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Medication Guide
IANUVIA® (jah-NEW-vee-ah) (sitagfiptin) Tablets
Read this Medication Guide carefully befnmm stmmun‘,lMlMA and each time you get a refill. There may be new
information. This information does not take mfif“m nm your doctor about your medical condition or your
treatment. If you have any questions about ask your or pharmacist.
What is the most important information | should know about JANUVIA?
Serious side effects can happen in peaple taking JANUVIA, including inflammation of the pancreas (pancreatitis) which may
be severe and lead to death.
Certain medical problems make you more likely to get pancreatitis.
Before you start taking JANUVIA:
Teli your doctor if you have ever had
© pancreatitis
© stones in your gallbladder (galistones)
* 3 history of alcoholism
high biood triglyceride levels
* kidney problems
St? taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe
and will not go aww pain may be felt going from your abdomen through to your back. The pain may happen with or
without vomiting. may be symptoms of pancreatitis.
What is JANUVIA?
© JANUVIA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with
type 2 diabetes. =
* JANUVIA is not for people with type 1 diabetes.
© JANUVIA is not for people with diabetic ketoacidosis (increased ketones in your biood or urine).
« If you have had pancreatitis (infiammation of the gancmas) in the past, it is not known if you have a higher
chance of getting pancreatitis while you take g
« It is not known if JANUVIA is safe and effective when used in children under 18 years of age.
Who should not take JANUVIA?
Do not take JANUVIA if:
* you are aflergic to an&oi the ingredients in JANUVIA. See the end of this Medication Guide for a complete list of
ingredients in JANUV
Symptoms of a serious allergic reaction to JANUVIA 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
What should | tell my doctor before taking JANUVIA?
Before you take JANUVIA, tell your doctor if you:
© have or have had inflammation of your pancreas (pancreatitis).
© have kidney probiems.
* have any other medical conditions.
« are pregnant or plan to become pregnant. It is not known if JANUVIA 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.
:If you take JANUVIA at any time during ancy, talk with your doctor about how you can join
eet Lo oe e
baby. You can enroll in this registry by calling 1-800- .
®are bveast—taedmfi plan to breast-feed. It is not known if JANUVIA will pass into your breast milk. Talk with your
doctor about the way to feed your baby if you are taking JANUVIA.
Tell mfl' doctor about all the medicines you take, inciuding prescription and non-prescription medicines, vitamins,
and herbal supplements.
Know tgg 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 | take JANUVIA?
* Take JANUVIA 1 time each day exactly as your doctor tells you.
* You can take JANUVIA with or without food.
« Take JANUVIA tablets whole. Do not split, crush, or chew JANUVIA tablets before swallowing. If you cannot
swallow JANUVIA tablets whole tell your doctor.
* Your doctor may do blood tests from time to time to see how well your kidneys are working. Your doctor may
change your dose of JANUVIA based on the results of your blood tests.
Your doctor may tell you to take JANUVIA ammh other diabetes medicines. Low blood sugar can happen more often
when JANUVIA s taken with certain other dial medicines. See “What are the possible side effects of JANUVIA?".
*lf you miss a dose, take it as swnaswummmwhlzoudonmmmmbevuMim is time for your next dose,
skip the missed dose and go back to your regular schedule. Do not take two doses of JANUVIA at the same time.
« If you take too much JANUVIA, call your doctor or local Poison Control Center right away.
« When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or
smfi:?é the amount of diabetes medicine that &nfiafl may change. Tell your doctor right away if you have any
of these conditions and follow your doctor’s in ions.
© Check your blood sugar as your doctor tells you to.
Terms and Conditions
« This voucher is valid for 1 free 30-day trial supply of JANUVIA.
Limit 1 voucher per patient for the duration of the program.
o Valid for 1-time use only. Free trial offer is valid only for up to 30 tablets of JANUVIA. No purchase is necessary. Refills are not required.
« This voucher is not transferable. No substitutions are permitted. Cannot be combined with any other free trial, coupon, discount, prescription savings card, or other offer.
* This voucher is not insurance.
