Adlyxin

Adlyxin Side Effects Center

What Is Adlyxin?

Adlyxin (lixisenatide) Injection, for subcutaneous use acts as a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

What Are Side Effects of Adlyxin?

Common side effects of Adlyxin include

nausea,
vomiting,
headache,
diarrhea,
dizziness,
indigestion,
constipation,
abdominal distention,
abdominal pain,
injection site reactions (pain, itching, redness),
hypoglycemia (low blood sugar – symptoms include headache, dizziness, drowsiness, confusion, weakness, irritability, hunger, sweating, fast heartbeat, feeling jittery), and
severe allergic reaction (anaphylaxis).

Dosage for Adlyxin

The starting dose of Adlyxin is 10 mcg subcutaneously once daily for 14 days. Increase the dose to the maintenance dose of 20 mcg once daily starting on Day 15.

What Drugs, Substances, or Supplements Interact with Adlyxin?

Adlyxin may interact with any oral medications as it may slow the rate of absorption (such as antibiotics, acetaminophen, oral contraceptives), sulfonylurea, or basal insulin. Tell your doctor all medications and supplements you use.

Adlyxin During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or intend to become pregnant while using Adlyxin. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. It is unknown if Adlyxin passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Adlyxin (lixisenatide) 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.

Adlyxin Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, severe rash; rapid heartbeats; trouble swallowing; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky; or
kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

nausea, vomiting, diarrhea;
headache;
dizziness; or
low blood sugar.

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.

Read the entire detailed patient monograph for Adlyxin (Lixisenatide Injection)

Adlyxin Professional Information

SIDE EFFECTS

The following serious reactions are described below or elsewhere in the prescribing information:

Anaphylaxis and Serious Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Pancreatitis [see WARNINGS AND PRECAUTIONS]
Hypoglycemia with Concomitant Use of Sulfonylurea or Basal Insulin [see WARNINGS AND PRECAUTIONS]
Renal Failure [see WARNINGS AND PRECAUTIONS]
Immunogenicity [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 a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pool Of Placebo-Controlled Trials

The data in Table 1 are derived from the placebo-controlled trials [see Clinical Studies].

These data reflect exposure of 2869 patients to ADLYXIN and a mean duration of exposure to ADLYXIN of 21.7 weeks. Across the treatment arms, the mean age of patients was 56.1 years, 2.3% were 75 years or older and 48.2% were male. The population in these studies was 63.7% White, 2.6% Black or African American, 32.0% Asian; 18.9% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 8.1%. At baseline, 11.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 mL/min/1.73 m²) in 95.3% of the pooled study populations.

Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of ADLYXIN in the pool of placebo-controlled trials. These adverse reactions were not present at baseline, occurred more commonly on ADLYXIN than on placebo, and occurred in at least 5% of patients treated with ADLYXIN.

Table 1: Adverse Reactions Reported in ≥5% of ADLYXIN-Treated Patients with Type 2 Diabetes Mellitus and Occurring More Frequently Compared to Placebo

Adverse reaction	Placebo (N=1639)	ADLYXIN (N=2869)
Nausea	6%	25%
Vomiting	2%	10%
Headache	6%	9%
Diarrhea	6%	8%
Dizziness	4%	7%
*hypoglycemia is discussed separately

Gastrointestinal Adverse Reactions

In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving ADLYXIN than placebo (placebo 18.4%, ADLYXIN 39.7%). More patients receiving ADLYXIN (4.3%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.5%). Investigators graded the severity of gastrointestinal adverse reactions occurring on ADLYXIN as “mild” in 64.2% of cases, “moderate” in 32.3% of cases, or “severe” in 3.5% of cases. The majority of these adverse reactions occurred during the first 3 weeks after starting treatment.

In addition to the reactions in Table 1, the following adverse reactions were reported in >2% of patients and more frequently in ADLYXIN-treated patients than placebo (frequencies listed, respectively, as: placebo; ADLYXIN): dyspepsia (0.2%, 3.2%), constipation (1.8%, 2.8%), abdominal distension (0.9%, 2.2%), abdominal pain upper (0.9%, 2.2%), abdominal pain (1.5%, 2.0%).

Hypoglycemia

Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose <60 mg/dL or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose value was available.

Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia in which the patient required the assistance of another person, associated with a plasma glucose level below 36 mg/dL or, associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose was available.

