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Pegasys (Peginterferon Alfa-2a) - Indications and Dosage

 
 



INDICATIONS AND USAGE

PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).

DOSAGE AND ADMINISTRATION

There are no safety and efficacy data on treatment for longer than 48 weeks. Consideration should be given to discontinuing therapy after 12 to 24 weeks of therapy if the patient has failed to demonstrate an early virologic response (see CLINICAL STUDIES).

PEGASYS

The recommended dose of PEGASYS monotherapy is 180 µg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.

PEGASYS AND COPEGUS COMBINATION

The recommended dose of PEGASYS when used in combination with ribavirin is 180 µg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly. The recommended dose of COPEGUS and duration for PEGASYS/COPEGUS therapy is based on viral genotype (see Table 5).

The daily dose of COPEGUS is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (eg, genotype), response to therapy, and tolerability of the regimen.

Since COPEGUS absorption increases when administered with a meal, patients are advised to take COPEGUS with food.

Table 5    PEGASYS and COPEGUS Dosing Recommendations
Genotype PEGASYS Dose COPEGUS Dose Duration
Genotype 1, 4 180 µg <75 kg = 1000 mg
>/=75 kg = 1200 mg
48 weeks
48 weeks
Genotype 2, 3 180 µg 800 mg 24 weeks
Genotypes 2 & 3 showed no increased response to treatment beyond 24 weeks (see Table 3). Data on genotypes 5 and 6 are insufficient for dosing recommendations.

A patient should self-inject PEGASYS only if the physician determines that it is appropriate and the patient agrees to medical follow-up as necessary and training in proper injection technique has been provided to him/her (see illustrated PEGASYS MEDICATION GUIDE for directions on injection site preparation and injection instructions).

PEGASYS should be inspected visually for particulate matter and discoloration before administration, and not used if particulate matter is visible or product is discolored. Vials and prefilled syringes with particulate matter or discoloration should be returned to the pharmacist.

DOSE MODIFICATIONS

If severe adverse reactions or laboratory abnormalities develop during combination COPEGUS/PEGASYS therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, COPEGUS/PEGASYS therapy should be discontinued.

PEGASYS

GENERAL

When dose modification is required for moderate to severe adverse reactions (clinical and/or laboratory), initial dose reduction to 135 µg (which is 0.75 mL for the vials or adjustment to the corresponding graduation mark for the syringes) is generally adequate. However, in some cases, dose reduction to 90 µg (which is 0.5 mL for the vials or adjustment to the corresponding graduation mark for the syringes) may be needed. Following improvement of the adverse reaction, re-escalation of the dose may be considered (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).

HEMATOLOGICAL

Table 6    PEGASYS Hematological Dose Modification Guidelines
Laboratory Values PEGASYS Dose Reduction Discontinue PEGASYS if:
ANC <750/mm3 135 µg ANC <500/mm3, treatment should be suspended until ANC values return to more than 1000/mm3.
         Reinstitute at 90 µg and monitor ANC
Platelet <50,000/mm3 90 µg Platelet count <25,000/mm3

PSYCHIATRIC: DEPRESSION

Table 7    Guidelines for Modification or Discontinuation of PEGASYS and for Scheduling Visits for Patients with Depression
Depression Severity Initial Management (4-8 weeks) Depression
Dose modification Visit schedule Remains stable Improves Worsens
Mild No change Evaluate once weekly by visit and/or phone Continue weekly visit schedule Resume normal visit schedule (See moderate or severe depression)
Moderate Decrease PEGASYS dose to 135 µg (in some cases dose reduction to 90 µg may be needed) Evaluate once weekly (office visit at least every other week) Consider psychiatric consultation. Continue reduced dosing If symptoms improve and are stable for 4 weeks, may resume normal visit schedule. Continue reduced dosing or return to normal dose (See severe depression)
Severe Discontinue PEGASYS permanently Obtain immediate psychiatric consultation Psychiatric therapy necessary

RENAL FUNCTION

In patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 µg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored.

LIVER FUNCTION

In patients with progressive ALT increases above baseline values, the dose of PEGASYS should be reduced to 135 µg. If ALT increases are progressive despite dose reduction or accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be immediately discontinued.

