Medical Editor: John P. Cunha, DO, FACOEP
What Is Zegalogue?
Zegalogue (dasiglucagon) is an antihypoglycemic agent used to treat severe low blood sugar (hypoglycemia) in pediatric and adult patients with diabetes aged 6 years and above.
What Are Side Effects of Zegalogue?
Zegalogue may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- fast or slow heartbeat,
- severe headache,
- blurred vision,
- pounding in your neck or ears,
- hunger,
- sweating,
- irritability,
- dizziness,
- anxiety, and
- shakiness
Get medical help right away, if you have any of the symptoms listed above.
Side effects of Zegalogue include:
- nausea,
- vomiting,
- headache,
- diarrhea, and
- injection site pain
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Zegalogue
The dose of Zegalogue in adults and pediatric patients aged 6 years and older is 0.6 mg.
Zegalogue In Children
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.
The safety and effectiveness of Zegalogue have not been established in pediatric patients younger than 6 years of age.
What Drugs, Substances, or Supplements Interact with Zegalogue?
Zegalogue may interact with other medicines such as:
- beta-blockers,
- indomethacin, and
- warfarin
Tell your doctor all medications and supplements you use.
Zegalogue During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Zegalogue; it is unknown how it would affect a fetus. It is unknown if Zegalogue passes into breast milk. Zegalogue is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is unlikely to cause harm to an exposed infant. Consult your doctor before breastfeeding.
Additional Information
Our Zegalogue (dasiglucagon) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Type 1 Diabetes: What Are The Symptoms? See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; difficulty breathing; fast or slow heartbeat; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe headache, blurred vision, pounding in your neck or ears; or
- new or ongoing low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky.
Common side effects may include:
- nausea, vomiting, diarrhea;
- headache;
- pain where an injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Diabetes is defined best as... See AnswerSIDE EFFECTS
The following important adverse reactions are described elsewhere in the labeling:
- Hypersensitivity and Allergic Reactions [see WARNINGS AND PRECAUTIONS]
Clinical 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 placebocontrolled 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].
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.
Immunogenicity
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].
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. |
Read the entire FDA prescribing information for Zegalogue (Dasiglucagon Injection)
© Zegalogue Patient Information is supplied by Cerner Multum, Inc. and Zegalogue Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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