Emgality

To prevent migraines, the recommended starting dose of Emgality (Galcanezumab) is 240 mg (2 injections of 120 mg each) injected subcutaneously (under the skin). After the first dose, the regular dose is 120 mg injected subcutaneously once a month. Emgality (Galcanezumab) is intended to prevent migraines. It should not be used for the immediate treatment of migraines.

To decrease the number of cluster headaches within a cluster period, the recommended dose is 300 mg (3 injections of 100 mg) injected subcutaneously once a month. It should be started at the beginning of a cluster of headaches. After 3 weeks your doctor will decide if you should continue treatment. If you do continue treatment, no more than 300 mg of Emgality (Galcanezumab) should be administered per month during the cluster period. Emgality (Galcanezumab) should not be used after the end of a cluster period or during the remission time.

If you are using Emgality (Galcanezumab) at home, your doctor will ensure that you understand exactly how to use it. Make sure you ask any and all questions necessary to ensure that you use it exactly as prescribed. Please read the package insert for information on how to inject the medication properly. It is important to visit your doctor regularly while you are using Emgality (Galcanezumab) to ensure that the medication is working safely and effectively.

Before injecting the medication, check it carefully for particles or discolouration. If the solution is discoloured, has particles in it, or is cloudy, discard the syringe or pre-filled pen and use another one.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Emgality (Galcanezumab) exactly as prescribed by your doctor.

If you miss a dose, inject it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Emgality (Galcanezumab) in the refrigerator in its original packaging to protect it from light and moisture. Remove the pen or syringe from the refrigerator 30 minutes before injecting it, to allow it to come to room temperature. Do not freeze or shake Emgality (Galcanezumab). Keep this, and all medications, out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause constipation - to prevent this, drink plenty of water or juice, and eat more dietary fibre; it may cause itching at the site where the medication is used; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause redness and swelling at the injection site; it can cause dizziness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

100 mg/mL
Each 1 mL of sterile, preservative-free, clear, colourless-to-slightly-yellow solution contains 100 mg of Emgality (Galcanezumab). Nonmedicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, and water for injection.

Emgality (Galcanezumab) is available in single-use pre-filled syringes.

120 mg/mL
Each 1 mL of sterile, preservative-free, clear, colourless-to-slightly-yellow solution contains 120 mg of Emgality (Galcanezumab). Nonmedicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, and water for injection.

Emgality (Galcanezumab) is available in single-use pre-filled syringes or single use pre-filled pens for injection.

Do not take Emgality (Galcanezumab) if you are allergic to Emgality (Galcanezumab) or any ingredients of the medication.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Emgality (Galcanezumab).

Allergic reactions: Emgality (Galcanezumab) may cause allergic reactions such as a rash, hives, or itching. On rare occasions, a Anaphylaxis (severe allergic reaction) may occur, causing difficulty breathing, abdominal cramps, nausea and vomiting, or swelling of the throat (anaphylaxis). An allergic reaction may occur within minutes of injecting the dose, or the reaction may be delayed to almost a month after the dose. If you experience any signs of a serious allergic reaction, get immediate medical attention.

Cardiovascular disease: The safety and effectiveness of using Emgality (Galcanezumab) have not been determined for people who have recently had Heart Attack, Angina, Stroke, high blood pressure, or other heart conditions. If you have heart problems or high blood pressure, discuss with your doctor how Emgality (Galcanezumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Emgality (Galcanezumab), and whether any special monitoring is needed.

Pregnancy: Emgality (Galcanezumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Emgality (Galcanezumab), contact your doctor immediately. It takes several months for the body to remove Emgality (Galcanezumab). If you plan to become pregnant, talk to your doctor to determine how long you should wait after stopping Emgality (Galcanezumab).

Breast-feeding: It is not known if Emgality (Galcanezumab) passes into breast milk. If you are breast-feeding and are taking Emgality (Galcanezumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Emgality (Galcanezumab) have not been established for children.

Seniors: The safety and effectiveness of Emgality (Galcanezumab) have not been established for adults 65 years of age or older.

This medication is typically used only once a month. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. If you forget a dose, the injection should be administered as soon as possible and next injection dose should be planned after 1 month to reassume normal schedule.