COPEGUS

Table 8    COPEGUS Dosage Modification Guidelines
Laboratory Values Reduce Only
COPEGUS Dose to 600 mg/day * if:
Discontinue COPEGUS if:
Hemoglobin in patients with no cardiac disease <10 g/dL <8.5 g/dL
Hemoglobin in patients with history of stable cardiac disease >/=2 g/dL decrease in hemoglobin during any
4 week period treatment
<12 g/dL despite 4 weeks at reduced dose
* One 200 mg tablet in the morning and two 200 mg tablets in the evening.

Once COPEGUS has been withheld due to a laboratory abnormality or clinical manifestation, an attempt may be made to restart COPEGUS at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that COPEGUS be increased to the original dose (1000 mg or 1200 mg).

RENAL IMPAIRMENT

COPEGUS should not be used in patients with creatinine clearance <50 mL/min (see WARNINGS and COPEGUS Package Insert).

HOW SUPPLIED

SINGLE DOSE VIAL

Each PEGASYS (peginterferon alfa-2a) 180 µg single use, clear glass vial provides 1.0 mL containing 180 µg peginterferon alfa-2a for sc injection. Each package contains 1 vial (NDC 0004-0350-09).

VIALS MONTHLY CONVENIENCE PACK

Four vials of PEGASYS (peginterferon alfa-2a), 180 µg single use, clear glass vials, in a box with 4 syringes and 8 alcohol swabs (NDC 0004-0350-39). Each syringe is a 1 mL(1 cc) volume syringe supplied with a 27 gauge, 1/2 inch needle with needle-stick protection device.

PREFILLED SYRINGES MONTHLY CONVENIENCE PACK

Four prefilled syringes of PEGASYS (peginterferon alfa-2a), 180 µg single use, graduated, clear glass prefilled syringes, in a box with 4 needles and 4 alcohol swabs (NDC 0004-0352-39). Each syringe is a 0.5 mL (1/2 cc) volume syringe supplied with a 27 gauge, 1/2 inch needle with needle-stick protection device.

STORAGE

Store in the refrigerator at 2° to 8°C (36° to 46°F). Do not freeze or shake. Protect from light. Vials and prefilled syringes are for single use only. Discard any unused portion.

REBETRON™ is a trademark of Schering Corporation.

Revised: December 2003

MEDICATION GUIDE

PEGASYS®

(peginterferon alfa-2a)

Before you start taking PEGASYS (PEG-ah-sis), alone or in combination with COPEGUS® (Co-PEG-UHS), please read this Medication Guide carefully. Read this Medication Guide each time you refill your prescription in case new information has been added and make sure the pharmacist has given you the medicine your healthcare provider prescribed for you. Reading the information in this Medication Guide does not take the place of talking with your healthcare provider.

If you are taking PEGASYS in combination with COPEGUS, you should also read the Medication Guide for COPEGUS (ribavirin, USP) Tablets.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PEGASYS THERAPY?

PEGASYS, taken alone or in combination with COPEGUS, is a treatment for some people who are infected with hepatitis C virus. However, PEGASYS and COPEGUS can have serious side effects that may cause death in rare cases. Before starting PEGASYS therapy, you should talk with your healthcare provider about the possible benefits and the possible side effects of treatment, to decide if either of these treatments is right for you. If you begin treatment you will need to see your healthcare provider regularly for examinations and blood tests to make sure your treatment is working and to check for side effects.

The most serious possible side effects of PEGASYS taken alone or in combination with COPEGUS include:

Risks to Pregnancy:

Taking PEGASYS in combination with COPEGUS tablets can cause death, serious birth defects or other harm to your unborn child. If you are a woman of childbearing age, you must have negative pregnancy tests just before beginning treatment, during treatment, and for 6 months after you have stopped treatment. You must not become pregnant while either you or your partner are being treated with the PEGASYS/COPEGUS combination therapy or for 6 months after stopping therapy. Men and women should use two forms of birth control while taking the combination therapy and for the 6 months after treatment is completed. If you are a man, one of the two forms of birth control should be a condom. You must use birth control even if you believe that you are not fertile or that your fertility is low. You should talk to your healthcare provider about birth control for you and your partner.

If you are pregnant, you or your male partner must not take PEGASYS/COPEGUS combination therapy. If you or your partner are being treated and you become pregnant either during treatment or within 6 months of stopping treatment, call your healthcare provider right away.

