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Metformin, Saxagliptin

Saxagliptin and Metformin Hydrochloride

1GM; 2.5MG BASE, 1GM; 5MG BASE, 500MG; 5MG BASE tablet, extended releaseUnited StatesMarketedAuthorised 31 Jul 2023

Indications

Saxagliptin and metformin hydrochloride extended-release 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) ]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

( 1 ) Limitations of Use:

Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.1 )

1.1Limitations of Use Saxagliptin

and metformin hydrochloride extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Contraindications

Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with:

Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ).
Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
A history of a serious hypersensitivity reaction to saxagliptin, metformin HCl, or any of the ingredients in saxagliptin and metformin hydrochloride extended-release tablets. Reactions such as anaphylaxis, angioedema, or exfoliative skin conditions have been reported [ see Warnings and Precautions (5.6) and Adverse Reactions (6.2) ].
Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ). ( 4 )
Metabolic acidosis, including diabetic ketoacidosis. ( 4 )
History of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to saxagliptin, metformin HCl, or any of the ingredients in saxagliptin and metformin hydrochloride extended-release tablets. ( 4 )

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Metformin, Saxagliptin

Saxagliptin and Metformin Hydrochloride

1GM; 2.5MG BASE, 1GM; 5MG BASE, 500MG; 5MG BASE tablet, extended releaseUnited StatesMarketedAuthorised 31 Jul 2023

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Indications

( 1 ) Limitations of Use:

Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.1 )

1.1Limitations of Use Saxagliptin

and metformin hydrochloride extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Contraindications

Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with:

Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ).
Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
A history of a serious hypersensitivity reaction to saxagliptin, metformin HCl, or any of the ingredients in saxagliptin and metformin hydrochloride extended-release tablets. Reactions such as anaphylaxis, angioedema, or exfoliative skin conditions have been reported [ see Warnings and Precautions (5.6) and Adverse Reactions (6.2) ].
Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ). ( 4 )
Metabolic acidosis, including diabetic ketoacidosis. ( 4 )
History of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to saxagliptin, metformin HCl, or any of the ingredients in saxagliptin and metformin hydrochloride extended-release tablets. ( 4 )

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5.1Lactic Acidosis

There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels generally > 5 mcg/mL.

Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk. If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of saxagliptin and metformin hydrochloride extended-release tablets. In saxagliptin and metformin hydrochloride extended-release tablet-treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin HCl is dialyzable, with a clearance of up to 170 mL/minute under good hemodynamic conditions).

Hemodialysis has often resulted in reversal of symptoms and recovery. Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur instruct them to discontinue saxagliptin and metformin hydrochloride extended-release tablets and report these symptoms to their health care provider. For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: Renal Impairment The post-marketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.

The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [ see Clinical Pharmacology (12.3) ]:

Before initiating saxagliptin and metformin hydrochloride extended-release tablets, obtain an estimated glomerular filtration rate (eGFR).
Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with an eGFR less than 30 mL/minute/1.73 m 2 [ see Contraindications (4) ].
Initiation of saxagliptin and metformin hydrochloride extended-release tablets is not recommended in patients with eGFR between 30 and 45 mL/minute/1.73 m 2 .
Obtain an eGFR at least annually in all patients taking saxagliptin and metformin hydrochloride extended-release tablets. In patients at increased risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.
In patients taking saxagliptin and metformin hydrochloride extended-release tablets whose eGFR later falls below 45 mL/minute/1.73 m 2 , assess the benefit and risk of continuing therapy. Drug Interactions The concomitant use of saxagliptin and metformin hydrochloride extended-release tablets with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance or increase metformin accumulation [ see Drug Interactions (7) ]. Therefore, consider more frequent monitoring of patients. Age 65 or Greater The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal function more frequently in elderly patients [ see Use in Specific Populations (8.5) ]. Radiological Studies with Contrast Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis. Stop saxagliptin and metformin hydrochloride extended-release tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and restart saxagliptin and metformin hydrochloride extended-release tablets if renal function is stable. Surgery and Other Procedures Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension and renal impairment. Saxagliptin and metformin hydrochloride extended-release tablets should be temporarily discontinued while patients have restricted food and fluid intake. Hypoxic States Several of the post-marketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur, discontinue saxagliptin and metformin hydrochloride extended-release tablets. Excessive Alcohol Intake Alcohol potentiates the effect of metformin on lactate metabolism and this may increase the risk of metformin-associated lactic acidosis. Warn patients against excessive alcohol intake while receiving saxagliptin and metformin hydrochloride extended-release tablets. Hepatic Impairment Patients with hepatic impairment have developed with cases of metformin-associated lactic acidosis. This may be due to impaired lactate clearance resulting in higher lactate blood levels. Therefore, avoid use of saxagliptin and metformin hydrochloride extended-release tablets in patients with clinical or laboratory evidence of hepatic disease. Mitochondrial Dise

