Dosage: The recommended dose of Pasurta is 70 mg administered once monthly.
Some patients may benefit from a dosage of 140 mg administered once monthly [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
If Pasurta dose is missed, administer as soon as possible. Thereafter, Pasurta can be scheduled monthly from the date of the last dose.
Special populations: Pediatrics: The safety and effectiveness of Pasurta has not been studied in pediatric patients.
Geriatrics: Clinical studies of Pasurta did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. No dose adjustment is required as the pharmacokinetics of erenumab are not affected by age.
Renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment. Population pharmacokinetic analysis of integrated data from the Pasurta clinical trials did not reveal a difference in the pharmacokinetics of erenumab in patients with mild or moderate renal impairment relative to those with normal renal function. Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) have not been studied.
Hepatic impairment: No clinical studies have been performed in patients with hepatic impairment. Erenumab, as a human monoclonal antibody, is not metabolized by cytochrome P450 enzymes and hepatic clearance is not a major clearance pathway for erenumab.
Method of administration: Pasurta is administered subcutaneously.
Pasurta is intended for patient self-administration.
Administration should be performed by an individual who has been trained to administer the product. To administer the 140 mg dose, give two consecutive subcutaneous injections of 70 mg each of Pasurta.
For detailed instructions on storage, handling and administration, follow the directions provided in the Instructions for Use and Handling under Patient Counselling Information.
Important administration instructions: Visually inspect Pasurta for particles and discoloration. Pasurta is a clear to opalescent, colorless to light yellow solution. Do not use if the solution is cloudy or discolored or contains flakes or particles.
Administer Pasurta subcutaneously in the abdomen, thigh, or upper arm. If the patient wants to use the same injection site, make sure it is not the same spot used for a previous injection. Do not inject into areas where the skin is tender, bruised, red, or hard.
Prefilled syringes are for single use and designed to deliver the entire contents with no residual content.
The gray needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.