JANUMET XR (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tablets: JANUMET XR, 50 mg/500 mg, are light blue, bi-convex oval, film-coated tablets with “78″ debossed on one side. They are supplied as follows:

NDC 0006-0078-61 unit-of-use bottles of 60
NDC 0006-0078-62 unit-of-use bottles of 180
NDC 0006-0078-82 bulk bottles of 1000.

Tablets: JANUMET XR, 50 mg/1000 mg, are light green, bi-convex oval, film-coated tablets with “80″ debossed on one side. They are supplied as follows:

NDC 0006-0080-61 unit-of-use bottles of 60
NDC 0006-0080-62 unit-of-use bottles of 180
NDC 0006-0080-82 bulk bottles of 1000.

Tablets: JANUMET XR, 100 mg/1000 mg, are blue, bi-convex oval, film-coated tablets with “81″ debossed on one side. They are supplied as follows:

NDC 0006-0081-31 unit-of-use bottles of 30
NDC 0006-0081-54 unit-of-use bottles of 90
NDC 0006-0081-82 bulk bottles of 1000.

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Store in a dry place with cap tightly closed. When container is subdivided, dispense into a USP tightly closed, moisture-resistant container.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Lactic Acidosis

Inform patients of the risks of lactic acidosis due to the metformin component, its symptoms, and conditions that predispose to its development, as noted in Warnings and Precautions (5.1). Advise patients to discontinue JANUMET XR immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, dizziness, slow or irregular heart beat, sensation of feeling cold (especially in the extremities) or other nonspecific symptoms occur. Gastrointestinal symptoms are common during initiation of metformin treatment and may occur during initiation of JANUMET XR therapy; however, inform patients to consult their physician if they develop unexplained symptoms. Although gastrointestinal symptoms that occur after stabilization are unlikely to be drug related, such an occurrence of symptoms should be evaluated to determine if it may be due to lactic acidosis or other serious disease. Instruct patients to inform their doctor that they are taking JANUMET XR prior to any surgical or radiological procedure, as temporary discontinuation of JANUMET XR may be required until renal function has been confirmed to have returned to its prior level [see Warnings and Precautions (5.1)].

Counsel patients against excessive alcohol intake, either acute or chronic, while receiving JANUMET XR.

Inform patients about the importance of regular testing of renal function and hematological parameters when receiving treatment with JANUMET XR.

Pancreatitis

Inform patients that acute pancreatitis has been reported during postmarketing use of JANUMET XR. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to promptly discontinue JANUMET XR and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.2)].

Heart Failure

Inform patients of the signs and symptoms of heart failure. Before initiating JANUMET XR, ask patients about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Instruct patients to contact their health care provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.3)].

Hypoglycemia

Inform patients that the incidence of hypoglycemia is increased when sitagliptin with or without metformin is added to an insulin secretagogue (e.g., sulfonylurea) or insulin therapy and that a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

Hypersensitivity Reactions

Inform patients that allergic reactions have been reported during postmarketing use of sitagliptin, one of the components of JANUMET XR. If symptoms of allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JANUMET XR and seek medical advice promptly.

Severe and Disabling Arthralgia

Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see Warnings and Precautions (5.10)].

Bullous Pemphigoid

Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur [see Warnings and Precautions (5.11)].

Administration Instructions

Inform patients that the tablets must be swallowed whole and never split, crushed or chewed.

Incompletely Dissolved Tablets in Feces

Inform patients that incompletely dissolved JANUMET XR tablets may be eliminated in the feces. Tell patients that, if they repeatedly see tablets in feces, they should report this finding to their health care provider. Assess adequacy of glycemic control if a patient reports repeatedly observing tablets in feces.

Overdosage

Advise patients to notify their health practitioner or call the Poison Control Center immediately in case of JANUMET XR overdose.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2012-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

uspi-mk0431a-xrt-1908r015

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2017
Medication GuideJANUMET® XR (JAN-you-met XR)(sitagliptin and metformin hydrochloride extended-release)Tablets
Read this Medication Guide carefully before you start taking JANUMET XR and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about JANUMET XR, ask your doctor or pharmacist.
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 buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:

  • you feel cold in your hands or feet
  • you feel dizzy or lightheaded
  • you have a slow or irregular heartbeat
  • you feel very weak or tired
  • you have unusual (not normal) muscle pain
  • you have trouble breathing
  • you feel sleepy or drowsy
  • you have stomach pains, nausea or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with JANUMET XR if you:

  • have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
  • have liver problems
  • 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 surgery
  • have a heart attack, severe infection, or stroke

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your JANUMET XR for a while if you have any of these things.

JANUMET XR can have other serious side effects. See What are the possible side effects of JANUMET XR?

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.

