Consumer Information for: ARANESP

Usual dose

ARANESP is given to patients as an injection. The method of injection depends on your clinical condition as indicated below.

For patients with chronic kidney disease, one of the following methods will be used:

• under your skin (subcutaneous); or
• into the venous line connecting the hemodialysis machine to your vein (intravenous), if you are on hemodialysis

You and your doctor will determine which is best for you. Your doctor will determine how much you must take and how often you need to take it. ARANESP is given once a week or in some cases, once every two weeks. Your doctor will try to keep your hemoglobin between 100 and 115 g/L, not to exceed 120 g/L.

For cancer patients, there is only one method for injection as follows:

• under your skin (subcutaneous)

Your doctor will determine how much you must take and how often you need to take it. ARANESP is typically given once a week or in some cases, once every two or three weeks. Your doctor should use the lowest dose of ARANESP needed to help you avoid RBC transfusions. Once you have finished your chemotherapy course, ARANESP should be discontinued.

Overdose

If self-administering this medication, be sure to adhere to the prescribed dose.

Severe hypertension (including hypertensive crisis and malignant hypertension) has been observed following overdose with ARANESP. If there is a significant increase in your blood pressure seek immediate medical attention.

Missed Dose

You should ask your doctor what to do if you miss a dose of ARANESP.

Administration

IMPORTANT: TO HELP AVOID CONTAMINATION AND POSSIBLE INFECTION DUE TO INJECTION, PLEASE READ AND FOLLOW THESE INSTRUCTIONS CAREFULLY.

The following section contains step-by-step instructions on self-administering ARANESP by subcutaneous (under-the-skin) injection. Part A of these instructions describes the process of setting up for your injection. Part B of these instructions contains specific instructions for patients who have been prescribed ARANESP Vials^†. If you have been prescribed ARANESP prefilled syringes, you can ignore Part B. Part C provides directions on selecting and preparing the injection site and the process of self-injection. Part D provides instructions on the activation of the needle guard on used prefilled syringes. Part E provides instructions on the safe disposal of used needles.

It is important that you do not try to give yourself the injection until you have received special training from your doctor or nurse. It is also important that you dispose of the used needles in a puncture-proof container. Do not use ARANESP in a prefilled syringe if the grey cover on the needle is off, or the needle guard (yellow sleeve on the syringe) has been activated (pulled to extend over the needle).

Always follow the instructions provided by your doctor, nurse or pharmacist concerning the dosage and administration of ARANESP. Do not change the dose or method of administration of ARANESP, without consulting your doctor. If you are not sure about giving the injection or you have any questions, please ask your doctor, nurse or pharmacist for help.

Part A - Setting up for the injection

1. Find a comfortable, clean, well-lit working place with a flat surface such as a table.


2. Remove the ARANESP vial† or prefilled syringe from the refrigerator and place it on your flat working surface. Allow it to reach room temperature. This should take about 30 minutes. Do not leave the vial† or prefilled syringe in direct sunlight and do not use it if it has been frozen.


3. Inspect the vial† or prefilled syringe. Check that the strength on the vial† or syringe is the strength that your doctor prescribed for you. Check the date on the label to be sure that the product has not expired. ARANESP should be a clear, colourless solution. If the solution has particles or is discoloured, do not use it, and check with a doctor, nurse, or pharmacist. DO NOT SHAKE THE VIAL† OR PREFILLED SYRINGE. Shaking may damage the ARANESP. If the product has been shaken vigorously, the solution may appear foamy and it should not be used.


4. Assemble the supplies you will need for an injection:
   
   ARANESP vial† and the correct disposable syringe and needle
   
   OR
ARANESP prefilled syringe with a transparent (clear) yellow plastic needle guard attached

5. In addition to your medication, you will need alcohol swabs, a cotton ball or piece of gauze, and a puncture-proof container for disposal of used needles. When you have all these materials assembled, and are ready to begin, wash your hands well with soap and warm water.
   

   ---

   ^† Single-use vials are not available in Canada.

Part B - ARANESP Vials^†

If you are using ARANESP Vials^†, the doctor or nurse will give you instructions on how to measure your dose of ARANESP and draw it from the vial into the syringe. Only use the syringe that your doctor prescribes. This dose will be measured in millilitres. You should only use a syringe that is marked in tenths of millilitres or mL (for example, 0.2 mL). The doctor or nurse may refer to an "mL" as a "cc" (1 mL = 1 cc). Using an unmarked syringe can lead to a mistake in the dose. If you do not use the correct syringe, you could inject too much or too little ARANESP. Each ARANESP vial is designed to be used only once. Do not put the needle through the rubber stopper more than once. Use only disposable syringes and needles. Use the syringes and needles only once and dispose of them as instructed by your doctor or nurse (see Part D below).

