Saxagliptin 2.5 mg Tablet, Film Coated, 500-count — NDC 68462-726-05 (Billing 68462-0726-05)
This is a package of 500 tablets of Saxagliptin 2.5 mg Tablet, Film Coated from Glenmark Pharmaceuticals Inc., USA, marketed since Jul 2023 and currently FDA-listed.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 065430
- GCN: 27393
- GPI-14 (Medi-Span): 27550065100320
- HICL (First Databank): 036471
- AHFS class code: 68:20.05.00
- RxCUI (RxNorm): 858036
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Dipeptidyl Peptidase 4 Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It helps lower blood sugar in adults with type 2 diabetes, along with diet and exercise. It isn't for type 1 diabetes or diabetic ketoacidosis.
- Take one tablet by mouth once a day, with or without food. Swallow it whole; don't cut, crush or chew it. If you miss a dose, skip it and take the next one on time. Don't double up...
- Some people get cold-like symptoms, urinary tract infections or headaches. You might notice swelling in your legs or feet, especially if you also take a TZD diabetes medicine. If y...
- Call right away for severe stomach pain that won't go away, shortness of breath, unusual tiredness or swelling, facial or throat swelling, severe joint pain, or skin blisters. Some...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Saxagliptin — tap one for details:
Saxagliptin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $8.94 | $4,468.05 / 500 tablets |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68462-0726-05 You're viewing this | 500 TABLET, FILM COATED in 1 BOTTLE | — | — | 2023-07-31 | — | Active |
| 68462-0726-30 68462-726-30 Main listing | 30 TABLET, FILM COATED in 1 BOTTLE | $1.14 / ea | $34.33 | 2023-07-31 | — | Active |
| 68462-0726-90 68462-726-90 | 90 TABLET, FILM COATED in 1 BOTTLE | $1.14 / ea | $103.00 | 2023-07-31 | — | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 68462-0726-30?
What NDC number is used to bill for this package of Saxagliptin 2.5 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Saxagliptin 2.5 mg 00378-4705-77 | Mylan | 90 tablets | $1.144 | AB | Availability likely | — |
| Saxagliptin 2.5 mg 65862-0825-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Saxagliptin 2.5 mgthis 68462-0726-05 | Glenmark | 500 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Saxagliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1.1 ) Limitations of use: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.2 )
1.1Monotherapy and Combination Therapy Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies ( 14 ) ].
1.2Limitation of Use Saxagliptin tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
1.1Monotherapy and Combination Therapy Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies ( 14 ) ].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Recommended dosage is 2.5 mg or 5 mg orally once daily taken regardless of meals. ( 2.1 ) • Patients with an eGFR < 45 mL/min/1.73 m 2 (moderate or severe renal impairment, or end-stage renal disease): Recommended dosage is 2.5 mg once daily regardless of meals. ( 2.2 ) • Assess renal function before starting saxagliptin tablets and periodically thereafter.
( 2.2 ) • Limit the dosage of Saxagliptin tablets to 2.5 mg daily for patients also taking strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole). ( 2.3 )
2.1Recommended Dosage The recommended dosage of saxagliptin tablets is 2.5 mg or 5 mg orally once daily taken regardless of meals. Do not cut, crush, or chew Saxagliptin tablets. If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose
2.2Dosage in Patients with Renal Impairment Assess renal function prior to initiation of saxagliptin tablets and then as clinically indicated [see Use in Specific Populations ( 8.6 )]. The recommended dosage of saxagliptin tablets in patients with an eGFR greater than or equal to 45 mL/ minute /1.73 m 2 is the same as the recommended dosage in patients with normal renal function [see Dosage and Administration ( 2.1 )]. The dosage of saxagliptin tablets is 2.5 mg orally once daily for patients with eGFR < 45 mL/min/1.73 m 2 w[hich includes a subset of moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis] [ see Clinical Pharmacology (12.3) and Clinical Studies (14.2) ].
Saxagliptin tablets should be administered following hemodialysis. Saxagliptin tablets have not been studied in patients undergoing peritoneal dialysis.
