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Soliqua is a brand name for Insulin Glargine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Inject subcutaneously once a day within the hour prior to the first meal of the day. 1 ) SOLIQUA 100/33 pen delivers 15 units to 60 units per injection. 2 ) Maximum daily dosage is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide).
1 ) Discontinue basal insulin or GLP-1 receptor agonist prior to initiation. 2 ) In patients naive to basal insulin or to a GLP-1 receptor agonist, currently on less than 30 units of basal insulin, or on a GLP-1 receptor agonist, the recommended starting dosage is 15 units subcutaneously once daily.
2 ) In patients inadequately controlled on 30 to 60 units of basal insulin, the starting dosage is 30 units subcutaneously once daily. 2 ) See Full Prescribing Information for titration recommendations. 3 ) Inject subcutaneously in abdominal area, thigh, or upper arm and rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
5 ) Do not administer intravenously, or via an infusion pump. 5 ) Do not dilute or mix with any other insulin products or solutions. 1 Important Dosage Information SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide.
Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day. The SOLIQUA 100/33 pen delivers doses from 15 to 60 units in a single injection. 2) ] . 5) ] . 2 Recommended Starting Dose In patients naive to basal insulin or to a GLP-1 receptor agonist, currently on a GLP-1 receptor agonist or currently on less than 30 units of basal insulin daily: Discontinue therapy with basal insulin or a GLP-1 receptor agonist prior to initiation of SOLIQUA 100/33.
The recommended starting dosage of SOLIQUA 100/33 is 15 units (15 units insulin glargine and 5 mcg lixisenatide) given subcutaneously once daily. In patients currently on 30 to 60 units of basal insulin daily, with or without a GLP-1 receptor agonist: Discontinue therapy with basal insulin or GLP-1 receptor agonist prior to initiation of SOLIQUA 100/33.
The recommended starting dosage of SOLIQUA 100/33 is 30 units (30 units insulin glargine and 10 mcg lixisenatide) given subcutaneously once daily.
Table 1:
Units of Insulin Glargine and Micrograms of Lixisenatide in Each Dosage of SOLIQUA 100/33 SOLIQUA 100/33 (dose window display) The dose window on the SOLIQUA 100/33 pen displays numbers for the even units and displays lines for the odd units.
13) ] The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The safety of SOLIQUA 100/33 (n=834, with a mean treatment duration of 203 days) has been evaluated in two clinical studies (30 weeks duration) in type 2 diabetes patients. The studies, Study A and B [see Clinical Studies (14) ] , had the following characteristics: mean age was approximately 59 years; approximately 50% were male, 90% were Caucasian, 6% were Black or African American, and 18% were Hispanic.
5. The mean BMI at baseline was 32 kg/m 2 . 73 m 2 . 6) ] . The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors.
For these reasons, comparing rates of hypoglycemia in clinical trials for SOLIQUA 100/33 with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.
In the SOLIQUA 100/33 program, severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions and documented symptomatic hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by a self-monitored plasma glucose value equal to or less than 70 mg/dL (see Table 4 ).
No clinically important differences in risk of severe hypoglycemia between SOLIQUA 100/33 and comparators were observed in clinical trials.
5 WARNINGS AND PRECAUTIONS Anaphylaxis and Serious Hypersensitivity Reactions : Severe, life-threatening, and generalized allergic reactions can occur. Instruct patients to discontinue use if a reaction occurs and promptly seek medical attention.
1 ) Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including SOLIQUA 100/33. Discontinue if pancreatitis is suspected. 2 ) Never share a SOLIQUA 100/33 prefilled pen between patients, even if the needle is changed.
, insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. 4 ) Overdose Due to Medication Errors : SOLIQUA 100/33 contains two drugs.
Instruct patients to always check the label before each injection since accidental mix-ups with insulin products can occur. Do not exceed the maximum dose or use with other GLP-1 receptor agonists. 5 ) Hypoglycemia : May be life-threatening.
Increase frequency of glucose monitoring with changes to insulin dosage, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. 6 ) Acute kidney injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
SOLIQUA 100/33 is not recommended in patients with end-stage renal disease. 7 ) Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. 8 ).
