{"id":5513,"date":"2020-12-21T14:58:07","date_gmt":"2020-12-21T14:58:07","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5513"},"modified":"2021-07-24T08:31:18","modified_gmt":"2021-07-24T08:31:18","slug":"apealea","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/apealea\/","title":{"rendered":"Apealea &#8211; Paclitaxel uses, dose and side effects"},"content":{"rendered":"\n<p>60 mg&nbsp;powder for&nbsp;infusion&nbsp;solution<br>paclitaxel<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Apealea is and what it is used for<\/h2>\n\n\n\n<p>Apealea is a cancer drug and contains the active substance paclitaxel, which belongs to a group of drugs called taxanes.&nbsp;Paclitaxel affects or inhibits the growth of rapidly dividing cells, such as tumor cells.<\/p>\n\n\n\n<p>Apealea is used to&nbsp;<strong>treat the<\/strong>&nbsp;following&nbsp;<strong>cancers<\/strong>&nbsp;in adults, in combination with another medicine called carboplatin:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>epithelial ovarian cancer &#8211; a cancer of the ovaries (the organ that produces ova in women)<\/li><li>primary peritoneal cancer &#8211; a cancer of the peritoneum (the membrane that sits between the abdominal wall and the internal organs)<\/li><li>cancer of the fallopian tubes (the connection between the ovaries and the uterus).<\/li><\/ul>\n\n\n\n<p>It is used when other treatments have not worked.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you get Apealea<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Apealea<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are breast-feeding<\/li><li>if the number of neutrophilic&nbsp;leukocytes&nbsp;(a type of&nbsp;white blood cell&nbsp;) is below 1.5 \u00d7 10&nbsp;<sup>9<\/sup>&nbsp;\/ l before the start of treatment.<\/li><\/ul>\n\n\n\n<p>Talk to a doctor or nurse if you are unsure if any of the above apply to you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to&nbsp;<strong>your<\/strong>&nbsp;doctor or nurse&nbsp;<strong>before receiving<\/strong>&nbsp;Apealea if you:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>has hepatic, renal, or cardiac impairment &#8211; Apealea is not recommended for patients with severe hepatic or renal impairment<\/li><li>previously had nausea, vomiting, and diarrhea during cancer treatment.<\/li><\/ul>\n\n\n\n<p>Contact your doctor immediately if you&nbsp;<strong>during treatment<\/strong>&nbsp;must<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fever, pain, chills, feeling weak or other signs of&nbsp;infection<\/li><li>severe nausea, vomiting, or diarrhea<\/li><li>severe reactions at the infusion site<\/li><li>an&nbsp;allergic reaction<\/li><li>numbness, tingling, stinging sensation, sensitivity to touch, or muscle weakness.<\/li><\/ul>\n\n\n\n<p>You may need additional medication if you get any of these symptoms.&nbsp;Your doctor may want to postpone further treatment with Apealea or reduce the&nbsp;dose.<\/p>\n\n\n\n<p>Ask your doctor or nurse about hair loss and what can be done to avoid it.<br><\/p>\n\n\n\n<p>You will be closely monitored during treatment<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>with regular blood tests to ensure that it is safe for you to continue treatment<\/li><li>regarding symptoms of&nbsp;an allergic reaction&nbsp;during&nbsp;infusion&nbsp;one, e.g.<ul><li>redness&nbsp;and swelling at the infusion site<\/li><li>low&nbsp;blood pressure<\/li><li>breathing difficulties<\/li><li>facial swelling.<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Apealea is not recommended for children and adolescents under 18 years of age, as it has not been studied in this age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Apealea<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.<br><\/p>\n\n\n\n<p>In particular, talk to your doctor or nurse before receiving Apealea if you are using the following medicines:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Ketoconazole&nbsp;or other medicines used to treat fungal infections.