2.3Dosage Adjustment with Concomitant Use of Strong CYP3A4/5 Inhibitors The dosage of saxagliptin tablets is 2.5 mg orally once daily when used concomitantly with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) [ see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • 2.5 mg: pale yellow to yellow, biconvex, round, film-coated tablets with “G74” printed on one side, in blue ink. • 5 mg: pink, biconvex, round, film-coated tablets with “G75” printed on one side, in blue ink • Tablets: 5 mg and 2.5 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Saxagliptin tablets are contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin or any of the ingredients in saxagliptin tablets. Reactions such as anaphylaxis, angioedema, or exfoliative skin conditions have been reported with saxagliptin tablets [ see Warnings and Precautions ( 5.4 ) and Adverse Reactions (6.2) ]. • History of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to saxagliptin or any of the ingredients in saxagliptin.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue saxagliptin. ( 5.1 ) • Heart Failure: Consider the risks and benefits of saxagliptin in patients who have known risk factors for heart failure.
Monitor patients for signs and symptoms. ( 5.2 ) • Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues: Consider a lower dosage of insulin or insulin secretagogue when used in combination wtih Saxagliptin tablets ( 5.3 ) • Hypersensitivity-Related Events There have been postmarketing reports of serious hypersensitivity reactions such as anaphylaxis, angioedema, and exfoliative skin conditions. If hypersensitivity reactions occur, discontinue saxagliptin, treat promptly, and monitor until signs and symptoms resolve.
( 5.4 ) • Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate. ( 5.5 ) • Bullous Pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors.
Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue saxagliptin. ( 5.6 )
5.1Pancreatitis There have been postmarketing reports of acute pancreatitis in patients taking saxagliptin. In a cardiovascular outcomes trial enrolling participants with established atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors for ASCVD (SAVOR trial), cases of definite acute pancreatitis were confirmed in 17 of 8240 (0.2%) patients receiving saxagliptin compared to 9 of 8173 (0.1%) receiving placebo. Preexisting risk factors for pancreatitis were identified in 88% (15/17) of those patients receiving saxagliptin and in 100% (9/9) of those patients receiving placebo.
After initiation of saxagliptin, observe patients for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue saxagliptin and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using saxagliptin.
5.2Heart Failure In a cardiovascular outcomes trial enrolling participants with established ASCVD or multiple risk factors for ASCVD (SAVOR trial), more patients randomized to saxagliptin (289/8280, 3.5%) were hospitalized for heart failure compared to patients randomized to placebo (228/8212, 2.8%). In a time-to-first-event analysis the risk of hospitalization for heart failure was higher in the saxagliptin group (estimated Hazard Ratio: 1.27; 95% CI: 1.07, 1.51). Patients with a prior history of heart failure and patients with renal impairment had a higher risk for hospitalization for heart failure, irrespective of treatment assignment.
Consider the risks and benefits of saxagliptin prior to initiating treatment in patients at a higher risk for heart failure. Observe patients for signs and symptoms of heart failure during therapy. Advise patients of the characteristic symptoms of heart failure and to immediately report such symptoms.
If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of saxagliptin.
5.3Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues When saxagliptin was used in combination with insulin or an insulin secretagogue, the incidence of confirmed hypoglycemia was increased over that of placebo used in combination with insulin or an insulin secretagogue [ see Adverse Reactions (6.1) ]. Therefore, a lower dosage of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with saxagliptin [ see Drug Interactions (7.2)]. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
5.4Hypersen… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Pancreatitis [ see Warnings and Precautions (5.1) ] • Heart Failure [ see Warnings and Precautions (5.2) ] • Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [ see Warnings and Precautions ( 5.3 ) ] • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.4 ) ] • Severe and disabling arthralgia [ see Warnings and Precautions (5.5) ] • Bullous pemphigoid [ see Warnings and Precautions (5.6) ] • Most common adverse reactions (incidence ≥ 5% and more often than placebo) are upper respiratory tract infection, urinary tract infection, and headache.
( 6.1 ) • Peripheral edema was reported more commonly in patients treated with the combination of saxagliptin and a thiazolidinedione (TZD) than in patients treated with the combination of placebo and TZD. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience 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. Adverse Reactions in Efficacy Trials 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.
Adverse Reactions in Placebo-Controlled Trials in Adults with Type 2 Diabetes Mellitus The data in Table 1 are derived from a pool of 5 placebo-controlled clinical trials [ see Clinical Studies (14) ]. These data shown in the table reflect exposure of 882 patients to saxagliptin and a mean duration of exposure to saxagliptin of 21 weeks. The mean age of these patients was 55 years, 1.4% were 75 years of age or older and 48.4% were male.