Immunogenicity :
Patients may develop antibodies to insulin glargine and lixisenatide. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection-site reactions or allergic reactions, alternative antidiabetic therapy should be considered.
6) ] . In patients with serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33. 1) ] . During episodes of hypoglycemia. ( 4 ) Serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33 ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2) ] , titrate the dosage upwards or downwards by two to four units (see Table 2 ) every week based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal until the desired fasting plasma glucose is achieved.
4) and Drug Interactions (7) ] .
Table 2:
Recommended Titration of SOLIQUA 100/33 (Every Week) The recommended SOLIQUA 100/33 dosage is between 15 to 60 units (see Table 1 ). 4 Missed Doses Instruct patients who miss a dose of SOLIQUA 100/33 to resume the once-daily regimen as prescribed with the next scheduled dose.
Do not administer an extra dose or increase the dose to make up for the missed dose. 3) ] . Train patients on proper use and injection technique before initiating SOLIQUA 100/33. 5) ] . Visually inspect for particulate matter and discoloration prior to administration.
Only use SOLIQUA 100/33 if the solution is clear and colorless to almost colorless. Inject SOLIQUA 100/33 subcutaneously into the abdominal area, thigh, or upper arm. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
2) , Adverse Reactions (6) ] . 4) ] . Do not administer intravenously or via an insulin pump. Use SOLIQUA 100/33 with caution in patients with visual impairment who may rely on audible clicks to dial their dose. The SOLIQUA 100/33 pen dials in 1-unit increments.
Do not dilute or mix SOLIQUA 100/33 with any other insulin or solution. Do not split the dose of SOLIQUA 100/33.
Table 4:
Hypoglycemic Episodes in SOLIQUA 100/33-Treated Patients with T2DM SOLIQUA 100/33 Study A N=469 SOLIQUA 100/33 Study B N=365 Severe symptomatic hypoglycemia Defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
8 Gastrointestinal Adverse Reactions Gastrointestinal adverse reactions are the most commonly observed adverse reaction in patients using lixisenatide. Gastrointestinal adverse reactions occur more frequently at the beginning of SOLIQUA 100/33 therapy.
Gastrointestinal adverse reactions including nausea, diarrhea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, flatulence, gastroesophageal reflux disease, abdominal distension, and decreased appetite have been reported in patients treated with SOLIQUA 100/33.
6% in the insulin glargine–treated patients. 5) ] . Anaphylaxis and Hypersensitivity Lixisenatide In the lixisenatide 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. 1% or 7 cases per 10,000 patient years). 1) ] . 6) ]. Insulin glargine Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including SOLIQUA 100/33, and may be life-threatening.
Pancreatitis In clinical trials of lixisenatide there were 21 cases of pancreatitis among lixisenatide-treated patients and 14 cases in comparator-treated patients (incidence rate of 21 vs 17 per 10,000 patient-years). Lixisenatide cases were reported as acute pancreatitis (n=3), pancreatitis (n=12), chronic pancreatitis (n=5), and edematous pancreatitis (n=1).
Some patients had risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. 2% in placebo-treated patients. Injection-Site Reactions As with any insulin or GLP-1 receptor agonist–containing product, patients taking SOLIQUA 100/33 may experience injection-site reactions, including injection-site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection-site mass.
7%. 6) ]. Insulin Initiation and Intensification of Glucose Control Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy.
However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy. Peripheral Edema Some patients taking insulin glargine, a component of SOLIQUA 100/33 have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Weight Gain Weight gain can occur with insulin-containing products, including SOLIQUA 100/33, and has been attributed to the anabolic effects of insulin. 2 Postmarketing Experience The following additional adverse reactions have been identified during post approval use.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Insulin glargine:
Localized cutaneous amyloidosis at the injection site has occurred with insulins. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Lixisenatide:
Gastrointestinal : acute pancreatitis, hemorrhagic and necrotizing pancreatitis, ileus, intestinal obstruction, severe constipation including fecal impaction Hepatobiliary: cholecystitis, cholelithiasis requiring cholecystectomy Neurologic: dysgeusia, dysesthesia Pulmonary: pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.
