Fremanezumab for the prevention of chronic migraine (autoinjector pen)

Fremanezumab

Fremanezumab for the prevention of chronic migraine (autoinjector pen)

Who is this information for? What is its aim?

You have been prescribed fremanezumab (known as AJOVY) to help treat chronic migraine.

About fremanezumab

Fremanezumab is from a new group of medicines designed to bind to a substance called Calcitonin Gene-Related Peptide (CGRP) and block its ability to act and interact with its receptor. These medicines are known as monoclonal antibodies (mAbs). They are designed as antibodies that recognise and bind to the CGRP but have no other known interference with the immune system. This group of medicines has arisen from recent advances in our understanding of migraine and is the first preventative medicine designed specifically for migraine. It has been demonstrated that during a migraine attack CGRP levels rise, which can be temporarily blocked by migraine specific pain relief medications (medications specifically from the triptan group- e.g. sumatriptan, rizatriptan, zolmitriptan, eletriptan etc.) and this is thought to be how they produce the painkiller effects. However, the CGRP mAbs are able to do this effectively on a long- term basis.

The clinical trials have shown that it can be a very effective treatment in some patients with migraine, with 30-50% of patients reporting reduction in their migraine days by at least a half or more.

This medicine will be considered by your hospital doctor if you have:

• chronic migraine (more than 15 headache days per month, of which eight days have migrainous features, and this has been the case for at least three months);
• addressed any pain relief overuse;
• tried at least three preventative drug treatments from different drug groups (and these have been deemed sufficient trials) and they have been considered ineffective;
• considered a trial of cranial botulinum treatment -this is an alternative injectable treatment for chronic migraine, with 31-39 injections of botox given to specific sites in the face/head/neck/shoulders and a minimum of 2 treatments given 3 months apart.

This medication comes as an autoinjector pen containing 225mg of fremanezumab and is suitable for subcutaneous (just under the skin) self-delivery. When you first receive treatment you will be given monthly injections but if you continue to receive treatment beyond three months you will be given a choice of receiving:

a) three injections consecutively at the start (i.e. 225mg x 3 = 675mg) with follow up at three months,

or

b) having one injection (i.e. 225mg) every month for three months with follow up on completion of three months.

Both dosing schedules work as effectively but occasionally when the three injections are given at the start some patients may experience wearing off of therapeutic benefit towards the end of the three-month duration.

If you miss or have to delay a dose then you should take the omitted dose at the earliest opportunity. The next scheduled dose should be re-adjusted from this time point, i.e. restart the three-monthly or monthly clock. You must never administer a double dose to make up for a missed dose.

If you are going away on holiday, or travelling for work, then provided you can keep the medication chilled in a cool bag with a cold pack, so that the temperature will be less than 25oC, taking it with you is permissible providing you can ensure it is put back in the fridge at your destination within 24 hours. This must not be done repeatedly and should only be done on one occasion. If, due to travelling, it is not possible to guarantee a single time period out of the fridge, we recommend you delay your treatment until you are back at your home and take it as close to your due date as feasible.

If you notice any worrying signs or symptoms (as below) please inform your general practitioner (GP) and neurologist as soon as possible.

Dosing schedule

Schedule A

Day and date started:

Your neurologist will need to review you, together with your headache diary, in order to decide whether further treatment is advised. Further monthly 225mg or three-monthly 675mg fremanezumab injections may be recommended.

Schedule B

Day and date started:

Your neurologist will need to review you, together with your headache diary, in order to decide whether further treatment is advised. Further monthly 225mg or three-monthly 675mg fremanezumab injections may be recommended.

Storage

• Store in the refrigerator between 2-8°C.
• Protect from light until time of administration and keep within the original outer
• container / box.
• Do not freeze. Discard if this occurs.
• Do not shake the pen. Discard if this occurs.

Method of administration

You will be provided with a supply of fremanezumab / AJOVY autoinjector pens and will receive training from a healthcare specialist on administration before starting treatment.

Side effects

As with all medications, there are potential side effects, which may occur in a small number of patients.

The most common reported effects, occurring in more than 10% of patients, are:

• mild to moderate injection site pain
• skin reactions such as redness, bruising and swelling
• less common reported effects include injection site itching and rash

The majority of skin reactions are apparent within one hour and will resolve over 24 hours although injection site itch and rash often occurs 24-48 hours following injection.

Rarely reported side effects can include:

• more significant allergy including itching, rash, hives (pale red bumps or weals)
• trouble breathing
• swelling of the lips / tongue called angioedema

It is important to note that allergic reactions can occur several days to a month after using fremanezumab. You should remain vigilant for signs or symptoms during this time.

Seek emergency medical review immediately if you have any of the following symptoms, which may be part of an allergic reaction:

• swelling of your face, mouth, tongue, or throat
• difficulty breathing

Please ensure you inform any doctor / nurse / pharmacist involved in your care that you are being treated with fremanezumab / AJOVY.

Monitoring

Routine observations including your blood pressure and pulse rate should be performed prior to first starting treatment and these will be done in clinic by your neurology team.

Routine blood tests including liver function (LFTs) will be performed by the hospital prior to commencing treatment, and if you continue treatment beyond three months, again at six months. This should be organised by the hospital or your GP. If the initial blood tests performed when you first start treatment are abnormal, this will need to be repeated at three monthly intervals in the first year.

In order to receive treatment it is essential that you keep a headache diary for the three months preceding treatment. You will be expected to complete your headache diary on a daily basis and present this to your neurologist at the time of review. Without an ongoing complete headache diary you will not be considered for treatment beyond three months.

Contraindications and cautions - note for medical specialists

Fremanezumab must not be used if the patient has had previous hypersensitivity to the active drug or to any of the product contents. Furthermore, fremanezumab must be used with caution if a patient has had previous significant hypersensitivity to another of the CGRP mAbs.

The clinical trials excluded those with significant cardiovascular or cerebrovascular disease. The relative safety in this group is unknown so it should be used with caution in any individual with recent acute cardiovascular events, including MI, unstable angina, CABG, stroke or DVT and / or those deemed to be at serious cardiovascular risk.

Interactions - note for medical specialists

No formal clinical drug interaction studies have been conducted. However there are no expected drug interactions based upon the characteristics of this compound.

Risks

Do not stop taking fremanezumab unless your doctor tells you to as this may cause a dramatic worsening of your headache.

Pregnancy and breast feeding

Fremanezumab is not recommended for management of migraine if you are pregnant, actively planning a pregnancy or are breastfeeding. Women of childbearing age should take adequate contraceptive precautions. No data is available to recommend how long following stopping fremanezumab it is safe to become pregnant. We therefore recommend that on stopping fremanezumab contraception is maintained for a further six months, as it is considered this drug may stay within the body up to this time period.

This leaflet should be read in conjunction with the product characteristic leaflet that can be found inside all boxes of medication. The use of any medicine is based on considerations of how benefits outweigh potential side effects. Your prescribing doctor will discuss the risks and benefits of the medication as it relates to you and answer any further questions you may have.