225 mg injection, solution in prefilled pen
fremanezumab
1. What AJOVY is and what it is used for
What AJOVY is
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.
How AJOVY works
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
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?
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.
2. What you need to know before using AJOVY
Do not use AJOVY
Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
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.
Children and young people
AJOVY is not recommended for children and adolescents under 18 years of age as it has not been studied in this age group.
Other medicines and AJOVY
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
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.
Driving and using machines
This medicine is not expected to affect your ability to drive or use machines.
AJOVY contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
3. How to use AJOVY
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
Your doctor will discuss with you and decide on the most appropriate dosing schedule. There are two recommended dosing options:
- one injection (225 mg) once a month or
- three injections (675 mg) every 3 months.
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.
If you use more AJOVY than you should
If you have used more AJOVY than you should, tell your doctor.
If you forget to use AJOVY
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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)
Pain, hardening, or redness at the injection site
Common (may affect up to 1 in 10 people)
Itching at the injection site
Uncommon (may affect up to 1 in 100 people)
Skin rash at the injection site
Hypersensitivity reactions, such as skin rash, swelling, or hives (see section 2)
Reporting of side effects
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.
5. How to store AJOVY
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 ° C ‑ 8 ° C). Do not freeze.
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 ° 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is fremanezumab. Each pre-filled pen contains 225 mg of fremanezumab.
- The other ingredients are histidine, histidine hydrochloride monohydrate, sucrose, disodium edetate (‑dihydrate), polysorbate 80, water for injections.
What the medicine looks like and the contents of the pack
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 Authorization Holder and Manufacturer
Marketing Authorisation Holder
TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Teva Pharmaceuticals Europe BV
Swensweg 5
2031 GA Haarlem
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 | LithuaniaUAB Teva BalticsTel: +370 5 266 02 03 |
| BulgariaOctavis FAD Tel .: + 359 2 489 95 85 | Luxembourg / LuxemburgTEVA GmbHGermany / GermanyTel: +49 731 402 08 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 6400 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals IrelandL-IrelandTel: +353 51 321740 |
| GermanyTEVA GmbHTel .: +49 731 402 08 | The NetherlandsTeva Nederland BVTel: +31 800 022 8400 |
| EestiUAB Teva Baltics Eesti subsidiaryTel: +372 661 0801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceSpecify ABEE:Ηλ: +30 211 880 5000 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1 97 007 0 |
| SpainTeva Pharma, SLUTel: +34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| FranceTeva HealthTel: +33 1 55 91 78 00 | PortugalTeva Pharma – Pharmaceutical Products, LdaTel: +351 21 476 75 50 |
| CroatiaPliva Hrvatska dooTel: +385 1 37 20 000 IrelandTeva Pharmaceuticals IrelandTel: +353 (0) 1912 7700 | RomaniaTeva Pharmaceuticals SRLTel: +40 21 230 65 24 SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| IcelandActavis Pharmaceuticals Iceland ehf.Phone: +354 550 3300 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 57 26 79 11 |
| ItalyTeva Italia SrlTel: +39 02 89 17 98 1 | Finland / FinlandTeva Finland OyPuh / Tel: +358 20 180 5900 |
| ΚύπροςSpecify ABEEGreece:Ηλ: +30 211 880 5000 | |
| LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 673 23 666 | United KingdomTeva UK LimitedTel: +44 1977 628500 |
This leaflet was last modified 09/2020
Other sources of information
Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Instructions for use
AJOVY 225 mg solution for injection in a pre-filled pen
fremanezumab
Before using AJOVY pre-filled pen, carefully read through the step-by-step instructions below.
Important information:
- AJOVY prefilled pen is for single use only.
- Each AJOVY prefilled pen contains 225 mg fremanezumab. Depending on your prescribed dose, you will need to use 1 pre-filled pen or 3 pre-filled pens.
- AJOVY is injected under the skin ( subcutaneous injection ). You should not inject yourself until you have been trained by a doctor or nurse.
- Carefully read the leaflet for AJOVY to learn more about this medicine.
