Januvia (sitagliptin)

Januvia® is a prescription drug used to help control high blood sugar in patients with Type 2 Diabetes. It is an oral medication in the DPP-4 inhibitor class available in 25mg, 50mg, and 100mg tablets. There is currently no therapeutic generic available in the United States.

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Side Effects & Adverse Reactions

Warnings and Precautions

The warnings issued by Merck & Co. (.pdf) about Januvia include information about post-marketing reports of acute pancreatitis, acute renal failure, and an increased risk of hypoglycemia, as well as serious allergic reactions in some patients. Severe and disabling arthralgia (joint pain) is also reported as a side effect for some patients taking Januvia. The warning section states: “There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking Januvia.”

Serious Side Effects

In 2013, the Food and Drug Administration (FDA) issued a Safety Communication. The agency said it was investigating reports of the possibility of an increased risk of pancreatitis, as well as pre-cancerous findings, in patients prescribed Januvia. An earlier warning had been issued to healthcare professionals in 2009 about patients suffering acute pancreatitis. “Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009, that earlier warning states.

Acute Pancreatitis and Pancreatic Cancer Symptoms

When the pancreas becomes inflamed, the body’s digestive enzymes begin attacking that gland. That can result in tissue damage, infections, or cysts and bleeding, which can potentially spread to other organs in the body. The symptoms associated with pancreatitis, as reported by the Mayo Clinic, include upper abdominal pain, pain while eating or bending forward, nausea, vomiting, fever, rapid heartbeat, and tenderness when the abdomen is touched (mayoclinic.org). Other symptoms may be unexplained weight loss, or stool that are oily or exceptionally malodorous. Medical help should be sought immediately by any person taking Januvia who is experiencing any of these symptoms.

Pancreatic cancer symptoms include a yellowing of skin and whites of the eyes, appetite loss, weight loss, depression, and blood clots. Pancreatitis is known to be a precursor to pancreatic cancer.

History of Adverse Reactions to Januvia

In 2011, a study by researchers from UCLA on the use of incretin diabetes treatment suggested patients faced an increased risk for developing pancreatitis when measured against other existing type 2 diabetes therapies (gastrojournal.com). The researchers studied the adverse events reported to the FDA over a five-year period and concluded that the potential long-term actions of these drugs could lead to more patients developing pancreatic cancer.

An abstract from that study reports: “These data are consistent with case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1−based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer.” The risk of developing acute pancreatitis or pancreatic cancer was found to be even greater when two drugs are taken together by the patient —Sitagliptin (Januvia) and Exanatide, an injected diabetes drug marketed as Byetta by AstroZeneca.

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Legal Issues

Lawsuits have been filed against the makers of Januvia, based upon the allegation that the manufacturer failed to adequately warn about the increased risks of pancreatitis and pancreatic cancer. The U.S. District Court for the Southern District of California has consolidated lawsuits in that state due to the sheer volume of pending cases filed in lower courts (casd.uscourts.gov).

A November 12, 2013 order stated: “In order to eliminate any delay associated with the transfer of cases to this Court (of cases filed in or removed to other federal district courts), and to promote judicial efficiency, any plaintiff who alleges that Byetta, Janumet, Januvia and/or Victoza (“Incretin-based Therapies”) was the cause of pancreatic cancer, and whose case would be subject to transfer to this MDL [Multidistrict Litigation], the “MDL Proceedings”) may file his or her case directly in the MDL.”

If you or a loved one was prescribed Januvia or Byetta, or a combination of the two medications, and then developed either pancreatitis or pancreatic cancer, it is critical that you seek legal help. Some of the other diabetes drugs in this specific class of medications, called incretin memetics, include Bydureon, Onglyza, Victoza, Tradjenta, Nesina, and Janumet.

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FDA Safety Alerts

On March 14, 2013, the FDA announced they were evaluating studies suggesting an increased risk of pancreatitis and pre-cancerous cells in the pancreas of patients taking Type 2 Diabetes drugs in the incretin mimetic class. The suspect pharmaceuticals included Januvia as well as Janumet, Janumet XR, Juvisyn, Byetta, Bydureon, liraglutide (Victoza), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). The warning was only intended to notify healthcare professionals and the public that FDA would be looking more closely at the findings and patients were encouraged to continue use of their medications until otherwise instructed by their doctors (fda.gov).

On August 28, 2015, a FDA Safety Announcement warned the the Type 2 Diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin could cause crippling joint pain. People taking any of these drugs, including Januvia, were instructed to continue use but contact their physician immediately if experiencing any symptoms (fda.gov).

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Manufacturer Warnings

While no known Warnings have been issued by Merck & Co., the manufacturer's circular provided with the drug lists several Warnings and Precautions, including arthralgia (severe joint pain), hypoglycemia, and others noted by FDA (merck.com).

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FDA Labeling Changes

http://www.fda.gov/safety/medwatch/safetyinformation/ucm196611.htm

August 2015

In the wake of a new Safety Alert, the FDA issued label changes to include warnings of severe and disabling joint pains in some patients.