The population was 67.5% White, 4.6% Black or African American, 17.4% Asian, other races 10.5% and 9.8% were of Hispanic or Latino ethnicity. At baseline the population had type 2 diabetes mellitus for an average of 5.2 years and a mean HbA1c of 8.2%. Baseline estimated renal function was normal or mildly impaired (eGFR ≥ 60mL/min/1.73 m 2 ) in 91% of these patients.
Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of saxagliptin. These adverse reactions occurred more commonly on saxagliptin than on placebo and occurred in at least 5% of patients treated with saxagliptin. Table 1: Adverse Reactions in Placebo-Controlled Trials* Reported in ≥ 5% of Patients Treated with Saxagliptin 5 mg and More Commonly than in Patients Treated with Placebo % of Patients Saxagliptin 5 mg N=882 Placebo N=799 Upper respiratory tract infection 7.7
7.6Urinary tract infection 6.8
6.1Headache 6.5
5.9In patients treated with saxagliptin 2.5 mg, headache (6.5%) was the only adverse reaction reported at a rate ≥ 5% and more commonly than in patients treated with placebo. In the add-on to TZD trial, the incidence of peripheral edema was higher for saxagliptin 5 mg versus placebo (8.1% and 4.3%, respectively). The incidence of peripheral edema for saxagliptin 2.5 mg was 3.1%.
None of the reported adverse reactions of peripheral edema resulted in trial drug discontinuation. Rates of peripheral edema for saxagliptin 2.5 mg and saxagliptin 5 mg versus placebo were 3.6% and 2% versus 3% given as monotherapy, 2.1% and 2.1% versus 2.2% given as add-on therapy to metformin HCl, and 2.4% and 1.2% versus 2.2% given as add-on therapy to glyburide. The incidence rate of fractures was 1 and 0.6 per 100 patient-years, respectively, for saxagliptin (pooled analysis of 2.5 mg, 5 mg, and 10 mg) and placebo.
The 10 mg dosage is not an approved dosage. The incide… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Strong CYP3A4/5 inhibitors (e.g., ketoconazole): Coadministration with saxagliptin significantly increases saxagliptin concentrations. Limit saxagliptin dosage to 2.5 mg once daily when coadministered with a strong CYP3A4/5 inhibitor. ( 7.1 )
7.1Strong Inhibitors of CYP3A4/5 Enzymes Ketoconazole significantly increased saxagliptin exposure. Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). The dosage of saxagliptin should be limited to 2.5 mg when coadministered with a strong CYP3A4/5 inhibitor [ see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ].
7.2Insulin or Insulin Secretagogues Insulin and insulin secretagogues are known to cause hypoglycemia. Concomitant use of saxagliptin tablets with insulin or an insulin secretagogue may require lower dosages of insulin or the insulin secretagogue to reduce the risk of hypoglycemia [see Warnings and Precautions (5.3)].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Limited data with saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . No adverse developmental effects independent of maternal toxicity were observed when saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis and in pregnant and lactating rats during the pre- and postnatal period [see Data] .
The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with an HbA1c greater than 7 and has been reported to be as high as 20 to 25% in women with an HbA1c greater than 10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data In embryo-fetal development studies, saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis, corresponding to the first trimester of human pregnancy.
No adverse developmental effects were observed in either species at exposures 1503- and 152-times the 5 mg clinical dose in rats and rabbits, respectively, based on AUC. Saxagliptin crosses the placenta into the fetus following dosing in pregnant rats. In a prenatal and postnatal development study, no adverse developmental effects were observed in maternal rats administered saxagliptin from gestation day 6 through lactation day 21 at exposures up to 470-times the 5 mg clinical dose, based on AUC.
8.2Lactation Risk Summary There is no information regarding the presence of saxagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Saxagliptin is present in the milk of lactating rats [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for saxagliptin and any potential adverse effects on the breastfed infant from saxagliptin or from the underlying maternal condition.
Data Saxagliptin is secreted in the milk of lactating rats at approximately a 1:1 ratio with plasma drug concentrations.
