Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fremanezumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What AJOVY is AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body. How AJOVY works A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine. Fremanezumab attaches to CGRP and prevents it from working. This reduction in CGRP's activity reduces migraine attacks. What AJOVY is used for AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month. What are the benefits of using AJOVY AJOVY reduces the frequency of migraine attacks and days with headache. This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.
2.
What you need to know before you take it
e 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 precautions Talk to your doctor, pharmacist or nurse immediately if you get any signs of a serious allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY. These reactions can occur within 24 hours after using AJOVY but can sometimes be delayed.
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Tell your doctor if you have or have had cardiovascular disease (problems affecting the heart and blood vessels) before using this medicine, because AJOVY has not been studied in patients with certain cardiovascular diseases. Children and adolescents AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group. Other medicines and AJOVY Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known. If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use AJOVY while breast-feeding. Driving and using machines This medicine is not expected to have any effect on your ability to drive or use machines. AJOVY contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially "sodium-free".
3.
How to take it
AJOVY
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. AJOVY is given by injection under your skin (subcutaneous injection). Your doctor or nurse will explain to you or your caregiver how to give the injection. Do not inject AJOVY until you or your caregiver have been trained 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 and decide with you the most appropriate dosing schedule. There are two alternative recommended dosing options:
- one injection (225 mg) once a month (monthly dosing) or
- three injections (675 mg) every 3 months (quarterly dosing) If your dose is 675 mg, inject the three injections one after another, each in a different place. Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one. If you use more AJOVY than you should If you have used more AJOVY than you should, tell your doctor. If you forget or miss to use AJOVY If you have missed a dose of AJOVY, inject your 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 your doctor, pharmacist or nurse. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 2
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can occur: Very common (may affect more than 1 in 10 people) 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) Rash at the injection site Allergic reactions such as rash, swelling or hives (see section 2) Rare (may affect up to 1 in 1000 people) Serious allergic reactions (signs may include trouble breathing, swelling of the lips, tongue or severe rash) (see section 2. "Warnings and precautions").
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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
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 on the outer carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C – 8 C). Do not freeze. Keep the pre-filled pen in the outer carton to protect the medicine from light. This medicine may be removed from the refrigerator and stored at a temperature up to 30 °C for a maximum period of up to 7 days. The medicine must be discarded if it has been out of the refrigerator for longer than 7 days. Once stored at room temperature, do not place back in the refrigerator. Do not use this medicine if you notice that the outer carton has been tampered with, the pen is damaged, or the medicine is cloudy, discoloured, or contains particles. The pen is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6.
Contents of the pack and other information
What AJOVY contains The active substance is fremanezumab. Each pre-filled pen contains 225 mg of fremanezumab. The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections. What AJOVY looks like and contents of the pack AJOVY is a solution for injection (injection) in a single-dose pre-filled pen. AJOVY is a clear, colourless to slightly yellow solution. Each pre-filled pen contains 1.5 mL solution. AJOVY is available in packs containing 1 or 3 pre-filled pens. Not all pack sizes may be available in your country. Marketing Authorisation Holder Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom Manufacturer Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
This leaflet was last revised in September 2024.
PLGB 00289/2504
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Instructions for Use AJOVY® 225 mg solution for injection in pre-filled pen fremanezumab
Before you use the AJOVY pre-filled pen, read and carefully follow the step-by-step instructions. Important information:
- The AJOVY pre-filled pen is for single use only.
- Each AJOVY pre-filled pen contains 225 mg of fremanezumab. Depending on your dose you will need to use 1 pre-filled pen or 3 pre-filled pens.
- AJOVY is injected under your skin (subcutaneous injection). You should not inject yourself until you have been trained by your doctor or nurse.
- Carefully read the AJOVY package leaflet to learn more about your medicine.
- Do not shake the pre-filled pen.
- Put the carton back in the refrigerator immediately, if you have any unused pre-filled pens in the carton. AJOVY pre-filled pen (before use)
AJOVY pre-filled pen (after use)
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• •
The blue plunger moves down the viewing window during the injection. The blue plunger fills the window when the injection is complete. (Note: When the blue plunger has filled the viewing window you will still be able to see the grey stopper.) When injecting AJOVY, hold the pre-filled pen so that your hand does not cover the viewing window.
Step 1: Getting ready for an injection a) Gather the following supplies for your injection: − 1 or 3 AJOVY pre-filled pens to enable 1 or 3 injections depending on your dose − 1 alcohol swab per injection − 1 gauze pad or cotton ball per injection − 1 sharps disposal or puncture-resistant container b) Place the supplies you have gathered on a clean, flat surface. c) Wait for 30 minutes to let AJOVY reach room temperature (<30 °C) to reduce discomfort during injection. − Do not leave the pre-filled pen in direct sunlight. − Do not warm up the pre-filled pen using a microwave or any other heat source. d) Wash your hands with soap and water and dry well with a clean towel. e) Inspect your AJOVY pre-filled pen. − Check the pen label. Make sure the name AJOVY appears on the label. − Check that the medicine in the pen viewing window looks clear and is colourless to slightly yellow. − You may see small air bubbles in the pre-filled pen. This is normal. − Do not use the pre-filled pen if you see any of the following:
- The pen looks damaged.
