Drug Safety-related Labeling Changes (SrLC)

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TOUJEO MAX SOLOSTAR (BLA-206538)

(INSULIN GLARGINE RECOMBINANT)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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11/26/2019 (SUPPL-12)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Never Share a TOUJEO Solostar or TOUJEO Max Solostar Pen Between Patients

(Additions and/or revisions underlined)

TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

The data in Table 2 reflect the exposure of 1242 patients with type 2 diabetes to TOUJEO with mean exposure duration of 25 weeks. The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 13 years. Fifty-three percent were male, 88% were Caucasian, 7% were Black or African American, and 17% were Hispanic. At baseline, mean eGFR was 79 mL/min/1.73 m^2 and 27% of patients had an eGFR greater than or equal to 90 mL/min/1.73 m^2. The mean BMI was 35 kg/m^2. HbA1c at baseline was greater or equal to 8% in 66% of patients.

TOUJEO was studied in 233 pediatric patients (6-17 years of age) with type 1 diabetes for a mean duration of 26 weeks.

Common adverse reactions (occurring greater than or equal to 5%) in TOUJEO-treated subjects during clinical trials in adult patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Table 1 and Table 2, respectively. Common adverse reactions for TOUJEO-treated pediatric subjects with type 1 diabetes mellitus were similar to the adverse reactions listed in Table 1. Hypoglycemia is discussed in a dedicated subsection below.

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including TOUJEO. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for TOUJEO with the incidence of hypoglycemia for other products may be misleading and also may not be representative of hypoglycemia rates that will occur in clinical practice.

In the TOUJEO adult program, severe hypoglycemia was defined as an event requiring assistance of another person to administer a resuscitative action. In the pediatric program, severe hypoglycemia was defined as an event with semiconsciousness, unconsciousness, coma and/or convulsions in a patient who had altered mental status and could not assist in his own care and who may have required glucagon or intravenous glucose.

The incidence of severe hypoglycemia in adult patients with type 1 diabetes receiving TOUJEO as part of a multiple daily injection regimen was 6.6% at 26 weeks. The incidence of hypoglycemia with a glucose level less than 54 mg/dL with or without symptoms was 77.7% at 26 weeks.

The incidence of severe hypoglycemia in pediatric patients with type 1 diabetes receiving TOUJEO as part of a multiple daily injection regimen was 6% at 26 weeks and the incidence of hypoglycemia accompanied by a self-monitored or plasma glucose value less than 54 mg/dL regardless of symptoms was 80.3%.

The incidence of severe hypoglycemia in adult patients with type 2 diabetes was 5% at 26 weeks in patients receiving TOUJEO as part of a multiple daily injection regimen, and 1.0% and 0.9% respectively at 26 weeks in the two studies where patients received TOUJEO as part of a basal- insulin only regimen. The incidence of hypoglycemia accompanied by a self-monitored or plasma glucose value less than 54 mg/dL regardless of symptoms in patients with type 2 diabetes receiving TOUJEO ranged from 9% to 44.6% at 26 weeks and the highest risk was again seen in patients receiving TOUJEO as part of a multiple daily injection regimen.

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of TOUJEO to improve glycemic control in type 1 and type 2 diabetes mellitus have been established in pediatric patients 6 years of age and older.

The use of TOUJEO for this indication is supported by evidence from an adequate and well- controlled study in 463 pediatric patients 6 to 17 years of age with type 1 diabetes mellitus and from studies in adults with diabetes mellitus.

The safety and effectiveness of TOUJEO have not been established in pediatric patients less than 6 years of age.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share a TOUJEO SoloStar or TOUJEO Max SoloStar Pen Between Patients

Advise patients that they must never share TOUJEO SoloStar or TOUJEO Max SoloStar pen with another person even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.

Hyperglycemia or Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision.

Inform patients that if they change to TOUJEO from other basal insulins they may experience higher average fasting plasma glucose levels in the first weeks of therapy. Advise patients to monitor glucose daily when initiating TOUJEO.

Medication Errors

Instruct patients to always check the insulin label before each injection. The “300 units/mL (U-300)” is highlighted in honey gold on the labels of TOUJEO and TOUJEO Max SoloStar single-patient-use prefilled pens.

Inform patients that TOUJEO (insulin glargine injection) 300 units/mL contains 3 times as much insulin in 1 mL as standard insulin (100 units/mL). To avoid dosing errors and potential overdose, instruct patients to never use a syringe to remove TOUJEO from the TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen.

Inform patients that the dose counter of TOUJEO SoloStar or TOUJEO Max SoloStar single- patient-use prefilled pen shows the number of units of TOUJEO to be injected and no dose recalculation is required.

Administration

TOUJEO must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that TOUJEO must NOT be diluted or mixed with any other insulin or solution.

PATIENT INFORMATION

(Additions and/or revisions underlined)

What is TOUJEO?

  • TOUJEO is a long-acting man-made insulin used to control high blood sugar in adults and children who are 6 years of age and older with diabetes mellitus.

  • TOUJEO is not for use to treat diabetic ketoacidosis.

  • It is not known if TOUJEO is safe and effective in children under 6 years of age.

11/15/2019 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Additions and/or revisions underlined:

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia.

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant oral antidiabetic products may be needed.

Changing to TOUJEO from other Insulins

On a unit-to-unit basis, TOUJEO has a lower glucose lowering effect than LANTUS. In clinical trials, patients who changed to TOUJEO from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS. Higher doses of TOUJEO were required to achieve similar levels of glucose control compared to LANTUS in clinical trials.

The onset of action of TOUJEO develops over 6 hours following an injection. In type 1 diabetes patients treated with IV insulin, consider the longer onset of action of TOUJEO before stopping IV insulin. The full glucose lowering effect may not be apparent for at least 5 days.

To minimize the risk of hyperglycemia when initiating TOUJEO monitor glucose daily, titrate TOUJEO as described in this prescribing information, and adjust coadministered glucose- lowering therapies per standard of care.

6 Adverse Reactions

Newly added subsection:

6.3 Postmarketing Experience

The following additional adverse reactions have been identified during postapproval use of TOUJEO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Medication Errors

Additions and/or revisions underlined:

… To avoid dosing errors and potential overdose, instruct patients to never use a syringe to remove TOUJEO from the TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen.

PATIENT INFORMATION

How should I use TOUJEO?

In all instances, ‘disposable’ is replace with ‘single-patient-use’

Additions and/or revisions underlined:

  • TOUJEO is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).

  • Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.

    • Do not use the exact same spot for each injection.

    • Do not inject where the skin has pits, is thickened, or has lumps.

    • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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