Januvia


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Related to Januvia: metformin, dipeptidyl peptidase-4 inhibitor

sitagliptin phosphate

Januvia

Pharmacologic class: Dipeptidyl peptidase 4 (DPP-4) inhibitor

Therapeutic class: Hypoglycemic

Pregnancy risk category B

Action

Inhibits DPP-4 and slows inactivation of incretin hormones, helping to regulate glucose homeostasis through increased insulin release and decreased glucagon levels

Availability

Tablets: 25 mg, 50 mg, 100 mg

Indications and dosages

Adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus

Adults: 100 mg P.O. once daily

Dosage adjustment

• Moderate to severe renal insufficiency or end-stage renal disease

Contraindications

• History of serious hypersensitivity to drug (such as anaphylaxis or angioedema)

Precautions

Use cautiously in:
• concurrent administration of drugs that cause hypoglycemia (such as sulfonylureas or insulin)
• renal impairment, history of pancreatitis
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).

Administration

• Assess renal function before starting therapy.

Before starting drug, ask patient about possible risk factors for pancreatitis, such as history of pancreatitis, alcoholism, gallstones, or hypertriglyceridemia. However, it's unknown if these conditions make it more likely that pancreatitis will occur.
• Give with or without food.
• Be aware that drug shouldn't be used to treat type 1 diabetes mellitus or diabetic ketoacidosis.
• Know that when drug is used with a sulfonylurea, a lower dose of sulfonylurea may be required, to reduce risk of hypoglycemia.

Adverse reactions

CNS: headache

EENT: nasopharyngitis

GI: abdominal pain, nausea, vomiting, diarrhea, pancreatitis

GU: acute renal failure

Respiratory: upper respiratory tract infection

Other: hypersensitivity reactions (including anaphylaxis, angioedema, exfoliative skin conditions such as Stevens-Johnson syndrome)

Interactions

Drug-drug.Digoxin: minimally increased digoxin effect and blood level

Insulin, sulfonylureas: possible increased hypoglycemia risk

Patient monitoring

• Monitor renal function periodically.
• Measure patient's weight and body mass index periodically during therapy.
• Monitor blood glucose and hemoglobin A1c levels periodically during therapy.

Monitor patient for signs and symptoms of hypersensitivity reactions and immediately stop drug and institute emergency measures if such reactions occur.
• Check for diabetes signs and symptoms and disease progression routinely during therapy.

Be aware of postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue drug.

Patient teaching

• Instruct patient to take drug with or without food.
• Teach patient about signs and symptoms of hypoglycemia (such as blurred vision, confusion, tremor, sweating, excessive hunger, drowsiness, and fast heart rate).

Teach patient about signs and symptoms of hypersensitivity reactions (such as rash, throat swelling, or difficulty breathing) and to immediately contact prescriber if these occur.

Instruct patient to immediately discontinue drug and report if signs and symptoms of pancreatitis occur (persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting).
• Instruct patient to routinely monitor blood glucose levels at home.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.

sitaGLIPtin

(sit-a-glip-tin) ,

Januvia

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: enzyme inhibitors
Pregnancy Category: B

Indications

Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus; may be used as monotherapy or combination therapy with metformin, a thiazolidinedione, a sulfonylurea, or insulin.

Action

Inhibits the enzyme dipeptidyl peptidase-4 (DPP-4), which slows the inactivation of incretin hormones, resulting in increased levels of active incretin hormones. These hormones are released by the intestine throughout the day and are involved in regulation of glucose homeostasis. Increased/prolonged incretin levels result in an increase in insulin release and decrease in glucagon levels.

Therapeutic effects

Improved control of blood glucose.

Pharmacokinetics

Absorption: 87% absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: 79% excreted unchanged in urine, minor metabolism.
Half-life: 12.4 hr.

Time/action profile

ROUTEONSETPEAKDURATION
POrapid1–4 hr24 hr

Contraindications/Precautions

Contraindicated in: Type 1 diabetes mellitus;Diabetic ketoacidosis;Hypersensitivity.
Use Cautiously in: Renal impairment (dose ↓ required for CCr <50 mL/min);History of pancreatitis;History of angioedema to another DPP-4 inhibitor Obstetric / Use only if clearly needed. Lactation: Excretion into breast milk unknown; Pediatric: Safety not established; Geriatric: Consider age-related ↓ in renal function when determining dose.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Gastrointestinal

  • pancreatitis (life-threatening)
  • nausea
  • diarrhea

Genitourinary

  • acute renal failure

Respiratory

  • upper respiratory tract infection
  • nasopharyngitis

Musculoskeletal

  • arthralgia
  • back pain
  • myalgia

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • angioedema (life-threatening)
  • exfoliative skin conditions (stevens-johnson syndrome) (life-threatening)
  • rash
  • urticaria

Interactions

Drug-Drug interaction

May slightly ↑ serum digoxin levels; monitoring recommended.↑ risk of hypoglycemia when used with insulin, glyburide, glipizide, or glimepiride (may need to ↓ dose of insulin or sulfonylurea).

