ICD-10 Support

ICD-10 Support

The ICD-10 Diagnosis Codes for Providers

Please refer to the current policy for the latest codes since these codes are subject to change. The codes provided are not intended to be exhaustive. Please consult your ICD-10 code book for additional information.

Third-party reimbursement is affected by many factors. This document and the information and assistance provided by Janssen CarePath are presented for informational purposes only. They do not constitute reimbursement or legal advice. Janssen CarePath does not promise or guarantee coverage, levels of reimbursement, or payment.

Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no statement, promise, or guarantee, expressed or implied, by Janssen or its third-party service providers that these codes will be appropriate or that reimbursement will be made. The fact that a drug, device, procedure, or service is assigned an HCPCS code and a payment rate does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the Medicare program.

Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. Accordingly, the information may not be current or comprehensive. Janssen and its third-party service providers make no representations or warranties, expressed or implied, as to the accuracy of the information provided. In no event shall the third-party service providers or Janssen, or their employees or agents, be liable for any damages resulting from or relating to any information provided by, or accessed to or through, Janssen CarePath. All HCPs and other users of this information agree that they accept responsibility for the use of this program.

* CPT® – Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association, 2018.

Click below for ICD-10 Codes.

DIABETES MELLITUS

ICD-10 Indication ICD-10 Code
DIABETES MELLITUS  
Type 2 DIABETES MELLITUS E11.XXX*
*Use additional code to identify control using
insulin (Z79.4)
oral antidiabetic drugs (Z79.84)
oral hypoglycemic drugs (Z79.84)
Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) E11.00
Type 2 diabetes mellitus with hyperosmolarity with coma E11.01
Type 2 diabetes mellitus with diabetic nephropathy E11.21
Type 2 diabetes mellitus with diabetic chronic kidney disease E11.22*
*Use additional code to identify stage of chronic kidney disease (N18.1-N18.6)
Type 2 diabetes mellitus with other diabetic kidney complication E11.29
Type 2 diabetes mellitus with ophthalmic complications E11.3XXX*
*One of the following 7th characters is to be assigned to codes in subcategories E11.32, E11.33, E11.34, E11.35, and E11.37 to designate laterality of the disease
1 right eye
2 left eye
3 bilateral
4 unspecified eye
Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema E11.311
Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema E11.319
Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema E11.321
Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema E11.329
Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema E11.331
Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema E11.339
Type 2 diabetes with severe nonproliferative diabetic retinopathy with macular edema E11.341
Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema E11.349
Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema E11.351
Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula E11.352
Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula E11.353
Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment E11.354
Type 2 diabetes mellitus with stable proliferative diabetic retinopathy E11.355
Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema E11.359
Type 2 diabetes mellitus with diabetic cataract E11.36
Type 2 diabetes mellitus with diabetic mascular edema, resolved following treatment E11.37
Type 2 diabetes mellitus with other diabetic ophthalmic complication E11.39*
*Use additional code to identify manifestation, such as: diabetic glaucoma (H40-H42)
Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.40
Type 2 diabetes mellitus with diabetic mononeuropathy E11.41
Type 2 diabetes mellitus with diabetic polyneuropathy E11.42
Type 2 diabetes mellitus with diabetic autonomic (poly) neuropathy E11.43
Type 2 diabetes mellitus with diabetic amyotrophy E11.44
Type 2 diabetes mellitus with other diabetic neurological complication E11.49
Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene E11.51
Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene E11.52
Type 2 diabetes mellitus with other circulatory complications E11.59
Type 2 diabetes mellitus with diabetic neuropathic arthropathy E11.610
Type 2 diabetes mellitus with other diabetic arthropathy E11.618
Type 2 diabetes mellitus with diabetic dermatitis E11.620
Type 2 diabetes mellitus with foot ulcer E11.621*
*Use additional code to identify site of ulcer (L97.4-, L97.5-)
Type 2 diabetes mellitus with other skin ulcer E11.622*
