Emgality 120 mg solucion inyectable en pluma precargada

Prescribing Information for the Patient

Emgality 120mg Pre-filled Syringe Solution

galcanezumab

Read this entire prescribing information carefully before starting to use this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section4.

Emgality contains galcanezumab, a medication that blocks the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP, for its English acronym). People with migraines may have elevated levels of CGRP.

Emgality is used to prevent migraines in adults who have at least 4days of migraines per month.

Emgality may reduce the frequency of migraines and improve quality of life. It begins to work in about one week.

Do not use Emgality:

• if you are allergic to galcanezumab or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before or during treatment with Emgality if:

• you have a severe cardiovascular disease. Emgality has not been studied in patients with severe cardiovascular diseases.

Watch for allergic reactions

Emgality may potentially cause severe allergic reactions.Severe allergic reactions mainly occur within 1day after using Emgality, but some reactions may be delayed (occurring more than 1day and up to 4weeks after using Emgality).Some allergic reactions may be prolonged.You should monitor the appearance of signs of these reactions while using Emgality. Stop using Emgality and inform your doctor or seek medical attention immediately if you notice any signs of severe allergic reaction. These signs are listed under “Serious side effects” in section 4.

Children and adolescents

This medication should not be administered to children and adolescents under 18years because it has not been studied in this age group.

Other medications and Emgality

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are a woman with the possibility of becoming pregnant, it is recommended that you avoid becoming pregnant while using Emgality.

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication. It is preferable to avoid using Emgality during pregnancy, as the effects of this medication on pregnant women are unknown.

If you are breastfeeding or intend to start breastfeeding, consult your doctor before using this medication. You and your doctor should decide whether to breastfeed or use Emgality.

Driving and operating machines

Galcanezumab may have a small effect on the ability to drive and operate machines. Some patients have experienced vertigo while using Emgality.

Emgality contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose of 120mg; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

The pre-filled Emgality pen is for single use and contains a dose of Emgality (120 mg).

• The first time you receive Emgality, your doctor or nurse will administer two pens (240 mg in total).
• After the first dose, you will use one pen (120 mg) each month.

Your doctor will decide for how long you should use Emgality.

Emgality is administered through a subcutaneous injection under the skin. You and your doctor or nurse must decide if you can administer Emgality yourself.

It is essential that you do not attempt to inject until you have been trained on how to do so by your doctor or nurse. A caregiver can also administer your Emgality injection if they have been properly trained.

The pen should not be shaken.

Read the "Instructions for Use" of the pen carefully before using Emgality.

If you use more Emgality than you should

If you have injected more Emgality than you should, for example, if after the first dose of 240 mg you have injected the medication twice in one month, or if someone else has used Emgality accidentally, contact your doctor immediately.

If you forget to use Emgality

Do not inject a double dose to compensate for the missed injection.

If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then inject the next dose one month from that date.

If you interrupt treatment with Emgality

You should not stop using Emgality without first talking to your doctor.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Adverse Effects

Generally, allergic reactions to Emgality are mild to moderate (such as rashes or itching). Severe allergic reactions can rarely occur (affecting up to 1 in 1,000 people) and may include:

-Difficulty breathing or swallowing,

-Low blood pressure, which may cause dizziness or lightheadedness,

-Swelling of the neck, face, mouth, lips, tongue, or throat that may rapidly progress,

-Intense skin itching accompanied by rashes or hives.

Consult your doctor or seek immediate medical assistance if you notice any of these signs.

Other Adverse Effects Reported

Very Frequent Adverse Effects(may affect more than 1 in 10 people):

• Pain at the injection site
• Reactions at the injection site (e.g., redness, itching, rashes, swelling)

Frequent Adverse Effects(may affect up to 1 in 10 people):

• Dizziness (a sensation of spinning or feeling like everything is spinning)
• Constipation
• Itching
• Skin rash

Rare Adverse Effects(may affect up to 1 in 100 people):

• Urticaria (hives on the skin with a sensation of itching)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator(between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Emgality can be left out of the refrigerator for a single period of up to 7days at a temperature not exceeding 30°C. The pen should be discarded if stored at a higher temperature or for a longer period of time.

Do not use this medication if you observe that the pen is deteriorated, or the medication appears cloudy or has particles inside.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Emgality

• The active ingredient is galcanezumab. Each pre-filled pen contains 120 mg of galcanezumab in 1 ml of solution.
• The other components are: L-histidine, L-histidine hydrochloride monohydrate, polisorbate 80, sodium chloride, and water for injection.

Appearance of the product and contents of the package

Emgality is a solution for injection in a transparent glass syringe. Its color may vary from colorless to slightly yellow.

The syringe is inserted into a single-dose disposable pen. Package sizes of 1, 2, or 3 pre-filled pens.

Only some package sizes may be marketed.

Marketing Authorization Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer

Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.

Lilly, S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid, Spain.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information:

Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Parts of the Emgality pen: