Lixisenatide

Lixisenatide is a medicine used to lower blood glucose levels in adults with type 2 diabetes. It works by helping your body produce insulin and reducing the amount of sugar your liver makes. Lixisenatide belongs to the GLP-1 (glucagon-like peptide) group of diabetes medicines. It works by helping your body produce insulin and by reducing appetite. It also helps to reduce weight in some people. This medicine should be stored in a refrigerator until you need it but do not freeze it. It is normally injected under the skin once daily. The dose will depend on your condition and what other diabetes medicines you are taking. It should be taken within one hour before the first meal of the day preferably the same meal each day. Your doctor or nurse will show you how and where to inject the medicine. Follow the instructions carefully. Do not stop taking this medicine without talking to your doctor. If you do, your blood sugar levels may increase and put you at risk of serious complications. Remember that it is only part of a treatment program that should also include a healthy diet and regular exercise as advised by your doctor. Your lifestyle plays a big part in controlling diabetes. The most common side effects of this medicine include nausea, vomiting, diarrhea, and decreased appetite. It can also lead to low blood sugar levels (hypoglycemia) especially if you are also taking other medicines like insulin or sulphonylureas for treatment of diabetes. To prevent this, it is important to have regular meals and always carry a fast-acting source of glucose such as sugary candy or glucose candy with you. Before using it, let your doctor know if you have any pancreas or stomach problems or severe dehydration (loss of body water) or diabetic ketoacidosis (too much acid in your blood). This medicine may not be suitable. Pregnant or breastfeeding women should also consult their doctor before using this medicine. If you experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar, do not drive, use machinery or do any activity that requires alertness or clear vision until you are sure you can do them safely. Lixisenatide is an anti-diabetic medication. It works by increasing the release of insulin from pancreas, decreases hormones that raise blood sugar levels, slows down digestion, and reduces appetite.

• Type 2 diabetes mellitus

Lixisenatide binds to and activates glucagon-like peptide-1 (GLP-1) receptor to stimulate glucagon-dependent insulin secretion, suppress glucagon secretion and slow gastric emptying.

Adult Dose: Subcutaneous Adjunct to Type 2 diabetes mellitus Adult: Initially, 10 mcg once daily for 14 days, given within 1 hour before morning or evening meal. May increase dose to 20 mcg once daily starting on day 15. Missed dose should be given within 1 hour of the next meal. Renal Dose: Renal impairment Mild (CrCl 60-89 mL/min): No dosage adjustment required; monitoring for changes in renal function recommended because of a higher incidence of hypoglycemia, nausea, and vomiting observed in these patients during clinical trials Moderate (CrCl 30 to <60 mL/min): No dosage adjustment required; closely monitoring for adverse GI adverse effects and for changes in renal function is recommended because these symptoms may lead to dehydration and acute renal failure and worsening of chronic failure in these patients Severe (CrCl 15 to <30 mL/min): Data are limited; there were only 5 patients with severe renal impairment in all controlled studies; lixisenatide exposure was higher in these patients; closely monitor for GI adverse effects and for changes in renal function End-stage renal disease (CrCl <15 mL/min): Not recommended; no therapeutic experience

Your doctor or nurse will guide you how to use this medicine.

Common: • Nausea • Vomiting • Hypoglycaemia (low blood sugar level) in combination with insulin or sulphonylurea • Diarrhea • Headache • Dizziness

[CAUTION] Your ability to drive may be affected if your blood sugar is too low or too high. Do not drive if these symptoms occur. If you have been prescribed insulin too, don't inject insulin and Lyxumia 20 Solution for Injection at the same site. Store unused pens in the refrigerator. However, after the first use, you can store it at room temperature for 14 days. Lyxumia 20 Solution for Injection may cause stomach upset and nausea. To avoid it, eat smaller meals, limit fatty food intake and stop eating when you feel full. Notify your doctor immediately if you have severe and/or persistent upper abdominal pain and vomiting.

Documented hypersensitivity; hypersensitivity reactions, including anaphylaxis, have occurred with lixisenatide

Increased risk of hypoglycaemia with sulfonylureas or basal insulin. May reduce the rate of absorption of oral medications (e.g. antibiotics, paracetamol, oral contraceptives).

[UNSAFE] It is unsafe to consume alcohol with Lixisenatide.

[CONSULT YOUR DOCTOR] Information regarding the use of Lixisenatide during pregnancy is not available. Please consult your doctor.

[CONSULT YOUR DOCTOR] Lixisenatide is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

[CAUTION] Lixisenatide should be used with caution in patients with severe kidney disease. Dose adjustment of Lixisenatide may be needed. Please consult your doctor. Limited information is available on the use of Lixisenatide in these patients. No dose adjustment is recommended in patients with mild to moderate liver disease. [CONSULT YOUR DOCTOR] There is limited information available on the use of Lixisenatide in patients with liver disease. Please consult your doctor.

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