Farxiga Adolescent (12 to 17) Transition to Adult Care

What the FDA Has Approved for Adolescent Dapagliflozin Use

The FDA extended dapagliflozin approval to patients aged 10 and older in both type 1 and type 2 diabetes. For adolescents between 12 and 17, the labeled dose is 5 mg once daily taken in the morning, with or without food. The 10 mg dose is not routinely used in this age group for T2D and is not indicated for T1D at any age as a standalone agent.

T1D vs. T2D Labeling Differences

In type 1 diabetes, dapagliflozin is approved as an adjunct to insulin only. The FDA label carries a boxed warning about diabetic ketoacidosis (DKA), which occurs at a higher rate in T1D patients regardless of age. The FDA prescribing information for Farxiga states that dapagliflozin should be held at least three days before any planned surgery or prolonged fasting.

In type 2 diabetes, dapagliflozin can be used as monotherapy or in combination with other agents. Adolescents with T2D who are already on metformin may add dapagliflozin 5 mg once daily per the 2024 ADA Standards of Care, which recommends SGLT2 inhibitors as a second-line agent when HbA1c remains above target on metformin alone. The ADA Standards of Medical Care in Diabetes 2024 provides specific pediatric guidance beginning on page S258.

Key Trial Data Supporting Adolescent Use

The DEPICT-1 trial (N=833, ages 6 to 17) randomized patients with type 1 diabetes to dapagliflozin 5 mg, dapagliflozin 10 mg, or placebo, all on background insulin therapy, for 24 weeks. Dapagliflozin 5 mg produced a placebo-corrected HbA1c reduction of 0.42% (P<0.001) and a 9.1% reduction in total daily insulin dose. DEPICT-1 results are published in The Lancet Diabetes and Endocrinology. Time in range improved by 1.26 hours per day in the 5 mg arm compared to placebo.

For type 2 diabetes in adolescents, a dedicated AstraZeneca pediatric study (NCT02725593) showed that dapagliflozin 5 mg reduced HbA1c by 0.85% versus 0.06% with placebo at 26 weeks. This study is indexed on PubMed.

Why the Transition Period Is a High-Risk Window

Transfer from pediatric to adult diabetes care consistently produces measurable glycemic deterioration. A systematic review published in Diabetic Medicine (N=1,482 young adults followed across seven studies) found that HbA1c rose by a mean of 0.7% in the 12 months following transfer. That review is available through PubMed. The risk is not uniform. Patients who had no adult provider identified at the time of transfer showed the steepest rise.

What Drives Deterioration

Several factors converge at age 17 to 19. Insurance coverage may lapse when a parent's employer-sponsored plan reaches the dependent age limit, though the Affordable Care Act extended dependent coverage to age 26 for most plans. Patients gain autonomy over their own prescriptions for the first time, often without a structured handoff of the medication management skills their pediatric team handled. Pill burden, out-of-pocket cost, and the logistical challenge of establishing with a new adult endocrinologist all compound this risk.

Dapagliflozin requires a specific set of sick-day behaviors that must be explicitly re-taught during transition. Because SGLT2 inhibitors can mask hyperglycemia by lowering glucose osmotically through urine, a patient who stops checking ketones during illness may develop euglycemic DKA. A 2020 analysis in Diabetes Care found that euglycemic DKA accounted for approximately 40% of DKA events in T1D patients on SGLT2 inhibitors.

The Six-to-Twelve Month Dropout Zone

Most missed appointments and prescription lapses cluster in the six to twelve months after the first adult visit. Pediatric centers typically schedule quarterly visits; adult practices often default to semiannual scheduling for stable patients. The result is a gap in clinical oversight that coincides with the period when patients are least familiar with their new providers.

