Zegalogue dasiglucagon .6 mg/.6mL Injection, Solution, 1 syringe
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antihypoglycemic Agent class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Dasiglucagon injection is used along with emergency medical treatment to treat severe hypoglycemia (very low blood sugar) in adults and children 6 years of age and older with diabetes. Dasiglucagon injection is in a class of medications called glucagon receptor agonists. It works by causing the liver to release stored sugar to the blood.
Read the full MedlinePlus article ↗- No, Zegalogue is not a daily diabetes medicine. It's an emergency injection you keep on hand in case you — or your child — has a severe low blood sugar episode and can't safely eat...
- What is Zegalogue actually for? Is it something I take every day?
- Zegalogue comes as either an autoinjector or a prefilled syringe, and it's given as a shot just under the skin. You can inject it into the outer thigh, lower abdomen, buttocks, or...
- How do I — or someone with me — actually give this injection?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dasiglucagon Hydrochloride — tap one for details:
Dasiglucagon Hydrochloride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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6.44 mg / 0.6 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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3.82 mg / 0.6 mL
UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $493.896 | $296.34 / 0.6 ml |
| Medicaid paysCMS SDUD · 12 mo | $500.65 | $300.39 / 0.6 ml |
| Medicare drug plans payPart D · Q2 2026 | $506.76 | $304.06 / 0.6 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Zegalogue .6 mg/.6mLthis 00169-1912-01 | Novo | 1 syringe | $493.896 | — | Availability likely | — |
| Zegalogue .6 mg/.6mL 00169-1913-01 | Novo | 1 syringe | $494.052 | — | Availability likely | +0% |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11795204 ↗ | Method of use | U-3752 | Jan 6, 2034 |
| US 11795204 ↗ | Method of use | U-3752 | Jan 6, 2034 |
| US 10442847 ↗ | Drug substance | — | Mar 22, 2035 |
| US 10442847 ↗ | Drug substance | — | Mar 22, 2035 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Mar 22, 2026 |
| NPP | New Patient Population | Jun 18, 2029 |
| NCE | New Chemical Entity (5-year) | Mar 22, 2026 |
| NPP | New Patient Population | Jun 18, 2029 |
Is there a generic version of ZEGALOGUE 0.6 MG/0.6ML AUTOINJ?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00169-1912-01 You're viewing this | 1 CONTAINER in 1 PACKAGE (0169-1912-01) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS | $493.90 / mL | $296.34 | 2023-06-26 | Active |
| 00169-1912-02 | 2 PACKAGE in 1 CARTON (0169-1912-02) / 1 CONTAINER in 1 PACKAGE (0169-1912-12) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS | $492.83 / mL | $591.40 | 2023-06-26 | Active |
This pack effectively ties for the lowest per-mL cost of the 2 priced pack sizes ($493.90 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00169-1912-01?
What NDC number is used to bill for this package of Zegalogue dasiglucagon .6 mg/.6mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ZEGALOGUE ® is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. ZEGALOGUE is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only. ( 2.1 ) • The dose in adults and pediatric patients aged 6 years and older is 0.6 mg. ( 2.2 ) • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
( 2.1 ) • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
( 2.1 ) • Administer the injection into the lower abdomen, buttocks, thigh, or outer upper arm. ( 2.1 ) • Call for emergency assistance immediately after administering the dose. ( 2.1 ) • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE from a new device may be administered while waiting for emergency assistance.
( 2.1 ) • When the patient has responded to treatment, give oral carbohydrates. ( 2.1 ) • Do not attempt to reuse ZEGALOGUE. Each device contains a single dose of dasiglucagon and cannot be reused.
( 2.1 )
2.1Administration Instructions ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use.
Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized. Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver: • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use. • Visually inspect ZEGALOGUE prior to administration.
The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use. • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm. • Call for emergency assistance immediately after administering the dose. • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance. • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia. • Do not attempt to reuse ZEGALOGUE.
Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
2.2Recommended Dosage The recommended dose of ZEGALOGUE in adults and pediatric patients aged 6 years and older is 0.6 mg administered by subcutaneous injection into the lower abdomen, buttocks, thigh, or outer upper arm. If there has been no response after 15 minutes, an additional 0.6 mg dose of ZEGALOGUE from a new device may be administered.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS ZEGALOGUE injection is a clear, colorless solution available as: • 0.6 mg/0.6 mL single-dose autoinjector • 0.6 mg/0.6 mL single-dose prefilled syringe Injection: • 0.6 mg/0.6 mL single-dose autoinjector ( 3 ) • 0.6 mg/0.6 mL single-dose prefilled syringe ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS ZEGALOGUE is contraindicated in patients with: • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1) ] • Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2) ] Pheochromocytoma ( 4 ) Insulinoma ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because ZEGALOGUE may stimulate the release of catecholamines from the tumor. ( 4 , 5.1 ) • Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose, but ZEGALOGUE may stimulate exaggerated insulin release from an insulinoma and cause subsequent hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously.
