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The PEGASYS Prefilled Syringes Convenience Pack may help make your weekly injection process faster (there's no vial to prepare) and safer (you don't have to handle the needle until just before you inject). PEGASYS is the only pegylated interferon available this way.

Each Prefilled Syringes Convenience Pack contains:

  • 4 syringes filled with PEGASYS
  • 4 needles (with needle guards) to attach to the syringes
  • Alcohol swabs

With this streamlined design, you may be able to prepare and take your medication at times and in places that are more convenient for you. (However, remember to take PEGASYS on the same day, and at or around the same time, each week.) There's only one box of medication to store in the refrigerator, and each time you take a dose out you'll see how many weeks are left before you need to refill your prescription.

PEGASYS vials and PEGASYS prefilled syringes contain the same amount of the same medication. So if you think you would like the convenience of prefilled syringes, ask your doctor or pharmacist about switching.

INSTRUCTIONS FOR USING PEGASYS PRE-FILLED SYRINGES

PEGASYS Prefilled Syringes
Self-injection With Prefilled Syringes

Phase 1: Before you inject

Keep it cool

  • PEGASYS must be kept in the refrigerator (36ºF-46ºF/2ºC-8ºC), but never frozen. Avoid exposing PEGASYS to direct sunlight

Choose a setting

  • Find a clean, comfortable area
  • Have all medical supplies within reach

Make sure your PEGASYS Prefilled Syringes Monthly Convenience Pack contains the following items:

  • 4 syringes filled with medicine
  • 4 needles
  • Alcohol pads

Before you begin, you'll need (see visual A)

  • 1 PEGASYS Prefilled Syringe
  • 1 needle with needle guard
  • A puncture-resistant container (sharps container)
  • Alcohol pad

Visual A

Always inspect the syringe and the contents inside the syringe. DO NOT use PEGASYS if

  • The syringe is cracked or broken
  • Medicine is cloudy
  • Medicine has particles floating in it
  • Medicine is any color besides colorless or light yellow
  • Expiration date has passed

If you notice any of these things, call your doctor or pharmacist to let them know and to obtain a replacement.
Note: This guide contains the patient self-injection procedure for PEGASYS. It is not meant to offer instruction for the administration of any other type of medication. Perform this procedure only after consultation with your doctor on the use of PEGASYS.

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Phase 2: Injecting PEGASYS

To ensure maximum safety and comfort, please follow these steps during the self-injection process.

Step 1: Warm the refrigerated medicine by gently rolling the syringe in your hands for 1 minute. DO NOT SHAKE

Step 2: Wash hands with soap and warm water to prevent infection

  • Dry your hands with a paper towel and use the towel to turn off faucet

Step 3: Attach needle to syringe

  • Remove needle from package (DO NOT remove the plastic cap from the needle. Keep needle covered until the time of injection)
  • Remove and throw away the rubber cap on the tip of syringe
  • Put needle on the end of syringe barrel so that it fits tightly (see visual B)

Visual B

CHECKPOINT: If you need to put down the syringe, make sure the plastic cap covers the needle. NEVER let the needle touch any surface.

Step 4: Decide where to self-inject

  • Pick a place on stomach or thigh. Avoid the navel and waistline
  • Pick a different spot each time you give yourself an injection

Step 5: Prepare skin for injection

  • To avoid any discomfort, gently tap the area you plan to give yourself the injection
  • Clean the area with an alcohol pad
  • Let the skin dry for approximately 10 seconds

Step 6: Uncover the needle

  • Remove the plastic cap from the shield

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CHECKPOINT: DO NOT REMOVE the orange needle guard attached to the syringe above the needle. It is a safety device that is intended to help protect you and others from accidental needlesticks.

Step 7: Remove air bubbles from syringe

  • Hold syringe with needle pointed toward the ceiling
  • Using the thumb and finger, tap syringe to bring air bubbles to the top
  • Press plunger in slightly to push air bubbles out of the syringe

CHECKPOINT: Depending on the dose your doctor has prescribed, you may have to drain off some of the medicine prior to injection. The syringe has markings for 180 mcg, 135 mcg, and 90 mcg (see visual C). Your doctor will tell you which mark to use.

