Galcanezumab for the prevention of episodic and chronic migraine (autoinjector pen)

Who is the leaflet for? What is its aim?

You have been prescribed galcanezumab (known as EMGALITY) to help treat your migraine. This leaflet will tell you about galcanezumab and how to use it. You should keep it to hand for easy reference.

About galcanezumab

Galcanezumab 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.

It has been demonstrated that, during a migraine , nerves in the brain release several substances including CGRP. CGRP plays a role in maintaining the migraine by acting as a messenger and passing signals between certain nerves and the brain. In people prone to migraines, high levels of CGRP injected into the body can even trigger a migraine attack. Galcanezumab is a treatment that works by blocking CGRP, stopping it from sending those signals that make the migraine worse and keep it on-going. Another type of medication, which are the migraine-specific painkillers (medications specifically from the triptan group such as sumatriptan, rizatriptan, zolmitriptan, eletriptan etc.), stop CGRP from being released by nerves and work for a short time to relieve migraine pain. However, unlike the triptans, CGRP-blocking medications like galcanezumab can prevent migraines in the long-term.

Clinical trials have shown that CGRP mAbs can be a very effective treatment in some patients with migraine, with 30% to 50% of patients reporting a reduction in their migraine days by at least 50% (i.e. at least a halving of migraine days).This medicine will be considered by your hospital doctor if you have:

• Chronic migraine (more than fifteen headache days per month, with migraine on at least eight of these days, and this has been the case for at least three months)
• Episodic migraine (with four or more disabling migraine days per month, and this has been the case for at least three months)
• Addressed any pain relief overuse (which should be considered if there is regular acute painkiller medication taken on more than ten days per month for several months for any reason)
• Tried at least three preventative drug treatments from different drug groups (and these have been deemed sufficient trials) and they have been ineffective
• Considered a trial of cranial botulinum (Botox) treatment in the case of chronic migraine – this is an alternative injectable treatment for chronic migraine, with 31 to 39 injections of Botox given to specific sites in the face/ head/ neck/ shoulders and a minimum of two treatments given three months apart.

Medical considerations regarding suitability for treatment

Galcanezumab must not be used if you have had a previous serious adverse reaction to it which was thought to be due to allergy (called hypersensitivity) to the active drug or to any of the product contents. Furthermore, if you have had a significant allergic/hypersensitivity response to one of the other CGRP mAbs or gepants then you must make sure your prescribing neurologist is aware, as galcanezumab may not be the right treatment for you.

CGRP is one of several substances that acts on blood vessels to widen or open them up (dilate). It is therefore possible that Galcanezumab and the other CGRP mAbs will stop CGRP from being able to do this. The ability of blood vessels to dilate is particularly important when blood vessels narrow or become blocked to try and limit the damage, in the setting of conditions that include heart attacks and strokes. However, CGRP blocking therapies have been in use for some years without any significant report of their use causing concern in this regard. The clinical trials in patients taking galcanezumab did not include patients who had known significant heart (specifically heart attacks, angina, previous coronary artery bypass), brain (specifically stroke), or other diseases related to the blood vessels (leg clot or deep vein thrombosis, lung clot or pulmonary embolus). If you have, or have had, any of these conditions, please discuss this with your prescribing neurologist as the relative safety of this drug is uncertain and will need careful consideration.

High blood pressure has emerged in patients taking other CGRP mAbs and if you have pre-existing high blood pressure, or this has been a previous concern, please alert your prescribing neurology team as this may need to be managed separately before you embark on this treatment.

Will this interact with my other medications?

No formal clinical studies have been done looking to see if galcanezumab interacts with other medications. However, based on our knowledge of this drug, none are expected, and we do not suggest stopping other oral medications.

If you are taking another monoclonal antibody for a different medical condition please make sure your prescribing neurologist is aware as they will want to consider suitability and may recommend that the timing of administration of galcanezumab is removed from that of your other treatment.

