WARNINGS
What is the most important information I should know about JANUMET XR?
Serious side effects can happen in people taking JANUMET XR, including:
1. Lactic Acidosis. Metformin, one of the medicines in JANUMET XR, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
Stop taking JANUMET XR and call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis.
You:
• feel very weak or tired.
• have unusual (not normal) muscle pain.
• have trouble breathing.
• have unusual sleepiness or sleep longer than usual.
• have sudden stomach or intestinal problems with nausea and vomiting or diarrhea.
• feel cold, especially in your arms and legs.
• feel dizzy or lightheaded.
• have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis if you:
• have kidney problems. People whose kidneys are not working properly should not take
JANUMET XR.
• have liver problems.
• have congestive heart failure that requires treatment with medicines.
• drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking.
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever,
vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise
and do not drink enough fluids.
• have certain x-ray tests with dyes or contrast agents that are injected into your body.
• have surgery.
• have a heart attack, severe infection, or stroke.
2. Pancreatitis (inflammation of the pancreas) which may be severe and lead to death.
Certain medical problems make you more likely to get pancreatitis.
Before you start taking JANUMET XR: Tell your doctor if you have ever had
• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels Stop taking JANUMET XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
USES
What is JANUMET XR?
• JANUMET XR is a prescription medicine that contains 2 prescription diabetes medicines, sitagliptin (JANUVIA) and extended-release metformin hydrochloride. JANUMET XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
• JANUMET XR is not for people with type 1 diabetes.
• JANUMET XR is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
• If you have had pancreatitis (inflammation of the pancreas) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JANUMET XR.
• It is not known if JANUMET XR is safe and effective when used in children under 18 years of age.
Who should not take JANUMET XR?
Do not take JANUMET XR if: • your kidneys are not working properly. • you are allergic to any of the ingredients in JANUMET XR. See the end of this Medication Guide for a complete list of ingredients in JANUMET XR. Symptoms of a serious allergic reaction to JANUMET XR may include: • rash • raised red patches on your skin (hives) • swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing • you have diabetic ketoacidosis. See "What is JANUMET XR?".
What should I tell my doctor before taking JANUMET XR?
Before you take JANUMET XR, tell your doctor if you:
• have or have had inflammation of your pancreas (pancreatitis). • have kidney problems. • have liver problems.
• have heart problems, including congestive heart failure.
• drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking.
• are going to get an injection of dye or contrast agents for an x-ray procedure; JANUMET XR will need to be stopped for a short time. Talk to your doctor about when you should stop JANUMET XR and when you should start JANUMET XR again. See “What is the most important information I should know about JANUMET XR?”.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if JANUMET XR will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. Pregnancy Registry: If you take JANUMET XR at any time during your pregnancy, talk with your doctor about how you can join the JANUMET XR pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You can enroll in this registry by calling 1-800-986-8999.
• are breast-feeding or plan to breast-feed. It is not known if JANUMET XR will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUMET XR. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JANUMET XR may affect how well other drugs work and some drugs can affect how well JANUMET XR works.
HOW TO USE
How should I take JANUMET?
Take JANUMET exactly as your doctor tells you. Your doctor will tell you how many JANUMET tablets to take and when you should take them.
Your doctor may change your dose of JANUMET if needed.
Your doctor may tell you to take JANUMET along with certain other diabetes m edicines. Low blood sugar (hypoglycemia) can happen more often when JANUMET is taken with certain other diabetes medicines. See "What are the possible side effects of JANUMET?".
Take JANUMET with meals to help to lower your chance of having an upset stomach.
Do not break or cut JANUMET tablets before swallowing. If you cannot swallow JANUMET tablets whole, tell your doctor.
Continue to take JANUMET as long as your doctor tells you.
If you take too much JANUMET, call your doctor or local Poison Control Center right away.
If you miss a dose, take it as soon as you rem ember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses of JANUMET at the same time.
You may need to stop taking JANUMET for a short time. Call your doctor for instructions if you:
o are dehydrated (have lost too much body fluid). Dehydration can occur if you are sick with severe vomiting, diarrhea or fever, or if you drink a lot less fluid than normal.
o plan to have surgery.
o are going to get an injection of dye or contrast agent for an x-ray procedure. See "What is the most important information I should know about JANUMET?" and "What should I tell my doctor before taking JANUMET?”.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the
amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these problems and follow your doctor’s instructions.
Check your blood sugar as your doctor tells you to.
Stay on your prescribed diet and exercise program while taking JANUMET.
Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar
What are the possible side effects of JANUMET? JANUMET may cause serious side effects, including:
See the section WARNINGS above.
• Kidney problems, sometimes requiring dialysis.
• Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.
• Low blood sugar (hypoglycemia). If you take JANUMET with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUMET. Signs and symptoms of low blood sugar may include:
o headache
o irritability
o dizziness
o sweating
o weakness
o drowsiness
o hunger
o confusion
o feeling jittery
o fast heart beat
• Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUMET and call your doctor right away or get emergency medical help. See "Who should not take JANUMET?". Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
• Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
• Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUMET.
The most common side effects of JANUMET include:
stuffy or runny nose and sore
upper respiratory
low blood sugar (hypoglycemia) when used in combination with certain medicines, such as a sulfonylurea or insulin
throat infection
gas, upset stomach, indigestion weakness
nausea and vomiting
headache
diarrhea
Taking JANUMET with meals can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. If you have unusual or sudden stomach problems, talk with your doctor. Stomach problems that start later during treatment may be a sign of something more serious.
JANUMET may have other side effects, including swelling of the hands or legs. Swelling of the hands and legs can happen if you take JANUMET in combination with rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.
Tell your doctor if you have any side effect that bothers you, or does not go away.
These are not all the possible side effects of JANUMET. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of JANUMET.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use JANUMET for a condition for which it was not prescribed. Do not give JANUMET to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in JANUMET?
Active ingredients: sitagliptin and metformin hydrochloride
Inactive ingredients: microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and black iron oxide.
OVERDOSE
If you take too much JANUMET, call your doctor or local Poison Control Center right away.
MISSED DOSE
If you miss a dose, take it as soon as you rem ember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses of JANUMET at the same time
STORAGE
How should I store JANUMET?
Store JANUMET at room temperature, between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
Keep JANUMET and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 07/2022
Prescribing Information: revision date 07/2022
Carbonic Anhydrase Inhibitors
Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide.
Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with JANUMET may increase the risk for lactic acidosis.
Intervention: Consider more frequent monitoring of these patients.
Drugs that Reduce Metformin Clearance
Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine.
Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis.
Intervention: Consider the benefits and risks of concomitant use with JANUMET.
Alcohol
Clinical Impact: Alcohol is known to potentiate the effect of metformin on lactate metabolism.
Intervention: Warn patients against alcohol intake while receiving JANUMET.
Insulin Secretagogues or Insulin
Clinical Impact: Coadministration of JANUMET with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia.
Intervention: Patients receiving an insulin secretagogue or insulin may require lower doses of the insulin secretagogue or insulin.
Drugs Affecting Glycemic Control
Examples: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid.
Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control.
Intervention: When such drugs are administered to a patient receiving JANUMET, observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving JANUMET, observe the patient closely for hypoglycemia.
See the section WARNINGS above.
