Synjardy

Primary Uses

Synjardy is a combination of two medications, empagliflozin and metformin. It is primarily prescribed for the following purposes:

• Blood Sugar Control: It helps manage blood glucose levels in adults with type 2 diabetes when used in combination with a healthy diet and regular physical activity.
• Heart Health: It is used to lower the risk of death from heart-related causes (such as heart attack or stroke) in adults with type 2 diabetes who also have known heart disease.

How It Is Used

This medication is intended for long-term management of type 2 diabetes. It works by helping the kidneys remove glucose through urine and by decreasing the amount of sugar produced by the liver and absorbed by the intestines.

Important Limitations

Synjardy is not used to treat type 1 diabetes. It is also not intended for the treatment of diabetic ketoacidosis, which is a serious condition involving high levels of acid in the blood.

Dual Action for Blood Sugar Control

Synjardy contains two active ingredients, empagliflozin and metformin, which use different mechanisms to help manage blood glucose levels.

How Empagliflozin Works

Empagliflozin is part of a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works primarily through the kidneys. Normally, the kidneys filter sugar out of the blood and then reabsorb it back into the bloodstream. Empagliflozin blocks this reabsorption process, which allows the body to get rid of excess sugar through urination.

How Metformin Works

Metformin belongs to a class of medications known as biguanides. It helps lower blood sugar in three distinct ways:

• Reducing sugar production: It decreases the amount of glucose that the liver produces and releases into the blood.
• Improving insulin sensitivity: It helps the body respond more effectively to the insulin it naturally produces, allowing cells to use sugar for energy more efficiently.
• Decreasing sugar absorption: It reduces the amount of sugar the body absorbs from the food you eat during digestion.

By combining these two approaches, Synjardy helps provide more comprehensive blood sugar management than either medication might provide on its own.

Common Side Effects

The most frequently reported side effects of Synjardy involve the digestive system or mild respiratory symptoms. These may include:

• Nausea, vomiting, or diarrhea
• Stomach pain or gas
• A metallic taste in the mouth
• Headache
• Runny nose or sore throat

Infections

Because of how this medication works, it can increase the risk of certain types of infections:

• Yeast Infections: Both men and women may experience yeast infections of the genitals, which can cause itching, redness, or discharge.
• Urinary Tract Infections (UTIs): Some users may develop UTIs. In rare cases, these can become severe and lead to kidney infections or hospitalization.

Serious Side Effects

While rare, some side effects are serious and require immediate medical care:

• Lactic Acidosis: A dangerous buildup of lactic acid in the blood. Symptoms include unusual tiredness, muscle pain, trouble breathing, stomach pain with nausea, and feeling cold.
• Ketoacidosis: A condition where the body produces high levels of blood acids called ketones. This can occur even if blood sugar levels are not very high.
• Dehydration: This medication can cause the body to lose too much water and salt, leading to low blood pressure, dizziness, or fainting, especially when standing up.
• Fournier's Gangrene: A rare but life-threatening bacterial infection of the skin and tissue in the genital or anal area.
• Vitamin B12 Deficiency: Long-term use of metformin can lower the amount of vitamin B12 in the blood.
• Allergic Reactions: Serious reactions may involve a rash, hives, or swelling of the face, lips, and throat.

Lactic Acidosis Boxed Warning

Metformin, an active ingredient in Synjardy, can cause a rare but serious condition called lactic acidosis. This is a medical emergency caused by the buildup of lactic acid in the blood. The risk is higher in people with kidney or liver problems, those who are 65 or older, or those who have had surgery or certain x-ray procedures using contrast dye. Excessive alcohol intake also increases this risk.

Ketoacidosis

Empagliflozin, the other active ingredient, may increase the risk of ketoacidosis, a life-threatening condition where the body produces high levels of blood acids called ketones. This can occur even if blood sugar levels are near normal. Symptoms may include nausea, vomiting, stomach pain, generalized weakness, and difficulty breathing.