Mental health problems:

PEGASYS may cause some patients to develop mood or behavioral problems. Signs of these problems include irritability (getting easily upset), depression (feeling low, feeling bad about yourself or feeling hopeless), and anxiety. Some patients may have aggressive behavior. Some patients may develop thoughts about ending their lives (suicidal thoughts) and may attempt to do so. A few patients have even ended their lives. Former drug addicts may fall back into drug addiction or overdose. You must tell your healthcare provider if you are being treated for a mental illness or have a history of mental illness or if you are or have ever been addicted to drugs or alcohol. Call your healthcare provider immediately if you develop any of these problems while on PEGASYS treatment.

Blood problems:

Many patients taking PEGASYS have had a drop in the number of their white blood cells and their platelets. If the numbers of these blood cells are too low, you could be at risk for serious infections or bleeding.

COPEGUS causes a decrease in the number of your red blood cells (anemia). This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. If you have or have ever had any cardiovascular problems, talk with your healthcare provider before taking the combination of PEGASYS and COPEGUS.

Infections:

Some patients taking interferon have had serious infections. Sometimes these infections have been fatal. If you develop a fever that does not go away or gets higher, call your healthcare provider right away. Your healthcare provider will need to examine you to rule out your having a serious infection.

Body organ problems:

Some patients may experience lung problems (such as difficulty breathing or pneumonia) and eye problems that can cause blurred vision or loss of your vision.

Call your healthcare provider immediately if you develop any of these conditions:

  • You become very depressed or think about suicide
  • You have severe chest pain
  • You have trouble breathing
  • You have a change in your vision
  • You become pregnant
  • You notice unusual bleeding or bruising
  • You have psoriasis (a skin disease) and it gets worse while taking PEGASYS
  • High fever or a fever that does not go away
  • You have severe stomach pain or lower back pain
  • Bloody diarrhea

For more information on possible side effects with PEGASYS therapy, alone or in combination with COPEGUS, please read the section on "What are the possible side effects of PEGASYS, and PEGASYS taken with COPEGUS?" in this Medication Guide. You should also read the Medication Guide for COPEGUS tablets if you are taking that medicine with PEGASYS.

WHAT IS PEGASYS?

PEGASYS is a drug used to treat adults who have a lasting (chronic) infection with hepatitis C virus and who show signs that the virus is damaging the liver. Patients with hepatitis C have the virus in their blood and in their liver. PEGASYS reduces the amount of virus in the body and helps the body's immune system fight the virus. The drug COPEGUS are tablets that may be taken with PEGASYS to help fight the virus infection. Do not take COPEGUS by itself.

In some patients that have received PEGASYS treatment for approximately one year, the amount of the hepatitis C virus in the body was decreased to a level so low that it could not be measured by blood tests. After 3 months of therapy, your healthcare provider may ask you to have a blood test to help determine how you are responding to your treatment.

It is not known if PEGASYS, used alone or in combination with COPEGUS, can cure hepatitis C (permanently eliminate the virus) or if it can prevent liver failure or liver cancer that is caused by hepatitis C infection.

It is also not known if PEGASYS, alone or in combination with COPEGUS, will prevent one infected person from infecting another person with hepatitis C.

WHO SHOULD NOT TAKE PEGASYS, OR PEGASYS WITH COPEGUS?

Do not take PEGASYS or PEGASYS/COPEGUS therapy if you:

  • are pregnant, planning to get pregnant during treatment or during the 6 months after treatment or breast-feeding
  • are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with COPEGUS or during the 6 months after your treatment has ended
  • have hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) or unstable liver disease
  • had an allergic reaction to another alpha interferon or are allergic to any of the ingredients in PEGASYS or COPEGUS tablets
  • Do not take PEGASYS, alone or in combination with COPEGUS, if you have abnormal red blood cells such as sickle-cell anemia or thalassemia major.

If you have ever had any of the following conditions or serious medical problems, tell your healthcare provider before you start taking PEGASYS:

  • History of or current severe mental illness (such as depression or anxiety)
  • History of drug or alcohol addiction or abuse
  • History of heart disease or previous heart attack
  • History of cancer
  • Autoimmune disease (where the body's immune system attacks the body's own cells), such as psoriasis (a skin disease), systemic lupus erythematosus, rheumatoid arthritis
  • Kidney problems
  • Blood disorders
  • You take a medicine called theophylline
  • Diabetes (high blood sugar)
  • Problems with the thyroid gland
  • Liver problems, other than hepatitis C
  • Hepatitis B infection
  • HIV infection
  • Colitis (an inflammation of the bowels)

You should tell your healthcare provider if you are taking or planning to take other prescription or nonprescription medicines or vitamin and mineral supplements or herbal medicines.

