Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 8–9

HOS-136784 · Präparat HOS-097920

8 Warfarin and other coumarin derivatives After concomitant administration of warfarin 25 mg with repeated dosing of lixisenatide 20 mcg, there were no effects on AUC or INR (International Normalised Ratio) while Cmax was reduced by 19% and tmax was delayed by 7 hours. Based on these results, no dose adjustment for warfarin is required when co-administered with lixisenatide; however, frequent monitoring of INR in patients on warfarin and/or coumarin derivatives is recommended at the time of initiation or ending of lixisenatide treatment.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): coumarin (HOS-088372) warfarin (HOS-085950)

Wechselwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 9

HOS-136785 · Präparat HOS-097920

Digoxin After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected. The tmax of digoxin was delayed by 1.5 hour and the Cmax was reduced by 26%. Based on these results, no dose adjustment for digoxin is required when co-administered with lixisenatide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): digoxin (HOS-086172)

Wechselwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 9

HOS-136786 · Präparat HOS-097920

Ramipril After concomitant administration of lixisenatide 20 mcg and ramipril 5 mg during 6 days, the AUC of ramipril was increased by 21% while the Cmax was decreased by 63%. The AUC and Cmax of the active metabolite (ramiprilat) were not affected. The tmax of ramipril and ramiprilat were delayed by approximately 2.5 hours. Based on these results, no dose adjustment for ramipril is required when co-administered with lixisenatide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ramipril (HOS-089057) ramiprilat (HOS-089058)

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-136789 · Präparat HOS-097920

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-136790 · Präparat HOS-097920

The most frequently reported adverse reactions during treatment with Suliqua were hypoglycaemia and gastrointestinal adverse reactions (see section 'Description of selected adverse reactions' below).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-136791 · Präparat HOS-097920

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-136792 · Präparat HOS-097920

The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing frequency (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1 000 to <1/100; rare: ≥1/10 000 to <1/1 000; very rare: <1/10 000; not known: cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-136793 · Präparat HOS-097920

Table 1: Adverse drug reactions reported

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-136794 · Präparat HOS-097920

System organ Frequency class Very common Common Uncommon Rare Not Known Infections and Nasopharyngitis infestations Upper respiratory tract infection Immune system Urticaria disorders Metabolism and Hypoglycaemia nutrition disorders Nervous system Dizziness Headache disorders Dysgeusia Gastrointestinal Nausea Dyspepsia Delayed gastric disorders Diarrhoea Abdominal pain emptying Vomiting Hepatobiliary Cholelithiasis disorders Cholecystitis

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-136795 · Präparat HOS-097920

Skin and Cutaneous subcutaneous amyloidosis tissue disorders Lipodystrophy General disorders Injection site Fatigue and administration reactions site conditions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10–11

HOS-136796 · Präparat HOS-097920

10 Description of selected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-136797 · Präparat HOS-097920

Hypoglycaemia

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-136798 · Präparat HOS-097920

The following table describes the rate of documented symptomatic hypoglycaemia (≤ 3.9 mmol/L) and severe hypoglycaemia for both Suliqua and the comparator***.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-136799 · Präparat HOS-097920

Table 2: Documented symptomatic or severe hypoglycaemic adverse reactions Insulin naïve patients Switch from Switch from GLP-1 basal insulin receptor agonist*** Suliqua Insulin Lixisenatide Suliqua Insulin Suliqua GLP-1 glargine glargine receptor agonist*** N 469 467 233 365 365 255 256 Documented symptomatic hypoglycaemia* Patients with event, 120 110 15 146 155 71 6 n (%) (25.6%) (23.6%) (6.4%) (40.0%) (42.5%) (27.8%) (2.3%) Events per patient- 1.44 1.22 0.34 3.03 4.22 1.54 0.08 year, n Severe hypoglycaemia** Events per patient- year, 0 <0.01 0 0.02 <0.01 <0.01 0 n * Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of ≤3.9 mmol/L. ** Severe symptomatic hypoglycaemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. *** Liraglutide, exenatide BID (twice in a day) or extended release, dulaglutide or albiglutide

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-136800 · Präparat HOS-097920

Gastrointestinal disorders Gastrointestinal adverse reactions (nausea, vomiting and diarrhoea) were frequently reported adverse reactions during the treatment period. In patients treated with Suliqua, the incidence of related nausea, diarrhoea and vomiting was 8.4%, 2.2% and 2.2%, respectively. Gastrointestinal adverse reactions were mostly mild and transient in nature.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-136801 · Präparat HOS-097920

Immune system disorders Allergic reactions (urticaria) possibly related with Suliqua have been reported in 0.3% of patients. Cases of generalised allergic reaction including anaphylactic reaction and angioedema have been reported during marketed use of insulin glargine and lixisenatide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-136802 · Präparat HOS-097920

Immunogenicity Administration of Suliqua may cause formation of antibodies against insulin glargine and/or lixisenatide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-136803 · Präparat HOS-097920

The incidence of formation of anti-insulin glargine antibodies was 21% and 26.2%. In approximately 93% of the patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin. The incidence of formation of anti-lixisenatide antibodies was approximately 43%. Neither status for anti- insulin glargine antibodies nor for anti-lixisenatide antibodies had a clinically relevant impact on safety or efficacy.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11–12

HOS-136804 · Präparat HOS-097920

11 Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site of insulins and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Suliqua

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 12

HOS-136805 · Präparat HOS-097920

Injection site reactions Some (1.7%) patients using insulin containing therapy, including Suliqua have experienced erythema, local oedema, and pruritus at the site of injection.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.