AJOVY is a medicine that contains the active substance fremanezumab; a monoclonal antibody, ie a type of protein that recognizes and binds to a specific target in the body.<\/p>\n\n\n\n
How AJOVY works<\/strong><\/p>\n\n\n\n In migraines, a substance in the body, a so-called calcitonin-related peptide (CGRP), plays an important role. Fremanezumab binds to CGRP and prevents it from working. The reduced CGRP activity in turn leads to fewer migraine attacks. What AJOVY is used for<\/strong><\/p>\n\n\n\n AJOVY is used to prevent migraines in adults who have at least 4 days of migraines per month. What are the benefits of using AJOVY?<\/strong><\/p>\n\n\n\n AJOVY provides fewer migraine attacks and fewer days with headaches. This drug also alleviates the disability associated with migraines and reduces the need for drugs used to treat migraine attacks.<\/p>\n\n\n\n <\/p>\n\n\n\n Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6). Talk to a doctor, pharmacist, or nurse if you experience symptoms of an allergic reaction, e.g. difficulty breathing, swelling of the lips, and heavy or severe skin rash after injecting AJOVY. Tell your doctor if you have or have had cardiovascular disease (problems affecting your heart and blood vessels) before using this medicine as AJOVY has not been studied in patients with certain cardiovascular diseases.<\/p>\n\n\n\n AJOVY 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 Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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. You should not use AJOVY during pregnancy as the effect of this medicine on pregnant women is unknown. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine. You and your doctor should decide if you should use AJOVY while breast-feeding. This medicine is not expected to affect your ability to drive or use machines. This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. AJOVY is injected under the skin ( subcutaneous injection ). The doctor or nurse will explain to you or your healthcare provider how to give an injection. Do not inject AJOVY until you or your healthcare provider have been instructed by your doctor or nurse. Read the “Instructions for use” for the pre-filled pen carefully before using AJOVY. How much and when to inject<\/strong><\/p>\n\n\n\n Your doctor will discuss with you and decide on the most appropriate dosing schedule. There are two recommended dosing options:<\/p>\n\n\n\n If your dose is 675 mg, you should inject the three 225 mg injections one after the other but at different injection sites. Use some form of reminder such as taking a note in a calendar or diary to remember when to take the next dose, so that you do not miss a dose or take a dose too soon after the last dose.<\/p>\n\n\n\n If you have used more AJOVY than you should, tell your doctor.<\/p>\n\n\n\n If you miss a dose of AJOVY, inject the missed dose as soon as you can. Do not take a double dose to make up for a forgotten dose. If you are not sure when to inject AJOVY, talk to a doctor, pharmacist, or nurse. 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.<\/p>\n\n\n\n The following mild to moderate, short-term local skin reactions may occur around the injection site: Very common (may affect more than 1 user in 10)<\/em><\/p>\n\n\n\n Pain, hardening, or redness at the injection site<\/p>\n\n\n\n Common (may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\n Itching at the injection site Uncommon (may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\n Skin rash at the injection site<\/p>\n\n\n\n Hypersensitivity reactions, such as skin rash, swelling, or hives (see section 2)<\/p>\n\n\n\n <\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. <\/p>\n\n\n\n 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 pen label and carton after EXP. The expiration date is the last day of the specified month. Store in a refrigerator (2 \u00b0 C \u2011 8 \u00b0 C). Do not freeze.<\/p>\n\n\n\n Keep the pre-filled pen in the outer carton. Sensitive to light. This medicine can be taken out of the refrigerator and stored at a maximum of 25 \u00b0 C for a maximum period of 24 hours. The medicine must be discarded if it has been stored outside the refrigerator for more than 24 hours. Do not use this medicine if you notice that the outer carton has been tampered with, the pen has been damaged, or if the medicine is cloudy, discolored, or contains particles. The pen is for single use only. 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. AJOVY is an injection solution ( for injection ) in a pre-filled pen disposable. AJOVY is clear and colorless to a slightly yellowish solution. Each pre-filled pen contains 1.5 ml of solution. AJOVY is available in packs of 1 or 3 pre-filled pens. Not all pack sizes may be available in your country. Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n TEVA GmbH<\/p>\n\n\n\n Graf-Arco-Str. 3<\/p>\n\n\n\n 89079 Ulm<\/p>\n\n\n\n Germany Manufacturer<\/strong><\/p>\n\n\n\n Merckle GmbH<\/p>\n\n\n\n Graf-Arco-Str. 3<\/p>\n\n\n\n 89079 Ulm<\/p>\n\n\n\n Germany Teva Pharmaceuticals Europe BV<\/p>\n\n\n\n Swensweg 5<\/p>\n\n\n\n 2031 GA Haarlem<\/p>\n\n\n\n Netherlands Contact the representative of the marketing authorization holder to find out more about this medicine:
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<\/p>\n\n\n\n2. What you need to know before using AJOVY<\/h2>\n\n\n\n
Do not use AJOVY<\/h2>\n\n\n\n
<\/p>\n\n\n\nWarnings and cautions<\/h2>\n\n\n\n
<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and AJOVY<\/h2>\n\n\n\n
<\/p>\n\n\n\nPregnancy and breastfeeding<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nAJOVY contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use AJOVY<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you use more AJOVY than you should <\/h2>\n\n\n\n
If you forget to use AJOVY<\/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 AJOVY<\/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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<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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