*Use additional code to identify site of ulcer (L97.1-L97.9, L98.41-L98.49)
Type 2 diabetes mellitus with other skin complications E11.628
Type 2 diabetes mellitus with periodontal disease E11.630
Type 2 diabetes mellitus with other oral complications E11.638
Type 2 diabetes mellitus with hypoglycemia without coma E11.649
Type 2 diabetes mellitus with hyperglycemia E11.65
Type 2 diabetes mellitus with other specified complication E11.69*
*Use additional code to identify complication
Type 2 diabetes mellitus with unspecified complications E11.8
Type 2 diabetes mellitus without complications E11.9
OTHER SPECIFIED DIABETES MELLITUS E13.XXX*
*Use additional code to identify any
insulin use (Z79.4)
oral antidiabetic drugs (Z79.84)
oral hypoglycemic drugs (Z79.84)
... with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) E13.00
... with hyperosmolarity with coma E13.01
Other specified diabetes mellitus with diabetic nephropathy E13.21
Other specified diabetes mellitus with diabetic chronic kidney disease E13.22*
*Use additional code to identify stage of chronic kidney disease (N18.1-N18.6)
Other specified diabetes mellitus with other diabetic kidney complication E13.29
Other specified diabetes mellitus with ophthalmic complications E13.3XXX*
*One of the following 7th characters is to be assigned to codes in subcategories E13.32, E13.33, E13.34, E13.35, and E13.37 to designate laterality of the disease:
1 right eye
2 left eye
3 bilateral
4 unspecified eye
Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema E13.311
Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema E13.319
Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema E13.321
Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema E13.329
Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema E13.331
Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema E13.339
Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema E13.341
Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema E13.349
Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema E13.351
Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula E13.352
Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula E13.353
Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment E13.354
Other specified diabetes mellitus with stable proliferative diabetic retinopathy E13.355
Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema E13.359
Other specified diabetes mellitus with diabetic cataract E13.36
Other specified diabetes mellitus with diabetic macular edema, resolved following treatment E13.37
Other specified diabetes mellitus with other diabetic ophthalmic complication E13.39*
*Use additional code to identify manifestation, such as: diabetic glaucoma (H40-H42)
Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.40
Other specified diabetes mellitus with diabetic mononeuropathy E13.41
Other specified diabetes mellitus with diabetic polyneuropathy E13.42
Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy E13.43
Other specified diabetes mellitus with diabetic amyotrophy E13.44
Other specified diabetes mellitus with diabetic neurological complication E13.49
Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene E13.51
Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene E13.52
Other specified diabetes mellitus with other circulatory complications E13.59
Other specified diabetes mellitus with diabetic neuropathic arthropathy E13.610
Other specified diabetes mellitus with other diabetic arthropathy E13.618
Other specified diabetes mellitus with diabetic dermatitis E13.620
Other specified diabetes mellitus with foot ulcer E13.621*
*Use additional code to identify site of ulcer (L97.4-, L97.5)
Other specified diabetes mellitus with other skin ulcer E13.622*
*Use additional code to identify site of ulcer (L97.1-L97.9, L98.41-L98.49)
Other specified diabetes mellitus with other skin complications E13.628
Other specified diabetes mellitus with periodontal disease E13.630
Other specified diabetes mellitus with other oral complications E13.638
Other specified diabetes mellitus with hypoglycemia without coma E13.649
Other specified diabetes mellitus with hyperglycemia E13.65
Other specified diabetes mellitus with other specified complication E13.69*
*Use additional code to identify complication
Other specified diabetes mellitus with unspecified complications E13.8
Other specified diabetes mellitus without complication E13.9

For more information on the transition to ICD-10, visit the CMS Web site.

SOURCE:
American Medical Association. ICD-10-CM 2018: The Complete Official Codebook. 2017. American Medical Association.

INVOKANA® (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

INVOKANA® is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).

INVOKAMET® and INVOKAMET® XR are a combination of canagliflozin and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both canagliflozin and metformin HCl is appropriate.

