Certolizumab Pegol (Subcutaneous Route)

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Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the abdomen or thigh.

Certolizumab pegol may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

This medicine comes with a medication guide and patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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. This will help prevent skin problems.

To use the prefilled syringe:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
• Remove the carton with the syringe from the refrigerator and place it on the clean cloth.
• Allow 30 minutes for the syringe to warm up to room temperature. Do not warm this medicine in any other way.
• Wash your hands with soap and water before and after using this medicine.
• Choose an injection site on your body (e.g., abdomen or stomach area, or thigh). Clean the injection site with an alcohol swab, and do not touch the area until you are ready for injection.
• Remove the needle cover when you are ready to inject.
• Hold the syringe with one hand between the thumb and index fingers. Do not to touch the needle or let it touch any surface.
• Use your free hand to pinch and hold the skin at the injection site.
• Inject the medicine in a dart-like motion into the pinched skin at a 45-degree angle.
• Use your thumb to push the plunger and inject the full dose of the medicine. Pull the needle out of the skin.

If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Do not inject this medicine if blood enters the syringe. If you notice blood inside the syringe, pull the needle out and throw away the syringe and needle in a hard-closed container.

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 (prefilled syringe):
  • For Crohn's disease:
    • Adults—At first, 400 milligrams (mg) (given as two 200 mg) injected under the skin and at weeks 2 and 4. The recommended maintenance dose is 400 mg every four weeks.
    • Children—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis:
    • Adults—At first, 400 milligrams (mg) (given as two 200 mg) injected under the skin and at weeks 2 and 4, followed by 200 mg every other week. The recommended maintenance dose is 400 mg every four weeks.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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.

Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.

Throw away used syringes in a hard, closed container (puncture-resistant) that the needles cannot poke through. Keep this container away from children and pets.

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