Emgality · 4.5 Interaction with other medicinal products and other forms of interaction · 2

HOS-098489 · has-adverse-reaction-information · PDF-Seite 17

Summary of the safety profile Over 2 500 patients were exposed to galcanezumab in migraine prophylaxis studies supporting the initial registration of galcanezumab. Over 1 400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebo-controlled phase 3 studies. 279 patients were exposed for 12 months. The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection site pain (10.1 %/11.6 %), injection site reactions (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), constipation (1.0 %/1.5 %), pruritus (0.7 %/1.2 %) and urticaria (0.3 %/0.1 %). Most of the reactions were mild or moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse reactions. 17 Tabulated list of adverse reactions Table 1. List of adverse reactions in clinical studies and post-marketing reports Frequency estimate: 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). System organ class Very common Common Uncommon Rare Immune system Anaphylaxis disorders Angioedema Ear and labyrinth Vertigo disorders Gastrointestinal Constipation disorders Skin and Pruritus Urticaria subcutaneous Rash tissue disorders General disorders Injection site and administration pain site conditions Injection site reactionsa a Most frequently reported terms (≥ 1 %) were: Injection site reaction, Injection site erythema, Injection site pruritus, Injection site bruising, Injection site swelling. Description of selected adverse reactions Injection site pain or reactions The majority of reactions related to the injection site were mild to moderate and less than 0.5 % of patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an injection site reaction. The majority of injection site reactions were reported within 1 day and on average resolved within 5 days. In 86 % of the patients reporting injection site pain, the reaction occurred wi

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098483 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile Over 2 500 patients were exposed to galcanezumab in migraine prophylaxis studies supporting the initial registration of galcanezumab. Over 1 400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebo-controlled phase 3 studies. 279 patients were exposed for 12 months. The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection site pain (10.1 %/11.6 %), injection site reactions (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), constipation (1.0 %/1.5 %), pruritus (0.7 %/1.2 %) and urticaria (0.3 %/0.1 %). Most of the reactions were mild or moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse reactions. 4 Tabulated list of adverse reactions Table 1. List of adverse reactions in clinical studies and post-marketing reports Frequency estimate: 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). System organ class Very common Common Uncommon Rare Immune system Anaphylaxis disorders Angioedema Ear and labyrinth Vertigo disorders Gastrointestinal Constipation disorders Skin and Pruritus Urticaria subcutaneous Rash tissue disorders General disorders Injection site and administration pain site conditions Injection site reactionsa a Most frequently reported terms (≥ 1 %) were: Injection site reaction, Injection site erythema, Injection site pruritus, Injection site bruising, Injection site swelling. Description of selected adverse reactions Injection site pain or reactions The majority of reactions related to the injection site were mild to moderate and less than 0.5 % of patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an injection site reaction. The majority of injection site reactions were reported within 1 day and on average resolved within 5 days. In 86 % of the patients reporting injection site pain, the reaction occurred wi

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098485 · has-contraindication-information · PDF-Seite 16

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098479 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098484 · has-indication-information · PDF-Seite 15

Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

HOS-098478 · has-indication-information · PDF-Seite 2

Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

HOS-098481 · has-interaction-information · PDF-Seite 3

No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.

HOS-098487 · has-interaction-information · PDF-Seite 16

No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.

HOS-098488 · has-pregnancy-information · PDF-Seite 16

Pregnancy There are limited data from the use of galcanezumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 16 Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it is preferable to avoid the use of galcanezumab during pregnancy. Breast-feeding It is unknown whether galcanezumab is excreted in human milk. Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. Afterwards, use of galcanezumab could be considered during breast-feeding only if clinically needed. Fertility The effect of galcanezumab on human fertility has not been evaluated. Fertility studies in animals do not indicate harmful effects with respect to male and female fertility (see section 5.3).

HOS-098482 · has-pregnancy-information · PDF-Seite 3

Pregnancy There are limited data from the use of galcanezumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 3 Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it is preferable to avoid the use of galcanezumab during pregnancy. Breast-feeding It is unknown whether galcanezumab is excreted in human milk. Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. Afterwards, use of galcanezumab could be considered during breast-feeding only if clinically needed. Fertility The effect of galcanezumab on human fertility has not been evaluated. Fertility studies in animals do not indicate harmful effects with respect to male and female fertility (see section 5.3).

HOS-098486 · has-warning-information · PDF-Seite 16

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Cardiovascular risk Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). No safety data are available in these patients. Serious hypersensitivity Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported (see section 4.8). Serious hypersensitivity reactions may occur within 1 day after galcanezumab administration, however cases with a delayed onset (ranging from more than 1 day to 4 weeks after administration) have been reported. In some cases, hypersensitivity reactions had a prolonged duration. If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated (see section 4.3). Patients should be informed on the possibility of a delayed onset hypersensitivity reaction and instructed to contact their physician. Excipients This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially “sodium-free”.

HOS-098480 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Cardiovascular risk Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). No safety data are available in these patients. Serious hypersensitivity Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported (see section 4.8). Serious hypersensitivity reactions may occur within 1 day after galcanezumab administration, however cases with a delayed onset (ranging from more than 1 day to 4 weeks after administration) have been reported. In some cases, hypersensitivity reactions had a prolonged duration. If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated (see section 4.3). Patients should be informed on the possibility of a delayed onset hypersensitivity reaction and instructed to contact their physician. Excipients This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially “sodium-free”.