{"id":9112,"date":"2021-03-25T09:58:13","date_gmt":"2021-03-25T09:58:13","guid":{"rendered":"https:\/\/zeepedia.com\/?p=9112"},"modified":"2021-04-12T14:15:25","modified_gmt":"2021-04-12T14:15:25","slug":"fulvestrant-glenmark","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/fulvestrant-glenmark\/","title":{"rendered":"Fulvestrant Glenmark &#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 Glenmark is and what it is used for<\/h2>\n\n\n\n<p>Fulvestrant Glenmark 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 Glenmark 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 luteinizing hormone-releasing&nbsp;hormone&nbsp;(LHRH)&nbsp;agonist.<\/li><\/ul>\n\n\n\n<p>When Fulvestrant Glenmark 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 Glenmark may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or another 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 Glenmark<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Fulvestrant Glenmark<\/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>If any of the following applies to you, talk to your doctor, pharmacist, or nurse before using Fulvestrant Glenmark:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><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 Glenmark 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 Glenmark<\/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 if you are&nbsp;taking anticoagulants&nbsp;(medicines that prevent blood clots).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>You must not use Fulvestrant Glenmark if you are pregnant.&nbsp;If you can get pregnant, you should use an effective contraceptive during treatment with Fulvestrant Glenmark and for 2 years after the last&nbsp;dose.<br><\/p>\n\n\n\n<p>You must not breast-feed when you are being treated with Fulvestrant Glenmark.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Fulvestrant Glenmark 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 Glenmark contains excipients<\/h2>\n\n\n\n<p><strong>Fulvestrant Glenmark contains 500 mg alcohol (&nbsp;ethanol&nbsp;)<\/strong>&nbsp;&nbsp;per&nbsp;injection&nbsp;equivalent to 100 mg \/ ml (10% w \/ v).&nbsp;The amount in each&nbsp;injection&nbsp;of this medicine corresponds to 13 ml of beer or 5 ml of wine.<br><\/p>\n\n\n\n<p>The amount of alcohol in this medicine is unlikely to have any effects on adults and adolescents.<br><\/p>\n\n\n\n<p>The alcohol in this medicine may affect the effects of other medicines.&nbsp;Tell your doctor or pharmacist if you are taking any other medicines.<br><\/p>\n\n\n\n<p>If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.<br><\/p>\n\n\n\n<p>If you are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.<br><\/p>\n\n\n\n<p><strong>Fulvestrant Glenmark contains benzyl alcohol<\/strong><\/p>\n\n\n\n<p>This medicine contains 500 mg of benzyl alcohol per pre-filled&nbsp;syringe, equivalent to 100 mg\/ml.&nbsp;Benzyl alcohol can cause allergic reactions.<br><\/p>\n\n\n\n<p>If you are pregnant or breast-feeding or have liver or kidney disease, ask your doctor or pharmacist for advice before taking this medicine.&nbsp;Large amounts of benzyl alcohol can be stored in the body and can cause&nbsp;side effects&nbsp;(metabolic&nbsp;acidosis&nbsp;).<br><\/p>\n\n\n\n<p><strong>Fulvestrant Glenmark 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 Glenmark<\/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&nbsp;injections&nbsp;of 250 mg \/ 5 ml) once a month, with an additional&nbsp;dose&nbsp;of 500 mg two weeks after the first&nbsp;dose.<br><\/p>\n\n\n\n<p>Your doctor or nurse will give you Fulvestrant Glenmark 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\">If you use more Fulvestrant Glenmark then you should&nbsp;<\/h2>\n\n\n\n<p>If you have ingested too much medicine or if e.g.&nbsp;If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/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&nbsp;, 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 and \/ or throat which may be signs 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, 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 effect&nbsp;are<\/strong>&nbsp;(may affect more than one in 10)<\/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>Hemorrhoids<\/li><li>Rash<\/li><li>Allergic (hypersensitivity) 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&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 10)<\/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&nbsp;(increased risk of blood clots) *<\/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;)<br><\/li><\/ul>\n\n\n\n<p><strong>Less common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 100)<\/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>Inflammation of the liver (&nbsp;hepatitis&nbsp;)<\/li><li>Liver failure<\/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 Fulvestrant Glenmark can not be assessed on<\/p>\n\n\n\n<p>due to the underlying disease.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Fulvestrant Glenmark<\/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 and on the syringe label after &#8220;EXP&#8221;.&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 \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-8 \u00b0 C. After temperature deviations, the product should return immediately to the recommended storage conditions (stored and transported cold, 2 \u00b0 C-8 \u00b0 C) Temperature deviations have a cumulative effect on product quality and the 28-day time period must not be exceeded during the entire 2-year shelf life of Fulvestrant Glenmark. \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 pre-filled syringe in the original package.&nbsp;Sensitive to light.<br><\/p>\n\n\n\n<p>Healthcare professionals are responsible for the proper storage, use and disposal of Fulvestrant Glenmark.<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&nbsp;ethanol&nbsp;(96 percent), benzyl alcohol (E 1519), 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 Glenmark is a clear, colorless to yellow,&nbsp;viscous&nbsp;solution in a pre-filled&nbsp;syringe&nbsp;containing 5 ml&nbsp;solution for injection&nbsp;.&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 Glenmark is available in three pack sizes, one pack containing 1 pre-filled&nbsp;syringe&nbsp;, one pack containing 2 pre-filled syringes and one pack containing 6 pre-filled syringes.&nbsp;1, 2 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><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Glenmark Arzneimittel GmbH<\/p>\n\n\n\n<p>Industriestr.&nbsp;31<\/p>\n\n\n\n<p>82194 Gr\u00f6benzell<\/p>\n\n\n\n<p>Germany<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Laboralios Farmal\u00e1n, SA<\/p>\n\n\n\n<p>Calle La Vallina s \/ n, Edificio 2,<\/p>\n\n\n\n<p>Pol\u00edgono Industrial Navatejera,<\/p>\n\n\n\n<p>24193, Villaquilambre, Leon,<\/p>\n\n\n\n<p><\/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":[2385,2276,2386,2384,2278,2215,2216,2212,2213,2279],"class_list":["post-9112","post","type-post","status-publish","format-standard","hentry","category-f","category-medicines","tag-fulvestrant-doses","tag-fulvestrant-glenmark","tag-fulvestrant-side-effects","tag-fulvestrant-uses","tag-how-to-use-fulvestrant-glenmark","tag-injection","tag-injections","tag-medicine","tag-medicines","tag-side-effects-of-fulvestrant-glenmark"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9112","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=9112"}],"version-history":[{"count":6,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9112\/revisions"}],"predecessor-version":[{"id":9948,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9112\/revisions\/9948"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=9112"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=9112"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=9112"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}