Synjardy (empagliflozin and metformin)

Synjardy is a prescription medicine for Type 2 Diabetes Mellitus. It may be used alone or with other medications.

Synjardy belongs to a class of drugs called Antidiabetics, Biguanides; Antidiabetics, SGLT2 Inhibitors.

Synjardy’s safety and effectiveness have not been established in children younger than 18 years old.

What are the side effects of Synjardy?

LACTIC ACIDOSIS

Metformin-associated lactic acidosis can have severe symptoms, including death. It is often accompanied by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Elevated blood lactate levels, increased lactate/pyruvate ratio, and metformin plasma levels >5 mcg/mL characterize metformin-associated lactic acidosis.

Risk factors for metformin-associated lactic acidosis include renal impairment, use of carbonic anhydrase inhibitors, age 65 years old or greater, radiological procedures with contrast, surgery, hypoxic states, excessive alcohol intake, and hepatic impairment.

To reduce the risk of metformin-associated lactic acidosis, refer to the full prescribing information.

If metformin-associated lactic acidosis is suspected, discontinue Synjardy and seek medical attention. Hemodialysis is recommended.

Synjardy may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of face, lips, tongue, or throat,
• burning or painful urination,
• frequent or urgent urination,
• pink or bloody urine,
• little or no urination,
• unusual vaginal discharge, burning, itching, or odor,
• redness, itching, swelling of the penis,
• unusual discharge from the penis,
• pain, redness, swelling in or around genital or anal area,
• fever,
• feeling unwell,
• sudden sweating,
• shaking,
• fast heartbeat,
• hunger,
• blurred vision,
• dizziness,
• tingling hands or feet,
• thirst,
• increased urination,
• confusion,
• drowsiness,
• flushing,
• rapid breathing,
• fruity breath odor,
• vomiting,
• diarrhea,
• heavy sweating,
• dry mouth,
• thirst,
• lightheadedness, and
• fainting

If you experience any of the mentioned symptoms, seek medical help immediately.

The most common side effects of Synjardy include:

Report any bothersome side effects to your doctor.

These are not all the possible side effects of Synjardy. For more information, consult your doctor or pharmacist.

Contact your doctor for medical advice regarding side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Synjardy?

Prior To Initiation Of Synjardy

• Assess renal function before starting Synjardy.
• In patients with volume depletion, correct this condition before initiating Synjardy.

Recommended Dosage And Administration

• Individualize the starting dose of Synjardy based on the patient’s current regimen:
• Switch to Synjardy containing empagliflozin 5 mg if on metformin HCl;
• Switch to Synjardy containing metformin HCl 500 mg if on empagliflozin;
• Switch to Synjardy containing the same total daily doses of each component if already on empagliflozin and metformin HCl.

Dosage Recommendations In Patients With Renal Impairment

• Do not initiate Synjardy if eGFR is less than 45 mL/min/1.73 m 2 due to the metformin component.
• Synjardy is contraindicated if eGFR is less than 30 mL/min/1.73 m 2 or in patients on dialysis.

Discontinuation For Iodinated Contrast Imaging Procedures

Discontinue Synjardy before an iodinated contrast imaging procedure if eGFR is less than 60 mL/min/1.73 m 2 , patient has a history of liver disease, alcoholism or heart failure, or if intra-arterial iodinated contrast will be administered. Re-evaluate eGFR 48 hours after the imaging procedure and resume Synjardy if renal function is stable.

QUESTION

What drugs interact with Synjardy?

Table 4 Clinically Relevant Interactions with Synjardy

Is Synjardy safe to use while pregnant or breastfeeding?

• Inform pregnant patients and those of reproductive potential about potential fetal risks associated with Synjardy.
• Patients should report pregnancies to their physicians promptly. Breastfeeding is not recommended while taking Synjardy.