( 4 , 5.2 ) • Hypersensitivity and Allergic Reactions: Allergic reactions have been reported with glucagon products and may include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. ( 5.3 ) • Lack of Efficacy in Patients with Decreased Hepatic Glycogen: ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE to be effective.
Patients with these conditions should be treated with glucose. ( 5.4 )
5.1Substantial Increase in Blood Pressure in Patients with Pheochromocytoma ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor [see Contraindications (4) ] . If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.
5.2Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon products may produce an initial increase in blood glucose; however, ZEGALOGUE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. ZEGALOGUE is contraindicated in patients with insulinoma [see Contraindications (4) ] . If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously.
5.3Hypersensitivity and Allergic Reactions Allergic reactions have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.
5.4Lack of Efficacy in Patients with Decreased Hepatic Glycogen ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE administration to be effective. Patients with these conditions should be treated with glucose.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: • Hypersensitivity and Allergic Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥2%) associated with ZEGALOGUE are: Adults: nausea, vomiting, headache, diarrhea, and injection site pain Pediatrics: nausea, vomiting, headache, and injection site pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-800-727-6500 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 ZEGALOGUE cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 316 adult patients with type 1 diabetes and 20 pediatric patients with type 1 diabetes were exposed to ZEGALOGUE. The data in Table 1 reflect exposure of 116 adult patients to ZEGALOGUE in 2 placebo-controlled trials (mean age 40 years).
Table 2 reflects exposure of 20 pediatric patients exposed to ZEGALOGUE in a placebo-controlled trial. Eight patients were 7 to 11 years old, and 12 were 12 to 17 years old [see Clinical Studies (14) ] . Table 1.
Adverse Reactions Occurring ≥2% and More Frequently than with Placebo in ZEGALOGUE-treated Adult Patients within 12 hours of Treatment in 2 Placebo-Controlled Trials Adverse reaction type Placebo (N=53) Dasiglucagon (N=116) % of Patients % of Patients Nausea 4% 57% Vomiting 2% 25% Headache 4% 11% Diarrhea 0% 5% Injection site pain 0% 2% Table 2. Adverse Reactions Occurring ≥2% and More Frequently than with Placebo in ZEGALOGUE-treated Pediatric Patients within 12 hours of Treatment in a Placebo-Controlled Trial Adverse reaction type Placebo (N=11) Dasiglucagon Age 6-11 years (N=8) Dasiglucagon Age 12-17 years (N=12) Dasiglucagon All (N=20) % of Patients % of Patients % of Patients % of Patients Nausea 0% 25% 92% 65% Vomiting 0% 25% 67% 50% Headache 0% 0% 17% 10% Injection site pain 0% 0% 8% 5% Other Adverse Reactions Other adverse reactions in patients treated with dasiglucagon occurring within 12 hours of treatment include: hypertension, hypotension, bradycardia, presyncope, palpitations, and orthostatic intolerance.
6.2Immunogenicity As with all therapeutic peptides, there is a potential for immunogenicity with ZEGALOGUE. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, comparison of the incidence of antibodies to ZEGALOGUE with the incidence of antibodies to other products may be misleading. In clinical trials, 4/498 (<1%) of ZEGALOGUE-treated patients developed treatment-emergent anti-drug antibodies (ADAs). Two patients receiving a single dose of ZEGALOGUE had detectable ADAs to dasiglucagon for at least 14 months after dosing.
One ADA-positive patient receiving multiple doses of ZEGALOGUE had ADAs with transient neutralizing activity and with cross-reactivity against native glucagon. Although no safety or efficacy concerns were noted for these ADA-positive subjects, it is unknown whether ADAs may affect pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of the drug [see Clinical Studies (14) ] .
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 3. Clinically Significant Drug Interactions with ZEGALOGUE Beta-Blockers Clinical Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given ZEGALOGUE. Indomethacin Clinical Impact: In patients taking indomethacin, ZEGALOGUE may lose its ability to raise blood glucose or may even produce hypoglycemia.
