What Is Soliqua 100/33?

1. How does Soliqua work?

Two drugs with complementary jobs. Insulin glargine is a basal insulin that lasts about a day and controls fasting glucose. Lixisenatide is a GLP-1 receptor agonist with a half-life of about 3 hours that, injected before breakfast, slows gastric emptying and raises insulin for the meal that follows, covering the post-meal rise the basal insulin does not. The GLP-1 component also reduces appetite, which is why the combination avoids the weight gain that insulin alone produces.

The fixed ratio is the compromise. In separate pens the two doses would be set independently; in Soliqua the lixisenatide dose rises and falls with the insulin dose, 5 mcg at 15 units to 20 mcg at 60 units. The trade for that constraint is one injection, one pen, and a gentler start for the GLP-1 component than the 10 mcg Adlyxin ladder.

2. What is the Soliqua dose?

Any prior basal insulin or GLP-1 agonist is stopped when Soliqua starts. The dose is then titrated by 2 to 4 units a week toward the fasting glucose target a prescriber sets, the same way a basal insulin is titrated, with the lixisenatide dose following automatically. The pen is dialled in single units from 15 to 60 and cannot deliver less than 15; someone who needs more than 60 units of basal insulin cannot get the excess from Soliqua, which is why the label limits it to that range.

A missed dose is skipped, not made up: the label instructs patients to resume the once-daily regimen at the next scheduled dose, and not to take an extra dose or increase the dose to make up for the missed one.

The SoloStar pen injects subcutaneously into the abdomen, thigh, or upper arm, with injection sites rotated within the same region each time to limit lipodystrophy. It dials in 1-unit increments; the label instructs patients not to select a dose by counting the clicks, because that can dial the wrong dose, and to always check the number in the dose window instead. It cannot be given intravenously or through an insulin pump.

3. How much does Soliqua lower blood sugar?

Two 30-week trials, both against insulin glargine titrated the same way.

A third trial, LixiLan-G, tested the opposite direction: switching people already on a daily or weekly GLP-1 agonist (60% on liraglutide or exenatide twice daily, 40% on dulaglutide, exenatide extended-release, or albiglutide) to Soliqua instead of continuing their GLP-1 agonist. Over 26 weeks in 514 adults with baseline HbA1c 7.8%, switching to Soliqua brought HbA1c to 6.7% versus 7.4% on continued GLP-1 therapy, a 0.6-point difference, and 62% reached under 7% versus 26%. Nausea, vomiting, and documented hypoglycemia under 54 mg/dL were all more common after switching to Soliqua than on the GLP-1 agonist alone, though the trial’s abstract does not report a weight figure.

Adding the GLP-1 agonist to insulin did not reduce hypoglycemia; the insulin component sets that rate. The pattern is the same as Xultophy’s DUAL trials: the combination beats the insulin on HbA1c and weight, and beats the GLP-1 agonist alone on HbA1c at the cost of the GLP-1 agonist’s weight loss.

4. What are the side effects of Soliqua?

Hypoglycemia from the insulin, gastrointestinal effects from the lixisenatide.

The nausea rate is well below Adlyxin’s 25%, because the lixisenatide dose starts at 5 mcg rather than 10 and climbs with the insulin. The warnings that apply are hypoglycemia, pancreatitis, acute kidney injury from dehydration, hypersensitivity, hypokalemia from insulin, fluid retention with thiazolidinediones, and never sharing pens. In the trial tables, “hypoglycemia below 54 mg/dL” means documented symptomatic hypoglycemia at that glucose threshold; “severe hypoglycemia” means an episode requiring another person’s help to treat.

The medication-error warning is specific: Soliqua contains two drugs, so more than 60 units a day can overdose the lixisenatide component on top of the insulin, and the label instructs patients to check the pen label before every injection to avoid mix-ups with other insulins.

Several drug classes shift the picture further. ACE inhibitors, sulfonamide antibiotics, and fluoxetine can increase hypoglycemia risk; corticosteroids, oral contraceptives, and thyroid hormones can blunt Soliqua’s glucose-lowering effect; beta-blockers can do either and also blunt the warning symptoms of a low. Because lixisenatide slows gastric emptying, oral drugs that depend on hitting a threshold concentration quickly, such as antibiotics and acetaminophen, are taken at least 1 hour before the Soliqua injection, and oral contraceptives are taken at least 1 hour before or 11 hours after.

5. How is Soliqua stored?

An unopened pen goes in the refrigerator at 36 to 46°F (2 to 8°C) and must not be frozen; a frozen pen is discarded. Once opened, the pen is kept at room temperature up to 77°F (25°C), capped between injections to protect it from light, and discarded 28 days after the first use even if it still has insulin in it. Each 3 mL pen holds 300 units, and the label requires a 2-unit safety test dose before every injection in addition to the prescribed dose, so a pen delivers fewer full doses than 300 units divided by the dose alone. Needles are sold separately and must be compatible with the SoloStar pen.

