XELJANZ / XELJANZ XR Instructions For Use

INSTRUCTIONS FOR USE

XELJANZ (ZEL' JANS')
(tofacitinib)
Oral Solution

Read this Instructions for Use before you start taking XELJANZ Oral Solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important information about measuring XELJANZ Oral Solution:

Always use the oral dosing syringe that comes with XELJANZ Oral Solution to measure and take your prescribed dose. Ask your healthcare provider or pharmacist to show you how to measure your prescribed dose if you are not sure.

How should I store XELJANZ?

• Store XELJANZ Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
• Always store XELJANZ Oral Solution in the original bottle and carton to protect from light.

Keep XELJANZ and all medicines out of the reach of children.

Use XELJANZ Oral Solution within 60 days of opening the bottle. Throw away (discard) remaining XELJANZ Oral Solution after 60 days.

To help you remember when to throw away your bottle of XELJANZ Oral Solution, you can write the date when you first start to use it on the carton and below:

Date of first use ____ / ____ / ____.

Before each use:

Wash your hands with soap and water and place the items from the carton on a clean, flat surface.

Each carton of XELJANZ Oral Solution contains:

• 1 press-in bottle adapter
• 1 bottle of XELJANZ Oral Solution
• 1 oral dosing syringe

Step 1. Remove bottle from carton

Open the carton and remove the bottle of XELJANZ Oral Solution.

Step 2. Open bottle

Open the bottle by pushing down on the child-resistant cap and turning it to the left (counter-clockwise) as shown. Remove the seal off the top of the bottle (first time only).

Do not throw away the child-resistant cap.

Note: The bottle does not need to be shaken before use.

Step 3. Insert press-in bottle adapter (first time only)

Remove the press-in bottle adapter and oral dosing syringe from the plastic overwrap. With the bottle on a flat surface, push the ribbed end of the press-in bottle adapter all the way into the neck of the bottle with your thumbs while holding the bottle firmly.

Note: Do not remove the press-in bottle adapter from the bottle after it is inserted.

Step 4. Remove air from oral dosing syringe

Push the oral dosing syringe plunger all the way down to the tip of the syringe barrel to remove excess air.

Step 5. Insert the oral dosing syringe

Insert the oral dosing syringe tip into the upright bottle through the opening of the press-in bottle adapter until it is firmly in place.

Step 6. Withdraw dose from bottle

With the oral dosing syringe in place, turn the bottle upside down. Pull down on the plunger until the bottom of the plunger is even with the markings on the oral dosing syringe for your prescribed dose of oral solution.

If you see air bubbles in the oral dosing syringe, fully push the plunger in so that the oral solution flows back into the bottle. Then withdraw your prescribed dose of oral solution.

Step 7. Remove oral dosing syringe

Turn the bottle upright and place the bottle on a flat surface. Remove the oral dosing syringe from the press-in bottle adapter and bottle by pulling straight up on the oral dosing syringe barrel.

Step 8. Check the dose

Check that the correct dose was drawn up into the oral dosing syringe.

If the dose is not correct, insert the oral dosing syringe tip firmly into the press-in bottle adapter. Fully push in the plunger so that the oral solution flows back into the bottle. Repeat Step 6 and Step 7.

Step 9. Take the dose of XELJANZ

Place the tip of the oral dosing syringe into the inside of the cheek.

Slowly push the plunger all the way down to give all of the medicine in the oral dosing syringe. Make sure there is time to swallow the medicine.

Step 10. Close the bottle

Close the bottle tightly by turning the child-resistant cap to the right (clockwise), leaving the press-in bottle adapter in place.

Place the bottle back into the carton.

Close the carton to protect XELJANZ Oral Solution from light.

Step 11. Clean oral dosing syringe

Remove the plunger from the barrel by pulling the plunger and the barrel away from each other.

Rinse both with water after each use.

Allow to air dry. When the barrel and plunger are dry, put the oral dosing syringe back together by inserting the plunger into the barrel.

Store the oral dosing syringe with the XELJANZ Oral Solution.

Do not throw away the oral dosing syringe.

LAB-1422-1.0

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: September 2020