Consumer Information for: SEROSTIM

Usual Dose

SEROSTIM should be administered subcutaneously daily at bedtime according to the following dosage recommendations:

In patients who weigh less than 35 kg, SEROSTIM should be administered at a dose of 0.1 mg/kg subcutaneously daily at bedtime.

Treatment with the medicinal product should be initiated under the supervision of a specialised physician.

Preparing SEROSTIM for Administration
Here are the things you will need before you inject SEROSTIM:

• 3 alcohol swabs
• Cotton swab
• 3 cc syringe & 23 gauge needle for mixing
• BD insulin syringe for injection
• 1 vial of SEROSTIM
• Diluent vial (You need this sterile liquid - the diluent - to dissolve the SEROSTIM powder and make it injectable.)
• Syringe safety disposal container for used vials and needles

Always use unopened, sterile needles and syringes and keep the needles capped until needed.

TIP: Your doctor or nurse will explain how much diluent to add to the vial of SEROSTIM and how much SEROSTIM to inject.

Getting Ready to use SEROSTIM

1. Begin by choosing a clean flat surface (like a kitchen or bathroom counter).
2. Wash your hands thoroughly with soap and water. This helps prevent infection.
3. Check the expiration date of your SEROSTIM vial.

Drawing Up the Diluent

1. Carefully twist the needle cover off the long needle syringe.
2. Pull out the plunger to the amount recommended by your doctor or nurse. This brings air into the syringe.
3. Remove the flip-off cap from the diluent vial and discard. Wipe the rubber stopper of the vial with an alcohol swab.
4. Hold the vial firmly on the countertop. Put the needle into the stopper of the SEROSTIM diluent vial. Push the plunger of the syringe and inject the air into the vial.
5. Turn the vial upside down. Make sure the needle tip stays in the liquid. Pull back on the plunger until the marks on the barrel of the syringe show that the amount of the diluent suggested by your doctor or nurse has been drawn out.
6. If air bubbles appear in the syringe, gently push the plunger into the syringe to send the air into the vial. You may have to tap the syringe lightly so you can push the bubbles out. Draw up more diluent, if needed, until you have the amount your doctor has prescribed.
7. Pull out the needle from the diluent.

TIP: Be careful not to touch the uncapped needle with your fingers or let the needle touch anything.

Mixing SEROSTIM

1. Remove the flip-off cap from the SEROSTIM vial and discard. Wipe the rubber stopper of the vial with an alcohol swab.
2. With the same syringe, put the long needle into the stopper of the SEROSTIM vial. Gently place the needle tip against the vial wall. Slowly inject the diluent, aiming the stream of diluent at the glass wall of the vial. DO NOT AIM THE STREAM AT THE WHITE POWDER at the bottom of the vial.
3. Take out the needle and throw it away in the safety container.
4. Gently swirl (don’t shake) the vial until the powder is completely dissolved. The SEROSTIM mixture should be clear. If it stays hazy, cloudy or has pieces floating in it after mixing, do not use it.

TIP: If SEROSTIM becomes cloudy after mixing, return it to your pharmacist or nurse.

Preparing SEROSTIM for Injection

1. Re-wipe the rubber stopper of the SEROSTIM vial with an alcohol swab.
2. Pick up the insulin syringe with the short needle and carefully take off the needle cover.
3. Pull out the plunger to the amount recommended by your doctor or nurse. This brings air into the syringe.
4. Slowly insert the needle straight through the center of the rubber stopper of the vial of newly mixed SEROSTIM. Gently push the plunger to inject air into the vial.
5. Turn the vial upside down with the syringe needle still in it, holding the vial in one hand. Be sure the tip of the needle is in the solution. Using your other hand, slowly pull back on the plunger until the amount of SEROSTIM prescribed is in the syringe.
6. Remove the needle from the vial.
   Hold the syringe straight up and tap gently. Put the plastic needle guard back until injection time. The injection should be given as soon after filling the syringe as possible. Do not store SEROSTIM in the syringe.

TIP: Be careful not to touch the uncapped needle with your fingers - or let the needle touch anything.

Picking an Injection Site
You should pick a different site to inject each day, rotating through arms, legs and abdomen. The buttocks can be used, as well (see Injection Site Diagram). Keep track of your injection sites on a calendar. Using a site too often can lead to infection or irritation.

Injection Site Diagram

Injecting SEROSTIM

1. Clean the skin at the injection site with an alcohol swab using a circular motion.
   TIP: Let the skin dry after cleaning it with alcohol. This helps reduce stinging.
2. Remove the cap from the needle and, using the hand with which you write, pick up the syringe and hold it like a pencil.
3. Pinch up a generous fold of skin and hold it while quickly inserting the needle all the way in at a 90 degree angle to the skin. With your index finger, push the plunger in to inject the medication. Take as much time as you need to inject all the solution. You may wish to count to 5. TIP: When inserting the needle, you need very little force, but quick action.
4. As you release the skin from your grip, withdraw the needle at the same angle at which it was inserted. Place the cotton swab on the injection site and apply a gentle pressure.
5. Do not put the needle back in the needle guard. Carefully throw away the needle guard and all used needles and syringes in the safety container after a single use.
   TIP: NEVER reuse a needle.

Disposal containers must be made of thick, puncture-proof plastic with a lid that fits firmly, such as an empty pop bottle. Containers may be returned to the clinic for disposal or you may wish to contact your pharmacy for further information regarding the safe disposal of used syringes.

Things to remember

1. Make injections routine - give the injection at the same time each evening before bedtime.
2. Before mixing, store vials at room temperature.
3. Vials of SEROSTIM reconstituted with the diluent provided (Sterile Water for Injection, USP) should be used immediately (within 3 hours), and any unused solution should be discarded.
4. Check the expiration date.
5. Do not use if it turns cloudy, lumpy or discoloured.
6. Make certain that the dosage is equal to the amount prescribed.
7. Rotate your injection sites each time, as discussed with your nurse.
8. If you are unsure about the mixing of the medication or if you are having difficulty with the injection procedure, contact your nurse or doctor.

Overdose

There is no known antidote to SEROSTIM or any specific treatment for SEROSTIM overdose other than withholding treatment and patient observation. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Missed Dose

If you forget to take an injection on your usual day of the week, do not double your next injection. If you have forgotten more than one injection, contact your physician for advice on how to proceed.