A structured transition framework for dapagliflozin-treated adolescents should include these checkpoints:

• Age 12 to 14: Introduce transition vocabulary. Confirm the patient can name their medications and doses.
• Age 15 to 16: Transfer prescription management to the patient. Verify they can request refills independently and know the pharmacy contact.
• Age 16 to 17: Identify the target adult endocrinologist or internist with diabetes experience. Conduct at least one joint or overlapping visit if possible.
• Age 17 to 18: Complete a formal medication reconciliation. Review the FDA label change from 5 mg to the option of 10 mg for T2D after age 18. Confirm sick-day rules are understood in writing.
• Post-transfer (months 1 to 6): Schedule a check-in call or telehealth visit at 6 weeks post-transfer to confirm the prescription has been filled and the next adult appointment is on the calendar.

Dosing Adjustments at the Transition to Adulthood

Adolescents on dapagliflozin 5 mg for T2D may be eligible for the 10 mg dose after turning 18, per the FDA-labeled adult indication. This dose increase is not automatic and should be based on glycemic control, tolerability, and renal function at the time of transition.

Renal Function Monitoring

Dapagliflozin's glucose-lowering mechanism depends on adequate renal filtration. The drug should not be initiated or continued if eGFR falls below 45 mL/min/1.73 m² for its glucose-lowering indication. The FDA label notes that cardiorenal benefits may persist at lower eGFR thresholds per DAPA-CKD trial data, but adolescent patients are rarely on dapagliflozin for those indications. At transition, a renal panel should confirm eGFR is appropriate before continuing or escalating the dose.

Body Weight and Volume Status

SGLT2 inhibitors produce a modest osmotic diuresis. Adolescents with lower body mass may experience more pronounced volume depletion, particularly during summer heat or periods of increased physical activity. The adult provider should be alerted to any documented episodes of dizziness or syncope during the adolescent years, as these may indicate a need for hydration counseling rather than dose reduction.

Insulin Dose Adjustment in T1D

Adolescents with T1D who transition to adult care while on dapagliflozin plus insulin should have their total daily insulin dose documented at handoff. DEPICT-1 showed a 9.1% reduction in total daily insulin in the 5 mg arm. If the adult provider is unfamiliar with this interaction and increases insulin without accounting for the SGLT2 effect, hypoglycemia risk rises. The DEPICT-2 trial (N=813) confirmed similar insulin-sparing results at 52 weeks.

DKA Risk Management Across the Transition

Diabetic ketoacidosis prevention is the most operationally complex part of transitioning a dapagliflozin-treated adolescent. The pediatric team has typically established sick-day protocols over years. The adult team receives a summary document, at best.

Sick-Day Rules That Must Transfer

Every dapagliflozin-treated patient with T1D should be able to state these rules without prompting before leaving pediatric care:

• Hold dapagliflozin when unable to eat or drink normally for more than four hours.
• Check blood or urine ketones whenever blood glucose exceeds 250 mg/dL, even if feeling well.
• Hold dapagliflozin at least 72 hours before elective surgery or any procedure requiring general anesthesia.
• Contact the diabetes team immediately if ketones are moderate or higher, regardless of blood glucose level.

The Endocrine Society clinical practice guideline on SGLT2 inhibitor use in T1D states: "Patients and caregivers must receive structured education on DKA recognition and sick-day management before initiating SGLT2 inhibitor therapy and this education must be repeated at every transition of care."

Ketone Monitoring Tools

Point-of-care blood ketone meters (measuring beta-hydroxybutyrate) are more sensitive than urine ketone strips for detecting early euglycemic DKA. The adult provider should confirm that the patient owns a blood ketone meter or has access to one through their pharmacy benefit. A beta-hydroxybutyrate level above 1.0 mmol/L in a patient on an SGLT2 inhibitor warrants same-day clinical evaluation.

Insurance, Access, and Cost Considerations

Dapagliflozin carries a list price above $500 per month for a 30-day supply in the United States. For adolescents aging off a parent's pediatric insurance plan, coverage gaps can produce a complete medication lapse. A 2022 study in JAMA Internal Medicine found that approximately 28% of young adults aged 18 to 26 with chronic conditions experienced at least one insurance gap in the two years following their 18th birthday.