  • Once you know which mark to use, slowly and carefully push down on the red plunger rod of the syringe to push out excess medicine. Keep pushing down until the edge of the plunger stopper reaches the right mark on the side of the syringe
  • Visual C
  • DO NOT decrease your PEGASYS dose unless your doctor tells you to
  • DO NOT save or reuse any medication discharged from the syringe

Step 8: Perform the self-injection

  • Position the point of the needle (the bevel) so it's facing up (see visual D)
  • Pinch a fold of skin on the stomach or thigh firmly with your thumb and forefinger (see visuals E, F)
  • Hold the syringe like a pencil at a 45º to 90º angle over your skin, and in a quick motion, insert the needle as far as it will go into the pinched area of skin

Visual D Visual EVisual F

CHECKPOINT: Pull the plunger of the syringe back very slightly. If blood comes into the syringe, the needle has entered a blood vessel. DO NOT INJECT. Withdraw needle and discard syringe as outlined in Phase 3 (Cleaning up). Repeat the Phase 2 steps with a new prefilled syringe.

  • If no blood appears, release your skin and slowly push the plunger all the way down so that you get all of your medicine
  • Pull out the needle at the same angle you inserted it. Wipe the area clean with an alcohol pad.

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Phase 3: Cleaning up

Before you throw out the syringe and needle, place free end of the orange needle guard on a flat surface and push down on it until it clicks and covers the needle (see visual G). ALWAYS put used syringes and needles in a sharps container immediately after use (see visual H).

NEVER REUSE SYRINGES AND NEEDLES.

Visual GVisual H

Safety Information

What is PEGASYS?

PEGASYS is a medicine used to treat some adults who have hepatitis C and signs of liver damage. PEGASYS works to reduce the amount of virus in your blood, helping your body fight the virus.

PEGASYS® (Peginterferon alfa-2a), like other alpha interferons, can cause fatal or make life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In most patients, these conditions get better after you stop taking PEGASYS (see medication guide for more information and warnings).

What is COPEGUS?

COPEGUS is a medicine that works by slowing down the growth of the virus. COPEGUS should be taken with PEGASYS to fight the virus. Do not take COPEGUS by itself.

COPEGUS® (Ribavirin, USP) can be extremely harmful and cause birth defects in an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse. Also, ribavirin can harm your DNA and possibly cause cancer (see medication guide for more information and warnings).

Who should not take PEGASYS and COPEGUS?

Do not take PEGASYS alone or with COPEGUS if:

  • You are pregnant or your partner is pregnant
  • You or your partner plans to get pregnant during therapy or within 6 months after treatment ends
  • You are breastfeeding
  • You have hepatitis caused by your immune system (autoimmune hepatitis)
  • You have unstable or severe liver disease before or during treatment
  • You are allergic to alpha interferons or any of the ingredients in PEGASYS and COPEGUS
  • You have abnormal red blood cells (caused by conditions like sickle-cell anemia or thalassemia major)

What if I am pregnant or thinking about having a baby?

If you are a woman who could get pregnant, you must take pregnancy tests before, during and for 6 months after treatment ends to make sure you are not pregnant.

During treatment and for 6 months after treatment, female and male patients must:

  • Use two forms of birth control (one being a condom with spermicide)
  • Tell your doctor right away if you or your partner becomes pregnant. You or
    your doctor should also call the Ribavirin Pregnancy Registry at 1-800-593-2214

What medication should I avoid when I am taking PEGASYS and COPEGUS?

You should not take didanosine with COPEGUS. Talk to your doctor about all medications that you are taking.

What are the possible side effects?

The most common side effects of PEGASYS and COPEGUS are:

  • Flu-like symptoms (including fever, chills, muscle aches, joint pain, headaches)
  • Tiredness
  • Upset stomach (like nausea, taste changes, diarrhea)
  • Blood sugar problems (may lead to diabetes)
  • Skin problems (like rash, dry or itchy skin, redness and swelling at injection site)
  • Hair loss (temporary)
  • Trouble sleeping

The most serious side effects of PEGASYS and COPEGUS are:

  • Risks to pregnancies
  • Mental health problems (such as irritability, depression, anxiety, aggressiveness, trouble with drug addiction or overdose, thoughts about suicide, suicide attempts, suicide and thoughts about homicide)
  • Blood problems (like a drop in blood cells leading to increased risk for infections, bleeding and/or heart or circulatory problems)
  • Infections (which sometimes cause death)
  • Lung problems (like trouble breathing, pneumonia)
  • Eye problems (like blurred vision, loss of vision)
  • Autoimmune problems (such as psoriasis, thyroid problems)
  • Heart problems (including chest pain and, rarely, a heart attack)
  • Liver problems (rarely, liver function worsens). Patients with both the hepatitis C virus and HIV can have an increased chance of having liver failure during PEGASYS treatment. Change in a blood test that measures liver inflammation occurs more often in patients with hepatitis B. If you have a rise in this blood test you may need to be watched more closely with additional blood tests.

Tell your doctor immediately if you think you or your partner may be pregnant or if any of these symptoms occur.

This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.

Please see the medication guides and complete product information for PEGASYS and COPEGUS.

 

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