Renal: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis Skin and Subcutaneous Tissue: alopecia .
9 ) Hypokalemia : May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. 10 ) Fluid Retention and Heart Failure with Use of PPAR-gamma agonists : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.
11 ) Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. 12 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures.
Instruct patients to inform healthcare providers of any planned surgeries or procedures . 1% or 10 cases per 10,000 patient-years) and other serious hypersensitivity reactions including angioedema. Severe, life-threatening, generalized allergic reactions, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock can occur with insulins, including insulin glargine.
1) ] . Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis with SOLIQUA 100/33.
SOLIQUA 100/33 is contraindicated in patients with known serious hypersensitivity to lixisenatide or insulin glargine [see Contraindications (4) ] . If a hypersensitivity reaction occurs, the patient should discontinue SOLIQUA 100/33 and promptly seek medical attention.
2 Acute Pancreatitis Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists [see Adverse Reactions (6) ] . After initiation of SOLIQUA 100/33, observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting.
If pancreatitis is suspected, discontinue SOLIQUA 100/33 and initiate appropriate management. 3 Never Share a SOLIQUA 100/33 Prefilled Pen Between Patients SOLIQUA 100/33 prefilled pens must never be shared between patients, even if the needle is changed.
Sharing of the pen poses a risk for transmission of blood-borne pathogens. 6) ] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6) ] .
Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia.
Adjustments in concomitant oral antidiabetic treatment may be needed. 3) ] . 5 Overdose Due to Medication Errors SOLIQUA 100/33 contains two drugs: insulin glargine and lixisenatide. Administration of more than 60 units of SOLIQUA 100/33 daily can result in overdose of the lixisenatide component.
Do not exceed the 20-mcg maximum recommended dose of lixisenatide or use with other GLP-1 receptor agonists. Accidental mix-ups between insulin products have been reported. To avoid medication errors between SOLIQUA 100/33 and other insulins, instruct patients to always check the insulin label before each injection.
1) ] . Severe hypoglycemia can cause seizures, may be life-threatening or cause death. , driving or operating other machinery). SOLIQUA 100/33 (an insulin-containing product), or any insulin, should not be used during episodes of hypoglycemia [see Contraindications (4) ] .
Hypoglycemia can happen suddenly, and symptoms may differ in each individual and change over time in the same individual. 1) ] , or in patients who experience recurrent hypoglycemia. Risk Factors for Hypoglycemia The risk of hypoglycemia generally increases with intensity of glycemic control.
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. 2) ] . 1) ] . 7) ] . Risk Mitigation Strategies for Hypoglycemia Patients and caregivers must be educated to recognize and manage hypoglycemia.
Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
The long-acting effect of insulin glargine may delay recovery from hypoglycemia. 2) ] . 1) ]. Monitor renal function in patients reporting adverse reactions to SOLIQUA 100/33 that could lead to volume depletion, especially during dosage initiation and escalation of SOLIQUA 100/33.
6) ] . 8 Severe Gastrointestinal Adverse Reactions Use of GLP-1 receptor agonists, including SOLIQUA 100/33, has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6) ] . Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.
SOLIQUA 100/33 is not recommended in patients with severe gastroparesis. 9 Immunogenicity Patients may develop antibodies to insulin and lixisenatide following treatment. A pooled analysis of studies of lixisenatide-treated patients showed that 70% were antibody positive at Week 24.
4%) with the highest antibody concentrations (>100 nmol/L), an attenuated glycemic response was observed. 6) ] . If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection-site reactions or allergic reactions, alternative antidiabetic therapy should be considered.
10 Hypokalemia All insulin-containing products, including SOLIQUA 100/33, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death.
, patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations). 11 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin-containing products, including SOLIQUA 100/33.
Fluid retention may lead to or exacerbate heart failure. Patients treated with SOLIQUA 100/33 and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
12 Acute Gallbladder Disease Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. 2% in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
1) ]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking SOLIQUA 100/33, including whether modifying preoperative fasting recommendations or temporarily discontinuing SOLIQUA 100/33 could reduce the incidence of retained gastric contents.
Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking SOLIQUA 100/33.