Linagliptin

DEA Class; Rx

Common Brand Names; Tradjenta

Indicated for adults with type 2 diabetes mellitus along with diet and exercise to lower blood sugar; may be used as monotherapy or in combination with other common antidiabetic medications including metformin, sulfonylurea, pioglitazone, or insulin

Hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity)

Type 1 diabetes mellitus

Diabetic ketoacidosis

Nasopharyngitis (4.3%)

Hyperlipidemia (2.8%; with pioglitazone)

Cough (2.4%; with metformin and sulfonylurea)

Hypertriglyceridemia (2.4%; with sulfonylurea)

Weight gain (2.3%; with pioglitazone)

Hypoglycemia

• 7.6% overall incidence
• 22.9% incidence compared with placebo plus metformin and a sulfonylurea
• Incidence similar to placebo with monotherapy or combined with metformin or pioglitazone

Acute pancreatitis, including fatal pancreatitis

Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions

Severe and disabling arthralgia

Bullous pemphigoid

Rash

Mouth ulceration, stomatitis

Rhabdomyolysis

Heart failure

Hypoglycemia with concomitant use of insulin and insulin secretagogues

Use in combination with an insulin secretagogue (eg, sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial; a lower dose of insulin secretagogue or insulin may be required to reduce risk of hypoglycemia when used in combination with this drug

Rifampin decreased linagliptin exposure suggesting that the levels may be reduced when administered in combination with a strong P-gp or CYP 3A4 inducer; alternative treatment is strongly recommended when linagliptin is to be administered with P-gp or CYP 3A4 inducers

Serious hypersensitivity reactions reported including anaphylaxis, angioedema, and exfoliative skin conditions

Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate

Heart failure has been observed with two other members of the DPP-4 inhibitor class; consider risks and benefits of empagliflozin in patients with risk factors for heart failure; monitor for signs and symptoms; if heart failure develops, manage accordingly to standard of care and consider interrupting treatment

Bullous pemphigoid reported with DPP-4 inhibitor use, which required hospitalization; in reported cases, patients recovered with topical or systemic immunosuppressive treatment and discontinuation of DPP-4 inhibitor; patients should report development blisters/erosions; discontinue DPP-4 therapy and consult a dermatologist if bullous pemphigoid suspected

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with therapy

The limited data in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy

There is no information regarding presence of linagliptin in human milk, the effects on breastfed infant, or effects on milk production

Linagliptin

tablet

• 5mg