<\/li><li>Erythromycin, rifampicin: drug for the treatment of bacterial infections.<\/li><li>Fluoxetine: a drug used to treat depression.<\/li><li>Gemfibrozil: a drug used to lower blood fats.<\/li><li>Clopidogrel: a drug that reduces the risk of getting blood clots.<\/li><li>Cimetidine: a drug to reduce stomach acid.<\/li><li>Efavirenz, nevirapine, ritonavir, saquvinavir, indinavir, nelfinavir: medicines used to treat HIV infection.<\/li><li>Carbamazepine, phenytoin: drug for the treatment of&nbsp;epilepsy&nbsp;and certain pain conditions.<\/li><li>Cisplatin: a drug used to treat cancer.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>Tell your doctor before treatment if you are pregnant, think you may be pregnant, or breast-feeding.<br><\/p>\n\n\n\n<p>Apealea&nbsp;<strong>is not recommended during pregnancy<\/strong>, as paclitaxel may cause serious malformations.&nbsp;Patients who may become pregnant should use an effective contraceptive during treatment with Apealea and for six months afterward.<br><\/p>\n\n\n\n<p><strong>Stop breastfeeding<\/strong>&nbsp;while receiving the treatment, as paclitaxel passes into breast milk and may harm the baby.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Apealea can cause&nbsp;side effects&nbsp;such as fatigue or dizziness that may reduce your ability to drive or use machines.&nbsp;Do not drive or use machines if you have these symptoms.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Apealea contains sodium<\/h2>\n\n\n\n<p>After&nbsp;reconstitution, this medicinal&nbsp;product&nbsp;contains up to approximately 1.6 g&nbsp;sodium&nbsp;(the main ingredient in table salt\/table salt) per&nbsp;dose.&nbsp;This corresponds to 80% of the highest recommended daily intake of&nbsp;sodium&nbsp;for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to get Apealea<\/h2>\n\n\n\n<p>You get Apealea from a doctor or nurse by slow drip (&nbsp;infusion&nbsp;) into a vein.&nbsp;This will take about an hour.&nbsp;Dose&nbsp;one is based on your body surface area (calculated from your height and weight) and blood test results.&nbsp;The usual&nbsp;dose&nbsp;is 250 mg \/ m&nbsp;<sup>2<\/sup>&nbsp;body surface area, which is given every three weeks for up to six treatments.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor 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>Tell your doctor or nurse immediately<\/strong>&nbsp;if you get any of the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Very common<\/strong>&nbsp;(may affect&nbsp;<strong>more than 1<\/strong>&nbsp;user in&nbsp;<strong>10<\/strong>&nbsp;):<ul><li>nerve disorders in the arms and legs, causing tingling, numbness, or burning. *<\/li><\/ul><\/li><li><strong>Common<\/strong>&nbsp;(may affect&nbsp;<strong>up to 1 in 10<\/strong>&nbsp;people):<ul><li>fever<\/li><li>muscle weakness, cramps, or&nbsp;spasm&nbsp;are<\/li><li>allergic reactions, such as difficulty breathing, fainting, swelling of the face,&nbsp;itching, feeling hot, chills, especially during your&nbsp;infusion.&nbsp;In rare cases, these can lead to severe allergic&nbsp;shock.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>* May persist for more than six months after stopping paclitaxel use.<br><\/p>\n\n\n\n<p>Other&nbsp;side effects&nbsp;include their frequency:<\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(may affect&nbsp;<strong>more than 1<\/strong>&nbsp;user in&nbsp;<strong>10<\/strong>&nbsp;):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>the low number of neutrophilic&nbsp;leukocytes&nbsp;(a kind of&nbsp;white blood cell&nbsp;)<\/li><li>loss of appetite<\/li><li>diarrhea, nausea, vomiting<\/li><li>hair loss<\/li><li>pain or discomfort in joints or muscles<\/li><li>feeling weak, tired<\/li><li>infusion site reactions such as pain,&nbsp;inflammation, discoloration,&nbsp;redness, swelling, tingling, rash, bleeding.