If you have any questions about your health condition or about taking PEGASYS alone or in combination with COPEGUS, you should talk to your healthcare provider.

HOW SHOULD I TAKE PEGASYS, OR PEGASYS WITH COPEGUS?

PEGASYS is given by injection under the skin (subcutaneous injection). PEGASYS comes in two different forms (a liquid in a single use vial and a liquid in a prefilled syringe). Your healthcare provider will determine which is best for you. Your healthcare provider will also decide whether you will take PEGASYS alone or with COPEGUS. Your dose of PEGASYS is given as a single injection once per week. At some point, your healthcare provider may change your dose of PEGASYS or COPEGUS. Do not change your dose unless your healthcare provider tells you to change it. It is important that you take PEGASYS and COPEGUS exactly as your healthcare provider tells you. Once you start treatment with PEGASYS, do not switch to another brand of interferon without talking to your healthcare provider. Other interferons may not have the same effect on the treatment of your disease. Switching brands will also require a change in your dose.

Take your prescribed dose of PEGASYS once a week, on the same day of each week and at approximately the same time. Your total dose of COPEGUS tablets should be divided so you take it twice a day with food (breakfast and dinner). Taking half your dose of COPEGUS in the morning and the other half at night will keep the medicine in your body at a steady level. Do not take more than your prescribed dose of PEGASYS or COPEGUS. Be sure to read the Medication Guide for COPEGUS (ribavirin, USP) for complete instructions on how to take the COPEGUS tablets.

Your healthcare provider will train you and/or the person that will be giving you the PEGASYS injections on the proper way to give injections. Whether you give yourself the injection or another person gives the injection to you, it is important that you are comfortable with preparing and injecting a dose of PEGASYS, and you understand the instructions in "How do I inject PEGASYS?" At the end of this guide (see Appendix) there are detailed instructions on how to prepare and give yourself an injection of PEGASYS using the form your healthcare provider has prescribed for you.

If you miss a dose and you remember within 2 days of when you should have taken PEGASYS, give yourself an injection of PEGASYS as soon as you remember. Take your next dose on the day you would usually take it. If more than 2 days have passed, ask your healthcare provider what you should do. If you miss a dose of COPEGUS, take the missed dose as soon as you remember during the same day. Do not take 2 doses too close together in time. If it is late in the day, wait until the next day and go back on schedule. Do not double the next dose.

If you take more than the prescribed amount of PEGASYS, call your healthcare provider right away. Your healthcare provider may want to examine you and take blood for testing.

You must get regular blood tests to help your healthcare provider check how the treatment is working and to check for side effects.

WHAT SHOULD I AVOID WHILE TAKING PEGASYS, OR PEGASYS WITH COPEGUS?

  • If you are pregnant do not start taking or continue taking COPEGUS in combination with PEGASYS.
  • Avoid becoming pregnant while taking PEGASYS, alone or in combination with COPEGUS. PEGASYS, alone or in combination with COPEGUS, may harm your unborn child (death or serious birth defects) or cause you to lose your baby (miscarry). If you or your partner become pregnant during or within 6 months after treatment with COPEGUS, immediately report the pregnancy to your healthcare provider. You or your healthcare provider should call 1-800-526-6367. When you call this number, you will be asked for information about you and/or your partner that will be added to a pregnancy registry. This information will be used to help you and your healthcare provider make decisions about your treatment for hepatitis in the future. You, your partner and/or your healthcare provider may also be asked follow-up information on the outcome of the pregnancy.
  • Do not breast-feed your baby while on PEGASYS, alone or in combination with COPEGUS.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF PEGASYS, AND PEGASYS TAKEN WITH COPEGUS?

