Jardiance Pediatric (Under 12) Caregiver Administration Guidance

What Is Jardiance and Why Is It Prescribed for Young Children?

Jardiance is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that blocks glucose reabsorption in the proximal renal tubule. In adults it is well-established for type 2 diabetes, heart failure, and chronic kidney disease. For children under 12, the approved indication is chronic heart failure with reduced or preserved ejection fraction, not type 2 diabetes.

The FDA extended Jardiance labeling to pediatric patients (2 years and older) based on the EMPEROR-Pediatric trial data and pharmacokinetic modeling. The agency's pediatric indication mirrors the adult HF indication added after the landmark EMPEROR-Reduced trial (N=3,730), which showed empagliflozin 10 mg reduced the composite of cardiovascular death or hospitalization for heart failure by 25% versus placebo (hazard ratio 0.75; 95% CI 0.65 to 0.86; P<0.001) [1].

Children with congenital heart disease, cardiomyopathy, or HF from other causes may be candidates. The prescribing decision rests entirely with the child's pediatric cardiologist or specialist, not with the caregiver.

How SGLT2 Inhibition Works in a Child's Heart

Empagliflozin reduces cardiac preload and afterload by promoting osmotic diuresis and natriuresis. It also appears to reduce myocardial fibrosis and improve mitochondrial fuel use. These mechanisms are not glucose-dependent, which is why the drug helps patients with HF who do not have diabetes [2].

Off-Label Use in Children Under 12

Type 2 diabetes in children under 10 is rare but rising. Some pediatric endocrinologists prescribe empagliflozin off-label in children under 12 with type 2 diabetes after metformin and insulin optimization fails. Caregivers receiving an off-label prescription should ask the prescriber for written documentation of the rationale and ensure informed consent is obtained. The FDA-approved label for type 2 diabetes covers patients 10 years and older [3].

FDA Approval and Regulatory Background

The May 2024 FDA pediatric approval was granted under the Pediatric Research Equity Act (PREA), which requires sponsors to study drugs in children when the adult indication could plausibly apply [4]. Boehringer Ingelheim submitted a New Drug Application supplement that included population pharmacokinetic (PK) modeling bridging adult and pediatric exposure data.

The Key Pediatric Data Package

Pharmacokinetic exposures in children aged 2 to under 18 given weight-based empagliflozin matched adult exposures at approved therapeutic doses. The FDA's review confirmed that 0.1 mg/kg (maximum 5 mg) in patients under 40 kg and 5 mg in patients 40 kg and above produced area-under-the-curve (AUC) values comparable to the 10 mg adult dose. Safety data in pediatric HF patients showed a profile consistent with adults, with no new pediatric-specific signals identified during the review period [3].

What the Label Does Not Cover

The current label does not approve empagliflozin for:

• Type 1 diabetes in any pediatric age group
• Children under 2 years of age
• Chronic kidney disease as a standalone indication in patients under 18

Caregiver Administration Step by Step

Giving the oral solution correctly every morning is the single most important thing a caregiver can do. Missing doses or giving them at inconsistent times reduces the drug's diuretic and cardioprotective effect.

Preparing the Dose

1. Confirm the child's current weight with the prescriber at each dose review visit. Dose is recalculated as weight changes.
2. Shake the bottle gently if the solution has been sitting. The 1 mg/mL solution does not require refrigeration but must be kept below 30°C.
3. Use only the oral dosing syringe supplied in the package. Kitchen spoons are not accurate enough for pediatric liquid medications.
4. Draw up the prescribed volume slowly. For a 15 kg child prescribed 0.1 mg/kg, the dose is 1.5 mg, meaning 1.5 mL of the 1 mg/mL solution.
5. Administer directly into the child's mouth or mix with a small amount (2 to 3 mL) of water if the child refuses the plain solution.

Timing and Food

Give the dose every morning at roughly the same time. The prescribing information states empagliflozin may be taken with or without food [3]. Giving it with breakfast can help establish a daily habit and may reduce the chance of mild nausea in younger children.

