{"id":9110,"date":"2021-03-25T09:56:21","date_gmt":"2021-03-25T09:56:21","guid":{"rendered":"https:\/\/zeepedia.com\/?p=9110"},"modified":"2021-04-12T14:17:21","modified_gmt":"2021-04-12T14:17:21","slug":"fulvestrant-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/fulvestrant-accord\/","title":{"rendered":"Fulvestrant Accord &#8211; Fulvestrant uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n250 mg&nbsp;solution for injection&nbsp;in a pre-filled&nbsp;syringe<br>fulvestrant<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Fulvestrant Accord is and what it is used for<\/h2>\n\n\n\n<p>Fulvestrant Accord 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 Accord 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 \u2011 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 luteinizing hormone-releasing&nbsp;hormone&nbsp;(LHRH)&nbsp;agonist.<\/li><\/ul>\n\n\n\n<p>When Fulvestrant Accord 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.<\/p>\n\n\n\n<p>Fulvestrant contained in the Fulvestrant Accord may also be approved for the treatment of other diseases not mentioned in this product information.&nbsp;Ask your doctor, pharmacist,, or other healthcare professional 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 Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Fulvestrant Accord<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you are pregnant or breastfeeding<\/li><li>if you have severe liver problems.<\/li><\/ul>\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<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Fulvestrant Accord if any of the following applies to you:<\/li><li>kidney or liver problems<\/li><li>low&nbsp;platelet count&nbsp;(contributes to blood clotting), bleeding disorder<\/li><li>previous problems with blood clots<\/li><li>problems with bone mineral loss (&nbsp;osteoporosis&nbsp;)<\/li><li>alcohol problem.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Fulvestrant Accord is not intended for children and adolescents under 18 years of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Fulvestrant Accord<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken,, or might take any other medicines.<br><\/p>\n\n\n\n<p>You must tell your doctor if you are taking anticoagulants&nbsp;<\/p>\n\n\n\n<p>(medicines that prevent blood clots).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding,, and fertility<\/h2>\n\n\n\n<p>You must not use Fulvestrant Accord if you are pregnant.&nbsp;If you could become pregnant, use an effective contraceptive when you are being treated with Fulvestrant Accord and for 2 years after your last&nbsp;dose.<br><\/p>\n\n\n\n<p>You must not breast-feed when you are being treated with Fulvestrant Accord.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Fulvestrant Accord is unlikely to affect your ability to drive or use machines, but if you feel tired after the 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 Accord contains ethanol (alcohol), benzyl alcohol, benzyl benzoate<\/h2>\n\n\n\n<p><strong>This medicine contains 10% by&nbsp;volume of ethanol&nbsp;(alcohol)<\/strong>, ie up to 500 mg per&nbsp;dose, equivalent to 10 ml of beer, or 4 ml of wine per&nbsp;dose.&nbsp;Harmful to people suffering from alcoholism.&nbsp;Attention should be paid to high-risk groups such as patients with liver disease or&nbsp;epilepsy.<br><\/p>\n\n\n\n<p><strong>Fulvestrant Accord contains 500 mg benzyl alcohol per&nbsp;injection<\/strong>, equivalent to 100 mg\/ml.<\/p>\n\n\n\n<p>Benzyl alcohol can cause allergic reactions.&nbsp;If you have had liver or kidney problems, talk to 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;).<br><\/p>\n\n\n\n<p><strong>Fulvestrant Accord contains 750 mg benzyl benzoate per&nbsp;injection<\/strong>, equivalent to 150 mg\/ml.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Fulvestrant Accord<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<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>Your doctor or nurse will give you Fulvestrant Accord as a slow&nbsp;intramuscular&nbsp;injection, one in each buttock.<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>You may need immediate medical attention if you get any of the following side effects:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue,,&nbsp;and\/or throat which may be a sign of anaphylactic reactions<\/li><li>Thromboembolism (increased risk of blood clots) *<\/li><li>Inflammation of the liver (&nbsp;hepatitis&nbsp;)<\/li><li>Liver failure<\/li><\/ul>\n\n\n\n<p><strong>Tell your doctor or pharmacist if you experience the following&nbsp;side effects&nbsp;are<\/strong>&nbsp;:<br><\/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>Injection site reactions, such as pain and\/or 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>Hemorrhoids<\/li><li>Rash<\/li><li>Allergic reactions (&nbsp;hypersensitivity reactions&nbsp;) reaction, including swelling of the face, lips, tongue,, and\/or throat<\/li><\/ul>\n\n\n\n<p><strong>Other side