8.4Pediatric Use The safety and effectiveness of saxagliptin as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus have not been established. in pediatric patients.. Effectiveness of saxagliptin tablets was not demonstrated in a 26-week, placebo-controlled, double-blind randomized clinical trial with a 26-week safety extension (NCT03199053) in 164 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus
8.5Geriatric Use In the seven, double-blind, controlled clinical safety and efficacy trials of saxagliptin, a total of 4751 (42%) of the 11301 patients randomized to saxagliptin were 65 years and over, and 1210 (10.7%) were 75 years and over. No overall differences in safety or effectiveness were observed between patients65 years of age and older and younger adult patients. Saxagliptin and its active metabolite are eliminated in part by the kidney.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function [ see Dosage and Administration (2.2)and Clinical Pharmacology (12.3) ].
8.6Renal Impairment In a 12-week rando… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Limited data with saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . No adverse developmental effects independent of maternal toxicity were observed when saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis and in pregnant and lactating rats during the pre- and postnatal period [see Data] .
The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with an HbA1c greater than 7 and has been reported to be as high as 20 to 25% in women with an HbA1c greater than 10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data In embryo-fetal development studies, saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis, corresponding to the first trimester of human pregnancy.
No adverse developmental effects were observed in either species at exposures 1503- and 152-times the 5 mg clinical dose in rats and rabbits, respectively, based on AUC. Saxagliptin crosses the placenta into the fetus following dosing in pregnant rats. In a prenatal and postnatal development study, no adverse developmental effects were observed in maternal rats administered saxagliptin from gestation day 6 through lactation day 21 at exposures up to 470-times the 5 mg clinical dose, based on AUC.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of saxagliptin as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus have not been established. in pediatric patients.. Effectiveness of saxagliptin tablets was not demonstrated in a 26-week, placebo-controlled, double-blind randomized clinical trial with a 26-week safety extension (NCT03199053) in 164 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus
🧓 Geriatric Use ▾
8.5Geriatric Use In the seven, double-blind, controlled clinical safety and efficacy trials of saxagliptin, a total of 4751 (42%) of the 11301 patients randomized to saxagliptin were 65 years and over, and 1210 (10.7%) were 75 years and over. No overall differences in safety or effectiveness were observed between patients65 years of age and older and younger adult patients. Saxagliptin and its active metabolite are eliminated in part by the kidney.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function [ see Dosage and Administration (2.2)and Clinical Pharmacology (12.3) ].
🆘 Overdosage ▾
10 OVERDOSAGE In a controlled clinical trial, once-daily, orally-administered saxagliptin in healthy patients at doses up to 400 mg daily for 2 weeks (80-times the MRHD) had no dose-related clinical adverse reactions and no clinically meaningful effect on QTc interval or heart rate. In the event of an overdose, initiate appropriate supportive treatment as dictated by the patient’s clinical status. Saxagliptin and its active metabolite are removed by hemodialysis (23% of dose over 4 hours).
Contact the Poison Help Line, (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production.
In patients with type 2 diabetes mellitus, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved. Saxagliptin is a competitive DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.
12.2Pharmacodynamics In patients with type 2 diabetes mellitus, administration of saxagliptin inhibits DPP-4 enzyme activity for a 24-hour period. After an oral glucose load or a meal, this DPP-4 inhibition resulted in a 2- to 3-fold increase in circulating levels of active GLP-1 and GIP, decreased glucagon concentrations, and increased glucose-dependent insulin secretion from pancreatic beta cells. The rise in insulin and decrease in glucagon were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Cardiac Electrophysiology In a randomized, double-blind, placebo-controlled, 4-way crossover, active comparator trial using moxifloxacin in 40 healthy subjects, saxagliptin was not associated with clinically meaningful prolongation of the QTc interval or heart rate at daily doses up to 40 mg (8-times the MRHD).
12.3Pharmacokinetics The pharmacokinetics of saxagliptin and its active metabolite, 5-hydroxy saxagliptin were similar in healthy subjects and in patients with type 2 diabetes mellitus. The C max and AUC values of saxagliptin and its active metabolite increased proportionally in the 2.5 to 400 mg dose range. Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its active metabolite were 78 ng•h/mL and 214 ng•h/mL, respectively.
The corresponding plasma C max values were 24 ng/mL and 47 ng/mL, respectively. The average variability (%CV) for AUC and C max for both saxagliptin and its active metabolite was less than 25%. No appreciable accumulation of either saxagliptin or its active metabolite was observed with repeated once-daily dosing at any dose level.
No dose- and time-dependence were observed in the clearance of saxagliptin and its active metabolite over 14 days of once-daily dosing with saxagliptin at doses ranging from 2.5 to 400 mg. . Absorption The median time to maximum concentration (T max ) following the 5 mg once daily dose was 2 hours for saxagliptin and 4 hours for its active metabolite. Effect of Food Administration with a high-fat meal resulted in an increase in T max of saxagliptin by approximately 20 minutes as compared to fasted conditions.