6. Who needs extra caution or should avoid Soliqua?

The label flags several groups. In pregnancy, the risk summary notes that published data on insulin glargine have not shown a clear association with birth defects or miscarriage, but lixisenatide caused visceral and skeletal defects in pregnant rats and rabbits at doses in the range of clinical exposure, so Soliqua should be used in pregnancy only if the benefit justifies the fetal risk. Safety and effectiveness have not been established in children.

Kidney impairment needs care because the pen contains insulin as well as lixisenatide. The label’s statement that no dose adjustment is needed for mild to moderate impairment refers to the lixisenatide component; insulin requirements can fall as kidney function declines, so Soliqua as a whole may need dose adjustment and closer glucose monitoring, and the label asks for that monitoring. Experience in severe impairment is limited, and the label recommends against use in end-stage renal disease (eGFR under 15). Hepatic impairment has not been formally studied; the label asks for closer monitoring there too. People with kidney or liver impairment are at higher risk of hypoglycemia.

7. How does Soliqua relate to Lantus and Adlyxin?

Soliqua is not a new drug so much as a new pen. Lantus is Sanofi’s brand of insulin glargine by itself, dosed once daily with no fixed ceiling other than what a prescriber sets. Adlyxin is Sanofi’s brand of lixisenatide by itself, started at 10 mcg and stepped up to 20 mcg on its own ladder, with a nausea rate around 25% in its trials.

Soliqua combines the same two active ingredients, insulin glargine and lixisenatide, in one SoloStar pen at a fixed 100/33 ratio, so switching onto it means stopping both a separate basal insulin (Lantus or another glargine product) and a separate GLP-1 agonist. The tradeoff for the single pen is that neither ingredient’s dose can be adjusted independently of the other, and the lixisenatide starts lower (5 mcg at the 15-unit starting dose) than Adlyxin’s own starting dose, which is part of why Soliqua’s nausea rate runs below Adlyxin’s.

8. How does Soliqua compare with Xultophy?

The choice between them is mostly the GLP-1 component: a short-acting agonist that targets one meal versus a long-acting one that acts all day and carries the class boxed warning. The Xultophy page has its DUAL trial numbers. For a log, the entry is product, date, units, injection site, and the meal it preceded; the lixisenatide dose need not be recorded separately, since it follows from the units. How GLP-1 tracking works covers what to record.

9. Soliqua FAQ

• What does 100/33 mean?

  Concentration, not a dose. Each mL of Soliqua contains 100 units of insulin glargine and 33 mcg of lixisenatide. When you dial a number of units, you get that many units of insulin plus one-third of a microgram of lixisenatide per unit: 15 units is 15 units of glargine and 5 mcg of lixisenatide; 60 units is 60 units and 20 mcg.

• What is the Soliqua starting dose?

  15 units once daily for people new to insulin, on a GLP-1 agonist, or on less than 30 units a day of basal insulin. 30 units once daily for people on 30 to 60 units a day of basal insulin. The dose is then adjusted by 2 to 4 units a week toward a fasting glucose target, up to a maximum of 60 units. Any prior basal insulin or GLP-1 agonist is stopped when Soliqua starts.

• When do you inject Soliqua?

  Once daily within the hour before the first meal of the day. The timing comes from the lixisenatide component, which is short-acting and works on the meal it precedes; the glargine component lasts the full day regardless.

• How is Soliqua different from Xultophy?

  Same idea, different pair. Soliqua is insulin glargine plus lixisenatide, a short-acting GLP-1 agonist, dosed 15 to 60 units before the first meal. Xultophy 100/3.6 is insulin degludec plus liraglutide, a long-acting GLP-1 agonist, dosed 10 to 50 units at any time of day. Xultophy carries the thyroid C-cell boxed warning from liraglutide; Soliqua has no boxed warning.

• Does Soliqua cause weight gain?

  Less than insulin alone. In LixiLan-O, weight fell 0.3 kg on Soliqua over 30 weeks against a 1.1 kg gain on glargine alone and a 2.3 kg loss on lixisenatide alone. In LixiLan-L, weight fell 0.7 kg on Soliqua versus a 0.7 kg gain on glargine. The GLP-1 component offsets the insulin's weight effect.

• How is Soliqua stored?

  Unopened pens go in the refrigerator at 36 to 46°F and must not be freezing; a frozen pen is discarded. Once a pen is in use it stays at room temperature, up to 77°F, out of the pen box but with the cap on between doses, and is discarded 28 days after the first injection whether or not it is empty.

• Is Soliqua the same as Lantus or Adlyxin?

  No. Lantus is a brand of insulin glargine alone. Adlyxin is lixisenatide alone. Soliqua puts both ingredients from those two products into one SoloStar pen at a fixed ratio, so it replaces both rather than being either one.

10. Sources