Janumet XR

Indications for Use

Janumet XR is used to treat type 2 diabetes. It contains two active ingredients, sitagliptin and metformin, which work together to help lower blood sugar levels in adults. This medication is often prescribed when blood sugar levels are not sufficiently managed by diet, exercise, or other single-ingredient diabetes medications.

How It Is Used

This medication is part of a comprehensive treatment plan that includes:

• Dietary changes: Following a meal plan recommended by a healthcare provider.
• Physical activity: Maintaining a regular exercise routine.
• Blood sugar monitoring: Regularly checking glucose levels as directed.

Limitations of Use

Janumet XR is specifically for type 2 diabetes and is not used for certain other conditions, including:

• Type 1 diabetes.
• Diabetic ketoacidosis (a serious condition involving high levels of ketones in the blood or urine).

Healthcare providers may also consider a patient's history of certain medical conditions, such as pancreatitis, before prescribing this medication, as its effects in those specific situations may not be fully established.

How Janumet XR Works

Janumet XR contains two medicines, sitagliptin and metformin, which work together to manage blood sugar in different ways:

• Sitagliptin: This ingredient is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing the levels of natural substances called incretins in the body. Incretins help control blood sugar by signaling the pancreas to release more insulin, especially after eating. They also signal the liver to stop producing excess sugar.
• Metformin: This ingredient belongs to a class of drugs called biguanides. It helps lower blood sugar by reducing the amount of glucose the liver produces and decreasing the amount of sugar the intestines absorb from food. It also helps the body become more sensitive to its own insulin, allowing the insulin to work more effectively.

The extended-release (XR) formulation is designed to release the medication slowly into the bloodstream over time. By combining these two mechanisms, the medication helps lower blood sugar levels both after meals and throughout the day.

Common Side Effects

The most frequent side effects of Janumet XR involve the digestive system or respiratory tract. These may include:

• Diarrhea, nausea, or upset stomach
• Gas and abdominal pain
• Headache
• Symptoms of a cold, such as a stuffy nose or sore throat

Serious Side Effects

Some side effects can be severe and require prompt medical evaluation. These include:

• Pancreatitis: Severe pain in the upper stomach that spreads to the back, with or without vomiting.
• Heart Failure: Shortness of breath (even while lying down), sudden weight gain, or swelling in the legs and feet.
• Kidney Issues: A decrease in urination or swelling in the lower body.
• Severe Joint Pain: Intense or persistent discomfort in the joints.
• Skin Reactions: Development of blisters or skin peeling.
• Low Blood Sugar (Hypoglycemia): This is more likely if Janumet XR is used with other diabetes drugs like insulin. Symptoms include shakiness, sweating, and confusion.

A rare but life-threatening condition called lactic acidosis can occur. Seek emergency medical care if you experience extreme tiredness, unusual muscle pain, trouble breathing, or feeling cold in your arms and legs.

Lactic Acidosis

Janumet XR contains metformin, which has a boxed warning for lactic acidosis. This is a rare but serious metabolic complication that occurs when metformin builds up in the bloodstream. It is a medical emergency that requires immediate hospitalization.

The risk of lactic acidosis is increased in individuals with certain conditions, including:

• Severe kidney impairment.
• Liver disease.
• Congestive heart failure.
• Heavy alcohol consumption.
• Dehydration or severe infection.

Medical procedures involving radiologic contrast (dye) or surgery may require temporarily stopping Janumet XR to prevent kidney injury and the subsequent risk of lactic acidosis.

Pancreatitis

Acute pancreatitis (inflammation of the pancreas) has been reported in people taking sitagliptin. This condition can be severe or life-threatening. The medication is typically discontinued if persistent, severe abdominal pain occurs, which may radiate to the back and may be accompanied by vomiting.

Heart Failure

There is an association between DPP-4 inhibitors, such as sitagliptin, and an increased risk of heart failure. Monitoring for symptoms is common, particularly for signs such as unusual shortness of breath, increased tiredness, or swelling in the feet and ankles.

Kidney Function

Because metformin is primarily excreted by the kidneys, kidney function must be assessed before starting treatment and monitored at least annually thereafter. Janumet XR is not recommended for individuals with severe kidney disease or those undergoing dialysis.

Severe Joint Pain

DPP-4 inhibitors may cause severe and disabling joint pain (arthralgia). This reaction can occur shortly after starting the drug or after years of use. Symptoms generally resolve after the medication is stopped.