- The expiration date has passed or the pre-filled pen has been out of the refrigerator for longer than 7 days.
- The medicine is cloudy, discoloured, or contains particles.
f) Choose your injection area. − Choose an injection area from the following areas:
- Your stomach area (abdomen), avoid about 5 cm around the belly button
- The front of your thighs, about 5 cm above the knee and 5 cm below the groin
- The back of your upper arms, in the fleshy areas of the upper back portion − If multiple injections are required, they may be given in the same or different area (abdomen, thigh, upper arm), but you should avoid injecting in exactly the same place. 6
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g) Clean your injection area. − Clean the chosen injection area using a new alcohol swab. − Wait 10 seconds to allow the skin to dry before injecting. − Do not inject AJOVY into an area that is tender, red, hot, bruised, hardened, tattooed or that has scars or stretch marks. Step 2: How to inject a) Remove the protective cap and do not replace. − Pull the protective cap straight off. Do not twist. − Do not put the protective cap back on the pre-filled pen, to avoid injury and infection. − Do not touch the needle shield area.
b) Inject by following the steps below. −
Place the pre-filled pen at a 90° angle against your skin at the injection site.
−
Press down on the pre-filled pen and keep pressed down against the skin for about 30 seconds. Do not remove pressure until the 3 steps below are complete.
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1. You hear the first "click" (this signals the start of the injection and the blue plunger starts to move).
2. You hear a second "click" (about 15 seconds after the first "click"; the plunger will be moving to the bottom of the viewing window as the medicine is being injected).
3. You wait another 10 seconds (to make sure all of the medicine is injected).
c) Check that the blue plunger has filled the viewing window and remove the pre-filled pen from your skin. − After you have injected all of the medicine, i.e. the blue plunger has filled the viewing window and you are able to see the grey stopper, remove the pre-filled pen from the skin by lifting the pre-filled pen straight up and dispose straightaway into a sharp disposal container (see step 3). − As the pre-filled pen is lifted from the skin, the needle shield returns to the original position and locks into place, covering the needle. − Do not put the protective cap back on the pre-filled pen at any time to avoid injury and infection.
d) Apply pressure at the injection site. − Use a clean, dry cotton ball, or gauze to gently press on the injection site for a few seconds. − Do not rub the injection site or re-use the pre-filled pen.
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Step 3: Disposal of the pre-filled pen a) Dispose of your pre-filled pen right away. − Put your used pre-filled pens in a sharps disposal container right away after use. − Do not throw away (dispose of) pre-filled pens with your household waste. − Do not recycle used sharps disposal container.
b) Ask your doctor, pharmacist or nurse how to throw away the container.
If your dose is 675 mg, repeat steps 1 e) to 3 a) with the second and third pre-filled pen to inject the full dose.
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Frequently asked questions about Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen
How do I take Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen?
Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen comes as injection containing 225mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen?
The active substance in Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen is fremanezumab.
Are there equivalent medicines to Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen?
Medicines with the same active substance, strength and form include: Ajovy (fremanezumab) 225 mg solution for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: fremanezumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
4.2. Posology and method of administration
The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine.
Posology
Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with fremanezumab.
Two subcutaneous dosing options are available:
• 225 mg once monthly (monthly dosing) or
• 675 mg every three months (quarterly dosing), which is administered as three consecutive subcutaneous injections of 225 mg each.
When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen.
When initiating treatment with fremanezumab, concomitant migraine preventive treatment may be continued if considered necessary by the prescriber (see section 5.1).
The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to continue treatment is recommended regularly thereafter.
Missed dose
If a fremanezumab injection is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen. A double dose must not be administered to make up for a missed dose.
Special Populations
Elderly
There is limited data available on the use of fremanezumab in patients ≥65 years of age. Based on the results of population pharmacokinetic analysis, no dose adjustment is required (see section 5.2).
Renal or hepatic impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
Paediatric population
The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established. No data are available.
Method of administration
Subcutaneous use.
AJOVY is for subcutaneous injection only. It should not be administered by the intravenous or intramuscular route. AJOVY can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, injection sites should be alternated.
Patients may self-inject if instructed in subcutaneous self-injection technique by a healthcare professional. For further instructions on administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions
Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity and urticaria, were reported with fremanezumab in clinical trials and in the post-marketing setting. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration.
