{"id":9121,"date":"2021-03-25T10:54:33","date_gmt":"2021-03-25T10:54:33","guid":{"rendered":"https:\/\/zeepedia.com\/?p=9121"},"modified":"2021-04-12T14:08:51","modified_gmt":"2021-04-12T14:08:51","slug":"fulvestrant-sun","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/fulvestrant-sun\/","title":{"rendered":"Fulvestrant SUN &#8211; Fulvestrant uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n250 mg solution for injection, pre-filled syringe<br>fulvestrant<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Fulvestrant SUN is and what it is used for<\/h2>\n\n\n\n<p>Fulvestrant SUN contains the active substance fulvestrant, which belongs to the group of estrogen blockers.&nbsp;Estrogen&nbsp;er, a type of female sex hormone may in some cases be involved in the growth of breast cancer.<br><\/p>\n\n\n\n<p>Fulvestrant SUN is used either:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>alone to treat postmenopausal women with a type of breast cancer called estrogen receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or<\/li><li>in combination with palbociclib for the treatment of women with a type of breast cancer called hormone receptor-positive,&nbsp;human&nbsp;epidermal&nbsp;growth&nbsp;factor&nbsp;receptor 2-negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic).&nbsp;Women who have not reached menopause will also be treated with a drug called a luteinizing hormone-releasing&nbsp;hormone&nbsp;(LHRH)&nbsp;agonist.<\/li><\/ul>\n\n\n\n<p>When Fulvestrant SUN is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.&nbsp;Ask your doctor if you have any questions about palbociclib.<br><\/p>\n\n\n\n<p>Fulvestrant contained in Fulvestrant SUN may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask doctors, pharmacists, or other healthcare professionals if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Fulvestrant SUN<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Fulvestrant SUN<\/h2>\n\n\n\n<p>&#8211; if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6).<\/p>\n\n\n\n<p>&#8211; if you are pregnant or breast-feeding<\/p>\n\n\n\n<p>&#8211; if you have severe liver problems.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before using Fulvestrant SUN if any of the following apply to you:<\/p>\n\n\n\n<p>&#8211; kidney or liver problems<\/p>\n\n\n\n<p>low&nbsp;platelet count&nbsp;(contributes to blood clotting), bleeding disorder<\/p>\n\n\n\n<p>&#8211; previous problems with blood clots<\/p>\n\n\n\n<p>&#8211; problems with bone mineral loss (&nbsp;osteoporosis&nbsp;)<\/p>\n\n\n\n<p>alcohol problem.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Fulvestrant SUN is not intended for use in children and adolescents below 18 years.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Fulvestrant SUN<\/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>You must tell your doctor about<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>your use&nbsp;of anticoagulants&nbsp;(medicines that prevent blood clots).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>You must not use Fulvestrant SUN if you are pregnant.&nbsp;If you can get pregnant, use an effective contraceptive when you are being treated with Fulvestrant SUN.<\/p>\n\n\n\n<p>You must not breast-feed while being treated with Fulvestrant SUN.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Fulvestrant SUN is unlikely to affect your ability to drive or use machines, but if you feel tired after treatment, avoid driving or using machines.<br><\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Fulvestrant SUN contains excipients<\/h2>\n\n\n\n<p><strong>Fulvestrant SUN contains&nbsp;10% w \/ v&nbsp;ethanol&nbsp;(alcohol),<\/strong>&nbsp;ie up to 1 g per&nbsp;dose, equivalent to 20 ml beer, or 8 ml wine per&nbsp;dose.&nbsp;Harmful to those who suffer from alcoholism.<\/p>\n\n\n\n<p>Attention should be paid to pregnant or lactating women and high-risk groups such as patients with liver disease or&nbsp;epilepsy.<br><\/p>\n\n\n\n<p><strong>Fulvestrant SUN&nbsp;contains castor oil<\/strong>, which can cause severe allergic reactions.