Warfarin Clinical Impact: ZEGALOGUE may increase the anticoagulant effect of warfarin. • Beta-blockers: Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7 ) • Indomethacin: In patients taking indomethacin, ZEGALOGUE may lose its ability to raise blood glucose or may produce hypoglycemia. ( 7 ) • Warfarin: ZEGALOGUE may increase the anticoagulant effect of warfarin.
( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on dasiglucagon use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Untreated hypoglycemia in pregnancy can cause complications and may be fatal. In animal reproduction studies, daily subcutaneous administration of dasiglucagon to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at exposures 7 and 709 times the human dose of 0.6 mg based on AUC, respectively (see Data ) .
Data Animal Data In an embryo-fetal development study, pregnant rats were treated daily with subcutaneous doses of 2, 10, and 24 mg/kg/day during the period of organogenesis (gestation day 6 to 17). Maternal toxicity, in terms of decreased body weight gain, lower fetal body weight, and delayed bone ossification, was observed at ≥10 mg/kg/day (≥475 times the human dose, based on AUC). In an embryo-fetal development study, pregnant rabbits were treated daily with subcutaneous doses of 0.1, 0.3, and 1 mg/kg/day during the period of organogenesis (gestation day 6 to 19).
Lower fetal body weight and delayed bone ossification were observed at 1 mg/kg/day (100 times the human dose, based on AUC), a dose that also induced maternal toxicity in terms of decreased body weight gain. At ≥0.3 mg/kg/day (≥20 times the human dose), dasiglucagon caused fetal skeletal and visceral malformations. No adverse fetal developmental effects were observed at 0.1 mg/kg/day, corresponding to exposure 7 times the human dose.
8.2Lactation Risk Summary There is no information on the presence of dasiglucagon in either human or animal milk, or the effects of the drug on the breastfed infant or milk production. Dasiglucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore unlikely to cause harm to an exposed infant.
8.4Pediatric Use The safety and effectiveness of ZEGALOGUE for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 6 years and above. Use of ZEGALOGUE for this indication is supported by evidence from a study in 42 pediatric patients with type 1 diabetes [see Clinical Studies (14.2) ] . The safety and effectiveness of ZEGALOGUE have not been established in pediatric patients younger than 6 years of age.
8.5Geriatric Use Clinical studies of ZEGALOGUE included too few patients 65 years of age and older to determine whether these patients respond differently from younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on dasiglucagon use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Untreated hypoglycemia in pregnancy can cause complications and may be fatal. In animal reproduction studies, daily subcutaneous administration of dasiglucagon to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at exposures 7 and 709 times the human dose of 0.6 mg based on AUC, respectively (see Data ) .
Data Animal Data In an embryo-fetal development study, pregnant rats were treated daily with subcutaneous doses of 2, 10, and 24 mg/kg/day during the period of organogenesis (gestation day 6 to 17). Maternal toxicity, in terms of decreased body weight gain, lower fetal body weight, and delayed bone ossification, was observed at ≥10 mg/kg/day (≥475 times the human dose, based on AUC). In an embryo-fetal development study, pregnant rabbits were treated daily with subcutaneous doses of 0.1, 0.3, and 1 mg/kg/day during the period of organogenesis (gestation day 6 to 19).
Lower fetal body weight and delayed bone ossification were observed at 1 mg/kg/day (100 times the human dose, based on AUC), a dose that also induced maternal toxicity in terms of decreased body weight gain. At ≥0.3 mg/kg/day (≥20 times the human dose), dasiglucagon caused fetal skeletal and visceral malformations. No adverse fetal developmental effects were observed at 0.1 mg/kg/day, corresponding to exposure 7 times the human dose.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ZEGALOGUE for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 6 years and above. Use of ZEGALOGUE for this indication is supported by evidence from a study in 42 pediatric patients with type 1 diabetes [see Clinical Studies (14.2) ] . The safety and effectiveness of ZEGALOGUE have not been established in pediatric patients younger than 6 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of ZEGALOGUE included too few patients 65 years of age and older to determine whether these patients respond differently from younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, and/or increases in blood pressure and heart rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a marked increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.
Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dasiglucagon is a glucagon receptor agonist, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for dasiglucagon to produce an antihypoglycemic effect.
12.2Pharmacodynamics After administration of ZEGALOGUE in adult patients with type 1 diabetes, the mean glucose increase from baseline at 90 minutes was 168 mg/dL (Figure 1). Figure 1. Mean plasma glucose over time in adults with type 1 diabetes administered 0.6 mg dasiglucagon In pediatric patients (7 to 17 years) with type 1 diabetes, the mean glucose increase at 60 minutes after administration of ZEGALOGUE was 162 mg/dL (Figure 2).