* You must be 18 years or older to redeem this voucher. Patient, pharmacist, and prescriber agree not to seek reimbursement for all or any part of the benefit received by the patient through this offer.
The free trial supply of JANUVIA cannot be used toward any out-of-pocket costs under any plan (such as true out-of-pocket expense [TrOOP]).
« This vaucher can be used only by eligible US residents at any participating eligible retail pharmacy in the United States. Product must originate in the United States.
« This voucher is the property of Merck and must be turned in on request.
« Merck reserves the right to rescind, revoke, or amend this offer at any time without notice. @
« Itis llegal 1o sell, purchase, trade, or counterfeit this voucher. Void if reproduced. Void where prohibited by law, taxed, or restricted. JO“UVIa.
« Please read the accompanying Medication Guide and discuss it with your doctor. Also available is the physician Prescribing Information. b
« Expiration Date: 06/30/2013 (sitagliptin) tablets
Stay on your prescribed diet and exercise program while taking JANUVIA. "
© Talk to your doctor about how to , recognize and manage low blood sugar (hypoglycemia), high blood
sugar (ro%uglycemm. and pmbm.y‘n‘m have because of mlrediam. . o
-mfiiccmmdm with regular blood tests, including your blood sugar levels and your
in AIC.
What are the possible side effects of JANUVIA?
Serious side effects have happened in people taking JANUVIA.
© See “What is the most important information | should know about JANUVIA?".
© Low blood (hypoglycemia). if you take JANUVIA with another medicine that can cause low blood sugar,
suchasas‘u?' urea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea
medag:ni&eusvemg:;?i‘n mzymedmbe%m uamfiuk'fizmmmmd&'bwww
may i :
© headache * imitability
© drowsiness © hunger
© weakness « fast heart beat
* dizziness © sweating
* confusion . fa:iumm - i
* Serigus allergic reactions. If you have a sos a serious ic reaction, JANUVIA
your doctor right away. See #M"&%r mmmay give you a% for your allergic
reaction and prescribe a different medicine for your diabetes.
« Kidney problems, sometimes requiring dialysis
The most common side effects of JANUVIA include:
© upper respiratory infection
« stuffy or runny nose and sore throat
* headache
JANUVIA may have other side effects, including:
© stomach upset and diarrhea
« swelling of the hands or legs, when JANUVIA is used with rosiglitazone (Avandia®). Rosiglitazone is another type
of diabetes medicine.
These are not all the possible side effects of JANUVIA. For more information, ask your doctor or pharmacist.
Tell your doctor if you have any side effect that bathers 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 | store JANUVIA?
Store JANUVIA at 68°F to 77°F (20°C to 25°C).
Keep JANUVIA and all medicines out of the reach of children.
General information about the use of JANUVIA
Medicines are sometimes prescribed for purposes that are not listed in Medication Guides. Do not use JANUVIA for a
condition for which it was not prescribed. Do not give JANUVIA 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 JANUVIA. If you would fike to know more
information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUVIA that
is written for health professionals. For more information, go to www JANUVIA.com or call 1-800-622-4477.
What are the ingredients in JANUVIA?
Active ingredient: sitagliptin.
Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium,
magnesium stearate, and sodium steavr fumarate. The tablet film coating contains the following inactive ingredients:
polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and 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
?voduoes 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.
Manuf. for. Merck Sharp & Dohme Corp., a subsidiary of
€3 MERCK& CO, INC, Whitehouse Station, N 08889, USA
Manufactured by: / )
Merck Sharp & Dohme (ltalia) S.p.A. J v-i’a.
dogniazl anu
- Pavia, Ita in) tablets
OR MERCK SHARP & DOHME LTD. Cranilington, Northumberland, UK NE23 3)U s
US Patent Nos.: 6,699,871 and 7,326,708
Avandia® is a registered trademark of GlaxoSmithKline.
Copyri#m © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved
Revised 04/2012
USMG-T-04311204R008
This Medication Guide has been approved by the U.S. Food and Drug Administration. DIAB-1039462-0002 08/12