<br><\/p>\n\n\n\n<p><strong>Fulvestrant SUN contains benzyl alcohol<\/strong><\/p>\n\n\n\n<p>This medicine contains 1 g of benzyl alcohol per&nbsp;dose, equivalent to 100 mg\/ml.&nbsp;Benzyl alcohol can cause allergic reactions.<\/p>\n\n\n\n<p>If you are pregnant or breast-feeding or have impaired liver or kidney function, consult your doctor or pharmacist before taking this medicine.&nbsp;Large amounts of benzyl alcohol can be stored in the body and cause&nbsp;side effects&nbsp;(metabolic&nbsp;acidosis&nbsp;).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Fulvestrant SUN<\/h2>\n\n\n\n<p>Your doctor or nurse will give you Fulvestrant SUN as a slow&nbsp;intramuscular&nbsp;injection, one in each buttock.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is 500 mg fulvestrant (two 250 mg \/ 5 ml&nbsp;injection&nbsp;s) once per month, with an additional&nbsp;dose&nbsp;at 500 mg two weeks after the initial&nbsp;dose&nbsp;a<strong>.<\/strong><br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/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, although not everybody gets them.<br><\/p>\n\n\n\n<p><strong>Serious&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<p><strong>If you get any of the following&nbsp;side effects, tell&nbsp;your doctor immediately&nbsp;:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and\/or throat (very common&nbsp;side effect&nbsp;) which may be a sign of anaphylactic reactions<\/li><li>thromboembolism (increased risk of blood clots) * (common&nbsp;side effect&nbsp;).&nbsp;Symptoms may include pain, deep pain and swelling in the affected area (especially in one leg), difficulty breathing, and chest pain (if a blood clot is transported to the lungs)<\/li><li>liver inflammation (&nbsp;hepatitis&nbsp;) (less common&nbsp;side effect&nbsp;).&nbsp;Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, increased tendency to bleed,&nbsp;itching,&nbsp;or chills<\/li><li>liver failure (less common&nbsp;side effect&nbsp;).&nbsp;Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes).<\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;ar<\/strong><\/p>\n\n\n\n<p><strong>Tell your doctor, pharmacist, or nurse if you get any of the following side effects:<\/strong><br><\/p>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;(may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>injection site reactions, such as pain and\/or&nbsp;inflammation<\/li><li>changes in liver enzyme values \u200b\u200b(shown by blood tests) *<\/li><li>nausea<\/li><li>weakness, fatigue *<\/li><li>joint and musculoskeletal pain<\/li><li>hot flashes<\/li><li>rash.<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>headache<\/li><li>vomiting, diarrhea, or decreased appetite *<\/li><li>urinary tract infection<\/li><li>back pain *<\/li><li>increase in&nbsp;bilirubin&nbsp;(a bile pigment produced by the liver)<\/li><li>decreased&nbsp;platelet count&nbsp;(&nbsp;thrombocytopenia&nbsp;)<\/li><li>vaginal&nbsp;bleeding<\/li><li>pain in the lower back that radiates to the leg on one side (sciatica)<\/li><li>sudden weakness, numbness, tingling, or loss of mobility in the leg, especially only on one side of the body, sudden difficulty walking or maintaining balance (&nbsp;peripheral&nbsp;neuropathy&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>thick, whitish&nbsp;vaginal discharge&nbsp;and fungal infection<\/li><li>bruising and bleeding at the injection site<\/li><li>increase in gamma-GT, a liver enzyme seen in a blood test<\/li><li>numbness, tingling, and pain<\/li><li>anaphylactic reactions.<\/li><\/ul>\n\n\n\n<p>* Includes&nbsp;side effects&nbsp;for which the exact effect of Fulvestant SUN cannot be assessed due to the underlying disease.<br><\/p>\n\n\n\n<p><strong>Reporting of&nbsp;side effects&nbsp;ar<\/strong><\/p>\n\n\n\n<p>If you get&nbsp;any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This also applies to any&nbsp;side effects&nbsp;not mentioned in this information.