• Gvoke is a brand (trade) name for glucagon which may be used to treat very low blood sugar levels (also called severe hypoglycemia) in people with diabetes.
• Gvoke (glucagon) works by activating glucagon receptors in the liver, which stimulates the breakdown of glycogen (the stored form of glucose in the liver) and the release of glucose into the bloodstream, which increases blood glucose concentrations. Glucagon only works if the liver has enough glycogen stored.
• Gvoke belongs to the class of medicines known as glucose-elevating agents.

• Gvoke may be used to treat severe hypoglycemia in adults and children aged two years and over. Gvoke increases blood glucose (sugar) levels quickly.
• A Gvoke injection can be lifesaving if a patient has severely low blood sugar and is unable to eat or drink something to increase it.
• Gvoke comes as an autoinjector (Gvoke Hypo), a premixed, prefilled, premeasured, and ready-to-use injection (Gvoke PFS) and Gvoke kit, a premixed, 1 mg/0.2 mL single-dose vial and syringe kit.
• Gvoke is available in two strengths: 0.5 mg/0.1 mL and 1 mg/0.2 mL.
• The Gvoke Hypopen, Gvoke kit, and prefilled syringe are for single-use only and you should not attempt to reuse them.

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:

• Nausea (30%), vomiting (16%), injection site reactions (7%), and headache (5%) were the most common side effects reported.
• The dosage of Gvoke changes according to age and weight. For adults and pediatric patients aged 12 and older, 1mg is recommended. An additional 1 mg dose may be given after 15 minutes if no response is seen. For pediatric patients aged 2 to less than 12 years of age or for those who weigh less than 45kg the recommended dose is 0.5mg with an additional 0.5mg if no response is seen within 15 minutes.
• Gvoke should not be given to people with OKE is contraindicated in patients with pheochromocytoma, insulinoma or with a previous allergic reaction to Gvoke or any other ingredient contained in the preparation.
• Gvoke may not be effective in people with low levels of glycogen stored in their liver. This may include people in states of starvation, with adrenal insufficiency, or with chronic hypoglycemia. These people need to be treated with glucose.
• An uncommon skin rash normally associated with glucagonomas (glucagon-producing tumors) called necrolytic migratory erythema (NME) has been reported following continuous glucagon infusion. Symptoms include scaly, itchy, red, raised areas of skin, blisters, and ulcers. These may affect the face, groin, perineum, and legs or be more widespread. This skin rash may not resolve on discontinuation.
• Secondary hypoglycemia may occur if glucagon is administered to patients with glucagonoma. Monitor for this and treat people with oral or IV glucose.

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

• Talk to your friends, family, and work colleagues about what the symptoms of low blood sugar are (for example, confusion, coordination difficulties, difficulty eating or drinking due to confusion or being uncooperative, unconsciousness, and seizures) and that you may need their help to administer Gvoke, which should be administered straight away. Severe hypoglycemia should be treated as an emergency as if it is left untreated it may cause seizure, coma, or death. Instruct your caregivers to place you in the recovery position and call 911 if they ever find you unconscious.
• Once your blood sugar levels have returned to a more normal level, remember to eat something. You should also see a healthcare professional straight away.
• Gvoke should be injected into the lower abdomen, outer thigh, or upper outer arm. Roll any clothes away from the intended injection site to expose the skin. Do not inject Gvoke through clothing.
• To use the Gvoke Hypopen, grip the barrel in your hand with the needle end pointing downwards. Push and hold the Gvoke HypoPen firmly against the skin and listen for a “click”. Continue to hold the Gvoke HypoPen in place for 5 seconds. The injection is complete when the viewing window is red. Call for emergency help. If the patient has not responded within 15 minutes call 911, and give another dose of Gvoke HypoPen. Once the patient has woken up and can swallow the patient should eat something that is a fast-acting source of sugar and a long-acting source of sugar.
• You should inspect your supplies of Gvoke periodically to check that the solution is clear and it has not gone past its expiry date. Even though you should not use expired medicines if an expired Gvoke is the only injection available for somebody who needs glucagon, then consider administering it.
• Store Gvoke in its sealed original foil pouch at room temperature, 68° to 77°F (20° to 25°C). Do not refrigerate or freeze.

• Gvoke increases blood sugars quickly. In adult patients, blood glucose levels started to rise within 10 minutes and reached a peak after 90 minutes of 176 mg/dL. In children aged 2 to 18, levels rose within 10 minutes and reached a peak after about 70 minutes of 134 mg/dL (2 to less than 6 years), 145 mg/dL (6 to less than 12 years), and 123 mg/dL (12 to less than 18 years).

Medicines that interact with Gvoke may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Gvoke. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Gvoke include:

• beta-blockers, such as acebutolol, atenolol, or timolol (may cause a transient increase in pulse or blood pressure)
• indomethacin (Gvoke may lose its ability to raise blood glucose or may even produce hypoglycemia)
• warfarin (Gvoke may increase the anticoagulant effect).

Note that this list is not all-inclusive and includes only common medications that may interact with Gvoke. You should refer to the prescribing information for Gvoke for a complete list of interactions.