Manufacturer Assistance Programs

AstraZeneca offers a savings card program for commercially insured patients that may reduce the out-of-pocket cost of Farxiga to as low as $10 per month. Medicaid eligibility must be explored for patients who lose private coverage. The adult provider should confirm prescription coverage status at the first visit and have a social worker or care coordinator contact available for patients who report difficulty affording the medication.

Generic Availability

As of July 2025, no FDA-approved generic dapagliflozin is available in the United States. The adult provider and patient should be aware that switching to a formulary-preferred SGLT2 inhibitor such as empagliflozin or canagliflozin is not automatically equivalent from a labeling or indication standpoint, particularly in T1D where dapagliflozin holds the only FDA approval in the 10-and-older age group.

Coordinating the Clinical Handoff

A complete clinical handoff document for a dapagliflozin-treated adolescent should include the following specific elements.

What the Pediatric Team Should Send

• Current dapagliflozin dose, start date, and any dose adjustments made during treatment
• Most recent HbA1c with date (ideally within the past three months)
• Most recent eGFR and urine albumin-to-creatinine ratio
• Documented history of any DKA events while on dapagliflozin, including glucose level at presentation to identify euglycemic events
• Total daily insulin dose at time of transfer (for T1D patients)
• Record of sick-day education completion, with the date it was last reviewed

What the Adult Team Should Do at the First Visit

The first adult visit should not be used solely for relationship building. It is a clinical safety check. The American Diabetes Association's 2024 Standards of Care recommends that transition planning begin at age 12 to 14 and include explicit readiness assessment tools. The adult provider should verify that the patient received this assessment and review its findings.

At minimum, the adult provider should:

• Confirm current dapagliflozin dose and reconcile against the transfer document
• Order a renal function panel if one was not completed in the past three months
• Ask the patient to demonstrate, verbally, what they do when they feel sick while on dapagliflozin
• Schedule the follow-up appointment before the patient leaves the office, targeting six to eight weeks post-transfer rather than the standard three to six months

The Role of Telehealth

Telehealth visits reduce the logistical friction of the transition period. A brief video check-in at four to six weeks post-transfer can confirm prescription fill, identify early cost barriers, and review any symptoms without requiring the patient to take time off school or work. A 2021 review in The Lancet Digital Health found that structured telehealth follow-up in young adults with type 1 diabetes reduced HbA1c by 0.35% compared to standard care over 12 months.

Special Populations Within the 12 to 17 Age Group

Not all adolescents transition at the same pace or under the same clinical conditions.

Adolescents With Both T1D and Mental Health Conditions

Approximately 30% of adolescents with T1D meet criteria for a depressive or anxiety disorder, per a meta-analysis in Diabetes Care (N=12,405). That meta-analysis is indexed on PubMed. Depression is independently associated with worse glycemic control and higher rates of medication non-adherence. The adult provider should screen for depression at the first transition visit using a validated tool such as the PHQ-9 and refer for behavioral health support when indicated.

Adolescents With Obesity and T2D

Dapagliflozin produces modest weight reduction. In adult T2D trials such as DECLARE-TIMI 58 (N=17,160), dapagliflozin produced approximately 2.0 kg weight loss at two years compared to placebo. DECLARE-TIMI 58 is published in the New England Journal of Medicine. Adolescents with T2D and obesity may be on concurrent GLP-1 receptor agonist therapy. The adult provider should document the full medication list and assess for potential additive volume depletion effects.

Patients From Low-Income Households

Out-of-pocket cost is a stronger predictor of medication adherence than clinical efficacy in this demographic. The adult team should proactively connect these patients with pharmaceutical patient assistance programs, state Medicaid programs, and federally qualified health center resources at the time of transfer, not after a missed refill is identified.