- Increase insulin production in your pancreas when your blood sugar is high, especially after you eat. This is when the body needs the most help lowering blood sugar.
- Reduce the amount of sugar made by your liver, especially after you eat, when your body doesn't need it.
Selected Risk Information About JANUVIA
Serious side effects can happen in people who take JANUVIA, including pancreatitis, which may be severe and lead to death. Before you start taking JANUVIA, tell your doctor if you've ever had pancreatitis. Stop taking JANUVIA and call your doctor right away if you have pain inyour 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.
Do not take JANUVIA if you are allergic to any of its ingredients, including sitagliptin. Symptoms of serious allergic reactions to JANUVIA, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away.
Kidney problems, sometimes requiring dialysis, have been reported.
If you take JANUVIA with another medicine that can cause low blood sugar (hypoglycemia), 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 JANUVIA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, and feeling jittery.
Your doctor may do blood tests before and during treatment with JANUVIA to see how well your kidneys are working. Based on these results, your doctor may change your dose of JANUVIA. The most common side effects of JANUVIA are upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Important Limitations of Use
Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Januvia has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Januvia.
Patients with Renal Insufficiency
For patients with mild renal insufficiency (creatinine clearance [CrCl] greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), no dosage adjustment for Januvia is required.
For patients with moderate renal insufficiency (CrCl greater than or equal to 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the dose of Januvia is 50 mg once daily.
For patients with severe renal insufficiency (CrCl less than 30 mL/min, approximately corresponding to serum creatinine levels of greater than 3.0 mg/dL in men and greater than 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily. Januvia may be administered without regard to the timing of dialysis.
Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [SeeClinical Pharmacology (12.3).] There have been postmarketing reports of worsening renal function in patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.
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What is Januvia?
Januvia (sitagliptin) is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.
Januvia is for people with type 2 diabetes. It is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.
Januvia may also be used for purposes not listed in this medication guide.
Do not use Januvia if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Januvia can cause pancreatitis. Stop using this medicine and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and loss of appetite.
Januvia can cause a serious allergic reaction. Get emergency medical help if you have a fever, sore throat, swelling or burning in your face, skin pain, and a skin rash that spreads and causes blistering and peeling.
Before taking this medicine
Do not use Januvia if you are allergic to sitagliptin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
To make sure Januvia is safe for you, tell your doctor if you have:
- kidney disease (or if you are on dialysis); or
- a history of pancreatitis.
FDA pregnancy category B. Januvia is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
How should I take Januvia?
Take Januvia exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Januvia with or without food. Follow your doctor's instructions.
Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating.
Keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.
Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.
Januvia is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store Januvia at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).
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 | |
| Systematic (IUPAC) name | |
|---|---|
| (R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine | |
| Clinical data | |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a606023 |
| Licence data | EMA:Link |
| Pregnancy cat. | B (US) |
| Legal status | Prescription Only (S4) (AU)POM (UK) ℞-only (US) |
| Routes | Oral |
| Pharmacokinetic data | |
| Bioavailability | 87% |
| Protein binding | 38% |
| Metabolism | Hepatic (CYP3A4- andCYP2C8-mediated) |
| Half-life | 8 to 14 h[1] |
| Excretion | Renal (80%)[1] |
| Identifiers | |
| CAS number | 486460-32-6 |
| ATC code | A10BH01 |
| PubChem | CID 4369359 |
| DrugBank | DB01261 |
| ChemSpider | 3571948 |
| UNII | QFP0P1DV7Z |
| ChEBI | CHEBI:40237 |
| ChEMBL | CHEMBL1422 |
| Chemical data | |
| Formula | C16H15F6N5O |
| Mol. mass | 407.314 g/mol |
 (what is this?) (verify) | |
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What Is Type 2 Diabetes?
Type 2 diabetes is a condition in which:
- Your pancreas does not make enough insulin.
- The insulin that your body makes does not work as well as it should.
- Your liver also makes too much sugar. When sugar (glucose) builds up in the blood, over time it can lead to serious medical problems.
One of the goals of treating type 2 diabetes is to lower blood sugar.
Lowering and controlling blood sugar may help prevent or delay complications of type 2 diabetes, such as:
- heart problems
- kidney problems
- blindness
- amputation
JANUVIA is not approved to treat the serious problems that may result from high blood sugar.
High blood sugar can be lowered with diet and exercise and with certain medications, when necessary.
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