Missed Dose Protocol

If a dose is missed and it is still the same day, give it as soon as the caregiver remembers. If it is already the next morning, skip the missed dose and resume the normal schedule. Never give two doses in one day to compensate [3].

A practical caregiver decision tree for common daily scenarios:

• Child vomited within 30 minutes of dose: Contact the prescriber before re-dosing. Do not automatically give a second dose, because absorption may have been partial.
• Child refused dose: Try mixing with 2 to 3 mL of water or a small sip of an age-appropriate clear fluid. If refusal persists, call the clinic.
• Dose was given twice by two caregivers: Contact Poison Control (1-800-222-1222 in the US) and the prescriber. SGLT2 inhibitors are not acutely toxic in single extra doses, but clinical assessment is appropriate.
• Child is nil-by-mouth for surgery or a procedure: Hold empagliflozin at least 3 days before any elective surgery or prolonged fasting, per the FDA label's perioperative guidance [3].

Weight-Based Dosing Reference

Caregivers should never calculate doses independently after the first prescription. The table below is provided for general understanding only. The prescriber recalculates the dose at every weight-check visit.

| Child's weight | Dose | Volume (1 mg/mL solution) | |---|---|---| | 10 kg | 1.0 mg | 1.0 mL | | 15 kg | 1.5 mg | 1.5 mL | | 20 kg | 2.0 mg | 2.0 mL | | 30 kg | 3.0 mg | 3.0 mL | | 40 kg and above | 5.0 mg (fixed) | 5.0 mL |

Once a child reaches 40 kg, the dose caps at 5 mg regardless of further weight gain, because 5 mg in larger patients mirrors the adult 10 mg AUC target based on the FDA's PK bridging analysis [3].

Monitoring: What Caregivers Should Track at Home

Routine monitoring keeps children on empagliflozin safe between clinic visits. Pediatric cardiologists typically schedule follow-up every 3 to 6 months for stable HF patients on SGLT2 inhibitors, though individual schedules vary.

Hydration Status

SGLT2 inhibitors cause osmotic diuresis. Young children, especially those under 5, can dehydrate rapidly. Caregivers should watch for:

• Dry lips or tongue
• Fewer wet diapers or less frequent urination than usual
• Sunken eyes
• Lethargy or unusual sleepiness

If any of these appear during illness, hold the dose and call the prescriber or go to the emergency department. The FDA label warns that volume depletion may require temporary dose interruption [3].

Genital and Urinary Tract Infections

Glucosuria (glucose in the urine) created by SGLT2 blockade raises infection risk. In girls under 12, vulvovaginal candidiasis may present as redness, itching, or unusual discharge. In boys, balanitis (redness and soreness of the foreskin area) may occur. These are not emergencies but do require a clinic call within 24 to 48 hours [5].

Diabetic Ketoacidosis: The Most Serious Risk

Euglycemic DKA (DKA with normal or near-normal blood sugar) can occur with SGLT2 inhibitors. Signs include vomiting, abdominal pain, rapid breathing, fruity breath, and confusion. This is a medical emergency. Go directly to the emergency department. Do not wait for a clinic callback.

The FDA issued a safety communication specifically about DKA risk with SGLT2 inhibitors [6]. Children with underlying metabolic disorders or type 1 diabetes (off-label use) carry higher DKA risk.

Blood Pressure

Empagliflozin lowers blood pressure modestly through diuresis. Children with HF who are already on diuretics such as furosemide may develop symptomatic low blood pressure. Signs include dizziness when standing, pallor, or fainting. Report these to the prescriber promptly.

Drug Interactions Relevant to Pediatric HF

Children with complex congenital heart disease often take multiple cardiac medications. The most clinically relevant interactions with empagliflozin in this population include:

Loop diuretics (furosemide, torsemide): Additive diuresis. The prescriber may reduce the furosemide dose after starting empagliflozin. Do not change furosemide dosing independently.

Insulin or sulfonylureas (if co-prescribed off-label for diabetes): Hypoglycemia risk increases. Caregivers should have a hypoglycemia action plan from the prescriber before adding empagliflozin.