There was a 27% increase in the AUC of saxagliptin when given with a meal as compared to fasted conditions. Saxagliptin may be administered with or without food. Distribution The in vitro protein binding of saxagliptin and its active metabolite in human serum is negligible.
Therefore, changes in blood protein levels in various disease states (e.g., renal or hepatic impairment) are not expected to alter the disposition of saxagliptin. Elimination Metabolism The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5). The major metabolite of saxagliptin is also a DPP4 inhibitor, which is one-half as potent as saxagliptin.
Therefore, strong CYP3A4/5 inhibitors and inducers will alter the pharmacokinetics of saxagliptin and its active metabolite [ see Drug Interactions (7.1) ]. Excre… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production.
In patients with type 2 diabetes mellitus, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved. Saxagliptin is a competitive DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Saxagliptin Tablets are available in the strengths and packages listed in Table 16 Table 16: Saxagliptin Tablet Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Package Size NDC Code 2.5 mg pale yellow to yellow, biconvex, round, film-coated “G74” printed on one side in blue ink Bottles of 30 Bottles of 90 Bottles of 500 68462-726-30 68462-726-90 68462-726-05 5 mg pink, biconvex, round, film-coated “G75” printed on one side in blue ink Bottles of 30 Bottles of 90 Bottles of 500 Carton of 100 (10x10 unit-dose) 68462-727-30 68462-727-90 68462-727-05 68462-727-14 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3-hydroxytricyclo[3.3.1.1 3,7 ]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C 18 H 25 N 3 O 2 •H 2 O and the molecular weight is 333.43.
The structural formula is: Saxagliptin monohydrate is a white to off-white powder. It is soluble in methanol, ethanol; sparingly soluble in water. Each film-coated tablet of saxagliptin for oral use contains either 2.79 mg saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose.
In addition, the film coating contains the following inactive ingredients: hypromellose, iron oxide yellow (2.5 mg tablet only), iron oxide red (5 mg tablet only), polyethylene glycol and titanium dioxide. The imprinting ink contains the following: ammonium hydroxide, n-butyl alcohol, FD&C blue #2, isopropyl alcohol, propylene glycol and shellac. saxagliptistructure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Pancreatitis Inform patients that acute pancreatitis has been reported during postmarketing use of saxagliptin tablets. Educate patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis.
Instruct patients to promptly discontinue saxagliptin tablets and contact their healthcare provider if persistent severe abdominal pain occurs [ see Warnings and Precautions (5.1) ]. Heart Failure Inform patients of the signs and symptoms of heart failure. Before initiating saxagliptin tablets, ask patients if they have a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment.
Instruct patients to contact their healthcare provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [ see Warnings and Precautions (5.2) ]. Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues Inform patients that hypoglycemia can occur, particularly when insulin or an insulin secretagogue is used in combination with saxagliptin tablets. Educate patients about the risks, symptoms and appropriate management of hypoglycemia [see Warnings and Precautions (5.3)].
Hypersensitivity Reactions Patients should be informed that serious allergic (hypersensitivity) reactions, such as angioedema, anaphylaxis, and exfoliative skin conditions, have been reported during postmarketing use of saxagliptin tablets. If symptoms of these allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking saxagliptin tablets and seek medical advice promptly [see Warnings and Precautions (5.4)].
Severe and Disabling Arthralgia Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [ see Warnings and Precautions ( 5.5 ) ].
Bullous Pemphigoid Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur [ see Warnings and Precautions (5.6) ]. Missed Dose If a dose is missed, advise patients to take saxagliptin tablets as soon as they remember unless it is time for their next dose.
Instruct patients not to take two doses of saxagliptin tablets at the same time. Administration Instructions Advise patients not to cut, crush, or chew saxagliptin tablets. Trademarks are the property of their respective owners.
Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2025 image001
💬 Medication Guide ▾
Medication Guide Saxagliptin (SAX-a-GLIP-tin) Tablets, for oral use What is the most important information I should know about saxagliptin tablets? Serious side effects can happen to people taking saxagliptin tablets , including: 1)Inflammation of the pancreas (pancreatitis)which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking saxagliptin tablets: Tell your healthcare provider if you have ever had • inflammation of your pancreas (pancreatitis) • stones in your gallbladder (gallstones) • a history of alcoholism • high blood triglyceride levels Stop taking saxagliptin tablets and contact your healthcare provider right away if you have pain in your 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. 2)Heart failure. Heart failure means your heart does not pump blood well enough.