3.
Heart failure. Heart failure means that your heart does not pump blood well enough.
Before you start taking JANUMET XR, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms:
  • increasing shortness of breath or trouble breathing, especially when you lie down
  • swelling or fluid retention, especially in the feet, ankles or legs
  • an unusually fast increase in weight
  • unusual tiredness
These may be symptoms of heart failure.
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:
  • you have severe kidney problems.
  • 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) or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

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 severe 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 may 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 over-the-counter medicines, vitamins, and herbal supplements. JANUMET XR may affect how well other drugs work and some drugs can affect how well JANUMET XR works.Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take JANUMET XR?
  • Take JANUMET XR exactly as your doctor tells you. Your doctor will tell you how many JANUMET XR tablets to take and when you should take them.
  • Your doctor may change your dose of JANUMET XR if needed.
  • Your doctor may tell you to take JANUMET XR along with certain other diabetes medicines. Low blood sugar (hypoglycemia) can happen more often when JANUMET XR is taken with certain other diabetes medicines. See “What are the possible side effects of JANUMET XR?“.
  • Take JANUMET XR 1 time each day with a meal to help to lower your chance of having an upset stomach. It is better to take JANUMET XR with your evening meal.
  • Take JANUMET XR tablets whole. Do not break, cut, crush, dissolve, or chew JANUMET XR tablets before swallowing. If you cannot swallow JANUMET XR tablets whole, tell your doctor.
  • You may see something that looks like the JANUMET XR tablet in your stool (bowel movement). If you see tablets in your stool several times, talk to your doctor. Do not stop taking JANUMET XR without talking to your doctor.
  • Continue to take JANUMET XR as long as your doctor tells you.
  • If you take too much JANUMET XR, call your doctor or local Poison Control Center right away.
  • If you miss a dose, take it with food as soon as you remember. 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 XR at the same time.
  • You may need to stop taking JANUMET XR for a short time. Call your doctor for instructions if you:
  • 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 XR.
  • Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
  • Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
  • Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with JANUMET XR.
What are the possible side effects of JANUMET XR?Serious side effects have happened in people taking JANUMET XR or the individual medicines in JANUMET XR.
  • See “What is the most important information I should know about JANUMET XR?“.
  • Low blood sugar (hypoglycemia). If you take JANUMET XR 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 XR. Signs and symptoms of low blood sugar may include:
  • headache
  • drowsiness
  • irritability
  • hunger
  • dizziness
  • confusion
  • sweating
  • feeling jittery
  • weakness
  • fast heart beat
  • Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUMET XR and call your doctor right away. See “Who should not take JANUMET XR?“. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
  • Kidney problems, sometimes requiring dialysis.
  • Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET XR, 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 XR, 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 XR.

The most common side effects of JANUMET XR include:

  • stuffy or runny nose and sore throat
  • gas, upset stomach, indigestion
  • headache
  • upper respiratory infection
  • weakness
  • diarrhea
  • low blood sugar (hypoglycemia) when used in combination with certain medications, such as a sulfonylurea or insulin.
  • nausea and vomiting
Taking JANUMET XR 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 XR may have other side effects, including swelling of the hands or legs. Swelling of the hands and legs can happen if you take JANUMET XR in combination with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medicine. These are not all the possible side effects of JANUMET XR. For more information, ask your doctor or pharmacist. Tell your doctor if you have any side effect that bothers you, is unusual, or does not go away.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store JANUMET XR? Store JANUMET XR at 68°F to 77°F (20°C to 25°C). Store in a dry place and keep cap tightly closed.Keep JANUMET XR and all medicines out of the reach of children.
General information about the use of JANUMET XR. Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use JANUMET XR for a condition for which it was not prescribed. Do not give JANUMET XR to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about JANUMET XR. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUMET XR that is written for health care professionals. For more information go to www.janumetxr.com or call 1-800-622-4477.
What are the ingredients in JANUMET XR? Active ingredients: sitagliptin and metformin hydrochloride extended-releaseInactive ingredients:
  • All doses of JANUMET XR Tablets contain: povidone, hypromellose, colloidal silicon dioxide, sodium stearyl fumarate, propyl gallate, polyethylene glycol, and kaolin. Film coating contains hypromellose, hydroxypropyl cellulose, titanium dioxide, FD&C #2/Indigo Carmine Aluminum Lake and carnauba wax.
  • In addition the JANUMET XR 50 mg/500 mg Tablets also contain: microcrystalline cellulose.
  • In addition the JANUMET XR 50 mg/1000 mg Tablets also contain: yellow iron oxide.
What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.
Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC., Whitehouse Station, NJ 08889, USA For patent information: www.merck.com/product/patent/home.html. The trademarks depicted herein are owned by their respective companies. Copyright © 2012-2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. usmg-mk0431a-xrt-1708r008

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