INVOKANA® is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). However, the effectiveness of INVOKAMET®/INVOKAMET® XR in reducing the risk of major cardiovascular events in adults with type 2 diabetes and cardiovascular disease has not been established.

INVOKANA®, INVOKAMET®, and INVOKAMET® XR are not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Important Safety Information for INVOKANA® (canagliflozin), INVOKAMET® (canagliflozin/metformin HCl), and INVOKAMET® XR (canagliflozin/metformin HCl extended-release)

WARNING: LACTIC ACIDOSIS AND LOWER-LIMB AMPUTATION

Lactic Acidosis

  • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L); anion gap acidosis (without evidence of ketonuria or ketonemia); an increased lactate:pyruvate ratio, and metformin plasma levels generally >5 mcg/mL. 
  • Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
  • Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information.
  • If metformin-associated lactic acidosis is suspected, immediately discontinue INVOKAMET®/ INVOKAMET® XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Risk of Lower-Limb Amputation

  • An approximately 2-fold increased risk of lower-limb amputations associated with INVOKANA® was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
  • Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
  • Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
  • Monitor patients receiving INVOKANA®/ INVOKAMET®/INVOKAMET® XR for infection, new pain or tenderness, sores, or ulcers involving the lower limbs, and discontinue if these complications occur.

CONTRAINDICATIONS

  • Moderate to severe renal impairment (eGFR below 45 mL/min/1.73 m2), end stage renal disease (ESRD), or patients on dialysis
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis
  • Serious hypersensitivity reaction to INVOKANA® or metformin

WARNINGS and PRECAUTIONS

  • Lactic Acidosis: Postmarketing cases of metformin-associated lactic acidosis, including fatal cases, were reported. 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. Additional findings included elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate:pyruvate ratio, and metformin plasma levels generally >5 mcg/mL.

    If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of INVOKAMET®/INVOKAMET® XR. Prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin.

    Educate patients and their families about the symptoms of lactic acidosis and if symptoms occur instruct them to discontinue INVOKAMET®/INVOKAMET® XR and report these symptoms to their healthcare provider.

    Recommendations to reduce the risk include:

    Renal Impairment: Obtain an eGFR before initiation and at least annually thereafter, and more frequently in patients at increased risk of renal impairment.

    Drug Interactions: More frequent monitoring is recommended when administered with drugs that impair renal function, result in hemodynamic change, interfere with acid-base balance, or increase metformin accumulation (eg, cationic drugs).

    Age 65 or Greater: Assess renal function more frequently in elderly patients.

    Radiological Studies with Contrast: Stop INVOKAMET®/INVOKAMET® XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR of 45 to 60 mL/min/1.73 m2; 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 INVOKAMET®/INVOKAMET® XR if renal function is stable.

    Surgery and Other Procedures: Discontinue INVOKAMET®/INVOKAMET® XR while patients have restricted food and fluid intake.

    Hypoxic States: Discontinue INVOKAMET®/INVOKAMET® XR in conditions associated with hypoxemia.

    Excessive Alcohol Intake: Warn patients against excessive alcohol intake while receiving INVOKAMET®/INVOKAMET® XR.

    Hepatic Impairment: Avoid use of INVOKAMET®/INVOKAMET® XR in patients with evidence of hepatic disease.

  • Lower-Limb Amputation: An approximately 2-fold increased risk of lower-limb amputations associated with INVOKANA® was observed in CANVAS and CANVAS-R, two randomized, placebo-controlled trials evaluating patients with type 2 diabetes who had either established cardiovascular disease or were at risk for cardiovascular disease. The risk of lower-limb amputations was observed at both the 100-mg and 300-mg once-daily dosage regimens. 

    Amputations of the toe and midfoot (99 out of 140 patients with amputations receiving INVOKANA® in the two trials) were the most frequent; however, amputations involving the leg, below and above the knee, were also observed (41 out of 140 patients with amputations receiving INVOKANA® in the two trials). Some patients had multiple amputations, some involving both lower limbs.