Table 2 summarizes the incidence of symptomatic hypoglycemia and severe hypoglycemia in seven placebo-controlled efficacy/safety studies.

Table 2: Incidence (%) of Symptomatic Hypoglycemia and Severe Hypoglycemia in Patients with Type 2 Diabetes Mellitus During the 24-week Main Treatment Period

Background therapy	Placebo	ADLYXIN
Monotherapv-	N=122	N=239
Symptomatic (%)	2	2
Severe (%)	0	0
With Metformin	N=432	N=946
Symptomatic (%)	1	3
Severe (%)	0	0
With Sulfonvlurea +/- metformin	N=377	N=656
Symptomatic (%)	11	15
Severe (%)	0	0.2
With Pioplitazone +/- metformin	N=161	N=323
Symptomatic (%)	1	3
Severe (%)	0	0
With Basal insulin +/- metformin	N=213	N=374
Symptomatic (%)	23	28
Severe (%)	0	1
With Basal insulin +/- sulfonvlurea	N=111	N=108
Symptomatic (%)	22	47
Severe (%)	0	0
With Insulin Glareine and metformin +/-thiazolidinedione	N=223	N=223
Symptomatic (%)	14	22
Severe (%)	0	0.4
*12-week treatment duration

Injection Site Reactions

Injections site reactions (e.g., pain, pruritus and erythema) were reported more frequently in ADLYXIN-treated patients (4%) than placebo treated patients (2 %).

Anaphylaxis And Hypersensitivity

In the ADLYXIN development program anaphylaxis cases were adjudicated. Anaphylaxis was defined as a skin or mucosal lesion of acute onset associated with at least 1 other organ system involvement. Symptoms such as hypotension, laryngeal edema or severe bronchospasm could be present but were not required for the case definition. More cases adjudicated as meeting the definition for anaphylaxis occurred in ADLYXIN-treated patients (incidence rate of 0.2% or 16 cases per 10,000 patient years) than placebo treated patient (incidence rate of 0.1% or 7 cases per 10,000 patient years).

Allergic reactions (such as anaphylactic reaction, angioedema and urticaria) adjudicated as possibly related to the study medication were observed more frequently in ADLYXIN-treated patients (0.4%) than placebo-treated patient (0.2%) [see WARNINGS AND PRECAUTIONS].

Immunogenicity

In the pool of 9 placebo-controlled studies, 70% of patients exposed to lixisenatide tested positive for anti-lixisenatide antibodies during the trials. In the subset of patients (2.4%) with the highest antibody concentrations (>100 nmol/L), an attenuated glycemic response was observed. A higher incidence of allergic reactions and injection site reactions occurred in antibody positive patients [see WARNINGS AND PRECAUTIONS].

Anti-lixisenatide antibody characterization studies have demonstrated the potential for development of antibodies crossreactive with endogenous GLP-1 and glucagon, but their incidence has not been fully determined and the clinical significance of these antibodies is not currently known.

No information regarding the presence of neutralizing antibodies is currently available.

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, the incidence of antibodies to lixisenatide cannot be directly compared with the incidence of antibodies with other products.

DRUG INTERACTIONS

Delayed Gastric Emptying Effects On Oral Medications

ADLYXIN delays gastric emptying which may reduce the rate of absorption of orally administered medications. Use caution when coadministering oral medications that have a narrow therapeutic ratio or that require careful clinical monitoring. These medications should be adequately monitored when concomitantly administered with ADLYXIN. If such medications are to be administered with food, patients should be advised to take them with a meal or snack when ADLYXIN is not administered.

Oral medications that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, or medications for which a delay in effect is undesirable, such as acetaminophen, should be administered at least 1 hour before ADLYXIN injection [see CLINICAL PHARMACOLOGY].

Patients taking oral contraceptives should be advised to take them at least 1 hour before ADLYXIN administration or at least 11 hours after the dose of ADLYXIN [see CLINICAL PHARMACOLOGY].

Dosage Adjustment Of Sulfonylurea Or Basal Insulin With Concomitant Use With ADLYXIN

When ADLYXIN is added to a sulfonylurea or basal insulin, there is a potential risk of hypoglycemia. A reduction of the concomitantly administered sulfonylurea or basal insulin may be necessary [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Read the entire FDA prescribing information for Adlyxin (Lixisenatide Injection)

&Copy; Adlyxin Patient Information is supplied by Cerner Multum, Inc. and Adlyxin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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