Possible, serious side effects include:

  • Risk to pregnancy, mental health problems including suicidal thoughts, blood problems, infections, and body organ problems: See "What is the most important information I should know about PEGASYS therapy?" in this Medication Guide.
  • Autoimmune problems: Some patients may develop a disease where the body's own immune system begins to attack itself (autoimmune disease) while on PEGASYS therapy. These diseases can include psoriasis or thyroid problems. In some patients who already have an autoimmune disease, the disease may worsen while on PEGASYS therapy.
  • Heart problems: PEGASYS may cause some patients to experience chest pain, and very rarely a heart attack. Patients who already have heart disease could be at greatest risk. Tell your healthcare provider if you have or have had a heart problem in the past.
    Common, but less serious, side effects include:
  • Flu-like symptoms: Most patients who take PEGASYS have flu-like symptoms that usually lessen after the first few weeks of treatment. Flu-like symptoms may include fever, chills, muscle aches, joint pain, and headaches. Taking pain and fever reducers such as acetaminophen or ibuprofen before you take PEGASYS can help with these symptoms. You can also try taking PEGASYS at night. You may be able to sleep through the symptoms.
  • Extreme fatigue (tiredness): Many patients may become extremely tired while on PEGASYS therapy.
  • Upset stomach: Nausea, taste changes, diarrhea, and loss of appetite occur commonly.
  • Blood sugar problems: Some patients may develop a problem with the way their body controls their blood sugar and may develop diabetes.
  • Skin reactions: Some patients may develop rash, dry or itchy skin, and redness and swelling at the site of injection.
  • Hair thinning: Temporary hair loss is not uncommon during treatment with PEGASYS.
  • Trouble sleeping

These are not all of the side effects of PEGASYS, and PEGASYS taken with COPEGUS. Your healthcare provider or pharmacist can give you a more complete list.

Talk to your healthcare provider if you are worried about side effects or find them very bothersome.

General advice about prescription medicines

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns or questions about PEGASYS, contact your healthcare provider. Do not use PEGASYS for a condition or person other than that for which it is prescribed. If you want to know more about PEGASYS, your healthcare provider or pharmacist will be able to provide you with detailed information that is written for healthcare providers.

If you are taking COPEGUS (ribavirin, USP) in combination with PEGASYS, also read the Medication Guide supplied with that medicine.

Keep this and all drugs out of the reach of children.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: December 2003

Medication Guide Appendix: Instructions for Preparing and Giving a Dose with a PEGASYS® Prefilled Syringe

HOW SHOULD I STORE PEGASYS PREFILLED SYRINGES?

PEGASYS must be stored in the refrigerator at a temperature of 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS outside of the refrigerator for more than 24 hours. Do not freeze PEGASYS. Keeping PEGASYS at temperatures outside the recommended range can destroy the medicine.

Each PEGASYS prefilled syringe can only be used once. Discard after use.

Do not shake the prefilled syringe of PEGASYS. If PEGASYS is shaken too hard, it will not work properly. Protect PEGASYS from light during storage.

Keep this and all other medicines out of the reach of children.

HOW DO I PREPARE AND INJECT PEGASYS?

You should read through all of these directions and ask your healthcare provider for help if you have any questions before trying to give yourself an injection. It is important to follow these directions carefully. Talk to your healthcare provider if you have any questions about PEGASYS.

Your healthcare provider may not want you to take all the medicine that comes in the prefilled syringe. To appropriately administer the dose that your healthcare provider tells you to take, you may have to get rid of some of the medicine before injecting the medicine.

If you ever switch between using prefilled syringes and vials, talk to your healthcare provider about how much PEGASYS to use. Equal volumes of liquid from the prefilled syringes and the vials DO NOT contain the same amount of PEGASYS. If you switch between prefilled syringes and vials, you will have to adjust the volume of liquid that you use to give your injection. If you do not adjust this, you could accidentally take too much or too little of your medicine.

If you are giving this injection to someone else, a healthcare provider must teach you how to avoid needle sticks. Being stuck by a used needle can pass diseases on to you.

The prefilled syringes are used for injecting PEGASYS under the surface of the skin (subcutaneous).

1. Collect all the materials you will need before you start to give the injection:

· One PEGASYS prefilled syringe Monthly Convenience Pack containing an inner carton holding the PEGASYS prefilled syringe

· A puncture-resistant container for cleaning up when you are finished

2. Open the convenience pack and look at the contents.

· Each convenience pack has everything you need for the PEGASYS injection.