Method of delivery and dosage

The medication comes as an autoinjector pen containing 120mg of galcanezumab and is suitable for subcutaneous (just under the skin) self-delivery. When you first receive treatment, you will be given two injections to be administered consecutively (120mg x 2 = 240mg). You will then administer one injection (120mg) every four weeks for three months, with a follow up appointment after this to determine whether further treatment is indicated.

Supplies of medication will normally be arranged through our external homecare pharmacy partners.

After three months your neurology team will need to review you, together with your headache diary, and decide whether further treatment is advised. Further monthly 120mg galcanezumab injections may be recommended if this has been well tolerated and you have met the criteria for sufficient improvement in your migraine days or headache load of:

• At least 50% (i.e. more than halved) if, prior to treatment, you had less than fifteen headache days per month (this includes migraine days)
• At least 30% (i.e. improved by more than a third) if, prior to treatment, you had more than fifteen headache days per month (with at least eight of these being migraine days).

Travelling with the medication

If you are going away on holiday, or travelling for work, then you should be able to take the medication with you, provided you can transport it appropriately and at the correct temperature. Controlling the temperature during transport is vital to maintain the viability of the treatment. You can transport EMGALITY by either:

b) Keeping it chilled at a temperature of 2°C to 8°C in a cool bag with a cold pack. This should be for the shortest time possible (must be less than 24 hours). You must put it directly in the fridge at your destination; or

b) Keeping it at a temperature less than 30°C, during which time it can be kept unrefrigerated, but must be used within seven days. (If this time is exceeded the medication should be discarded).

Taking the medication out of the fridge must not be done repeatedly and should, in normal circumstances, only be done once, at the time you are due to administer it. If, due to travelling, it is not possible to guarantee that you will meet the recommendations above, we suggest that you delay your treatment until you are back home and then take it as close to your due date as feasible.

Storage and handling

• Store in the refrigerator between 2°C and 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 galcanezumab / EMGALITY autoinjector pens and will receive training from a healthcare specialist on self-administration before starting treatment.

Before injection:

1. Remove galcanezumab (EMGALITY) from the refrigerator. Immediately return any remaining autoinjector pens to the original container/ box in the refrigerator. Allow the autoinjector pen/s you will be using to reach room temperature before administration. This will take approximately 30 minutes. Once taken out of the refrigerator and allowed to reach room temperature, the autoinjector pen/s must not be returned to the refrigerator.
2. DO NOT attempt to heat the pen to bring it to room temperature quickly.

DO NOT leave the autoinjector pen in direct sunlight.

DO NOT shake the autoinjector pen.

1. Check that the autoinjector pen is intact, untampered with, has come from a box with the name galcanezumab (EMGALITY) on the label, and is within the expiry date. The liquid should be clear and colourless to light yellow. Discard if the liquid is cloudy, discoloured, frozen or contains visible particles. Air bubbles are normal, and the autoinjector pen is still safe for use.
2. Collect the equipment you will need to administer the treatment: galcanezumab (EMGALITY) autoinjector pen, alcohol wipe, cotton wool ball and the dedicated bin provided to collect all the waste (called a yellow sharps bin).
3. Wash your hands thoroughly and dry them with a clean towel.
4. Select the injection site – either the abdomen (at least two inches / five centimetres from the belly button), the front of the thigh (at least two inches / five centimetres above the knee or two inches / five centimetres below the groin), the back of the upper arm, or the buttocks. You should not inject into areas where the skin is tender, bruised, red, hardened, scarred, tattooed or has stretch marks. Choose a different injection site each time.
5. Clean the chosen injection site with the alcohol wipe provided and leave to dry for a minimum of 10 seconds. Do not touch this area again before injecting.

