How should I use Ajovy?

• Use Ajovy injection exactly as it was prescribed. Follow all directions on your prescription label and read all medication guides or instruction sheets.
• Ajovy is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
• Ajovy is usually given as 1 injection once a month, or as 3 injections (in separate syringes) once every 3 months.
• Read and carefully follow any Instructions for Use provided with your medicine. Do not use fremanezumab-vfrm if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
• Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
• Store Ajovy in the original carton in a refrigerator, protected from light. Do not freeze or shake this medicine.
• Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the medicine with hot water, sunlight, or a microwave.
• You may store Ajovy for up to 24 hours at room temperature. Throw the medicine away if it has been at room temperature for 24 hours or longer.
• Each single-use prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
• Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Ajovy dosing information

Usual Adult Dose for Migraine Prophylaxis:

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

Use: For the preventive treatment of migraine.

Side effects requiring immediate medical attention

Along with its needed effects, fremanezumab (the active ingredient contained in Ajovy) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fremanezumab:

More common

• Fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Side effects not requiring immediate medical attention

Some side effects of fremanezumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Fremanezumab Pregnancy Warnings

Benefit should outweigh risk

Risk Summary: There are no data on the developmental risks associated with this drug in human pregnancy.

Published data suggest that women with migraine headaches may be at an increased risk of preeclampsia during pregnancy. The estimated rate of major birth defects and miscarriage in women with migraine are similar to rates reported in women without migraine. There are no controlled data in human pregnancy.

Fremanezumab Breastfeeding Warnings

Benefit should outweigh risk

There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

This drug is a large protein molecule and therefore the amount in milk, if excreted, is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Human IgG is known to be excreted in breast milk during the first few days after birth. Therefore, consider holding this drug for the first few days after birth, and then, may consider use if clinically needed.

Dosage

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

• Serious hypersensitivity to the active substance or any product excipients
• Safety and efficacy have not been established in patients younger than 18 years.

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 option: 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 2C to 8C; Protect from light

In-use: Once removed from refrigerator, may keep at temperatures below 25C for up to 24 hours

Do not shake; do not freeze; do not expose to extreme heat or direct sunlight

References:

https://www.drugs.com/dosage/fremanezumab.html

https://www.ajovy.com