Anaphylactic reactions have been reported rarely with fremanezumab (see section 4.8). Most reactions have occurred within 24 hours of administration although some reactions have been delayed. Patients should be warned about the symptoms associated with hypersensitivity reactions. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and do not continue treatment with fremanezumab (see section 4.3).
In the post-marketing period, one patient who was taking multiple concomitant medications including lamotrigine, and treated with fremanezumab, was reported to have Stevens-Johnson Syndrome. This reaction has also been rarely reported to occur in patients taking other anti- CGRP monoclonal antibodies, along with concomitant medications including lamotrigine.
If a hypersensitivity reaction occurs, discontinuation of fremanezumab administration should be considered and appropriate therapy should be initiated.
Major cardiovascular diseases
Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). No safety data are available in these patients.
Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., is essentially “sodium-free”.
4.5. Interaction with other medicinal products and other forms of interaction
No formal clinical drug interaction studies have been performed with AJOVY. No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab. Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and migraine preventive medicinal products during the clinical studies did not affect the pharmacokinetics of fremanezumab.
Fremanezumab is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.
Additionally, the effects of medications for the acute treatment (specifically analgesics, ergots, and triptans) and preventive treatment of migraine were evaluated in a population PK model, and found not to influence fremanezumab exposure.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data on the developmental risk associated with the use of fremanezumab in pregnant women. Fremanezumab has a long half-life. This should be taken into consideration for women who are pregnant or plan to become pregnant while using fremanezumab.
There is a limited amount of data from the use of AJOVY in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of AJOVY during pregnancy.
Breast-feeding
There are no data on the presence of fremanezumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fremanezumab and any potential adverse effects on the breastfed infant from fremanezumab or from the underlying maternal condition.
It is unknown whether fremanezumab is excreted in human milk. Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. Afterwards, use of fremanezumab could be considered during breast-feeding only if clinically needed.
Fertility
There are no fertility data in humans. Available non-clinical data do not suggest an effect on fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
AJOVY has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
A total of over 2,500 patients (more than 1,900 patient years) have been treated with AJOVY in registration studies. More than 1,400 patients were treated for at least 12 months.
Commonly reported adverse drug reactions (ADRs) were local reactions at the injection site (pain [24%], induration [17%], erythema [16%] and pruritus [2%]).
The adverse reactions that most commonly led to discontinuations were injection site reactions (1%). Table 1 summarizes adverse reactions reported in the 3-month placebo-controlled studies (Study 1 and Study 2), and the 1-month follow-up period after those studies.
Tabulated list of adverse reactions
ADRs from clinical studies and post-marketing reports are presented according to MedDRA system organ classification. Within each frequency grouping, ADRs are presented in the order of decreasing seriousness. Frequency categories are based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). Within each system organ class, ADRs are ranked by frequency, most frequent reactions first.
Table 1: Adverse reactions occurring with an incidence of at least 2% for either dosing regimen of fremanezumab and at least 2% greater than placebo in Studies 1 and 2
Fremanezumab 225 mg Monthly
(n = 290)
%
Fremanezumab 675 mg Quarterly
(n = 667)
%
Placebo
Monthly
(n = 668)
%
Injection site reactionsa
43
45
38
a Injection site reactions include multiple related adverse event terms, such as injection site pain, induration and erythema.
The following ADRs have been identified for AJOVY (Table 2).
Table 2: Adverse reactions
MedDRA System Organ Class
Frequency
Adverse Reaction
Immune system disorders
Uncommon
Hypersensitivity reactions such as rash, pruritus, urticaria and swelling
Rare
Anaphylactic reaction
General disorders and administration site conditions
Very common
Injection site pain
Injection site induration
Injection site erythema
Common
Injection site pruritus
Uncommon
Injection site rash
Description of selected adverse reactions
Serious hypersensitivity reactions
Anaphylactic reactions have been reported rarely. These reactions mostly occurred within 24 hours of administration although some reactions have been delayed.
Injection site reactions
The most frequently observed local reactions at the injection site were pain, induration and erythema. All local injection site reactions were transient and predominantly mild to moderate in severity. Pain, induration and erythema were typically observed immediately after injection while pruritus and rash appeared within a median of 24 and 48 hours, respectively. All injection site reactions resolved, mostly within a few hours or days. Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Immunogenicity
In placebo-controlled studies, 0.4 % of patients (6 out of 1,701) treated with fremanezumab developed anti-drug antibodies (ADA). The antibody responses were of low titer. One of these 6 patients developed neutralising antibodies. With 12 months of treatment, ADA were detected in 2.3% of the patients (43 out of 1,888) with 0.95% of the patients developing neutralising antibodies. The safety and efficacy of fremanezumab were not affected by ADA development.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Doses up to 2,000 mg have been administered intravenously in clinical trials without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary.
💬 Ask about this leaflet
Ask anything about Ajovy (fremanezumab) 225 mg solution for injection in pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.