios Pfizer, Lda.Phone: +351 21 423 5500<\/td><\/tr><tr><td><strong>France<\/strong>PfizerTel: +33 (0) 1 58 07 34 40<\/td><td><strong>Romania<\/strong>Pfizer Rom\u00e2nia SRLPhone: +40 (0)21 207 28 00<\/td><\/tr><tr><td><strong>Hrvatska<\/strong>Pfizer Croatia dooPhone: + 385 1 3908 777<\/td><td><strong>Slovenija<\/strong>Pfizer branch of marketing s po\u0142o\u0161ka farmacevtske activities, LjubljanaPhone: + 386 (0)1 52 11 400<\/td><\/tr><tr><td><strong>Ireland<\/strong>Pfizer Healthcare IrelandPhone: 1800 633 363 (toll free)+44 (0)1304 616161<\/td><td><strong>Slovenian Republic<\/strong>Pfizer Luxembourg SARL, organiza\u010dn\u00e1 zlo\u017ekaPhone: +421 2 5941 8500<\/td><\/tr><tr><td><strong>Iceland<\/strong>Icepharma hf.Phone: + 354 540 8000<\/td><td><strong>Finland\/Finland<\/strong>Pfizer OyTel: +358 (0) 9 43 00 40<\/td><\/tr><tr><td><strong>Italy<\/strong>Pfizer SrlPhone: +39 06 33 18 21<\/td><td><strong>Sweden<\/strong>Pfizer phone: +46 (0)8 550 520 00<\/td><\/tr><tr><td><strong>Cyprus<\/strong>PFIZER \u0395\u039b\u039b\u0391\u03a3 \u0391.\u0395.&nbsp;(CYPRUS BRANCH)Phone: +357 22 817690<\/td><td><strong>United Kingdom (Northern Ireland)<\/strong>Pfizer LimitedPhone: +44 (0)1304 616161<\/td><\/tr><tr><td><strong>Latvia<\/strong>Pfizer Luxembourg SARL branch in LatviaPhone: +371 670 35 775<\/td><td>&nbsp;<\/td><\/tr><tr><td><strong>Lithuania<\/strong>Pfizer Luxembourg SARL branches in LithuaniaTel.&nbsp;+3705 2514000<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>SOMAVERT is used for the treatment of\u00a0acromegaly\u00a0, a hormonal disorder that involves increased secretion of\u00a0growth hormone\u00a0(\u00a0GH\u00a0) and\u00a0IGF\u00a0-I (\u00a0Insulin\u00a0like growth factors), which can lead to increased bone growth, swelling in soft tissues, heart disease and other problems.<\/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":[2200,18530],"tags":[24495,24501,24491,24494,24496,24500,24492,24493,24498,24499],"class_list":["post-23421","post","type-post","status-publish","format-standard","hentry","category-medicines","category-s","tag-benefits-of-pegvisomant","tag-benefits-of-somavert","tag-pegvisomant","tag-pegvisomant-side-effects","tag-somavert","tag-somavert-side-effects","tag-what-is-pegvisomant","tag-what-pegvisomant-is-used-for","tag-what-somavert-is-used-for","tag-whwhat-is-somavert"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23421","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=23421"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23421\/revisions"}],"predecessor-version":[{"id":23455,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23421\/revisions\/23455"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=23421"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=23421"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=23421"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}