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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 24.04.2022
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Soliqua is a combination of Soliqua and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or Lixisenatide (Soliqua).
Limitations of Use:
- Soliqua has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
- Soliqua is not recommended for use in combination with any other product containing Lixisenatide (Soliqua) or another GLP-1 receptor agonist.
- Soliqua is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
- Soliqua has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis.
- Soliqua has not been studied in combination with prandial insulin.
Soliqua is an injectable prescription medicine that contains 2 diabetes medicines, Soliqua, that may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise in people who are not controlled with long-acting (basal) insulin (less than 60 units daily) or Lixisenatide (Soliqua).
Soliqua:
- has not been studied in people with a history of pancreatitis.
- is not recommended for people who also take Lixisenatide (Soliqua) or other medicines called GLP-1 receptor agonists.
- is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
- has not been studied in people who have a stomach problem that causes slow emptying of the stomach (gastroparesis). Soliqua is not for people with slow emptying of the stomach.
- has not been studied in people who also take a short-acting (prandial) insulin.
It is not known if Soliqua is safe and effective in children under 18 years of age.
Important Dosage Information
The following are important dosing information for Soliqua, a combination of Soliqua:
- Discontinue therapy with Lixisenatide (Soliqua) or basal insulin prior to initiation of Soliqua.
- In patients inadequately controlled on less than 30 units of basal insulin or on Lixisenatide (Soliqua), the recommended starting dosage of Soliqua is 15 units (15 units Insulin Glargine (Soliqua)/5 mcg Lixisenatide (Soliqua)) given subcutaneously once daily.
- In patients inadequately controlled on 30 to 60 units of basal insulin, the recommended starting dosage of Soliqua is 30 units (30 units Insulin Glargine (Soliqua)/10 mcg Lixisenatide (Soliqua)) given subcutaneously once daily.
- Administer Soliqua subcutaneously once a day within the hour prior to the first meal of the day.
- The maximum dosage of Soliqua is 60 units (60 units Insulin Glargine (Soliqua)/20 mcg Lixisenatide (Soliqua)).
- The Soliqua Pen delivers doses from 15 to 60 units in a single injection.
- Use alternative antidiabetic products if patients require a Soliqua daily
Dosage:
- below 15 units, or
- over 60 units
Table 1 presents the units Insulin Glargine (Soliqua) and the micrograms of Lixisenatide (Soliqua) in each dosage of Soliqua.
Table 1: Units of Insulin Glargine (Soliqua) and Micrograms of Lixisenatide (Soliqua) in Each Dosage of Soliqua
Soliqua (dose window display)* | Insulin Glargine (Soliqua) component dose | Lixisenatide (Soliqua) component dose | Comment |
2 | --- | --- | Safety test dose - not for injection |
15 | 15 units | 5 mcg | Recommended starting dosage for patients previously treated with Lixisenatide (Soliqua) or less than 30 units of basal insulin |
16 | 16 units | 5.3 mcg | |
17 | 17 units | 5.7 mcg | |
18 | 18 units | 6 mcg | |
19 | 19 units | 6.3 mcg | |
20 | 20 units | 6.7 mcg | |
21 | 21 units | 7 mcg | |
22 | 22 units | 7.3 mcg | |
23 | 23 units | 7.7 mcg | |
24 | 24 units | 8 mcg | |
25 | 25 units | 8.3 mcg | |
26 | 26 units | 8.7 mcg | |
27 | 27 units | 9 mcg | |
28 | 28 units | 9.3 mcg | |
29 | 29 units | 9.7 mcg | |
30 | 30 units | 10 mcg | Recommended starting dosage for patients previously treated with 30 to 60 units of basal insulin |
31 | 31 units | 10.3 mcg | |
32 | 32 units | 10.7 mcg | |
33 | 33 units | 11 mcg | |
34 | 34 units | 11.3 mcg | |
35 | 35 units | 11.7 mcg | |
36 | 36 units | 12 mcg | |
37 | 37 units | 12.3 mcg | |
38 | 38 units | 12.7 mcg | |
39 | 39 units | 13 mcg | |
40 | 40 units | 13.3 mcg | |
41 | 41 units | 13.7 mcg | |
42 | 42 units | 14 mcg | |
43 | 43 units | 14.3 mcg | |
44 | 44 units | 14.7 mcg | |
45 | 45 units | 15 mcg | |
46 | 46 units | 15.3 mcg | |
47 | 47 units | 15.7 mcg | |
48 | 48 units | 16 mcg | |
49 | 49 units | 16.3 mcg | |
50 | 50 units | 16.7 mcg | |
51 | 51 units | 17 mcg | |
52 | 52 units | 17.3 mcg | |
53 | 53 units | 17.7 mcg | |
54 | 54 units | 18 mcg | |
55 | 55 units | 18.3 mcg | |
56 | 56 units | 18.7 mcg | |
57 | 57 units | 19 mcg | |
58 | 58 units | 19.3 mcg | |
59 | 59 units | 19.7 mcg | |
60 | 60 units | 20 mcg | Maximum daily dosage |
* The dose window on the Soliqua pen displays numbers for the even units and displays lines for the odd units. |
Titration Of Soliqua
- After starting with the recommended dosage of Soliqua, based upon prior insulin dose or Lixisenatide (Soliqua) use, titrate the dosage upwards or downwards by two to four units 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. The dosage of Soliqua is between 15 to 60 units.