<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect&nbsp;<strong>up to 1 in 10<\/strong>&nbsp;people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>the low number of&nbsp;leukocytes&nbsp;and&nbsp;granulocytes&nbsp;(a type of&nbsp;white blood cell&nbsp;)<\/li><li>low&nbsp;platelet count&nbsp;(&nbsp;platelets&nbsp;) or&nbsp;red blood cells<\/li><li>reduced sensitivity to touch<\/li><li>abnormal sensory impressions such as tingling, burning, tingling, or numb skin or mouth<\/li><li>dizziness or a feeling of dizziness<\/li><li>taste disturbance<\/li><li>headache<\/li><li>fast heartbeat<\/li><li>discomfort or pain in the chest<\/li><li>low&nbsp;blood pressure,&nbsp;redness&nbsp;(&nbsp;flushing&nbsp;), phlebitis, vensm\u00e4rta, increased blood flow to parts of the body<\/li><li>difficulty breathing, nasal congestion<\/li><li>abdominal pain, constipation, flatulence<\/li><li>dry mouth,&nbsp;inflammation&nbsp;of the oral&nbsp;mucosa<\/li><li>redness, rash,&nbsp;itching,&nbsp;hives<\/li><li>pain in e.g. arms, legs, chest or at the&nbsp;tumor&nbsp;a<\/li><li>back pain, skeletal pain<\/li><li>swelling of the ankles, feet, face, or fingers.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect&nbsp;<strong>up to 1 in 100<\/strong>&nbsp;people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>blood poisoning<\/li><li>was in body tissue<\/li><li>pneumonia,&nbsp;influenza,&nbsp;inflammation&nbsp;of the tonsils<\/li><li>herpes&nbsp;simplex (a viral infection), respiratory infections<\/li><li>urinary tract infection,&nbsp;inflammation&nbsp;of the bladder<\/li><li>skin infections, including&nbsp;infection&nbsp;at the infusion site<\/li><li>coagulation problems (when the blood clots)<\/li><li>lack of white and&nbsp;red blood cells&nbsp;and&nbsp;platelets<\/li><li>low levels of&nbsp;potassium,&nbsp;magnesium,&nbsp;or&nbsp;sodium<\/li><li>severe fluid loss (&nbsp;dehydration&nbsp;)<\/li><li>allergic reactions to other drugs, such as&nbsp;penicillin<\/li><li>depression, insomnia, anxiety\/worry<\/li><li>an epileptic seizure lasting longer than five minutes or more than one seizure within five minutes<\/li><li>coma, to feel very sleepy, drowsy, and\/or to be severely unaffected<\/li><li>low muscle tension, facial paralysis<\/li><li>toxic effects on the nervous system<\/li><li>cognitive&nbsp;disorder (difficulty thinking or processing thoughts, difficulty remembering)<\/li><li>brain damage, abnormal fluid accumulation inside the brain<\/li><li>stroke<\/li><li>blurred vision, eye problems or irritation, watery eyes<\/li><li>deafness, inner ear disorder,&nbsp;tinnitus&nbsp;(ringing in the ears)<\/li><li>vascular disorders, such as<ul><li>formation of blood clots<\/li><li>vascular inflammation<\/li><li>accumulation of water in&nbsp;the tissue&nbsp;due to blocked lymphatic vessels<\/li><li>hot flashes<\/li><li>bleeding<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>cardiac arrest,&nbsp;heart failure<\/li><li>bluish discoloration of lips or skin<\/li><li>atrial fibrillation&nbsp;(a disorder of the heart rhythm caused by irregular, rapid activity in the atria of the heart)<\/li><li>to feel their heartbeat (&nbsp;palpitation&nbsp;er), slow heartbeat<\/li><li>blood circulation failure<\/li><li>high&nbsp;blood pressure, changes in blood pressure, pallor<\/li><li>pulmonary embolism, narrowing of the airways<\/li><li>severe hypoxia due to abnormal breathing<\/li><li>difficulty producing voice sounds<\/li><li>nosebleeds, allergic&nbsp;inflammation&nbsp;inside the nose, runny nose<\/li><li>cough<\/li><li>pain or discomfort in the mouth and throat, sore throat, bleeding gums<\/li><li>inflammation&nbsp;of the abdominal wall, discomfort or swelling in the abdomen, lower abdominal pain<\/li><li>poor digestion, disturbed bowel function, very hard stools, bloody