To inject:

1. Make sure the white protective cap is on, and the device set to the locked position (padlock closed symbol) before beginning.
2. Remove the protective cap from the autoinjector pen treatment base (coloured white with blue arrows on). Once uncapped, it must be used, and you must not attempt to recap the pen. It is important that you twist the cap to remove it in the direction of the blue arrows and immediately dispose of the cap. DO NOT attempt to reveal the needle.
3. Place the uncapped base end of the autoinjector pen flat against the patch of skin selected for injection, holding the pen at right angles (90 degrees) to the skin.
4. Whilst pressing firmly on the skin, rotate the lock device on the top of the pen from the locked position (padlock closed) to the unlocked position (padlock open).
5. Whilst maintaining the pressure of the pen on the skin press and hold the teal blue button at the very top end.
6. Hold down and listen – the first click means that the injection has started, and you should keep holding the button down. You will hear a second click about 10 seconds later (the grey plunger should be easily visible), and you should keep holding the button down for another couple of seconds after this to ensure all the medication is injected.
7. Check that you can see that the grey plunger has moved into the treatment end viewing window and then, with care, fully remove the needle from your skin by pulling the pen straight up. Discard the used autoinjector pen unit directly into the yellow sharps bin. This is a single use autoinjector pen, do not attempt to reuse it.
8. Apply gentle pressure at the injection site for a few seconds using a clean, dry cotton wool ball. DO NOT rub the injection site.
9. If this is your first treatment, you will need to follow this up immediately with one further injection (following these same instructions) until you have administered your total of two autoinjector pens.
10. Always discard and dispose of used autoinjector pen units in your yellow sharps bin and never attempt to throw away any part in your household waste. You must never attempt to recycle your sharps bin, when full it should be disposed of appropriately. The homecare company who delivers your medication and sharps bin will advise you on arrangements for correct disposal.

You may find the video produced by the manufacturers of galcanezumab (EMGALITY) a useful reminder of how to administer the autoinjector pen. This can be found at: Injection-video (opens in a new tab)

Side-effects

As with all medications, there are potential side effects, which may occur in a small number of patients. If you notice any worrying signs or symptoms (as below) please inform your general practitioner (GP) and neurologist as soon as possible.

The most common reported effects, occurring in 1-2 patients in every 10 treated (i.e. 10-20%), 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. Most skin reactions are apparent within one hour and will resolve over 24 hours, although they can take up to five days to resolve following the injection.

Other common reported effects, occurring in 1-2 patients in every 100 treated (i.e.1-2%) of patients, are:

• constipation,
• feeling of dizziness or spinning (vertigo).

Rarely reported side effects can include:

• more significant allergy including hives / urticaria (pale red bumps or wheals),
• trouble breathing,
• swelling of the lips / tongue called angioedema.

It is important to note that allergic reactions can occur between several days and a couple of months after using galcanezumab. 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 that you inform any doctor / nurse / pharmacist involved in your care that you are being treated with galcanezumab (EMGALITY).

Missed doses

If you miss or must delay a dose, you should take the missed dose at the earliest opportunity. The next scheduled dose should be readjusted from this time point; the four weekly clock restarts from the day you took the missed dose. You must never administer a double dose to make up for a missed dose.

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. If you have not had routine blood tests including liver function (LFTs) in the last year these will be performed by the hospital prior to commencing treatment. If the initial blood tests performed when you first start treatment are abnormal, these will need to be repeated at three monthly intervals; whether or not they are continued will depend on the results. If the initial blood pressure is elevated, treatment will be postponed until your neurologist is satisfied that it is under control and your blood pressure will need to be monitored monthly 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 / clinical nurse specialist at the time of review. Without an ongoing complete headache diary, you will not be considered for treatment beyond three months.

Stopping galcanezumab

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

Pregnancy and breastfeeding

Galcanezumab 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 for the duration of the treatment. No data is available to recommend how long following stopping galcanezumab it is safe to become pregnant. We therefore recommend that on stopping galcanezumab contraception is maintained for a further six months, as it is considered this drug may stay within the body up to this time

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. Please contact the refractory headache team in the neurology department on 01223 216760 if you have any queries.