Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Användning hos patienter med nedsatt leverfunktion

Dosjusteringar krävs inte hos patienter med nedsatt leverfunktion.

Patients With Hepatic Impairment in Migraine Studies

Patients were excluded from enrollment in the phase 3 migraine prevention studies if they met any of the following criteria at screening:

1. Any liver tests outside the normal range at visit 1 that are clinically significant. The following hepatic enzyme findings must be discussed and judged not clinically significant by Lilly Medical prior to enrollment 

  • ALT >2X ULN

  • TBL >1.5X ULN, or

  • ALP >2X ULN.1

2. Have a history or presence of any other medical illness, but not limited to

  • hepatic disease, or

  • any clinically significant laboratory abnormality, that in the judgment of the investigator, indicates a medical problem that would preclude study participation.1

Dosage Adjustments Are Not Required In Patients With Hepatic Impairement

Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of galcanezumab have not been conducted.2

Renal elimination of IgG monoclonal antibody is low. Similarly, IgG monoclonal antibodies are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence the clearance of galcanezumab.2

Based on a population PK analysis, bilirubin concentration or Cockcroft-Gault creatinine clearance (range: 24 to 308 mL/min) did not significantly influence the apparent clearance of galcanezumab.2

No dose adjustment is required in patients with mild to moderate renal impairment or hepatic impairment.2

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.2

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.2

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Glossary

ALP = alkaline phosphatase

ALT = alanine aminotransferase

IgG = immunoglobulin G

PK = pharmacokinetics

TBL = total bilirubin

ULN = upper limit of normal

Datum fӧr senaste ӧversyn 2019 M02 18


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