1. Take the yellow color cap off the vial. Clean the rubber stopper with one alcohol swab.
   
2. Check the package containing the syringe. If the package has been opened or damaged, do not use that syringe. You should dispose of that syringe in the puncture-proof disposal container (see Part D below). If the syringe package is undamaged, open the package and remove the syringe.


3. Pull the needle cover straight off the syringe. Then, pull back on the plunger to draw air into the syringe. The amount of air drawn into the syringe should be the same amount (mL or cc) as the dose of ARANESP that your doctor prescribed.
   
4. Keep the vial on your flat working surface and insert the needle straight down through the rubber stopper.


5. Push the plunger of the syringe down to inject the air from the syringe into the vial of ARANESP.
   
6. Keeping the needle inside the vial, turn the vial upside down. Make sure that the tip of the needle is in the ARANESP liquid.
   
7. Keeping the vial upside down, slowly pull back on the plunger to fill the syringe with ARANESP liquid to the number (mL or cc) that matches the dose your doctor prescribed.


8. Keeping the needle in the vial, check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Then slowly push the plunger up to force the air bubbles out of the syringe. Keep the tip of the needle in the liquid and once again pull the plunger back to the number on the syringe that matches your dose. Check again for air bubbles. The air in the syringe will not hurt you, but too large an air bubble can reduce your dose of ARANESP. If there are still air bubbles, repeat the steps above to remove them.


9. Check again to make sure that you have the correct dose in the syringe. It is important that you use the exact dose prescribed by your doctor.

   ---

   ^† Single-use vials are not available in Canada.

Part C - Preparing Injection Site and Self-Injecting ARANESP

1. Choose an injection site. Four recommended injection sites for ARANESP include:
   • The outer area of your upper arms
   • The abdomen (except for the two inch area around your navel)
   • The front of your middle thighs
   • The upper outer areas of your buttocks
   

Choose a new site each time you inject ARANESP. Choosing a new site can help avoid soreness at any one site. Do not inject ARANESP into an area that is tender, red, bruised, or hard or that has scars or stretch marks.

2. Clean the injection site with a new alcohol swab.
   
3. Hold the syringe in the hand that you will use to inject ARANESP. Use the other hand to pinch a fold of skin at the cleaned injection site.
   
   NOTE: If using a prefilled syringe with a needle guard, pull the needle cover straight off the needle and hold the syringe barrel through the two needle guard windows when giving the injection.
   
4. Holding the syringe like a pencil, use a quick “dart like” motion to insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degrees) into the skin.
   
5. After the needle is inserted, let go of the skin. Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist.
   
6. When the syringe is empty, pull the needle out of the skin and place a cotton ball or gauze over the injection site and press for several seconds.
   

You should ONLY use a syringe and vial† once. You should discard the vial† with any remaining ARANESP.

Part D – Activation of the needle guard on used prefilled syringes

1. After injecting ARANESP from the prefilled syringe, do not recap the needle. Keep your hands behind the needle at all times. To activate the needle guard, hold the finger grip of the syringe with one hand and grasp the needle guard with your free hand, sliding it completely over the needle until the needle guard clicks into place. NOTE: If an audible click is not heard, the needle guard may not be completely activated.
   

Part E - Disposing of syringes and needles

Dispose of the syringe and needle or the syringe with activated needle guard as instructed by your doctor, nurse, or pharmacist, or by following these steps:

• Do NOT throw the needle or syringe in the household trash or recycle.
• Do NOT put the needle cover (the cap) back on the needle. Place all used needles and syringes in a hard plastic container, or a metal container with a plastic lid. Do not use glass or clear plastic containers, or any container that will be recycled or returned to a store.
• Properly label the container to indicate its contents. If a metal container such as a coffee can with a plastic lid is used, cut a small hole in the plastic lid and tape the lid onto the metal container. When the container is full, cover the hole and dispose of the container according to your doctor’s, nurse’s, or pharmacist’s instructions.
• If an opaque (do not use clear plastic), hard plastic container with a screw-on cap is used, always screw the cap on tightly after each use. When the container is full, tape around the cap or lid and dispose of the container according to the instructions provided by your doctor, nurse, or pharmacist. There may be special local laws that they will discuss with you.
• Always store the container out of the reach of children.
• You should always first check with your doctor, nurse, or pharmacist for instructions on how to properly dispose of a filled container. There may be local laws for disposal of used needles and syringes. Do not throw the container in household trash. Do not recycle.