    Lower-limb infections, gangrene, and diabetic foot ulcers were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.

    Before initiating, consider factors in the patient history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients about the importance of routine preventative foot care. Monitor patients for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores, or ulcers involving the lower limbs, and discontinue if these complications occur.

  • Hypotension: INVOKANA® causes intravascular volume contraction. Symptomatic hypotension can occur after initiating INVOKANA®/ INVOKAMET®/INVOKAMET® XR, particularly in the elderly, and in patients with impaired renal function, low systolic blood pressure, or on diuretics or medications that interfere with the renin-angiotensin-aldosterone system. Before initiating INVOKANA®/ INVOKAMET®/INVOKAMET® XR, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating therapy.
  • Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and 2 diabetes mellitus receiving SGLT2 inhibitors, including INVOKANA®. Fatal cases of ketoacidosis have been reported in patients taking INVOKANA®. Before initiating INVOKANA®/INVOKAMET®/INVOKAMET® XR, consider factors in patient history that may predispose to ketoacidosis. Monitor for ketoacidosis and temporarily discontinue in clinical situations known to predispose to ketoacidosis.
  • Acute Kidney Injury: INVOKANA® causes intravascular volume contraction and can cause acute kidney injury. Acute kidney injury, requiring hospitalization and dialysis, has been reported; some reports involved patients younger than 65 years of age. Before initiation, consider factors that may predispose patients to acute kidney injury. Consider temporarily discontinuing INVOKANA®/INVOKAMET®/INVOKAMET® XR in any setting of reduced oral intake or fluid losses; monitor patients for signs and symptoms of acute kidney injury. If it occurs, promptly discontinue and treat.

    Initiation of INVOKANA® may increase serum creatinine and decrease eGFR. Evaluate renal function prior to initiation and periodically thereafter. Dose adjustment and more frequent renal function monitoring are recommended in patients with an eGFR <60 mL/min/1.73 m2.

  • Urosepsis and Pyelonephritis: Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization have been reported in patients receiving SGLT2 inhibitors, including INVOKANA®. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate for signs and symptoms and treat promptly.
  • Use With Medications Known to Cause Hypoglycemia

    INVOKANA®
    INVOKANA® can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required.
    Metformin
    Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or when used concomitantly with other glucose-lowering agents (such as sulfonylureas or insulin) or ethanol. Monitor for a need to lower the dose of INVOKAMET®/INVOKAMET® XR.

  • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Necrotizing fasciitis of the perineum, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, has been identified in postmarketing surveillance in female and male patients with diabetes mellitus receiving SGLT2 inhibitors, including INVOKANA®. Serious outcomes have included hospitalization, multiple surgeries, and death. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INVOKANA®/INVOKAMET®/INVOKAMET® XR.
  • Genital Mycotic Infections: INVOKANA® increases risk of genital mycotic infections, especially in uncircumcised males or patients with prior infections. Monitor and treat appropriately.
  • Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and anaphylaxis, were reported with INVOKANA®; these reactions generally occurred within hours to days after initiation. If reactions occur, discontinue INVOKANA®/INVOKAMET®/INVOKAMET® XR; treat and monitor until signs and symptoms resolve.
  • Bone Fracture: Increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, was observed in patients using INVOKANA®. Prior to initiation, consider factors that contribute to fracture risk. 
  • Vitamin B12 Levels: Metformin may lower vitamin B12 levels. Measure hematological parameters annually and vitamin B12 at 2- to 3-year intervals and manage any abnormalities.
  • Increases in Low-Density Lipoprotein (LDL-C): Dose-related increases in LDL-C can occur with INVOKANA®. After initiation, monitor LDL-C and treat if appropriate.