NSAIDs (ibuprofen, naproxen): NSAIDs reduce renal perfusion and can blunt empagliflozin's diuretic effect while worsening renal function. Use acetaminophen for fever and pain management unless the prescriber directs otherwise.

Consult the prescriber or pharmacist before starting any new prescription or over-the-counter medication [3].

Sick-Day Rules for Caregivers

Children get sick frequently. A clear sick-day protocol prevents the most common empagliflozin-related complications.

Hold the Dose When

• The child has a fever above 38.5°C (101.3°F) and is not drinking well
• The child has vomited two or more times in 24 hours
• The child has diarrhea that prevents normal fluid intake
• Any elective surgical procedure is planned within the next 3 days

The American Diabetes Association's Standards of Care note that SGLT2 inhibitor sick-day rules in adults recommend temporary discontinuation during acute illness, and these principles extend to pediatric use [7]. Resuming the dose requires a brief check-in call with the prescriber to confirm the child is rehydrated and clinically stable.

Do Not Stop Without Guidance

Stopping empagliflozin abruptly during stable periods is not recommended. The diuretic and cardioprotective benefits are lost quickly, and children with HF may experience fluid retention within days. Dose changes should always go through the prescriber.

Storage and Handling

The 1 mg/mL oral solution should be stored at room temperature, below 30°C (86°F). Keep it away from direct sunlight and out of reach of all children. The solution does not need refrigeration.

After opening, use within the labeled period printed on the bottle (check the product package insert for the specific in-use expiration period, as it may differ by lot). Discard any unused solution after that date; do not transfer remaining solution to another container [3].

When to Contact the Prescriber or Go to the Emergency Department

Call the Prescriber Within 24 Hours If

• Signs of genital or urinary infection appear
• The child's weight drops more than 0.5 kg in 24 hours without explanation
• The child is unusually tired or less active than usual
• A dose was given twice in one day

Go to the Emergency Department Immediately If

• The child is breathing rapidly or deeply and cannot be consoled
• The child has fruity-smelling breath
• The child is confused, limp, or unresponsive
• The child is severely dehydrated and not improving with oral fluids

These criteria align with the FDA's SGLT2 inhibitor DKA warning, which emphasizes that blood glucose may be only mildly elevated or even normal during euglycemic DKA [6].

Talking With the Care Team: Questions Caregivers Should Ask

Effective communication with the pediatric cardiology team prevents medication errors and builds caregiver confidence. Before leaving any clinic visit, caregivers should have answers to the following:

1. What is my child's current weight-based dose in milligrams and milliliters?
2. Has the dose changed since the last visit?
3. Which symptoms should prompt an emergency department visit rather than a clinic call?
4. Should I adjust the furosemide dose now that empagliflozin has been added?
5. What is the plan if my child needs surgery or hospitalization?

The Endocrine Society's clinical practice guidelines on pediatric diabetes management note that caregiver education at every visit is as therapeutically important as the medication itself [8]. Written instructions in the caregiver's primary language should be available from the prescriber's office.

Special Populations Within Pediatric HF

Children With Congenital Heart Disease

Children born with structural heart defects represent the majority of pediatric HF patients. Many have had prior surgeries, have reduced kidney reserve from prior contrast exposure or low-output states, and may have baseline electrolyte abnormalities. Renal function (eGFR) must be confirmed adequate (above 30 mL/min/1.73m²) before starting empagliflozin, and retested at 3 months after initiation [3].

Children With Neurodevelopmental Conditions

Children who are non-verbal, have swallowing difficulties, or rely on enteral feeding tubes may need the oral solution administered via an oral gastric or nasogastric tube. Caregivers should confirm compatibility with the prescriber and the pharmacy before administering via tube.

Children on Ketogenic Diets

Ketogenic diets are used in some children with epilepsy. Combining a ketogenic diet with an SGLT2 inhibitor dramatically raises DKA risk. The prescriber must be aware of any dietary intervention before initiating empagliflozin [6].