LINAJENTA PLUS

Empagliflozin / Linagliptin – 30 Film-Coated Tablets

Available strengths:

• Empagliflozin 10 mg + Linagliptin 5 mg
• Empagliflozin 25 mg + Linagliptin 5 mg

Product Overview

Linajenta Plus is a combination oral antidiabetic medicine containing empagliflozin, an SGLT2 inhibitor, and linagliptin, a DPP-4 inhibitor.

It is used to improve blood glucose control in adults with type 2 diabetes mellitus, together with diet and exercise. The two active ingredients work through complementary mechanisms to help reduce blood glucose levels.

Active Ingredients

Each film-coated tablet contains one of the following combinations:

Linajenta Plus may be prescribed for:

• Improving glycemic control in adults with type 2 diabetes mellitus.
• Patients whose blood glucose is not adequately controlled with either component alone.
• Patients already taking empagliflozin and linagliptin separately who may benefit from a fixed-dose combination.
• Use alongside diet and exercise, and potentially with other antidiabetic medicines when appropriate.

Note: It is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Mechanism of Action

The two ingredients lower blood glucose through different pathways:

• Empagliflozin (SGLT2 inhibitor): Blocks sodium-glucose co-transporter 2 in the kidneys, reducing glucose reabsorption and increasing glucose elimination through urine.
• Linagliptin (DPP-4 inhibitor): Inhibits the DPP-4 enzyme, increasing the activity of incretin hormones. This enhances glucose-dependent insulin release and reduces glucagon secretion.

Together, they provide complementary blood-glucose-lowering effects.

Dosage and Administration

• The usual recommended starting dose is one tablet of 10/5 mg once daily, preferably in the morning.
• If additional blood glucose control is required and the starting dose is well tolerated, the physician may increase the dose to 25/5 mg once daily.
• May be taken with or without food.
• Swallow the tablet whole with water.
• If a dose is missed, take it when remembered unless it is nearly time for the next dose. Do not take a double dose.
• Kidney function and hydration status should be assessed before starting treatment.

Important: The 25/5 mg strength is not intended to be used as an additional tablet on top of the 10/5 mg strength.

Possible Side Effects

Common side effects:

• Urinary tract infections.
• Genital fungal infections, such as vaginal yeast infections or balanitis.
• Increased urination.
• Nasopharyngitis and upper respiratory tract infections.
• Thirst.
• Gastrointestinal discomfort.

Potentially serious adverse effects:

• Hypoglycemia, particularly when combined with insulin or sulfonylureas.
• Dehydration, low blood pressure, or dizziness.
• Diabetic ketoacidosis, which may occasionally occur even without markedly elevated blood glucose.
• Acute kidney injury, particularly in susceptible or dehydrated patients.
• Pancreatitis.
• Severe genital or urinary infections, including rare Fournier's gangrene.
• Severe allergic reactions.
• Bullous pemphigoid, a rare blistering skin condition.

Contraindications

Avoid use in patients with:

• Known hypersensitivity to empagliflozin, linagliptin, or any component of the formulation.
• A history of serious hypersensitivity reactions to DPP-4 inhibitors, such as anaphylaxis or angioedema.
• Diabetic ketoacidosis.

Use in severe renal impairment or dialysis is restricted according to the applicable product label. The fixed-dose combination may not be suitable for patients with significantly reduced kidney function.

Warnings and Precautions

• Kidney function: Assess renal function before treatment and periodically thereafter. Empagliflozin's glucose-lowering effect decreases as kidney function declines.
• Volume depletion: Monitor patients at risk of dehydration, especially older adults and those taking diuretics.
• Ketoacidosis: Seek urgent medical assessment if symptoms such as nausea, vomiting, abdominal pain, unusual tiredness, or difficulty breathing develop. Ketoacidosis can occur even when blood glucose is not extremely high.
• Genital and urinary infections: Maintain good genital hygiene and seek medical advice if symptoms of infection occur.
• Pancreatitis: Discontinue treatment and seek medical assessment if persistent severe abdominal pain, possibly radiating to the back, occurs.
• Foot care: Monitor for foot ulcers, infections, or other lower-limb complications, particularly in patients with peripheral vascular disease or neuropathy.
• Surgery and prolonged fasting: Treatment should generally be withheld for at least 3 days before major surgery or procedures associated with prolonged fasting, when possible, and restarted when the patient is clinically stable and eating normally.
• Heart failure: Monitor for symptoms such as worsening breathlessness, swelling, or sudden weight gain.

Drug Interactions

Potential interactions include:

• Insulin and sulfonylureas: May increase the risk of hypoglycemia; dose adjustment may be required.
• Diuretics: May increase fluid loss, dehydration, and hypotension.
• Rifampicin: May reduce linagliptin exposure and potentially decrease its effectiveness.
• Lithium: Empagliflozin may affect lithium concentrations; monitoring may be necessary.
• Other glucose-lowering medicines: Blood glucose should be monitored when used in combination.

Patients should inform their healthcare professional about all medicines and supplements they take.

Pregnancy and Breastfeeding

• Pregnancy: Not recommended, particularly during the second and third trimesters, because of potential effects on fetal kidney development. Alternative diabetes treatment should be discussed with the treating physician.
• Breastfeeding: Use is generally not recommended because of insufficient human safety data and potential concerns regarding infant kidney development.

Storage

• Store at room temperature according to the manufacturer's instructions.
• Keep in the original packaging, protected from moisture.
• Keep out of reach of children.

Patient Disclaimer

This information is provided for educational purposes only and is not intended to diagnose, treat, cure, or prevent any disease. Linajenta Plus should be used only under the supervision of a qualified healthcare professional. Patients should not start, adjust, or discontinue treatment without medical advice. Always refer to the manufacturer's leaflet for product-specific instructions.

References

The following official references provide information about the active ingredients, indications, dosing, safety, and precautions:

1. European Medicines Agency (EMA) – Glyxambi Product Information (Empagliflozin/Linagliptin).
2. DailyMed – Empagliflozin and Linagliptin: Prescribing Information.
3. U.S. FDA – Glyxambi Prescribing Information.
4. Australian Commission on Safety and Quality in Health Care – Glyxambi Medicine Information.