• Emgality is a brand (trade) name for galcanezumab which may be given to prevent migraine headaches in adults or to treat episodic cluster headaches in adults. Galcanezumab may also be called galcanezumab-gnlm.
• Galcanezumab works by blocking the effect of a protein, called CGRP (calcitonin gene-related peptide) which is involved in pain transmission. Emgality binds to CGRP and prevents it from interacting with the CGRP receptor.
• Emgality belongs to the class of medicines called CGRP inhibitors. Emgality may also be called a monoclonal antibody, which is a collection of identical proteins that have been developed to only target one substance in the body (in this case CGRP).

• Emgality may be administered to prevent migraine headaches in adults or to treat episodic cluster headaches in adults.
• People can easily be taught how to self-administer Emgality. Emgality is given monthly when administered to prevent migraines. Initially, it is given as a 240mg dose (two consecutive subcutaneous injections of 120 mg each) followed by a monthly dose of 120 mg. Emgality is injected subcutaneously (under the skin).
• For the treatment of episodic cluster headache, Emgality is given as three 100mg doses, which are taken one after the other at the start of a cluster period and then every month until the end of the cluster period.
• Emgality is available as a single-dose prefilled pen and syringe (120 mg/mL) and a 100 mg/mL single-dose prefilled syringe. Both the prefilled pen and prefilled syringe are for one-time use only and deliver the entire contents.
• Emgality is a monoclonal antibody and these tend to have few drug interactions and are unlikely to cause liver or kidney damage.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Injection site reactions, including pain, redness, swelling, or itching around the injection site, are the most common side effect of Emgality, reported in 18% of people. Other side effects reported in 1% to 10% of people include constipation, fatigue, dry mouth, hives (urticaria) or a rash, itchy skin, vertigo, or dizziness. Other gastrointestinal effects (such as bloating), anti-drug antibodies, and hypersensitivity reactions have also been reported.
• Emgality may cause weight gain in some people. A survey by Health Union reported 12% of people gained weight while being administered CGRP injections, such as Emgality, which included rapid weight gain of up to 10 to 14 pounds (4.5kg to 6.35kg) in the absence of other medication, dietary, or activity level changes.
• Hypersensitivity reactions have been reported with Emgality. Symptoms include shortness of breath, urticaria, rash, anaphylaxis, and angioedema. If a serious reaction occurs, Emgality should be discontinued and appropriate therapy administered.
• Emgality needs to be given by injection subcutaneously (under the skin), to avoid degradation by the stomach.
• It is not known if Emgality is safe or even effective in children. Trials also did not include people over the age of 65 years, so it is not known if older people are at a higher risk of side effects from Emgality.
• Because it is a large molecule, Emgality takes longer to start working, and works in the lining of the brain rather than in the brain itself.
• Emgality needs to be kept in the refrigerator until use. Before administration, Emgality should be allowed to sit at room temperature for 30 minutes. Do not warm Emgality by using a heat source such as hot water or a microwave. Emgality should not be shaken and it needs to be protected from sunlight. Emgality may be stored at room temperature for up to 30°C (86°F) for up to 7 days, but should not be placed back in the refrigerator after this time and if unused, it should be discarded.
• There is insufficient data to determine the risk of administering Emgality to pregnant women, and there is no data about its effects on a newborn when breastfeeding. Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
• Emgality is not available as a generic.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Emgality injections may hurt. Pain at the injection site is one of the most common side effects reported with Emgality injections and is reported in 18% of people. Other injection site reactions, such as redness, swelling, or itching around the injection site, are also common.
• Helpful tips to make Emgality injections less painful include taking Emgality out of the refrigerator 30 minutes before administering, to allow it to warm up to room temperature; placing an ice bag on the injection site for a few minutes before administering Emgality; not injecting Emgality into areas of skin that are bruised, red, hard, or covered with a rash; administering Emgality into the butt area, high up almost to the level of the hips; changing the area of skin you inject Emgality into each month.
• Each Emgality Pen is for one-time use only. Do not share or reuse your Emgality Pen.
• Your doctor will show you how to self-administer Emgality. You will need 2 pens for your first dose (1-time loading dose) and 1 pen for your monthly dose. Leave the base cap on until you are ready to inject. Do not use the pen if it looks damaged, the medicine is cloudy, discolored, or has small particles, it has passed its expiry date or the medication is frozen. Wash your hands with soap and water. Inject the medicine into your stomach area (but not within 2 inches of your belly button), into the front of your thighs at least 2 inches above the knee and 2 inches below the groin, or you can ask another person to give you the injection in the back of your upper arm or buttocks. Twist off the base cap. Place and hold the clear base flat and firmly against your skin. Turn the lock ring to the unlock position. Press and hold the teal injection button for 10 seconds. Remove the pen from your skin and throw it away in an approved container. Do not rub the injection site.
• Emgality has very few side effects and no reported drug interactions. However, if you experience any side effects, tell your doctor straight away, particularly if you develop shortness of breath, a rash, or edema.

• When Emgality (galcanezumab) is administered to prevent migraines, it starts working within one month of initiation, but it may take up to five or six months for the full effects of Emgality to be seen.
• Trials have shown that after one month, the number of migraine days had decreased by approximately 3.7 from baseline in participants assigned to Emgality compared to a decrease of approximately 1.6 in those assigned to placebo (an inactive injection). After six months (the end of the trial) the number of migraine days in the Emgality group had decreased by just over 5 compared with a decrease of approximately 3 days in those assigned to placebo. On average, over the one to 6 month period, Emgality decreased the number of headache days by 4.3 and 4.7 in two separate trials.
• 59% to 62% of people with migraine had at least a 50% reduction in their number of headache days after 6 months of treatment, 34% to 39% had at least a 75% reduction in their number of headache days after 6 months of treatment, and 12% to 16% had at least a 100% reduction from baseline in the number of monthly migraine headache days over the 6-month treatment period.
• When Emgality is administered for the treatment of cluster headaches, it starts working within one week of starting treatment, but it may take up to three weeks for the full effects to be seen.
• For cluster headaches, the average decrease in the number of headaches from baseline over weeks one to three was 8.7 in the Emgality group compared with 5.2 in the placebo group. 71.4% of people taking Emgality reported at least a 50% reduction in their number of headache days after 3 weeks of treatment compared to 52.6% of those taking a placebo.

There are currently no documented interactions with Emgality, according to the product information.

• Galcanezumab is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

You should refer to the prescribing information for Emgality for any updates or newly noted interactions.