Before you start taking saxagliptin tablets: Tell your healthcare provider if you • have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: • increasing shortness of breath or trouble breathing, especially when you lie down • an unusually fast increase in weight • swelling or fluid retention, especially in the feet, ankles or legs • unusual tiredness These may be symptoms of heart failure. What are saxagliptin tablets? • Saxagliptin tablets are a prescription medicine used along with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes mellitus. • Saxagliptin tablets are not recommended for people with type 1 diabetes mellitus. • Saxagliptin tablets are not recommended for people with diabetic ketoacidosis (increased ketones in your blood or urine).
It is not known if saxagliptin tablets are safe and effective in children. Who should not take saxagliptin tablets? Do not take saxagliptin tablets if you: • are allergic to any ingredients in saxagliptin tablets.
See the end of this Medication Guide for a complete list of ingredients in saxagliptin tablets. Symptoms of a serious allergic reaction to saxagliptin tablets may include: o swelling of your face, lips, throat, and other areas on your skin o difficulty with swallowing or breathing o raised, red areas on your skin (hives) o skin rash, itching, flaking, or peeling If you have these symptoms, stop taking saxagliptin tablets and contact your healthcare provider right away. Before taking saxagliptin tablets, tell your healthcare provider about all of your medical conditions, including if you: • have heart failure • have or have had inflammation of your pancreas (pancreatitis) • have kidney problems. • are pregnant or plan to become pregnant.
It is not known if saxagliptin tablets will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant. • are breast-feeding or plan to breast-feed. Saxagliptin may be passed in your milk to your baby.
Talk with your healthcare provider about the best way to feed your baby while you take saxagliptin tablets. Tell your healthcare provider 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 medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Saxagliptin tablets may affect the way other medicines work, and other medicines may affect how saxagliptin tablets work. Contact your healthcare provider if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of saxagliptin tablets might need to be changed.
How should I take saxagliptin tablets? • Take saxagliptin tabl… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of saxagliptin and its active metabolite, 5-hydroxy saxagliptin were similar in healthy subjects and in patients with type 2 diabetes mellitus. The C max and AUC values of saxagliptin and its active metabolite increased proportionally in the 2.5 to 400 mg dose range. Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its active metabolite were 78 ng•h/mL and 214 ng•h/mL, respectively.
The corresponding plasma C max values were 24 ng/mL and 47 ng/mL, respectively. The average variability (%CV) for AUC and C max for both saxagliptin and its active metabolite was less than 25%. No appreciable accumulation of either saxagliptin or its active metabolite was observed with repeated once-daily dosing at any dose level.
No dose- and time-dependence were observed in the clearance of saxagliptin and its active metabolite over 14 days of once-daily dosing with saxagliptin at doses ranging from 2.5 to 400 mg. . Absorption The median time to maximum concentration (T max ) following the 5 mg once daily dose was 2 hours for saxagliptin and 4 hours for its active metabolite. Effect of Food Administration with a high-fat meal resulted in an increase in T max of saxagliptin by approximately 20 minutes as compared to fasted conditions.
There was a 27% increase in the AUC of saxagliptin when given with a meal as compared to fasted conditions. Saxagliptin may be administered with or without food. Distribution The in vitro protein binding of saxagliptin and its active metabolite in human serum is negligible.
Therefore, changes in blood protein levels in various disease states (e.g., renal or hepatic impairment) are not expected to alter the disposition of saxagliptin. Elimination Metabolism The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5). The major metabolite of saxagliptin is also a DPP4 inhibitor, which is one-half as potent as saxagliptin.
Therefore, strong CYP3A4/5 inhibitors and inducers will alter the pharmacokinetics of saxagliptin and its active metabolite [ see Drug Interactions (7.1) ]. Excretion Saxagliptin is eliminated by both renal and hepatic pathways. Following a single 50 mg dose of 14 C-saxagliptin, 24%, 36%, and 75% of the dose was excreted in the urine as saxagliptin, its active metabolite, and total radioactivity, respectively.