effects:<\/strong><br><\/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>Headache<\/li><li>Vomiting, diarrhea, or decreased appetite *<\/li><li>Urinary tract infection<\/li><li>Back pain *<\/li><li>Elevation of&nbsp;bilirubin&nbsp;(a bile pigment produced by the liver)<\/li><li>Thromboembolism (increased risk of blood clots) *<\/li><li>Decreased&nbsp;platelet count&nbsp;(&nbsp;thrombocytopenia&nbsp;)<\/li><li>Vaginal 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<\/strong>&nbsp;(may affect up to 1 in 100 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Thick whitish&nbsp;vaginal discharge&nbsp;and fungal infection<\/li><li>Anaphylactic reactions<\/li><li>Bruising and bleeding at the injection site<\/li><li>Increase in gamma \u2011 GT, a liver enzyme seen in a blood test<\/li><li>Inflammation of the liver (&nbsp;hepatitis&nbsp;)<\/li><li>Liver failure<\/li><li>Numbness, tingling,, and pain<\/li><li>* Includes&nbsp;side effects&nbsp;for which the exact effect of fulvestrant cannot be assessed due to the underlying disease.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store the Fulvestrant Accord<\/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 EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Store and transport refrigerated (2 \u00b0 C \u2011 8 \u00b0 C).<br><\/p>\n\n\n\n<p>Deviations outside the temperature range 2 \u00b0 C \u2011 8 \u00b0 C must be limited.&nbsp;This includes avoiding storage at temperatures exceeding 30 \u00b0 C and not exceeding a period of 28 days where the average storage temperature of the product is below 25 \u00b0 C (but above 2 \u00b0 C \u2011 8 \u00b0 C).&nbsp;After temperature deviations, the product must be returned immediately to the recommended storage conditions (stored and transported refrigerated, 2 \u00b0 C \u2011 8 \u00b0 C).&nbsp;Temperature deviations have a cumulative effect on product quality and the time period of 28 days must not be exceeded during the entire shelf life of 2 years for Fulvestrant Accord.&nbsp;Exposure to temperatures below 2 \u00b0 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 the Fulvestrant Accord.<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<ul class=\"wp-block-list\"><li>The active substance is fulvestrant.&nbsp;Each pre-filled&nbsp;syringe&nbsp;(5 ml) contains 250 mg fulvestrant.<\/li><li>The other ingredients (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate and castor oil, refined.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Fulvestrant Accord is a clear, colorless to yellow,&nbsp;viscous&nbsp;solution.<br><\/p>\n\n\n\n<p>Fulvestrant Accord is supplied in a&nbsp;clear type I glass&nbsp;pre-filled&nbsp;syringe&nbsp;with a rubber stopper flask and plunger rod, with safety closure, containing 250 mg fulvestrant in 5 ml solution.<br><\/p>\n\n\n\n<p>A protected needle (BD SafetyGlide\u00ae) is also provided for connection to the syringe.<br><\/p>\n\n\n\n<p>Fulvestrant Accord is available in a package with two pre-filled syringes for single use.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>In&nbsp;<\/strong><strong>nnehavare Authorization<\/strong><\/p>\n\n\n\n<p>Accord Healthcare BV<\/p>\n\n\n\n<p>Winthontlaan 200<\/p>\n\n\n\n<p>3526 KV Utrecht<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Actavis Italy SpA<\/p>\n\n\n\n<p>Via Louis Pasteur 10<\/p>\n\n\n\n<p>Nerviano, MI, 20014<\/p>\n\n\n\n<p>Italy<br><\/p>\n\n\n\n<p>Accord Healthcare Limited<\/p>\n\n\n\n<p>Sage House, 319 Pinner Road<\/p>\n\n\n\n<p>North Harrow, Middlesex, HA1 4HF<\/p>\n\n\n\n<p>UK<br><\/p>\n\n\n\n<p>or<br><\/p>\n\n\n\n<p>Accord Healthcare Polska Sp.z oo<\/p>\n\n\n\n<p>ul.&nbsp;Lutomierska 50<\/p>\n\n\n\n<p>95-200 Pabianice<\/p>\n\n\n\n<p>Poland<br><\/p>\n\n\n\n<p>or<br><\/p>\n\n\n\n<p>Pharmadox Healthcare Ltd.<\/p>\n\n\n\n<p>KW20A Kordin Industrial Park<\/p>\n\n\n\n<p>Paola, PLA 3000, Malta<br><\/p>\n\n\n\n<p>or<br><\/p>\n\n\n\n<p>Accord Healthcare BV<\/p>\n\n\n\n<p>Winthontlaan 200<\/p>\n\n\n\n<p>3526 KV Utrecht<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p> 250 mg solution for injection in a 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":[2267,2385,2386,2384,2268,2215,2216,2212,2213,2269],"class_list":["post-9110","post","type-post","status-publish","format-standard","hentry","category-f","category-medicines","tag-fulvestrant-accord","tag-fulvestrant-doses","tag-fulvestrant-side-effects","tag-fulvestrant-uses","tag-how-to-use-fulvestrant-accord","tag-injection","tag-injections","tag-medicine","tag-medicines","tag-side-effects-of-fulvestrant-accord"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9110","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=9110"}],"version-history":[{"count":6,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9110\/revisions"}],"predecessor-version":[{"id":9951,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9110\/revisions\/9951"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=9110"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=9110"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=9110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}