- Shake not the pre-filled pen.
- Immediately put the carton back in the refrigerator if there are unused pre-filled pens in the carton.
AJOVY prefilled pen (before use)
AJOVY prefilled pen (after use)
- The blue plunger moves down the window during the injection. The blue plunger fills the window when the injection is complete. (Note: Once the blue plunger has filled the window, you will still be able to see the gray stopper.)
- When injecting AJOVY, hold the pre-filled pen so that your hand does not cover the window.
Step 1: Prepare for an injection
a) Develop the following accessories for the injection:
- 1 or 3 AJOVY pre-filled pens for 1 or 3 injections, depending on your prescribed dose.
- 1 alcohol dryer per injection.
- 1 gauze or cotton ball per injection.
- 1 container for stinging and cutting waste.
b) Place the accessories you have developed on a clean and flat surface.
c) Wait 30 minutes for AJOVY to reach room temperature (<30 ° C) to reduce discomfort during injection.
- Do not leave the pre-filled pen in direct sunlight.
- Heat is not the pre-filled pen in the microwave or by another heat source.
d) Wash your hands with soap and water and dry them thoroughly with a clean towel.
e) Inspect AJOVY prefilled pen.
- Check the pen label. Make sure it says AJOVY on the label.
- Check that the medicine in the pencil window is clear and colorless to slightly yellowish.
- You can see small air bubbles in the pre-filled pen. This is normal.
- Do not use the pre-filled pen if you notice any of the following:
- The pen appears damaged.
- The expiration date has passed or if the pre-filled pen has been removed from the refrigerator for more than 24 hours.
- The medicine is cloudy, discolored, or contains particles.
f) Select injection site.
- Choose an injection site from the following areas:
- Abdominal area (abdomen) but avoid the area about 5 cm around the navel.
- The front of the thighs, about 5 cm above the knee and 5 cm below the groin.
- The back of the upper arm, the area with a lot of adipose tissue on the upper part of the back of the arm.
- If several injections are required, they can be given in the same area or in another area (abdomen, thighs, upper arm), but you should avoid injecting in exactly the same place.
g) Clean the injection site.
- Clean the selected injection site with a new alcohol swab.
- Allow the skin to dry for 10 seconds before injecting.
- Inject not AJOVY in an area that is tender, red, bruised, hard skin, tattoos, scars, or stretch marks.
Step 2: How to inject
a) Remove the safety guard and do not replace it.
- Pull the safety guard straight out. Do not screw.
- To prevent injury and infection, do not put the safety cap back on the pre-filled pen.
- Do not touch the needle guard or the area around it.
b) Inject by following the steps below.
- Place the pre-filled pen at a 90 ° angle to the skin at the injection site.
- Press the pre-filled pen down and hold it against the skin for approximately 30 seconds. Do not remove the pressure until the 3 steps below are complete.
c) Check that the blue plunger has filled the window and remove the pre-filled pen from the skin.
- After you have injected all the medicine – ie. when the blue plunger has filled the window and you can see the gray stopper – remove the pre-filled pen from the skin by lifting the pre-filled pen straight up and immediately place it in a container for stinging and cutting residual waste (see step 3).
- When the pre-filled pen has been lifted from the skin, the needle cover returns to its original position and locks in place so that it covers the needle.
- To prevent injury and infection, never put the safety cap back on the pre-filled pen.
d) Press the injection site.
- Use a clean, dry cotton swab or gauze cloth to gently press on the injection site for a few seconds.
- Do not rub on the injection site or reuse the pre-filled pen.
Step 3: Discard the pre-filled pen
a) Dispose of the pre-filled pen immediately.
- Place the pre-filled pens used in a stinging and cutting waste container immediately after use.
- Do not throw away pencils with household waste.
- Recycle not a container for stabbing and cutting waste.
b) Ask your doctor, pharmacist, or nurse how to dispose of the container.
If your dose is 675 mg, repeat steps 1 (e) to 3 (a) with the second and third pre-filled pens to inject the full prescribed dose.