250, 500, 750, 1000, 1500, 2000, 3000, 4000 IU\u00a0powder and solvent for\u00a0injection\u00a0, solution\u00a0
efmoroctocog alpha (alpha efmoroctocogum) (\u00a0recombinant\u00a0coagulation factor\u00a0VIII)<\/p>\n\n\n\n
ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII Fc fusion protein. Factor VIII is a protein that is produced naturally in the body and which is necessary for the blood to be able to clot and stop bleeding.
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ELOCTA is a medicine used to treat and prevent bleeding in patients of all ages with hemophilia A (hereditary hemophilia due to factor VIII deficiency ).
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ELOCTA is produced by recombinant technology without the addition of any human or animal components in the manufacturing process.
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How ELOCTA works<\/strong><\/p>\n\n\n\n Patients with hemophilia A do not have factor VIII or the factor does not work properly. ELOCTA is used to replace the missing or malfunctioning factor VIII. ELOCTA increases the level of factor VIII in the blood and temporarily corrects the bleeding tendency. Talk to your doctor, pharmacist, or nurse before using ELOCTA.<\/p>\n\n\n\n Cardiovascular events<\/em><\/strong><\/p>\n\n\n\n If you have heart disease or are at risk of heart disease, you should be especially careful when using factor VIII medicines and talk to your doctor. Catheter-related complications<\/em><\/strong><\/p>\n\n\n\n If you need a central venous catheter (CVK) device, the risk of CVK-related complications in the form of local infections, the presence of bacteria in the blood, and blood clots at the site of the catheter should be considered. Documentation<\/em><\/strong><\/p>\n\n\n\n It is strongly recommended that the product name and batch number be noted each time ELOCTA is given.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. No effects on the ability to drive and use machines have been observed.<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.<\/p>\n\n\n\n However, depending on your body weight and dose, you may receive more than one vial. This should be considered if you have been prescribed a low-sodium diet. Treatment with ELOCTA is initiated by a physician experienced in the management of patients with hemophilia. Always use this medicine exactly as your doctor has told you (see section 7). If you are not sure, talk to your doctor, pharmacist, or nurse. ELOCTA is given as an injection into a vein. The doctor calculates the dose of ELOCTA (in international units or “IU”) depending on your individual needs for replacement therapy with Factor VIII and if the drug is used to prevent or treat bleeding. Talk to your doctor if you think your bleeding is not being controlled with the dose you are given. How often you need an injection depends on how well ELOCTA works for you. Your doctor will take appropriate laboratory tests to make sure you have enough factor VIII in your blood. Treatment of bleeding<\/strong><\/p>\n\n\n\n Dose one of ELOCTA is calculated based on your body weight and the level of factor VIII to be achieved. The target level for factor VIII depends on how severe the bleeding is and where it occurs. Prevention of bleeding<\/strong><\/p>\n\n\n\n The usual dose of ELOCTA is 50 IU per kg body weight, given every 3 to 5 days. Your doctor may adjust a dose between 25 and 65 IU per kg body weight. In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary.<\/p>\n\n\n\n ELOCTA can be used for children and young people of all ages. In children under 12 years of age, higher doses or more frequent injections may be needed.<\/p>\n\n\n\n Talk to your doctor as soon as possible. You should always use ELOCTA according to your doctor’s instructions. If you are not sure, talk to your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Do not take a double dose to make up for a forgotten dose. Take a dose as soon as you remember and then return to your normal dosing schedule. Ask your doctor or pharmacist if you are not sure what to do.<\/p>\n\n\n\n Do not stop using ELOCTA without consulting your doctor. If you stop using ELOCTA you may no longer be protected against bleeding or ongoing bleeding will not stop. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. If severe, sudden allergic reactions ( anaphylactic reaction ) occur, injection must be stopped immediately. You must contact a doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, skin rash, itching all over the body, hives, pressure on the chest, difficulty breathing, burning and tingling at the injection site, chills, hot flushes, headache, low blood pressure, general malaise, nausea, restlessness, and rapid heartbeat, dizziness or loss of consciousness. Among children previously untreated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients). However, for patients who have previously been treated with factor VIII (treatment for more than 150 days), the risk is less and the complication is less common (occurs in less than 1 in 100 users). With the development of antibodies, the drugs may stop working properly, and you may experience persistent bleeding. If this happens, consult a doctor immediately. The following side effects may occur with this medicine. Uncommon side effects (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n Headache, dizziness, taste change, slow heartbeat, high blood pressure, hot flashes, vascular pain after injection, cough, lower abdominal pain, rash, joint swelling, muscle aches, back pain, joint pain, general discomfort, chest pain, feeling cold and low blood pressure. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and vial label after \u201cEXP\u201d. The expiration date is the last day of the specified month. Do not use this medicine if it has been stored at room temperature for more than 6 months. Store in a refrigerator (2 \u00b0 C \u2011 8 \u00b0 C).<\/p>\n\n\n\n Do not freeze.<\/p>\n\n\n\n Store in the original package. Sensitive to light. Alternatively, ELOCTA can be stored at room temperature (maximum 30 \u00b0 C) for a continuous period of a maximum of 6 months. Make a note of the date when ELOCTA is removed from the refrigerator to room temperature on the carton. After storage at room temperature, the medicine must not be set in the refrigerator again. Prepared ELOCTA should be used immediately. If you can not use the reconstituted solution with ELOCTA immediately, it should be used within 6 hours. Do not set the reconstituted solution in the refrigerator. Protect the reconstituted solution from direct sunlight. The reconstituted solution will be ready to slightly pearlescent and colorless. Do not use this medicine if you notice that it is cloudy or contains visible particles. Dispose of any remaining solution appropriately. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n ELOCTA is supplied as a powder and solvent for solution for injection. The powder is a white to off-white powder or cake. The liquid provided for the preparation of the solution for injection is a clear, colorless liquid. After reconstitution, the liquid to be injected is clear to slightly pearlescent and colorless. One pack of ELOCTA contains 1 vial of powder, 3 ml of liquid in a pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 patches, and 1 gauze swab.<\/p>\n","protected":false},"excerpt":{"rendered":" ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII Fc fusion protein. Factor VIII is a protein that is produced naturally in the body and which is necessary for the blood to be able to clot and stop bleeding.<\/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":[2205,2200],"tags":[4527,4530,4531,4529,4532,4535,4536,4534,2213,4528,4533],"class_list":["post-8027","post","type-post","status-publish","format-standard","hentry","category-e","category-medicines","tag-efmoroctocog-alpha","tag-efmoroctocog-alpha-injection","tag-efmoroctocog-alpha-powder","tag-efmoroctocog-alpha-side-effects","tag-elocta","tag-elocta-injection","tag-elocta-powder","tag-elocta-side-effects","tag-medicines","tag-what-is-efmoroctocog-alpha","tag-whati-is-elocta"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8027","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=8027"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8027\/revisions"}],"predecessor-version":[{"id":10650,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8027\/revisions\/10650"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
<\/p>\n\n\n\n2. What you need to know before using ELOCTA<\/h2>\n\n\n\n
Do not use ELOCTA:<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nOther medicines and ELOCTA<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
ELOCTA contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use ELOCTA<\/h2>\n\n\n\n
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<\/p>\n\n\n\nUse for children and adolescents<\/h2>\n\n\n\n
If you use more ELOCTA then you should<\/h2>\n\n\n\n
If you forget to use ELOCTA<\/h2>\n\n\n\n
If you stop using ELOCTA<\/h2>\n\n\n\n
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store ELOCTA<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
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