Route/Dosage

Oral (Adults) 100 mg once daily.

Renal Impairment

Oral (Adults) CCr 30–<50 mL/min—50 mg once daily; CCr <30 mL/min—25 mg once daily.

Availability

Tablets: 25 mg, 50 mg, 100 mg Cost: 25 mg $801.18 / 90, 50 mg $816.93 / 90, 100 mg $816.93 / 90
In combination with: metformin (Janumet), metformin XR (Janumet XR). See combination drugs.

Nursing implications

Nursing assessment

  • Observe patient for signs and symptoms of hypoglycemic reactions (abdominal pain, sweating, hunger, weakness, dizziness, headache, tremor, tachycardia, anxiety).
  • Monitor for signs of pancreatitis (nausea, vomiting, anorexia, persistent severe abdominal pain, sometimes radiating to the back) during therapy. If pancreatitis occurs, discontinue sitagliptin and monitor serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, and lipase.
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
  • Lab Test Considerations: Monitor hemoglobin A1C prior to and periodically during therapy.
    • Monitor renal function prior to and periodically during therapy.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Do not confuse sitagliptin with sumatriptan. Do not confuse Januvia (sitagliptin) with Enjuvia (estrogens, conjugated B), Jantoven (warfarin), or Janumet (sitagliptin/metformin).
  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: May be administered without regard to food.

Patient/Family Teaching

  • Instruct patient to take sitagliptin as directed. Take missed doses as soon as remembered, unless it is almost time for next dose; do not double doses. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
  • Explain to patient that sitagliptin helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
  • Instruct patient not to share this medication with others, even if they have the same symptoms; it may harm them.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water, and notify health care professional.
  • Instruct patient in proper testing of blood glucose and urine ketones. These tests should be monitored closely during periods of stress or illness and health care professional notified if significant changes occur.
  • Advise patient to stop taking sitagliptin and notify health care professional promptly if symptoms of hypersensitivity reactions (rash; hives; swelling of face, lips, tongue, and throat; difficulty in breathing or swallowing) or pancreatitis occur.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage patients who become pregnant while taking sitagliptin to join the pregnancy registry by calling 1-800-986-8999.

Evaluation/Desired Outcomes

  • Improved hemoglobin A1C, fasting plasma glucose and 2-hr post-prandial glucose levels.

Januvia

(jə-no͞o′vē-ə)
A trademark for the drug sitagliptin phosphate.

Januvia

a trademark for sitagliptin.
References in periodicals archive ?
NEW YORK, June 17, 2013 /PRNewswire/ -- The law firm of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP has just commenced what is believed to be the first suit in New York for the development of pancreatic cancer in the user of three common anti-diabetic drugs: Byetta, Januvia and Janumet.
Marketed and pipeline class competitors are seen as "me-too" drugs and will struggle to attract share away from Januvia.
The report also finds that, similar to responses from physicians, managed care organizations' (MCOs) pharmacy directors say that Januvia prescribing has increased because of the e-prescribing program while branded rivals Onglyza and Tradjenta have faced reduced prescribing.
I am impressed by the multi-dimensional superiority demonstrated over Januvia as reported in the latest FREEDOM-2 top-line results.
Merck's Barceloneta facilities produce active ingredients found in Januvia and Janumet, Type 2 diabetes medications, and Simvastin, an active ingredient in the cholesterol medication Vytorin.
MSD also presented a study on how Januvia has helped millions of Muslim patients around the world maintain their glucose levels whilst fasting.
Diabetes drugs led by Januvia, Merck's third-biggest seller, generated $2.
Study Highlights Incidence of Cardiovascular Disease-Related Events and All-Cause Hospitalizations Associated with BYETTA Compared to Insulin, Thiazolidinediones, Sulfonylureas, Metformin and Januvia Retrospective Study of Nearly 375,000 Type 2 Diabetes Patients Presented at American Heart Association 2010 Scientific Sessions
In this study, overall adverse events were reported at a similar rate for individuals taking ONGLYZA 5 mg plus metformin and JANUVIA 100 mg plus metformin.
Hillblom Islet Research Centre at UCLA found that sitagliptin, sold in pill form as Januvia, caused abnormalities in the pancreas that are recognized as risk factors for pancreatitis and, with time, pancreatic cancer in humans.