Dehydration and Kidney Function

Synjardy can cause dehydration, which is the loss of too much body water and salt. Dehydration may lead to a sudden drop in blood pressure, dizziness, or lightheadedness, especially when standing up. This fluid loss can also cause or worsen kidney problems. Monitoring of kidney function is typically required before and during treatment.

Serious Infections

This medication may increase the risk of serious urinary tract infections and genital yeast infections. A rare but life-threatening bacterial infection called necrotizing fasciitis of the perineum (Fournier’s gangrene) has been reported. This infection causes damage to the tissue under the skin in the genital or anal area.

Vitamin B12 Levels

Long-term use of metformin may lead to low levels of vitamin B12 in the blood. Healthcare providers may monitor B12 levels periodically to prevent deficiency.

Contraindications

Synjardy should not be used by individuals with severe kidney disease, those on dialysis, or people with metabolic acidosis or diabetic ketoacidosis.

Pregnancy

Information regarding the use of Synjardy during pregnancy is limited. However, the empagliflozin component of this medication is not recommended during the second and third trimesters. Animal studies suggest that empagliflozin may affect the development of the baby's kidneys during these stages of pregnancy.

The metformin component may increase the likelihood of pregnancy in some individuals by stimulating ovulation in premenopausal people who do not have regular periods. If you are of childbearing age, discuss birth control options with your healthcare provider.

If you become pregnant while taking this medication, notify your doctor immediately. They may recommend alternative treatments, such as insulin, to manage blood sugar levels during pregnancy.

Breastfeeding

Breastfeeding is generally not recommended while taking Synjardy. It is not known if empagliflozin passes into human breast milk, but animal studies have shown it can be present and may pose a risk to the nursing infant's kidney development. Metformin is known to pass into breast milk in small amounts. Because of the potential for serious side effects in a nursing child, you should talk to your doctor about whether to stop the medication or stop breastfeeding.

Available Forms

Synjardy is available as a film-coated tablet for oral use. It is produced in different formulations:

• Immediate-release tablets: These tablets release the active ingredients into the body shortly after ingestion.
• Extended-release tablets: These tablets are designed to release the medication slowly over a longer period.

FDA Approval History

The FDA first approved Synjardy in August 2015 for use in adults with type 2 diabetes. In June 2023, the FDA expanded the approved use of Synjardy and Synjardy XR to include pediatric patients aged 10 years and older, providing a new oral treatment option for children with the condition.

Boxed Warning

Synjardy contains a Boxed Warning, the most serious type of warning required by the FDA. This warning concerns the risk of lactic acidosis, a rare but serious metabolic complication caused by the accumulation of metformin. This condition can be fatal and requires immediate hospitalization. Risk factors include kidney impairment, certain drug interactions, age 65 or older, and radiological studies using contrast dye.

Approved Indications

Synjardy is indicated as an addition to diet and exercise to improve glycemic control in:

• Adults with type 2 diabetes mellitus.
• Pediatric patients aged 10 years and older with type 2 diabetes mellitus.

The medication is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis. It is also contraindicated in patients with severe kidney disease, end-stage renal disease, or those receiving dialysis.

Factors Influencing Cost

The price of Synjardy can be affected by several factors, including:

• Insurance Coverage: Most commercial insurance and Medicare Part D plans provide coverage for Synjardy, but the out-of-pocket cost or copayment will depend on the specific plan's formulary tier.
• Pharmacy Choice: Prices may differ between retail pharmacies, mail-order services, and specialty pharmacies.
• Dosage and Quantity: The strength of the medication and the number of tablets dispensed per refill can impact the total price.

Generic Availability

Synjardy is a brand-name combination medication containing empagliflozin and metformin. While metformin is available as a low-cost generic on its own, the combination product is generally available only as a brand-name drug, which typically costs more than generic alternatives.

Financial Assistance

The manufacturer may offer savings cards or patient assistance programs to help reduce out-of-pocket expenses for eligible individuals. Patients should check with their healthcare provider or the manufacturer for current assistance options if they are uninsured or underinsured.