Presentation and Status in Health Basket
| Presentation | Basket | Yarpa | Pharmasoft |
|---|---|---|---|
|
Pre-filled Pen (Solution for Injection) 1 X 120 mg |
|
||
|
Pre-filled Pen (Solution for Injection) 2 X 120 mg |
|
Related information
Dosage
The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.
See prescribing information for full details.
Indications
Prophylaxis of migraine in adults who have at least 4 migraine days per
month.
Contra-Indications
Hypersensitivity to the active substance or to any of the excipients
Special Precautions
Serious hypersensitivity
Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported. 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 prescribing information for full details.
Side Effects
Very common: Injection site pain Injection site reactions.
Common: Vertigo, Constipation, Pruritus Rash
See prescribing information for full details.
Drug interactions
No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.
Pregnancy and Lactation
Pregnancy: There are limited data from the use of galcanezumab in pregnant women. 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.
Lactation: 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.
Overdose
Doses up to 600 mg have been administered subcutaneously to humans without dose-limiting toxicity.
In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