April 2015

Pruritus (severe itching of the skin) was added as a known Adverse Reaction

March 2012

Angiodema was included as a Hypersensitivity Reaction of Januvia. The FDA noted that the reaction has been noted with other DPP-4 inhibitor class drugs (such as Onglyza, Janumet, etc.).

September 2010

Label changes for sitagliptin drugs, including Janumet (sitagliptin and metformin HCL) were announced adding constipation, vomiting, and headaches to the list of Adverse Reactions.

December 2009

A Warnings and Precautions was added, noting reports of cutaneous vasculitis and accute pancreatitis - including fatal and non-fatal hemmorhagic and necrotizing pancreatitis - in patients taking Januvia. Patient Counseling Information was also added to labeling, alerting patients to reports of accute pancreatitis with the drug and instructions to discontinue use and contact their physician if severe abdominal pains occur.

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Uses

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History

There is currently no drug history available for this drug.

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Other Information

General Information

Januvia® is a new generation of oral medications known as “incretin therapies” for use in the treatment of type 2 diabetes. Incretins are hormones that stimulate decreased blood glucose, increasing the level of insulin that is released by the pancreas. Januvia is a brand name of the drug Sitagliptin, manufactured by Merck & Co. The company also produces a variation of the medication, marketed as Junumet. Januvia was approved by the FDA in 2006, and is now one of the most frequently prescribed type 2 diabetes treatment drugs on the market, with millions of prescriptions written every year.

How Januvia Works. Who Can Take It?

Januvia has been found to be effective in controlling the level of blood sugar in patients and decreasing sugars naturally released into the blood system by the liver. In essence, the patient has too much glucose in the blood, and the drug stimulates certain pancreatic cells to release insulin. The drug allows the incretins to remain in the blood longer and to help the pancreas to continue to produce insulin, removing the excess sugar.

The drug is only for use in certain patients and cannot be prescribed to patients who have diabetic ketoacidosis, a condition in which the patient presents with excess ketones (a result of prolonged blood sugar in the blood and insulin deficiency) in his or her urine.

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Januvia Manufacturers

Cardinal Health

Januvia | Cardinal Health

2.1 Recommended Dosing The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. 2.2 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. [See Clinical 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. 2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]

No Recall
Physicians Total Care, Inc.

Januvia | Physicians Total Care, Inc.

2.1 Recommended Dosing
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
2.2 Patients with Renal Insufficiency
For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women), no dosage adjustment for JANUVIA is required.

For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to ≤3.0 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily.

For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >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 hemodialysis.

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. [See Clinical Pharmacology (12.3).]
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Januvia | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

2.1 Recommended Dosing
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
2.2 Patients with Renal Insufficiency
For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women), no dosage adjustment for JANUVIA is required.

For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to ≤3.0 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily.

For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >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 hemodialysis.

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. [See Clinical 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.
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]

No Recall
Cardinal Health

Januvia | Wallace Pharmaceuticals Inc.

DOSAGE AND ADMINISTRATION: NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE.

The usual starting dose is as follows:

Adults and Adolescents (13 Years and Older): Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years: One ampule four times daily, taken one-half hour before meals and at bedtime.

Pediatric Patients Under 2 Years: Not recommended.

If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day.

Patients should be advised that the effect of Cromolyn Sodium, USP therapy is dependent upon its administration at regular intervals, as directed.

Maintenance Dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained.

Administration: Cromolyn Sodium, USP should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions:
Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. Stir solution. Drink all of the liquid.

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Clinical Solutions Wholesale

Januvia | Clinical Solutions Wholesale

2.1 Recommended Dosing
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
2.2 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. [See Clinical 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.
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]

No Recall
Merck Sharp & Dohme Corp.

Januvia | Henan Lingrui Pharmaceutical Co Ltd

Adults and children 12 years of age and older: two or three times daily, massage 5-10 minutes until the affected area gets heat.

Children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor.
Children under 2 years of age: Do not use, consult a doctor.
Refer to the above warnings: use otherwise than as directed may be dangerous.

No Recall
Remedyrepack Inc.

Januvia | Remedyrepack Inc.

The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. (2.1)

Dosage adjustment is recommended for patients with moderate or severe renal insufficiency or end-stage renal disease. (2.2)
Dosage Adjustment in Patients With Moderate, Severe and End Stage Renal Disease (ESRD) (2.2) 50 mg once daily 25 mg once daily
Moderate

CrCl ≥30 to <50 mL/min

~Serum Cr levels [mg/dL]

Men: >1.7– ≤3.0;

Women: >1.5– ≤2.5

Severe and ESRD

CrCl <30 mL/min
~Serum Cr levels [mg/dL]

Men: >3.0;

Women: >2.5;

or on dialysis

The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.

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. [See Clinical 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.

When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]

No Recall
Cardinal Health

Januvia | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Vertigo

For the control of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.

Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

No Recall
Cardinal Health

Januvia | Cardinal Health

2.1 Recommended Dosing
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
2.2 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. [See Clinical 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.
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]

No Recall