The average renal clearance of saxagliptin (~230 mL/min) was greater than the average estimated glomerular filtration rate (~120 mL/min), suggesting some active renal excretion. A total of 22% of the administered radioactivity was recovered in feces representing the fraction of the saxagliptin dose excreted in bile and/or unabsorbed drug from the gastrointestinal tract. Following a single oral dose of saxagliptin 5 mg to healthy subjects, the mean plasma terminal half-life (t 1/2 ) for saxagliptin and its active metabolite was 2.5 and 3.1 hours, respectively.
Specific Populations Geriatric Patients No dosage adjustment is recommended based on age alone. Elderly subjects (65 to 80 years) had 23% and 59% higher geometric mean C max and geometric mean AUC values, respectively, for saxagliptin than young subjects (18 to 40 years). Differences in active metabolite pharmacokinetics between elderly and young subjects generally reflected the differences observed in saxagliptin pharmacokinetics.
The difference between the pharmacokinetics of saxagliptin and the active metabolite in young and elderly subjects is likely due to multiple factors including declining renal function and metabolic capacity with increasing age. Age was not identified as a significant covariate on the apparent clearance of saxagliptin and its active metabolite in the population pharmacokinetic analysis. Male and Female Patients No dosage adjustment is recommended based on gender.
There were no differences observed in saxagliptin pharmacokinetics between males and females. Compared to males, fem… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In patients with type 2 diabetes mellitus, administration of saxagliptin inhibits DPP-4 enzyme activity for a 24-hour period. After an oral glucose load or a meal, this DPP-4 inhibition resulted in a 2- to 3-fold increase in circulating levels of active GLP-1 and GIP, decreased glucagon concentrations, and increased glucose-dependent insulin secretion from pancreatic beta cells. The rise in insulin and decrease in glucagon were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Cardiac Electrophysiology In a randomized, double-blind, placebo-controlled, 4-way crossover, active comparator trial using moxifloxacin in 40 healthy subjects, saxagliptin was not associated with clinically meaningful prolongation of the QTc interval or heart rate at daily doses up to 40 mg (8-times the MRHD).
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Glycemic Control Trials in Adults with Type 2 Diabetes Mellitus Saxagliptin has been studied as monotherapy and in combination with metformin HCl, glyburide, and thiazolidinedione (pioglitazone and rosiglitazone) therapy. A total of 4148 patients with type 2 diabetes mellitus were randomized in six, double-blind, controlled clinical trials conducted to evaluate the safety and glycemic efficacy of saxagliptin administered orally. A total of 3021 patients in these trials were treated with saxagliptin.
In these trials, the mean age was 54 years, and 71% of patients were White, 16% were Asian, 4% were Black or African American, and 9% were of other racial groups. An additional 423 patients, including 315 who received saxagliptin, participated in a placebo-controlled, dose-ranging trial of 6 to 12 weeks in duration. In these six, double-blind trials, saxagliptin was evaluated at doses of 2.5 mg and 5 mg once daily.
Three of these trials also evaluated an saxagliptin dose of 10 mg daily. The 10 mg daily dose of saxagliptin did not provide greater efficacy than the 5 mg daily dose. The 10 mg dosage is not an approved dosage.
Treatment with saxagliptin 5 mg and 2.5 mg doses produced statistically significant improvements in A1C, fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG) following a standard oral glucose tolerance test (OGTT), compared to control. Reductions in A1C were seen across subgroups including gender, age, race, and baseline BMI. Saxagliptin was not associated with significant changes from baseline in body weight or fasting serum lipids compared to placebo.
Saxagliptin has also been evaluated in five additional trials in patients with type 2 diabetes mellitus: an active-controlled trial comparing add-on therapy with saxagliptin to glipizide in 858 patients inadequately controlled on metformin HCl alone, a trial comparing saxagliptin to placebo in 455 patients inadequately controlled on insulin alone or on insulin in combination with metformin HCl, a trial comparing saxagliptin to placebo in 257 patients inadequately controlled on metformin HCl plus a sulfonylurea, a trial comparing saxagliptin to placebo in 315 patients inadequately controlled on dapagliflozin and metformin HCl, and a trial comparing saxagliptin to placebo in 170 patients with type 2 diabetes mellitus and moderate or severe renal impairment or ESRD.
