SOLIQUA 100-33 (insulin glargine,human recombinant analog/lixisenatide)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Acute pancreatitis

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Anterior ischemic optic neuropathy
Gastroparesis
Hypoglycemic disorder
Pregnancy

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Hypoglycemic disorder
Hypokalemia
Kidney disease with reduction in glomerular filtration rate (GFr)

There are 24 severe adverse reactions.

More Frequent	Less Frequent
None.	Hypersensitivity drug reaction Hypertension Intestinal obstruction

Rare/Very Rare
Acute kidney injury Acute pancreatitis Anaphylaxis Angioedema Anterior ischemic optic neuropathy Biliary calculus Bronchospastic pulmonary disease Cholecystitis Cystitis Dyspnea Gastrointestinal obstruction Hypersensitivity drug reaction Hypoglycemic disorder Hypokalemia Hypotension Ileus Localized cutaneous amyloidosis Neutropenic disorder Severe constipation Tongue swelling Urticaria

There are 48 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Headache disorder Nausea Pharyngitis Vomiting	Abdominal distension Alopecia Back pain Bronchitis Cataracts Constipation Cough Depression Dizziness Drowsy Dysesthesia Dyspepsia Edema Influenza Injection site sequelae Lipodystrophy Peripheral edema Rhinitis Sinusitis Skin rash Upper abdominal pain Upper respiratory infection Urinary tract infection Weight gain

Rare/Very Rare
Blurred vision Diarrhea Dysgeusia Eructation Fecal impaction Gastroesophageal reflux disease Headache disorder Irritable bowel syndrome Lip swelling Motion sickness Palpitations Pruritus of skin Rhinorrhea Sneezing Subcutaneous nodules Tachycardia Upper respiratory infection Urticaria Vertigo

Based on animal reproduction studies, there may be risks to the fetus from exposure to lixisenatide, a component of insulin glargine/lixisenatide, during pregnancy. Insulin glargine/lixisenatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The limited available data with insulin glargine/lixisenatide and lixisenatide in pregnant women is not sufficient to inform a drug-associated risk of major birth defects and miscarriage.

Published studies with insulin glargine use during pregnancy have not reported a clear association with insulin glargine and major birth defect or miscarriage risk. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated with visceral closure and skeletal defects at systemic exposures that decreased maternal food intake and weight gain during gestation, and that are 1-time and 6-times higher than the 20 mcg/day highest clinical dose, respectively, based on plasma AUC.

The estimated background risk of major birth defects is 6%-10% in women with pregestational diabetes with a HbA1c >7 and has been reported to be as high as 20%-25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S.

general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.

There is no information regarding the presence of lixisenatide and insulin glargine in human milk, the effects on the breastfed infant, or the effects on milk production. Endogenous insulin is present in human milk. Lixisenatide is present in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin glargine/lixisenatide and any potential adverse effects on the breastfed child from the combination drug or from the underlying maternal condition.

Of the total number of subjects (n=834) in controlled clinical studies of patients with type 2 diabetes, who were treated with insulin glargine/lixisenatide, 25.2% (n=210) were >=65 years of age and 4% (n=33) were >=75 years of age. No overall differences in effectiveness and safety were observed in the subgroup analyses across the age groups.

Nevertheless, caution should be exercised when insulin glargine/lixisenatide is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly.