Download Adlyxin

New Drug Introduction: Adlyxin/ Lixisenatide
Pharmacology
Manufacturer
Approval Date
Indications
Contraindications
Warnings/Precautions
Animal Toxicology
Pregnancy
Lactation
Pharmacokinetics
Drug Interactions –
Object Drugs
Drug Interactions –
Precipitant drugs
Adverse Effects
(treatment) [placebo]
Monitoring Efficacy
Monitoring Toxicity
Dosing - Initial
Dosing - Usual
Dosing - Max
Renal Adjustment
Hepatic Adjustment
GLP-1 Receptor Agonist
Sanofi
07/2016
FDA-Approved: Adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes.
Potential Off-Label Use: Weight loss
 Type 1 diabetes
 Anaphylaxis and severe hypersensitivity reactions
 Acute pancreatitis - discontinue if suspected; do not restart if confirmed.
Avoid with history of pancreatitis.
 Acute kidney injury – monitor renal function with renal impairment
reporting severe GI reactions. Avoid in ESRD.
 Gastroparesis – avoid use
 Hypoglycemia with concomitant use of sulfonylurea or basal insulin –
consider dose reduction of basal insulin or sulfonylurea
 Immunogenicity – patients may develop antibodies to lixisenatide.
 Thyroid C-cell tumor in rats (all doses); similar to other GLP-1s
Category C – Limited data in pregnant women. May carry risks to fetus
from exposure based on animal reproductive studies.
No information regarding presence in human milk.
Present in rat milk (9.4% transfer)
A – tmax 1-3.5 after SQ injection
D – Vd ≈ 100 L
M – No significant metabolism
E – Presumed to be eliminated renally and through proteolytic
degradation. Mean terminal half-life ≈ 3 hours.
Due to delayed gastric emptying, drug may impact absorption of orally
administered medications (e.g. concentration-dependent antibiotics,
narrow therapeutic index drugs, oral contraceptives)
-Advise patient to take these drugs 1 hour before or 11 hours after
injection
Hypoglycemia with concomitant basal insulin or sulfonylureas
-Dose reduction of basal insulin or sulfonylurea may be necessary
None
Nausea (25%) [6%]
Hypersensitivity (0.4%) [0.2%]
Vomiting (10%) [2%]
Hypoglycemia – basal ± SU
(47%) [22%]
Diarrhea (8%) [6%]
Headache (9%) [6%]
Pancreatitis (21 per 10,000 pt years)
[14 per 10,000 pt years]
Dizziness (7%) [4%]
Injection site reaction (4%) [2%]
Average A1c reduction ≈ 0.8%-1.2%
GI-related symptoms (N/V/D) especially with reduced kidney function
10 mcg once daily x 14 days 1 hour prior to first meal
20 mcg once daily 1 hour prior to first meal
20 mcg daily
Monitor for GI-related effects with reduced kidney function. Avoid in ESRD
None
Cost: Undetermined Source: Lexi-Drugs 08/15/2016
Dose(s)
Brandor – Generic
Adlyxin®- Lixisenatide
Bydureon®- Exenatide
Tanzeum® - Albiglutide
Trulicity®- Dulaglutide
Victoza®- Liraglutide
10 mcg pen
20 mcg pen
2 mg pen
30mg
50mg
0.75 mg pen
1.5 mg pen
0.6-1.8 mg pen (1.2mg dose)
0.6-1.8 mg pen (1.8mg dose)
$ 30-day supply
Cost TBD
Cost TBD
$692.00 (4 pens)
$527.24 (4 pens)
$527.24 (4 pens)
$689.76 (4 pens)
$689.76 (4 pens)
$544.00 (2 pens)
$831.00 (3 pens)
Summary
 Adlyxin, lixisenatide, is a new once daily GLP-1 agonist indicated as an adjunct to
diet and exercise to improve glycemic control in adults with type 2 diabetes
 Starting dose: 10mcg daily x 14 days Maintenance dose: 20mcg daily
 Dose NTI drugs, conc.-dependent ABX, and oral contraceptives 1 hour before or 11
hours after injection
 Reduce dose of insulin or SU’s when initiating lixisenatide
 Most common side effects are GI related (N/V/D)
 Avoid in ESRD, gastroparesis, or history or pancreatitis
 Place in therapy: 5th-in-class GLP-1 agonist without any currently known benefits over
other agents in class
References:
1. http://www.sanofi.com
2. Adlyxin® package insert. Sanofi. Aug. 2016.
3. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. Pfeffer,
M.A., Claggett, B., et al.:N Engl J Med 2015; 373:2247-2257
Date Prepared: 08/15/2016
Editor: Peter G. Koval, Pharm.D., BCPS
Author: Robert Vincent, Pharm.D., PGY-1 Resident Moses Cone Hospital