Figure 2. Mean plasma glucose over time in pediatric patients with type 1 diabetes administered 0.6 mg dasiglucagon Cardiac Electrophysiology At a dose resulting in more than 5 times the concentration achieved with the recommended therapeutic dose, ZEGALOGUE does not prolong the QT interval to any clinically relevant extent. Figure 1 Figure 2
12.3Pharmacokinetics Absorption ZEGALOGUE absorption following subcutaneous injection of 0.6 mg resulted in a mean peak plasma concentration of 5110 pg/mL (1510 pmol/L) at around 35 minutes. Distribution The mean apparent volume of distribution was 47 L to 57 L following subcutaneous administration. Elimination The half-life was approximately 30 minutes.
Metabolism Metabolism data indicated that dasiglucagon is cleared like native glucagon through proteolytic degradation pathways in blood, liver, and kidney. Specific Populations After administration of ZEGALOGUE in pediatric patients with type 1 diabetes, the mean peak plasma concentration of 3920 pg/mL occurred at around 21 minutes.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dasiglucagon is a glucagon receptor agonist, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for dasiglucagon to produce an antihypoglycemic effect.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied ZEGALOGUE injection is a clear, colorless solution supplied as follows: Presentation Strength Package Size NDC Single-dose autoinjector 0.6 mg/0.6 mL 1 0169-1912-01 Single-dose autoinjector 0.6 mg/0.6 mL 2 0169-1912-02 Single-dose prefilled syringe 0.6 mg/0.6 mL 1 0169-1913-01 Single-dose prefilled syringe 0.6 mg/0.6 mL 2 0169-1913-02
16.2Recommended Storage Store ZEGALOGUE in a refrigerator, 2°C to 8°C (36°F to 46°F). Keep away from the cooling element. Do not freeze.
ZEGALOGUE can be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 12 months. Record the date when the product was removed from the refrigerator in the space provided on the protective case. Do not return the product to the refrigerator after storing at room temperature.
Store in the provided protective case and protect from light. Discard ZEGALOGUE after the end of the 12-month period at room temperature storage, or after the expiration date stated on the product, whichever occurs first. The inside of the gray cap on ZEGALOGUE autoinjector contains dry natural rubber (a derivative of latex).
The inside of the gray needle cover on ZEGALOGUE prefilled syringe contains dry natural rubber (a derivative of latex).
📦 Storage and Handling ▾
16.2Recommended Storage Store ZEGALOGUE in a refrigerator, 2°C to 8°C (36°F to 46°F). Keep away from the cooling element. Do not freeze.
ZEGALOGUE can be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 12 months. Record the date when the product was removed from the refrigerator in the space provided on the protective case. Do not return the product to the refrigerator after storing at room temperature.
Store in the provided protective case and protect from light. Discard ZEGALOGUE after the end of the 12-month period at room temperature storage, or after the expiration date stated on the product, whichever occurs first. The inside of the gray cap on ZEGALOGUE autoinjector contains dry natural rubber (a derivative of latex).
The inside of the gray needle cover on ZEGALOGUE prefilled syringe contains dry natural rubber (a derivative of latex).
📋 Description ▾
11 DESCRIPTION ZEGALOGUE contains dasiglucagon hydrochloride, which is a glucagon analog and an antihypoglycemic agent. Dasiglucagon is comprised of 29 amino acids. The molecular formula of dasiglucagon (anhydrous, free-base) is C 152 H 222 N 38 O 50 , and its molecular mass is 3382 g/mol (anhydrous, free-base).
Dasiglucagon hydrochloride has the following chemical structure: ZEGALOGUE injection is a preservative free, sterile, aqueous, clear, and colorless solution for subcutaneous use in a single-dose prefilled syringe and an autoinjector. Each prefilled syringe and autoinjector contains 0.63 mg of dasiglucagon provided as dasiglucagon hydrochloride, which is a salt with 3 - 5 equivalents of hydrochloride, and contains the following inactive ingredients: 3.82 mg tromethamine, 6.44 mg sodium chloride, and water for injection.
Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 6.5. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions For Use). Recognition of Severe Hypoglycemia Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia. Administration Review the Patient Information and Instructions For Use with the patient and family members or caregivers.
Serious Hypersensitivity Inform patients that allergic reactions can occur with glucagon products like ZEGALOGUE. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3) ].