- 4 single use syringes filled with medicine (should be colorless to light yellow)

- four 27 gauge, 1/2 inch needles with needle stick protection device

- 4 alcohol swabs

· Do not use PEGASYS if:

- the medicine is cloudy

- the medicine has particles floating in it

- the medicine is any color besides colorless to light yellow

- the expiration date has passed

3. Warm the refrigerated medicine by gently rolling it in the palms of your hands for about one minute. Do not shake.

4. Wash your hands with soap and warm water to prevent infection.

5. Attachment of the needle to the PEGASYS prefilled syringe:

· Remove the needle from its package. Do not remove the needle shield yet. Keep the needle covered until just before you give the injection.

· Remove and discard the rubber cap from the tip of the syringe barrel.

· Put the needle onto the end of the syringe barrel so it fits tightly.

· Here is a picture of the assembled syringe:

· Keep the syringe in a horizontal position until ready for use.

· If you need to set the syringe down, make sure the plastic shield covers the needle. Never let the needle touch any surface.

6. Decide where you will give the injection.

· Pick a place on your stomach or thigh (see the picture at right). Avoid your navel and waistline. You should use a different place each time you give yourself an injection.

7. Prepare your skin for the injection.

· To minimize the discomfort from injections, you may want to gently tap the area where you plan to give yourself an injection.

· Clean the area using the alcohol pad. Let the skin dry for 10 seconds.

8. Uncover the needle.

· Remove the plastic safety shield covering the needle. Do not remove the orange cap that is attached to the end of the syringe and above the needle that is the needle-stick protection device.

9. Remove air bubbles from the syringe.

· Hold the syringe with the needle pointing up to the ceiling.

· Using your thumb and finger, tap the syringe to bring air bubbles to the top.

· Press the plunger in slightly to push air bubbles out of the syringe.

· Your healthcare provider may not want you to take all the medicine that comes in the prefilled syringe.

· To appropriately administer the dose that your healthcare provider tells you to take, you may have to get rid of some of the medicine before injecting the medicine.

· The syringe has markings for 180 mcg, 135 mcg, and 90 mcg. Your healthcare provider will tell you which mark to use.

· Once you know which mark to use, slowly and carefully press on the plunger rod of the syringe to push out medicine from the syringe. Keep pressing until the edge of the plunger stopper reaches the right mark on the side of the syringe.

· Do not decrease or increase your dose of PEGASYS unless your healthcare provider tells you to.

10. Give the injection of PEGASYS.

· Position the point of the needle (the bevel) so it is facing up.

· Pinch a fold of skin on your stomach or thigh firmly with your thumb and forefinger.

· Hold the syringe like a pencil at a 45° to 90° angle to your skin. In one quick motion, insert the needle as far as it will go into the pinched area of skin. 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 the needle and discard the syringe as outlined in step 11. Repeat the above steps with a new prefilled syringe and prepare a new site.

· 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 same angle you put it in.

· Wipe the area with an alcohol swab.

11. For safety reasons, before you dispose of the syringe and needle, place the free end of the orange cap on a flat surface and push down on it until it clicks and covers over the needle. Always place used syringes and needles in a puncture-resistant container immediately after use and never reuse them. Keep your disposal container out of the reach of children.

HOW SHOULD I DISPOSE OF MATERIALS USED TO INJECT PEGASYS?

There may be special state and local laws for disposal of used needles and syringes. Your healthcare provider or pharmacist should provide you with instructions on how to properly dispose of your used syringes and needles. Always follow these instructions.

The instructions below should be used as a general guide for proper disposal:

  • The needles and syringes should never be reused.
  • Place all used needles and syringes in a puncture-proof disposable container that is available through your pharmacy or healthcare provider (Sharp's container).
  • DO NOT use glass or clear plastic containers for disposal of needles and syringes.
  • Dispose of the full container as instructed by your healthcare provider or pharmacist.

DO NOT throw the container in your household trash. DO NOT recycle. Keep the container out of the reach of children.

Appendix revision date: December 2003

Medication Guide Appendix: Instructions for Preparing and Giving a Dose with a PEGASYS® Vial

HOW SHOULD I STORE PEGASYS VIALS?

PEGASYS must be stored in the refrigerator at a temperature of 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS outside of the refrigerator for more than 24 hours. Do not freeze PEGASYS. Keeping PEGASYS at temperatures outside the recommended range can destroy the medicine.

Each PEGASYS vial can only be used once. Discard after use.