DRUG INTERACTIONS

  • Drug Interactions With Metformin
    Carbonic Anhydrase Inhibitors
    Topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, or dichlorphenamide) frequently decrease serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs may induce metabolic acidosis. Use these drugs with caution in patients treated with metformin, as the risk of lactic acidosis may increase.
    Drugs That Reduce Metformin Clearance
    Drugs that are eliminated by renal tubular secretion (eg, cationic drugs such as cimetidine) may increase accumulation of metformin and risk for lactic acidosis.
    Alcohol
    Alcohol is known to potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake while receiving INVOKAMET®/INVOKAMET® XR.
    Drugs Affecting Glycemic Control
    Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. When such drugs are administered to a patient receiving INVOKAMET®/INVOKAMET® XR, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving INVOKAMET®/INVOKAMET® XR, the patient should be observed closely for hypoglycemia.
  • Drug Interactions With INVOKANA®
    UGT Enzyme Inducers
    Rifampin lowered INVOKANA® exposure, which may reduce the efficacy of INVOKANA®/ INVOKAMET®/INVOKAMET® XR. If an inducer of UGT enzymes must be co-administered with INVOKANA®/INVOKAMET®/INVOKAMET® XR, consider increasing the total daily dose of INVOKANA® to 300 mg if patients are currently tolerating a total daily dose of 100 mg INVOKANA®, have an eGFR >60 mL/min/1.73 m2, and require additional glycemic control. Consider alternate treatment in patients with an eGFR <60 mL/min/1.73 m2 who require additional glycemic control.
    Digoxin
    INVOKANA® increased digoxin exposure. Digoxin, as a cationic drug, also has the potential to compete with metformin for common renal tubular transport systems. Monitor patients with concomitant digoxin and adjust doses appropriately.
  • Drug/Laboratory Test Interference
    Positive Urine Glucose Test
    Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
    Interference With 1,5-Anhydroglucitol (1,5-AG) Assay
    Monitoring glycemic control with 1,5-AG assay is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: INVOKANA®/INVOKAMET®/INVOKAMET® XR is not recommended in pregnant women, especially during the second and third trimesters.
  • Nursing Mothers: INVOKANA®/INVOKAMET®/INVOKAMET® XR is not recommended while breastfeeding.
  • Females and Males of Reproductive Potential: Discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin may result in ovulation in some anovulatory women.
  • Pediatric Use: Safety and effectiveness of INVOKANA®​/INVOKAMET®/INVOKAMET® XR in patients <18 years of age have not been established.
  • Geriatric Use: Frequently monitor renal function after initiating INVOKANA®​/INVOKAMET®/INVOKAMET® XR in elderly patients and adjust dose accordingly.
    INVOKANA®
    Patients ≥65 years had a higher incidence of adverse reactions related to reduced intravascular volume, particularly with the 300-mg dose; more prominent increase in the incidence was seen in patients who were ≥75 years. Smaller reductions in HbA1c relative to placebo were seen in patients ≥65 years compared to younger patients.
    Metformin
    The initial and maintenance dosing of metformin should be conservative in elderly patients due to potential decreased renal function. Adjust dose based on assessment of renal function.
  • Renal Impairment: INVOKANA®​/INVOKAMET®/INVOKAMET® XR should not be used in patients with severe renal impairment (eGFR <45 mL/min/1.73 m2), with end-stage renal disease, or receiving dialysis.
  • Hepatic Impairment: Metformin use in patients with hepatic impairment has been associated with some cases of lactic acidosis. INVOKANA® has not been studied in patients with severe hepatic impairment. INVOKANA®​/INVOKAMET®/INVOKAMET® XR is not recommended in patients with hepatic impairment.

OVERDOSAGE

  • In the event of an overdose with INVOKANA®​/INVOKAMET®/INVOKAMET® XR, contact the Poison Control Center. Employ the usual supportive measures.

ADVERSE REACTIONS

  • The most common (≥5%) adverse reactions with INVOKANA® were female genital mycotic infections, urinary tract infections, and increased urination.
  • The most common adverse reactions due to initiation of metformin are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for INVOKANA®.

Please see full Prescribing Informationincluding Boxed WARNINGS, and Medication Guide for INVOKAMET® and INVOKAMET® XR.

 

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