Usual Adult Dose for Migraine Prophylaxis

225 mg subcutaneously once a month

• Alternatively, 675 mg subcutaneously may be administered once every 3 months

Comments:

• To administer 675 mg subcutaneously, 3 consecutive subcutaneous injections of 225 mg are given.
• If switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration.

Use: For the preventive treatment of migraine.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

CONTRAINDICATIONS:

• Serious hypersensitivity to the active substance or any product excipients; reactions have included anaphylaxis and angioedema

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
For subcutaneous administration use only

• Administer one 225 mg subcutaneous injection once a month OR 3 separate injections of 225 mg at 3 different sites once every 3 months
• Administer subcutaneously into abdomen, thigh, or upper arm; for multiple injections, the same body location may be used, but injection sites must be rotated
• Do not inject into areas that are tender, bruised, red, or indurated

SWITCHING DOSE OPTIONS: Administer first dose of the new regimen on the next scheduled date of administration
MISSED DOSE: If a dose is missed, administer as soon as possible; thereafter, next injection can be scheduled from the date of the last dose

Storage requirements:

• Not in use: Refrigerate 36F to 46F (2C to 8C); Protect from light
• In-use: Once removed from refrigerator, may keep at temperatures below 86F (30C) for a maximum of 7 days; once removed from refrigerator, do not place back in refrigerator
• Do not shake; do not freeze; do not expose to extreme heat or direct sunlight

Reconstitution/preparation techniques:

• Remove from refrigerator and allow to sit at room temperature from 30 minutes prior to use; do not warm using a heat source such as hot water or microwave
• Once removed from refrigerator, must be used or discarded within 24 hours; protect from direct sunlight
• Consult manufacturer's product information for additional information and illustrations

Compatibility: Do not inject at the same injection site with any other drugs

General:

• Both monthly and quarterly dosing regimens have shown statistically significant improvement compared to placebo in key efficacy outcomes.
• This drug may be administered by a healthcare provider, patient or caregiver; if this is to be administered by patient or caregiver, ensure proper training is provided.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients and/or caregivers should be instructed to contact their health care provider if they have questions on administration.
• Patients should be informed that hypersensitivity reactions may occur, and they should notify their healthcare provider if they develop.

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