stools<\/li><li>inflammation&nbsp;or disorder of the liver, elevated liver enzymes in the blood<\/li><li>painful severe swelling in deep layers of skin, mainly on the face<\/li><li>skin discoloration, pigmentation disorder<\/li><li>dermatitis with blisters<\/li><li>increased sweating, cold sweats<\/li><li>dry skin, nail effect<\/li><li>bleeding in one joint<\/li><li>the feeling of heaviness in the legs<\/li><li>multi-organ failure that can lead to death<\/li><li>tissue swelling caused by excess fluid<\/li><li>hernia (&nbsp;hernia&nbsp;)<\/li><li>feeling of warmth<\/li><li>low body temperature<\/li><li>vaginal&nbsp;bleeding<\/li><li>abnormally high levels of substances that contain nitrogen in the blood.<\/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>redness&nbsp;and swelling of the palms and soles of the feet which can lead to the skin flaking.<\/li><\/ul>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Apealea<\/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 vial label and carton after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p><strong>O&nbsp;<\/strong><strong>opened vials:<\/strong>&nbsp;Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Keep the vial in the outer carton.&nbsp;Sensitive to light.<br><\/p>\n\n\n\n<p><strong>After opening<\/strong>, it is recommended that Apealea be used immediately.<br><\/p>\n\n\n\n<p>Any unused product or waste material should be disposed of in accordance with local requirements.&nbsp;Medicines should not be disposed of via wastewater or household waste.&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 paclitaxel.&nbsp;Each&nbsp;vial&nbsp;contains 60 mg paclitaxel.&nbsp;After&nbsp;reconstitution, each milliliter solution contains 1 mg paclitaxel (micellar).<\/li><li>Other ingredients:<ul><li><em>N<\/em>&nbsp;&#8211; (&nbsp;<i>all-tr<\/i>ans&nbsp;pinoresinol) \u2011L \u2011 cysteic acid methyl ester sodium salt<\/li><li><em>N<\/em>&nbsp;&#8211; (13\u2011&nbsp;<em>cis<\/em>&nbsp;\u2011retinol) \u2011L \u2011 cysteic acid methyl ester sodium salt<\/li><li>sodium hydroxide (for&nbsp;pH&nbsp;adjustment)<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>See section 2 &#8220;Apealea contains sodium&#8221;.<\/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>Apealea is supplied as a greenish-yellow to yellow powder in a&nbsp;glass&nbsp;vial&nbsp;with a rubber stopper and aluminum seal.<br><\/p>\n\n\n\n<p>Each carton contains 1&nbsp;glass&nbsp;vial&nbsp;with a powder equivalent to 60 mg paclitaxel.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Oasmia Pharmaceutical AB<\/p>\n\n\n\n<p>Contact the marketing authorization holder to find out more about this medicine.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Apealea is a cancer drug and contains the active substance paclitaxel, which belongs to a group of drugs called taxanes. Paclitaxel affects or inhibits the growth of rapidly dividing cells, such as tumor cells.<\/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":[2201,2200],"tags":[10254,10257,10249,10252,10258,10253,10256,10255,10250,10251],"class_list":["post-5513","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-apealea","tag-apealea-powder","tag-paclitaxel","tag-paclitaxel-powder","tag-side-effects-of-apealea","tag-side-effects-of-paclitaxel","tag-what-apealea-is-used-for","tag-what-is-apealea","tag-what-is-paclitaxel","tag-what-paclitaxel-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5513","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=5513"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5513\/revisions"}],"predecessor-version":[{"id":12575,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5513\/revisions\/12575"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5513"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5513"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5513"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}