Monotherapy A total of 766 patients with type 2 diabetes mellitus inadequately controlled on diet and exercise (A1C ≥ 7% to ≤ 10%) participated in two 24-week, double-blind, placebo-controlled trials evaluating the efficacy and safety of saxagliptin monotherapy. In the first trial, following a 2-week single-blind diet, exercise, and placebo lead-in period, 401 patients were randomized to 2.5 mg, 5 mg, or 10 mg of saxagliptin or placebo. The 10 mg dosage is not an approved dosage.
Patients who failed to meet specific glycemic goals during the trial were treated with metformin HCl rescue therapy, added on to placebo or saxagliptin. Efficacy was evaluated at the last measurement prior to rescue therapy for patients needing rescue. Dose titration of saxagliptin was not permitted.
Treatment with saxagliptin 2.5 mg and 5 mg daily provided significant improvements in A1C, FPG, and PPG compared to placebo (Table 4). The percentage of patients who discontinued for lack of glycemic control or who were rescued for meeting prespecified glycemic criteria was 16% in the saxagliptin 2.5 mg treatment group, 20% in the saxagliptin 5 mg treatment group, and 26% in the placebo group. Table 4: Glycemic Parameters at Week 24 in a Placebo-Controlled Trial of Saxagliptin Monotherapy in Patients with Type 2 Diabetes Mellitus* Efficacy Parameter Saxagliptin 2.5 mg N=102 Saxagliptin 5 mg N=106 Placebo N=95 Hemoglobin A1C (%) N=100 N=103 N=92 Baseline (mean) 7.9 8
7.9Change from baseline (adjusted mean † ) −0.4 −0.5 +0.2 Difference from placebo (adjusted mean † ) −0.6 ‡ −0.6 ‡ 95% Confidence… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity was evaluated in 2-year studies conducted in CD-1 mice and Sprague-Dawley rats. Saxagliptin did not increase the incidence of tumors in mice dosed orally at 50, 250, and 600 mg/kg up to 870-times (males) and 1165-times (females) the 5 mg/day clinical dose, based on AUC. Saxagliptin did not increase the incidence of tumors in rats dosed orally at 25, 75, 150, and 300 mg/kg up to 355-times (males) and 2217-times (females) the 5 mg/day clinical dose, based on AUC.
Mutagenesis Saxagliptin was not mutagenic or clastogenic in a battery of genotoxicity tests (Ames bacterial mutagenesis, human and rat lymphocyte cytogenetics, rat bone marrow micronucleus and DNA repair assays). The active metabolite of saxagliptin was not mutagenic in an Ames bacterial assay. Impairment of Fertility Saxagliptin administered to rats had no effect on fertility or the ability to maintain a litter at exposures up to 603-times and 776-times the 5 mg clinical dose in males and females, based on AUC.
13.2Animal Toxicology and/or Pharmacology Saxagliptin produced adverse skin changes in the extremities of cynomolgus monkeys (scabs and/or ulceration of tail, digits, scrotum, and/or nose). Skin lesions were reversible within exposure approximately 20-times the 5 mg clinical dose, but in some cases were irreversible and necrotizing at higher exposures. Adverse skin changes were not observed at exposures similar to (1- to 3-times) the 5 mg clinical dose.
Clinical correlates to skin lesions in monkeys have not been observed in human clinical trials of saxagliptin.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity was evaluated in 2-year studies conducted in CD-1 mice and Sprague-Dawley rats. Saxagliptin did not increase the incidence of tumors in mice dosed orally at 50, 250, and 600 mg/kg up to 870-times (males) and 1165-times (females) the 5 mg/day clinical dose, based on AUC. Saxagliptin did not increase the incidence of tumors in rats dosed orally at 25, 75, 150, and 300 mg/kg up to 355-times (males) and 2217-times (females) the 5 mg/day clinical dose, based on AUC.
Mutagenesis Saxagliptin was not mutagenic or clastogenic in a battery of genotoxicity tests (Ames bacterial mutagenesis, human and rat lymphocyte cytogenetics, rat bone marrow micronucleus and DNA repair assays). The active metabolite of saxagliptin was not mutagenic in an Ames bacterial assay. Impairment of Fertility Saxagliptin administered to rats had no effect on fertility or the ability to maintain a litter at exposures up to 603-times and 776-times the 5 mg clinical dose in males and females, based on AUC.
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel NDC 68462-726-90 Saxagliptin Tablets, 2.5 mg 2pt5mglabel
Package/Label Display Panel NDC 68462-727-90 Saxagliptin Tablets, 5 mg 5mglabel
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
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