&nbsp;You can also report&nbsp;side effects&nbsp;directly via<\/p>\n\n\n\n<p>The Medical Products Agency<\/p>\n\n\n\n<p>Box 26<\/p>\n\n\n\n<p>751 03 Uppsala<\/p>\n\n\n\n<p>www.lakemedelsverket.se<\/p>\n\n\n\n<p>By reporting&nbsp;side effects, you can help increase drug safety information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Fulvestrant SUN<\/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 carton or syringe label after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Store and transport cold (2 \u00b0 C-8 \u00b0 C).<br><\/p>\n\n\n\n<p>Deviations outside the temperature range 2 \u00b0 C-8 \u00b0 C must be limited.&nbsp;This includes avoiding storage at temperatures exceeding 30&nbsp;<sup>o<\/sup>&nbsp;C and not exceeding a period of 28 days during which <\/p>\n\n\n\n<p>the average storage temperature for the product is below 25 \u00b0 C (but above 2 \u00b0 C-8 \u00b0 C).&nbsp;After temperature deviations, the product must be returned immediately to the recommended storage conditions (stored and transported in a refrigerator, 2 \u00b0 C-8 \u00b0 C).&nbsp;Temperature deviations have a cumulative effect on the product quality and the time period of 28 days must not be exceeded during the entire shelf life of Fulvestrant SUN.&nbsp;Exposure to temperatures below 2&nbsp;<sup>\u00b0<\/sup>&nbsp;C does not damage the product, provided it is not stored below -20 \u00b0 C.<br><\/p>\n\n\n\n<p>Store the prefilled syringe in the original package.&nbsp;Sensitive to light.<br><\/p>\n\n\n\n<p>The healthcare staff is responsible for the correct storage, use, and disposal of Fulvestrant SUN.<br><\/p>\n\n\n\n<p>This medicine may pose a risk to the aquatic environment.&nbsp;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<p>&#8211; The active substance is fulvestrant.&nbsp;Each pre-filled&nbsp;syringe&nbsp;(5 ml) contains 250 mg fulvestrant.<\/p>\n\n\n\n<p>The other ingredients (excipients) are&nbsp;ethanol&nbsp;(96%), benzyl alcohol (E1519), benzyl benzoate, and castor oil (refined).<\/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>Fulvestrant SUN is a clear, colorless to yellow,&nbsp;viscous&nbsp;solution in a pre-filled&nbsp;syringe&nbsp;fitted with a safety closure containing 5 ml&nbsp;solution for injection.&nbsp;Two syringes must be administered to reach the recommended monthly&nbsp;dose of&nbsp;500 mg.<br><\/p>\n\n\n\n<p>Fulvestrant SUN is available in four-pack sizes, consisting of packs containing 1, 2, 4, or 6 pre-filled syringes.&nbsp;One, 2, 4, or 6 protected needles (BD SafetyGlide) to connect to each&nbsp;syringe&nbsp;are also included.<br><\/p>\n\n\n\n<p>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>Sun Pharmaceutical Industries Europe BV<\/p>\n\n\n\n<p>Polarisavenue 87<\/p>\n\n\n\n<p>2132 JH Hoofddorp<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p><strong>This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/p>\n\n\n\n<p>Germany Fulvestrant SUN<\/p>\n\n\n\n<p>France Fulvestrant SUN<\/p>\n\n\n\n<p>Italy Fulvestrant SUN<\/p>\n\n\n\n<p>Netherlands Fulvestrant SUN<\/p>\n\n\n\n<p>Poland Fulvestrant SUN<\/p>\n\n\n\n<p>Romania Fulvestrant SUN<\/p>\n\n\n\n<p>Spain Fulvestrant SUN<\/p>\n\n\n\n<p>United Kingdom Fulvestrant SUN<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>250 mg solution for injection, pre-filled syringe<br \/>\nfulvestrant<\/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":[2385,2386,2257,2384,2258,2215,2216,2212,2213,2259],"class_list":["post-9121","post","type-post","status-publish","format-standard","hentry","category-f","category-medicines","tag-fulvestrant-doses","tag-fulvestrant-side-effects","tag-fulvestrant-sun","tag-fulvestrant-uses","tag-how-to-use-fulvestrant-sun","tag-injection","tag-injections","tag-medicine","tag-medicines","tag-side-effects-of-fulvestrant-sun"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9121","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=9121"}],"version-history":[{"count":7,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9121\/revisions"}],"predecessor-version":[{"id":9933,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9121\/revisions\/9933"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=9121"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=9121"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=9121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}