- To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be needed with changes in physical activity, meal patterns (i.e., macronutrient content or timing of food intake), or renal or hepatic function; during acute illness; or when used with other medications.
Table 2: Recommended Titration of Soliqua (Every Week)*
Self-Monitored Fasting Plasma Glucose | Soliqua Dosage Adjustment |
Above target range | +2 units (2 units of Insulin Glargine (Soliqua) and 0.66 mcg of Lixisenatide (Soliqua)) to +4 units (4 units Insulin Glargine (Soliqua) and 1.32 mcg Lixisenatide (Soliqua)) |
Within target range | 0 units |
Below target range | -2 units (2 units of Insulin Glargine (Soliqua) and 0.66 mcg of Lixisenatide (Soliqua)) to -4 units (4 units of Insulin Glargine (Soliqua) and 1.32 mcg Lixisenatide (Soliqua)) |
* The recommended Soliqua dosage is between 15 to 60 units |
Missed Doses
Instruct patients who miss a dose of Soliqua 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.
Important Administration Instructions
- The Soliqua prefilled pen is for single-patient use only.
- Train patients on proper use and injection technique before initiating Soliqua.
- Always check the Soliqua label before administration
- Visually inspect for particulate matter and discoloration prior to administration. Only use Soliqua if the solution is clear and colorless to almost colorless.
- Inject Soliqua 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.
- Do not administer intravenously, intramuscularly, or via an insulin pump.
- Do not dilute or mix Soliqua with any other insulin or solution.
- Do not split the dose of Soliqua.
How supplied
Dosage Forms And Strengths
Soliqua injection: 100 units Insulin Glargine (Soliqua) per mL and 33 mcg Lixisenatide (Soliqua) per mL is available as a clear, colorless to almost colorless solution in a 3 mL prefilled, disposable, single-patient use SoloStar® pen.
Storage And Handling
Soliqua is an injection supplied as a sterile, clear, colorless to almost colorless solution in a 3 mL prefilled, disposable, single-patient use pen injector:
Dosage Unit/Strength | Package size | NDC # |
3 mL Soliqua disposable prefilled pen 100 units/mL Insulin Glargine (Soliqua) and 33 mcg/mL Lixisenatide (Soliqua) | Package of 5 | 0024-5761-05 |
Needles are not included. Only use needles that are compatible for use with Soliqua prefilled pen.
Storage
Prior to first use, Soliqua pen should be stored in a refrigerator, 36°F-46°F (2°C-8°C). Do not freeze. Protect from light. Discard after the expiration date printed on the label.
Soliqua should not be stored in the freezer and should not be allowed to freeze. Discard Soliqua if it has been frozen.
After first use, store at room temperature below 86°F (30°C). Replace the pen cap after each use to protect from light.
Discard pen 14 days after first use.
Always remove the needle after each injection and store the Soliqua pen without a needle attached. This prevents contamination and/or infection, or leakage of the Soliqua pen, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.
sanofi-aventis U.S. LLC; Bridgewater, NJ 08807 A SANOFI COMPANY. Revised: Nov 2016
See also:
What is the most important information I should know about Soliqua?
Soliqua is contraindicated:
- During episodes of hypoglycemia.
- In patients with hypersensitivity to Soliqua, either of the active drug substances (Insulin Glargine (Soliqua) or Lixisenatide (Soliqua)), or any of its excipients. Hypersensitivity reactions including anaphylaxis have occurred with both Lixisenatide (Soliqua) and Insulin Glargine (Soliqua).
- Read all the detailed Instructions for Use that come with your prescription for instructions on using the pen and injecting the injection.
- Use this medicine exactly as your healthcare provider tells you to.
- Do not change your dose unless your healthcare provider has told you to change your dose.
- Your healthcare provider should teach you how to inject Soliqua before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider.
- Inject Soliqua only one time each day within one hour before the first meal of the day.
- If you miss a dose, take your next scheduled dose at your regular time. Do not take an extra dose or increase your dose to make up for the missed dose.
- Check the label on the pen each time you give your injection to make sure you are using the correct medicine.
- Do not inject more than 60 units each day. Soliqua contains two medicines: Soliqua. If you take too much Soliqua, it can cause severe nausea and vomiting. Do not take this medicine with other GLP-1 receptor agonists. If you inject too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
- Only use Soliqua that is clear, colorless to almost colorless. If you see small particles, return it to your pharmacy for a replacement.
- Change (rotate) your injection sites within the area you chose with each dose. Do not use the same spot for each injection to avoid skin thickening or pits at the injection site (lipodystrophy).
- Inject your dose under the skin (subcutaneously) of your abdomen, thigh or upper arm. Do not use this medicine in an insulin pump or inject it into your vein (intravenously) or muscle (intramuscularly).
- Do not mix Soliqua in any other type of insulin or liquid medicine prior to injection.