Interactions

Drug Interactions The concomitant use of saxagliptin and metformin hydrochloride extended-release tablets with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance or increase metformin accumulation [ see Drug Interactions (7) ]. Therefore, consider more frequent monitoring of patients. 7 DRUG INTERACTIONS

Strong CYP3A4/5 inhibitors (e.g., ketoconazole): Coadministration with saxagliptin and metformin hydrochloride extended-release tablets significantly increases saxagliptin concentrations. Limit saxagliptin and metformin hydrochloride extended-release tablets dosage to 2.5 mg/1,000 mg once daily when coadministered with a strong CYP3A4/5 inhibitor. ( 2.3 , 7.1 )
Carbonic anhydrase inhibitors: May increase risk of lactic acidosis. Consider more frequent monitoring. ( 7.2 )
Drugs that reduce metformin clearance : May increase risk of lactic acidosis. Consider benefits and risks of concomitant use. ( 7.3 )
See full prescribing information for additional drug interactions. ( 7 )

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 dose of saxagliptin and metformin hydrochloride extended-release tablets should be limited to 2.5 mg of saxagliptin when coadministered with a strong CYP3A4/5 inhibitor [ see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ].

7.2Carbonic Anhydrase Inhibitors Topiramate

or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with saxagliptin and metformin hydrochloride extended-release tablets may increase the risk for lactic acidosis.

7.3 Drugs that Reduce Metformin Clearance Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see Clinical Pharmacology (12.3) ].

Consider the benefits and risks of concomitant use.

7.4Alcohol

Alcohol is known to potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake while receiving saxagliptin and metformin hydrochloride extended-release tablets.

7.5Insulin or Insulin Secretagogues Insulin

and insulin secretagogues are known to cause hypoglycemia. Concomitant use of saxagliptin and metformin hydrochloride extended-release 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 (5.5) ].

7.6Drugs Affecting Glycemic Control

Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These medications include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving saxagliptin and metformin hydrochloride extended-release tablets, observe the patient closely for loss of blood glucose control.

When such drugs are withdrawn from a patient receiving saxagliptin and metformin hydrochloride extended-release tablets, observe the patient closely for hypoglycemia.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Limited available data with saxagliptin and metformin hydrochloride extended-release tablets or saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Published trials with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [ see Data ]. No adverse developmental effects independent of maternal toxicity were observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during the period of organogenesis [ 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 Saxagliptin 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.

Metformin HCl Metformin HCl did not cause adverse developmental effect when administered to pregnant Sprague Dawley rats and rabbits up to 600 mg/kg/day during the period of organogenesis. This represents an exposure of about 2- and 6-times a 2,000 mg clinical dose based on body surface area (mg/m 2 ) for rats and rabbits, respectively. Saxagliptin and Metformin Saxagliptin and metformin coadministered to pregnant rats and rabbits during the period of organogenesis did not result in adverse developmental effects considered clinically relevant in either species.

Doses tested in rats provided exposure up to 100- and 10-times clinical exposure, and doses tested in rabbits provided exposure up to 249- and 1-times clinical exposure relative to the clinical dose of 5 mg saxagliptin and 2,000 mg metformin. Minor skeletal abnormalities associated with maternal toxicity were observed in rats. In rabbits, coadministration was poorly tolerated in a subset of mothers (12 of 30), resulting in death, moribundity, or abortion.

However, among surviving mothers with evaluable litters, maternal toxicity was limited to marginal reductions in body weight over the course of gestation days 21 to 29, associated with fetal body weight decrements of 7%, and a low incidence of delayed ossification of the fetal hyoid bone.

Adverse reactions

The following serious adverse reactions are described below or elsewhere in the prescribing information:

Lactic Acidosis [ see Boxed Warning and Warnings and Precautions (5.1) ]
Pancreatitis [ see Warnings and Precautions (5.2) ]
Heart Failure [ see Warnings and Precautions (5.3) ]
Vitamin B 12 Concentrations [ see Warnings and Precautions (5.4) ]
Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [ see Warnings and Precautions (5.5) ]
Hypersensitivity Reactions [ see Warnings and Precautions (5.6) ]
Severe and disabling arthralgia [ see Warnings and Precautions (5.7) ]
Bullous pemphigoid [ see Warnings and Precautions (5.8) ]
Most common adverse reactions with metformin HCl extended release (incidence > 5% and more often than placebo) are: diarrhea and nausea/vomiting. ( 6.1 )
Most common adverse reactions with saxagliptin (incidence ≥ 5% and more often than placebo) are: upper respiratory tract infection, urinary tract infection, and headache. ( 6.1 )
Adverse reactions with coadministered saxagliptin and metformin HCl (incidence ≥ 5% and more often than placebo) are: headache and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 Placebo-Controlled Trials in Adults with Type 2 Diabetes Mellitus Metformin HCl In placebo-controlled monotherapy trials of metformin HCl extended-release, diarrhea and nausea/vomiting were reported in > 5% of metformin-treated patients and more commonly than in placebo-treated patients (9.6% versus 2.6% for diarrhea and 6.5% versus 1.5% for nausea/vomiting).

