Proper Use

Drug information provided by: Merative, Micromedex®

A nurse or other trained health professional will give you this medicine. It is given through as a shot under your skin, usually in the buttocks, stomach, thighs, or upper arm. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

Your doctor will give you the first dose of this medicine at the beginning and when restarting the medicine after you had an allergic reaction to the injection. You will need to stay for at least 60 minutes to check for serious unwanted effects.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, hard, burned, inflamed, or has scars, birthmarks, rashes, moles, or tattoos.

If more than one injection is needed, you may inject into the body area at least 2 inches away from each other. The second injection site can be on the same or different part of the body.

It is very important that you understand the requirements of the Palynziq® REMS program, and become familiar with the Palynziq® medication guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide and patient instructions if you do not have one.

Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.

Check the liquid in the prefilled syringe. It should be clear or colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake.

Do not remove the needle cap from the prefilled syringe until you are ready to use it.

You might not use all of the medicine in each prefilled syringe. Use each prefilled syringe only one time. Do not save an open syringe.

You may also take other medicines (eg, allergy medicine, fever medicine, or stomach medicine) before using the injection to prevent serious unwanted effects. You may also have your caregiver or family member stay with you for at least 60 minutes after injecting each dose to check for these effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (solution):
    • For lowering phenylalanine levels in the blood:
      • Adults—The starting dose is usually 2.5 milligrams (mg) injected under the skin once a week for 4 weeks. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 60 mg injected under the skin once a day for 16 weeks.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may also keep this medicine at room temperature for up to 30 days. Do not return it to the refrigerator once you keep it at room temperature.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Portions of this document last updated: Feb. 01, 2024

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