- Do not remove Soliqua from the throw away (disposable) prefilled pen with a syringe.
- Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
Your dose may need to change because of a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Diabetes mellitus, type 2: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
See also:
What other drugs will affect Soliqua?
Medications That Can Affect Glucose Metabolism
A number of medications affect glucose metabolism and may require dose adjustment of Soliqua and particularly close monitoring.
Drugs That May Increase the Risk of Hypoglycemia | |
Drugs: | Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. |
Intervention: | Dose reductions and increased frequency of glucose monitoring may be required when Soliqua is coadministered with these drugs. |
Drugs That May Decrease the Blood Glucose Lowering Effect of Soliqua | |
Drugs: | Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones |
Intervention: | Dose increases and increased frequency of glucose monitoring may be required when Soliqua is coadministered with these drugs. |
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Soliqua | |
Drugs: | Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. |
Intervention: | Dose adjustment and increased frequency of glucose monitoring may be required when Soliqua is coadministered with these drugs. |
Drugs That May Blunt Signs and Symptoms of Hypoglycemia | |
Drugs: | Beta-blockers, clonidine, guanethidine, and reserpine |
Intervention: | Increased frequency of glucose monitoring may be required when Soliqua is coadministered with these drugs. |
Effects Of Delayed Gastric Emptying On
Oral Medications
Lixisenatide (Soliqua) 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 Lixisenatide (Soliqua). If such medications are to be administered with food, patients should be advised to take them with a meal or snack when Lixisenatide (Soliqua) is not administered.
- Antibiotics, acetaminophen, or other medications that are particularly dependent on threshold concentrations for efficacy or for which a delay in effect is undesirable, should be administered at least 1 hour before Soliqua injection.
Oral contraceptives should be taken at least 1 hour before Soliqua administration or 11 hours after.
See also:
What are the possible side effects of Soliqua?
The following adverse reactions are discussed elsewhere:
- Anaphylaxis and Serious Hypersensitivity Reactions
- Pancreatitis
- Hypoglycemia
- Acute Kidney Injury
- Hypokalemia
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 (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 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. The mean duration of diabetes was 10.3 years, mean HbA1c at screening for Study A was 8.2 and Study B 8.5. The mean BMI at baseline was 32 kg/m². Baseline eGFR was ≥ 60 mL/min in 87.2% of the pooled study population and mean baseline eGFR was 83.0 ml/min/1.73m².
Table 3: Adverse Reactions Occurring in ≥ 5% of Soliqua-Treated Patients with Type 2 Diabetes Mellitus from Two Pooled Clinical Trials
Soliqua, % (n=834) | |
Nausea | 10.0 |
Nasopharyngitis | 7.0 |
Diarrhea | 7.0 |
Upper respiratory tract infection | 5.5 |
Headache | 5.4 |
Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, and insulin containing products including Soliqua. 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 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 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.
Table 4: Severe or Documented Symptomatic Hypoglycemic Episodes in SOLIQUA-Treated Patients with T2DM
Soliqua Study A N=469 | Soliqua Study B N=365 | |
Severe symptomatic hypoglycemia* (%) | 0 | 1.1 |
Documented symptomatic hypoglycemiaf (%) | 25.6 | 40 |
* Defined as an event requiring assistance of another person to actively administer carbohydrate, gluca gon, or other resuscitative actions † 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 |
Gastrointestinal Adverse Reactions
Gastrointestinal adverse reactions occur more frequently at the beginning of Soliqua 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.
Lipodystrophy
Administration of insulin subcutaneously, including Soliqua, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.
Anaphylaxis And Hypersensitivity
Lixisenatide (Soliqua)
In the Lixisenatide (Soliqua) 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 Lixisenatide (Soliqua)-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 Lixisenatide (Soliqua)-treated patients (0.4%) than placebo-treated patients (0.2%).
Insulin Glargine (Soliqua)
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Soliqua and may be life threatening.
Injection-Site Reactions
As with any insulin or GLP-1 receptor agonist-containing product, patients taking Soliqua may experience injection-site reactions, including injection-site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection-site mass. In the clinical program the proportion of injection-site reactions occurring in patients treated with Soliqua was 1.7%.
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 (Soliqua), a component of Soliqua/30 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, and has been attributed to the anabolic effects of insulin.
Immunogenicity
Soliqua
As with all therapeutic proteins, there is potential for immunogenicity. 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 Soliqua in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
After 30 weeks of treatment with Soliqua in two phase 3 trials, the incidence of formation of anti-Insulin Glargine (Soliqua) antibodies was 21.0% and 26.2%. In approximately 93% of the patients, anti-Insulin Glargine (Soliqua) antibodies showed cross-reactivity to human insulin. The incidence of formation of anti-Lixisenatide (Soliqua) antibodies was approximately 43%.
Lixisenatide (Soliqua)
In the pool of 9 placebo-controlled studies, 70% of patients exposed to Lixisenatide (Soliqua) tested positive for anti-Lixisenatide (Soliqua) 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.
Anti-Lixisenatide (Soliqua) antibody characterization studies have demonstrated the potential for development of antibodies cross-reactive 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.