Robust CVOT program - CAROLINA

Document ID: PC-MY-102222

23/03/2022

Author: Boehringer Ingelheim

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PC-MY-102222
Production date: March 2022

What is Linagliptin (Trajenta®)?

Linagliptin (Trajenta®) is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Linagliptin (Trajenta®) should not be used in patients with type 1 diabetes or for treatment of diabetic ketoacidosis (increased ketones in the blood or urine).

If your patients have had inflammation of the pancreas (pancreatitis) in the past, it is not known if they have a higher chance of getting pancreatitis while you take Linagliptin (Trajenta®). If pancreatitis is suspected, linagliptin should be promptly discontinued and appropriate management should be initiated.
 

Important safety information

What important information I should know about Linagliptin (Trajenta®)?

Special warnings and precautions should be considered when taking Linagliptin (Trajenta®), there have been some post-marketing reports of severe and disabling arthralgia, acute pancreatitis and bullous pemphigoid. Before your patients start taking Linagliptin (Trajenta®), ask your patients if they have type 1 diabetes or diabetic ketoacidosis, taking an anti-diabetic medicine known as “sulphonylurea”, allergic reactions to any other medicines or history of pancreatitis.

What are the contraindications to Linagliptin (Trajenta®)?

Linagliptin (Trajenta®) should not be given to patients who are allergic to its active ingredients or any of the other ingredients of this medicine.

Please advise patients to stop taking Linagliptin (Trajenta®) and seek medical consult immediately if they experience the symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion. Hypoglycaemia is an identified side effect when Linagliptin (Trajenta®) is taken together with metformin and a sulphonylurea.

Some patients have experienced allergic reactions (hypersensitivity) which may be serious, including wheezing and shortness of breath (bronchial hyperactivity).

Some patients experienced rash, hives (urticaria), swelling of the face, lips, tongue and throat that may cause difficulty in breathing or swallowing (angioedema). Should they experience any of the signs of illness mentioned above, patients should be advised to stop taking Linagliptin (Trajenta®) and seek medical consult right away.

Do not give Linagliptin (Trajenta®) if your patients experience any of the following serious side effects: Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).

What should I ask my patients before prescribing Linagliptin (Trajenta®)?

Ask your patients if they are currently undergoing treatment for tuberculosis and might be taking Rifampicin. Closely monitor the glucose level of your patients and consider alternative treatments in cases of insufficient efficacy. If your patients are taking Linagliptin (Trajenta®) with another medicine that can cause low blood sugar, such as sulphonylurea or insulin, his/ her risk of getting low blood sugar is higher. The dose of a sulphonylurea or insulin may need to be lowered while your patients take Linagliptin (Trajenta®).

Ask your patients if they are pregnant or planning to be pregnant or are breastfeeding or planning to breastfeed. There are limited data on the use of Linagliptin (Trajenta®) in pregnant women. It is also not known whether the drug is excreted in human milk. As a precautionary measure, it is preferable to avoid the use of Linagliptin (Trajenta®) during pregnancy and breastfeeding.

For more information, please see Prescribing Information.