Januvia (Sitagliptin Phosphate)

Januvia can cause severe and disabling joint pain. Patients should be monitored for signs of pancreatitis, including persistent severe abdominal pain, which may radiate to the back and may or may not be accompanied by vomiting. The medication should be discontinued if pancreatitis is suspected.

Please speak to your doctor before taking Januvia.

Tell your healthcare provider if you have or have had inflammation of your pancreas (pancreatitis) if you had kidney problems, heart failures or are pregnant or plan to become pregnant (see pregnancy section for more details).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medications and show it to your doctor and pharmacist when you get a new drug.

Let your healthcare provider know of anything you are allergic to.

The active ingredient in Januvia is sitagliptin.

The inactive ingredients are microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate.

The tablet film coating contains the inactive ingredients of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.

Januvia is prescribed by itself or with other diabetes medications.

Take Januvia as instructed by your doctor and pharmacist. Review directions on the medication guide, prescription label, and instruction sheets. Your doctor may choose to adjust your dosage. Be sure to follow their instructions carefully.

It can be taken with or without food.

Your doctor may recommend checking blood glucose levels regularly and sharing results during visits.

Store medication at room temperature and away from heat, direct light, and moisture.

The most common side effect experienced by patients taking Januvia includes a stuffy, runny nose, sore throat, headache, or upper respiratory infection.

When Januvia was used with a drug called rosiglitazone, some reported side effects, including upset stomach, swelling of hands and feet, and diarrhea.

As with any medication, side effects may occur. However, most patients do not experience any severe side effects.

Hypoglycemia

Even though sitagliptin does not cause hypoglycemia, low blood sugar levels may result from medications part of your diabetes treatment, such as sulfonylurea or insulin. Your doctor may adjust the dosage of one or more medications you are taking during your treatment.

Alcohol consumption, surgery, exercise, stress, skipping meals, and illness can affect blood sugar levels.

To treat episodes of hypoglycemia, consume a glucose tablet, sugar packet, sugary snack (candy, jellybeans, raisins, crackers), or sugar drink (non-diet soda or fruit juice).

Your doctor may prescribe a glucagon injection kit in case the patient loses consciousness due to hypoglycemia. Educate family and friends on what to do in the event of loss of consciousness due to hypoglycemia and how to inject glucagon.

Avoid strenuous exercise, high alcohol consumption, skipping meals, or consuming a low among calories to prevent hypoglycemia.

Let your doctor know if you experience episodes of hypoglycemia.

Hyperglycemia

Patients may experience symptoms of hyperglycemia as part of their diabetes treatment.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled clinical studies as both monotherapy and combination therapy with metformin, pioglitazone, or rosiglitazone and metformin, the overall incidence of adverse reactions, hypoglycemia, and discontinuation of therapy due to clinical adverse reactions with Januvia was similar to placebo.

In combination with glimepiride, with or without metformin, the overall incidence of clinical adverse reactions with Januvia was higher than with placebo, in part related to a higher incidence of hypoglycemia; the incidence of discontinuation due to clinical adverse reactions was similar to placebo.

Two placebo-controlled monotherapy studies, one of 18- and one of 24-week duration, included patients treated with Januvia 100 mg daily, Januvia 200 mg daily, and placebo. Five placebo-controlled add-on combination therapy studies were also conducted: one with metformin; one with pioglitazone; one with metformin and rosiglitazone; one with glimepiride (with or without metformin); and one with insulin (with or without metformin). In these trials, patients with inadequate glycemic control on a stable dose of the background therapy were randomized to add-on therapy with Januvia 100 mg daily or a placebo.

The adverse reactions, excluding hypoglycemia, were reported regardless of investigator assessment of causality in 5% of patients treated with Januvia 100 mg daily and more commonly than in patients treated with placebo.

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.

Pregnancy Registry: If you take Januvia at any time during your pregnancy, talk with your doctor about how you can join the Januvia 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.

Let your doctor know if you are breastfeeding or plan to breastfeed. It is not known if Januvia will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking Januvia.

Store Januvia at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep Januvia and all medicines out of the reach of children.

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