Trajenta (Linagliptin)

What is Tradjenta (linagliptin)?

Tradjenta is a medication prescribed to improve blood sugar levels in adult patients with type 2 diabetes. Tradjenta is prescribed to be taken once daily long-term.

Tradjenta belongs to the drug class dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors work by increasing the level of insulin your body makes after a meal. When insulin made by the body decreases, blood sugar levels will rise to high levels. Very high blood sugar levels can be dangerous and life-threatening.

What are the Indications for Tradjenta?

Tradjenta is prescribed as part of a treatment plan to manage blood sugar levels consisting of exercise, diet changes, and regular blood sugar testing. Any change in diet and activity can affect blood sugar levels.

Tradjenta is not recommended:

• For treatment of type 1 diabetes.
• For treatment of diabetic ketoacidosis.
• If you are allergic or have had an allergic reaction to Tradjenta (linagliptin) or ingredients in Tradjenta.

How is Tradjenta used?

Tradjenta can be taken alone or with other diabetes medications. Tradjenta is available in tablet form.

Storage

Tradjenta should be stored at room temperature between 68°F and 77°F (20°C and 25°C).

Keep out of reach of children.

Instruction

Take Tradjenta by mouth as directed by your doctor. Tradjenta can be taken with or without food. Take Tradjenta as a whole tablet – do not break, chew, or crush the tablet.

Ask your doctor or pharmacist for further direction if you do not understand the instruction.

Take Tradjenta for the entire prescribed duration even if you start to feel better.

Dosage

Tradjenta comes in tablet form as a 5-mg tablet to be taken once daily.

Side Effects

It’s important to understand that although Tradjenta is FDA approved, it comes with side effects that may or may not affect you.

Before starting Tradjenta, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Tradjenta, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Stuffy or runny nose
• Sore throat
• Cough
• Diarrhea

Serious Side Effects

Severe adverse reactions while taking Tradjenta can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Low blood sugar: headache, irritability, confusion, blurred vision, slurred speech, dizziness or light-headedness, shakiness, fast heartbeat, mood change, anxiety, or excessive hunger.
• Skin reaction: large, fluid-filled blisters known as bullous pemphigoid or erosion of the skin.
• Joint pain

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Tradjenta, tell your doctor or pharmacist:

• If you are allergic to any medications such as Tradjenta
• If you have or have had heart failure or kidney problems
• If you have or have had inflammation of your pancreas (pancreatitis)
• If you are pregnant or plan to become pregnant
• If you are breastfeeding or plan to breastfeed

Heart Failure or Kidney Problems

Taking Tradjenta (a DPP-4 inhibitor medication) may increase your risk of heart failure. During trials of other DPP-4 inhibitor medications, heart failure was observed.

Heart failure symptoms include shortness of breath, fatigue, weakness, swelling in the legs, ankles, and feet, nausea, abdominal pain, persistent cough that may be tinged with blood, and loss of appetite. If you develop symptoms, contact your doctor right away.

Hypoglycemia or Low Blood Sugar

Taking Tradjenta in combination with another medication for diabetes, such as insulin, increases your risk of having low blood sugar levels. Symptoms include the inability to concentrate, irritability, shakiness, fast heartbeat, unusual weakness or tiredness, excessive hunger, and confusion.

Severe low blood sugar may become life-threatening, cause seizures, or result in death. Your doctor will create a treatment plan that includes monitoring your blood sugar level to determine if a change in treatment is necessary.

Inflammation of the Pancreas (Pancreatitis)

Taking Tradjenta may cause inflammation of your pancreas identified by severe pain in your stomach that does not go away. Pancreatitis can become severe and possibly fatal. If you develop symptoms, stop using Tradjenta and contact your doctor right away.

Joint Stiffness or Arthralgia

Taking Tradjenta may result in mild to severe or disabling joint stiffness, which can take years to form. Symptoms include pain or ache in the joints without swelling, limited joint motion, and locking of the joint.

If you develop symptoms, stop using Tradjenta and contact your doctor right away. Discontinuing Tradjenta typically resolves the symptoms of joint stiffness.

Pediatric Use

Tradjenta has not been established to be effective and safe for patients under 18 years of age.

Pregnant or Plan to Become Pregnant

There is limited information to determine if taking Tradjenta will result in harm to pregnant patients or fetuses. No adverse observations were found during clinical trials.

However, having uncontrolled or high blood sugar levels may cause complications during the pregnancy and delivery for both mother and baby. Complications include premature birth, low birth weight, and breathing problems. There is also an increased risk of miscarriage or stillborn. Your doctor will create a treatment plan to monitor your blood sugar levels.

Breastfeeding or Planning to Breastfeed

There is no information to determine if Tradjenta will pass through to human breastmilk; however, the medication was found to be present in rat milk during clinical testing. Consult with your doctor to determine whether you should take Tradjenta.

Skin Reaction and Bullous Pemphigoid

Taking Tradjenta may cause severe skin reactions such as Bullous Pemphigoid, where the skin develops fluid-filled blisters. Symptoms include itchy skin, blisters along creases or folds of the skin, eczema or rash, and blisters or sores in the mouth.

If you develop symptoms, stop using Tradjenta and contact your doctor right away.

Interactions & Contraindications

Before taking Tradjenta, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Rifampin

Taking Tradjenta while taking rifampin may decrease the effect of Tradjenta to maintain blood sugar levels. Your doctor may replace or discontinue this medication while you are taking Tradjenta.

Diabetic Medications and Insulins

Taking Tradjenta in combination with another medication for diabetes, such as insulin, increases your risk of having low blood sugar levels. Your doctor may reduce the dosage of other diabetic medications you are taking to prevent this.

Symptoms of low blood sugar include the inability to concentrate, irritability, shakiness, fast heartbeat, unusual weakness or tiredness, excessive hunger, and confusion.