Other Precautions

• Hypoglycemia: The risk of low blood sugar increases when Janumet XR is used in combination with insulin or insulin secretagogues (such as sulfonylureas).
• Vitamin B12 Deficiency: Long-term use of metformin may decrease vitamin B12 absorption, which may lead to anemia or peripheral neuropathy. Periodic blood tests may be used to monitor levels.
• Bullous Pemphigoid: This is a serious autoimmune skin reaction characterized by large, fluid-filled blisters. If skin blistering occurs, the medication is usually discontinued.
• Metabolic Acidosis: Janumet XR is contraindicated in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.

Pregnancy

There is limited research on the effects of Janumet XR in pregnant women. While metformin is generally considered to have a low risk of causing birth defects, the effects of sitagliptin on a developing fetus are not fully known. It is important to maintain good blood sugar control during pregnancy, as high blood sugar can cause complications for both the mother and the baby.

Metformin may also cause some premenopausal women who do not ovulate regularly to start ovulating again. This can increase the likelihood of an unintended pregnancy. If you are not planning a pregnancy, discuss effective birth control methods with your healthcare provider.

Breastfeeding

If you are breastfeeding or planning to breastfeed, talk to your healthcare provider about the potential risks. Key points include:

• Metformin: This component passes into breast milk in small quantities.
• Sitagliptin: It is not yet known if sitagliptin passes into human breast milk.

A healthcare provider can help determine if you should continue taking the medication or stop breastfeeding, based on your specific health needs and the potential impact on the infant.

Available Forms

Janumet XR is supplied as a film-coated, extended-release tablet. This formulation is intended for oral administration and is designed to release the medication slowly over time.

Active Components

Each tablet contains a combination of the following medications:

• Sitagliptin
• Metformin hydrochloride extended-release

FDA Approval and Indications

Janumet XR is approved by the U.S. Food and Drug Administration (FDA) to improve blood sugar control in adults with type 2 diabetes mellitus. It is intended for use in combination with diet and exercise. This medication is not approved for the treatment of type 1 diabetes or diabetic ketoacidosis.

Boxed Warning

The FDA requires a boxed warning for Janumet XR due to the risk of lactic acidosis, a rare but serious metabolic complication associated with the metformin component of the drug. Lactic acidosis can lead to low blood pressure, hypothermia, and death if not treated promptly. Risk factors for this condition include:

• Kidney impairment
• Advanced age (65 or older)
• Liver disease
• Congestive heart failure
• Excessive alcohol intake
• Severe infection or dehydration
• Undergoing surgery or certain radiological procedures using contrast dye

Safety Communications and Updates

The FDA has issued several safety updates and communications regarding the components of Janumet XR:

• Kidney Function Guidelines: In 2016, the FDA updated the labeling for metformin-containing products to reflect that they can be used safely in patients with mild to moderate kidney impairment, provided specific monitoring of kidney function is performed.
• Heart Failure Risk: The FDA has warned that medications in the DPP-4 inhibitor class, which includes sitagliptin, may increase the risk of heart failure. This risk is particularly relevant for patients who already have heart or kidney disease.
• Severe Joint Pain: The FDA has issued warnings that DPP-4 inhibitors may cause severe and disabling joint pain in some patients.
• Bullous Pemphigoid: The FDA has monitored reports of bullous pemphigoid, a skin condition characterized by large, fluid-filled blisters, in patients using DPP-4 inhibitors.

Factors Affecting Cost

The out-of-pocket price for Janumet XR is influenced by several factors, including:

• Insurance Coverage: Most commercial insurance plans and Medicare Part D cover Janumet XR, but the medication may be placed on a higher cost tier, resulting in different copay amounts.
• Pharmacy Selection: Prices can fluctuate between different retail pharmacies and mail-order services.
• Dosage and Quantity: The strength of the tablets and the number of days' supply per prescription will impact the total cost.

Brand vs. Generic

Janumet XR is a brand-name medication that combines sitagliptin and metformin extended-release. While metformin is available as a low-cost generic, the combination product Janumet XR is typically only available as a brand-name drug, which generally makes it more expensive than generic alternatives.

Financial Assistance

Patients may be able to reduce their costs through manufacturer savings cards or patient assistance programs. These programs are often available to eligible individuals who are uninsured or have commercial insurance. It is recommended to speak with a pharmacist or healthcare provider about options for managing the cost of this medication.