Recommended Dosing for Migraine: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.
Patients should be instructed to inject a missed dose as soon as possible and then resume monthly dosing.
The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to continue treatment is recommended regularly thereafter.
Elderly (≥65 years): There is limited information in subjects aged ≥65 years. No dose adjustment is required as the pharmacokinetics of galcanezumab are not affected by age.
Renal impairment/Hepatic impairment: No dose adjustment is required in patients with mild to moderate renal impairment or hepatic impairment.
Paediatric population: The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. No data are available.
There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine.
Important Administration Instructions: PONTEVIA is for subcutaneous use only.
PONTEVIA is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer PONTEVIA using the single-dose prefilled pen, including aseptic technique [see Storage]: Protect PONTEVIA from direct sunlight.
Prior to subcutaneous administration, allow PONTEVIA to sit at room temperature for 30 minutes. Do not warm by using a heat source such as hot water or a microwave.
Do not shake the product.
Inspect PONTEVIA visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Storage]. Do not use PONTEVIA if it is cloudy or there are visible particles.
Administer PONTEVIA in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. Do not inject into areas where the skin is tender, bruised, red, or hard.
The prefilled pen is single-dose and deliver the entire contents.