Diarrhea led to discontinuation of trial medication in 0.6% of the patients treated with metformin HCl extended-release. Saxagliptin 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 or older and 48.4% were male.

The population was 67.5% White, 4.6% Black or African American, 17.4% Asian, 10.5% other races and 9.8% were of Hispanic or Latino ethnicity. At baseline the population had diabetes for an average of 5.2 years and a mean HbA1c of 8.2%. Baseline estimated renal function was normal or mildly impaired (eGFR ≥ 60 mL/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 The 5 placebo-controlled trials include two monotherapy trials and one add-on combination therapy trial with each of the following: metformin HCl, thiazolidinedione, or glyburide. Table shows 24-week data regardless of glycemic rescue.

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

7.6 Urinary tract infection 6.8

6.1 Headache 6.5

5.9 In 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 1.0 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 saxagliptin dosage is not an approved dosage. The incidence rate of fracture events in patients who received saxagliptin did not increase over time. Causality has not been established and nonclinical studies have not demonstrated adverse effects of saxagliptin on bone. An event of thrombocytopenia, consistent with a diagnosis of idiopathic thrombocytopenic purpura, was observed in the clinical program. The relationship of this event to saxagliptin is not known.

Discontinuation of therapy due to adverse reactions occurred in 2.2%, 3.3%, and 1.8% of patients receiving saxagliptin 2.5 mg, saxagliptin 5 mg, and placebo, respectively. The most common adverse reactions (reported in at least 2 patients treated with saxagliptin 2.5 mg or at least 2 patients treated with saxagliptin 5 mg) associated with premature discontinuation of therapy included lymphopenia (0.1% and 0.5% versus 0%, respectively), rash (0.2% and 0.3% versus 0.3%), blood creatinine increased (0.3% and 0% versus 0%), and blood creatine phosphokinase increased (0.1% and 0.2% versus 0%).

Adverse Reactions with Concomitant Use with Insulin In the add-on to insulin trial [ see Clinical Studies (14.1) ], the incidence of adverse events, including serious adverse events and discontinuations due to adverse events, was similar between saxagliptin and placebo, except for confirmed hypoglycemia [ see Adverse Reactions (6.1) ]. Adverse Reactions Associated with Saxagliptin Coadministered with Metformin HCl Immediate-Release in Treatment-Naive Patients with Type 2 Diabetes Mellitus Table 2 shows the adverse reactions reported (regardless of investigator assessment of causality) in ≥ 5% of patients participating in an additional 24-week, active-controlled trial of coadministered saxagliptin and metformin HCl in treatment-naive patients.

Table 2: Coadministration of Saxagliptin and Metformin HCl Immediate-Release in Treatment-Naive Patients: Adverse Reactions Reported in ≥ 5% of Patients Treated with Combination Therapy of Saxagliptin 5 mg Plus Metformin HCl Immediate-Release (and More Commonly than in Patients Treated with Metformin HCl Immediate-Release Alone) Number (%) of Patients Saxagliptin 5 mg + Metformin HCl Metformin HCl immediate-release was initiated at a starting dose of 500 mg daily and titrated up to a maximum of 2,000 mg daily.

Our copy of this section ends here. The full text is in the official label at the FDA. Open in the register

Packs

Pack	Code	Status
METFORMIN HYDROCHLORIDE 1GM; SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE	ANDA205981-003	Prescription
METFORMIN HYDROCHLORIDE 500MG; SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE	ANDA205981-001	Prescription
METFORMIN HYDROCHLORIDE 1GM; SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE	ANDA205981-002	Prescription
METFORMIN HYDROCHLORIDE 1GM; SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE	ANDA206081-003	Discontinued
METFORMIN HYDROCHLORIDE 500MG; SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE	ANDA206081-001	Discontinued
METFORMIN HYDROCHLORIDE 1GM; SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE	ANDA206081-002	Discontinued
METFORMIN HYDROCHLORIDE 1GM; SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE	ANDA207678-002	Prescription
METFORMIN HYDROCHLORIDE 1GM; SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE	ANDA207678-003	Prescription
METFORMIN HYDROCHLORIDE 500MG; SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE	ANDA207678-001	Prescription

Saxagliptin and Metformin Hydrochloride

Indications

1.1Limitations of Use Saxagliptin

Contraindications

Two medicines in one question?

Saxagliptin and Metformin Hydrochloride

Indications

1.1Limitations of Use Saxagliptin

Contraindications

Two medicines in one question?

Warnings and precautions

5.1Lactic Acidosis

Interactions

7.1Strong Inhibitors of CYP3A4/5 Enzymes

7.2Carbonic Anhydrase Inhibitors Topiramate

7.4Alcohol

7.5Insulin or Insulin Secretagogues Insulin

7.6Drugs Affecting Glycemic Control

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

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