massive [45:<1%, postmarketing, and/or case reports: Acute pancreatitis, anaphylaxis, angioedema, exfoliative dermatitis, immune thrombocytopenia, increased creatine phosphokinase, increased serum creatinine Warnings/Precautions Concerns related to adverse effects: Arthralgia: Severe and disabling arthralgia has been reported with DPP-IV inhibitor use; onset may occur within one day to years after treatment initiation and may resolve with discontinuation of therapy. Some patients may experience a recurrence of symptoms if DPP-IV inhibitor therapy resumed. Bullous pemphigoid: DPP-4 inhibitor use has been associated with development of bullous pemphigoid; cases have typically resolved with topical or systemic immunosuppressive therapy and discontinuation of DPP-4 inhibitor therapy. Advise patients to report development of blisters or erosions. Discontinue therapy if bullous pemphigoid is suspected and consider referral to a dermatologist. Hematologic: Dose-related decrease in lymphocyte count has been observed; clinical significance is not known. Monitoring of lymphocyte counts may be warranted in patients with unusual or persistent infection. Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, and exfoliative dermatologic reactions have been reported; discontinue if signs/symptoms of severe hypersensitivity reaction occur. Events have generally occurred within the first 3 months of therapy, and may occur after the initial dose. Use with caution if patient has experienced angioedema with other DPP-IV inhibitor use. Pancreatitis: Cases of acute pancreatitis have been reported with use. Monitor for signs/symptoms of pancreatitis; discontinue use immediately if pancreatitis is suspected and initiate appropriate management. Use with caution in patients with a history of pancreatitis as it is not known if this population is at greater risk. Disease-related concerns: Heart failure: Heart failure that may require hospitalization has been reported in a multi-center, randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes with a history of, or at risk for, cardiovascular events; risk was increased in patients with preexisting heart failure or renal impairment and during the first 12 months of therapy (Scirica 2013; Scirica 2014). However, a population-based retrospective study in an ambulatory setting with relatively lower baseline cardiovascular risk factors failed to demonstrate increased risk in patients on saxagliptin compared to other agents (eg, sitagliptin, pioglitazone, sulfonylureas, insulin) (Toh 2016). Monitor for signs and symptoms of heart failure during therapy and consider discontinuation if condition develops. In a scientific statement from the American Heart Association, saxagliptin has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]). Renal impairment: Use with caution in patients with moderate to severe renal dysfunction (eGFR> <45 mL/minute/1.73 m 2 ) including end-stage renal disease (ESRD) requiring hemodialysis; dosing adjustment required. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions: Appropriate use: Not indicated for use in patients with type 1 diabetes mellitus (insulin dependent, IDDM) or with diabetic ketoacidosis (DKA). Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy. Monitoring Parameters Plasma glucose, HbA 1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017a]), renal function (prior to initiation of therapy and periodically thereafter); lymphocyte counts (if unusual or persistent infection); signs/symptoms of pancreatitis and/or heart failure Pregnancy Considerations In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017c; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes prior to conception and throughout pregnancy maternal blood glucose and HbA 1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008). Agents other than saxagliptin are currently recommended to treat diabetes in pregnant women (ADA 2017c). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache or common cold symptoms. Have patient report immediately to prescriber signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out), difficulty swallowing, skin blisters, skin breakdown, persistent joint pain, or severe joint pain (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about saxagliptin Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 14 Reviews Add your own review/rating Drug class: dipeptidyl peptidase 4 inhibitors Consumer resources Saxagliptin Saxagliptin (Advanced Reading) Professional resources Saxagliptin Hydrochloride (AHFS Monograph) Other brands: Onglyza Related treatment guides Diabetes, Type 2> ] Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Saxagliptin Rating 14 User Reviews 6.4 /10 14 User Reviews 6.4 Rate it! Drug Class Dipeptidyl peptidase 4 inhibitors Related Drugs dipeptidyl peptidase 4 inhibitors Januvia , Tradjenta , Onglyza , sitagliptin , linagliptin , Nesina Diabetes, Type 2 metformin , insulin aspart , glipizide , glimepiride , Januvia , pioglitazone , Victoza , Actos , Tradjenta , Glucophage , glyburide , Janumet , Invokana , Amaryl , Welchol , Onglyza , sitagliptin , Trulicity , Jardiance , Lantus , Farxiga , Levemir , Tresiba , Glucotrol , Bydureon , More... ample
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