Do not shake the vial of PEGASYS. If PEGASYS is shaken too hard, it will not work properly.

Protect PEGASYS from light during storage.

Keep this and all other medicines out of the reach of children.

HOW DO I INJECT PEGASYS?

The following instructions will help you learn how to measure your dose and give yourself an injection of PEGASYS. You should read through all of these directions and ask your healthcare provider for help if you have any questions before trying to give yourself an injection. It is important to follow these directions carefully. Talk to your healthcare provider if you have any questions about PEGASYS.

If you are giving an injection to someone else, a healthcare provider must teach you how to avoid needle sticks. Being stuck by a used needle can pass diseases on to you.

1. Collect all the materials you will need before you start to give the injection:

· One vial of PEGASYS

· One syringe and needle

· Several alcohol pads

· A puncture-resistant container to dispose of the needle and syringe when you are finished

If you have received the PEGASYS Convenience Pack, it includes PEGASYS, safety syringes and needles with a needle-stick protection device attached, and alcohol swabs.

2. Check the date on the carton the PEGASYS comes in and make sure the expiration date has not passed, then remove a vial from the package and look at the medicine.

· Do not use PEGASYS if:

- the medicine is cloudy

- the medicine has particles floating in it

- the medicine is any color besides colorless to light yellow

- the expiration date has passed

3. Warm the refrigerated medicine by gently rolling it in the palms of your hands for about one minute. Do not shake.

4. Wash your hands with soap and warm water to prevent infection.

5. Take the vial of PEGASYS and flip off the plastic top covering the vial opening, and clean the rubber stopper on the top of the vial with a different alcohol pad.

If you are not sure how much medicine to use or which mark to use, STOP and call your healthcare provider right away.

6. Remove the needle and syringe from their packaging and attach the needle to the end of the syringe.

· If you are using a syringe and needle supplied with the PEGASYS Convenience Pack, the needle is already attached to the syringe and it will have a needle-stick protection device attached. Remove the clear protective cap from the end of the needle. Do not remove the orange cap that is attached to the end of the syringe and above the needle that is the needle-stick protection device.

· Pull the plunger back so the end of it is to the mark on the syringe barrel that matches the dose prescribed for you by your healthcare provider. This will pull air into the syringe barrel.

· Push the needle through the center of the stopper on the vial.

· Slowly inject all the air from the syringe into the air space above the solution. Do not inject air into the fluid.

· Keep the needle inside the vial and turn both upside down. Hold the vial and syringe straight up. Slowly pull back on the plunger until the medicine is in the syringe up to the mark that matches your dose. Make sure the needle tip always stays in the medicine (not in the air space above it).

· When the medicine is up to the right mark on the syringe barrel, take the syringe and needle out of the rubber stopper on the vial.

· Keep the syringe pointing up until you are ready to use it.

· If you need to set the syringe down, make sure that you never let the needle touch any surface.

7. Remove air bubbles from the syringe.

· Hold the syringe with the needle pointing up to the ceiling.

· Using your thumb and finger, tap the syringe to bring air bubbles to top.

· Press the plunger in slightly to push air bubbles out of the syringe.

8. Decide where you will give the injection.

· Pick a place on your stomach or thigh (see the picture below). Avoid your navel and waistline. You should use a different place each time you give yourself an injection.

9.Prepare your skin for the injection.

· To minimize the discomfort from injections, you may want to gently tap the area where you plan to give yourself an injection.

· Clean the area using an alcohol pad. Let the skin dry for 10 seconds.

10. Give the injection of PEGASYS.

· Position the point of the needle (the bevel) so it is facing up.

· Pinch a fold of skin on your stomach or thigh firmly between your thumb and forefinger.

· Hold the syringe like a pencil at a 45° to 90° angle to your skin. In one quick motion, insert the needle as far as it will go into the pinched area of skin. 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 the needle and discard the syringe as outlined in step 11. Repeat the above steps with a new vial and syringe and prepare a new site.

· 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 same angle you put it in. Wipe the area with an alcohol pad.

11. For safety reasons, always place used syringes and needles in a puncture-resistant container immediately after use and never reuse them.

· If you are using a syringe with a needle-stick protection device, before you dispose of the syringe and needle, place the free end of the orange cap on a flat surface and push down on it until it clicks and covers over the needle.

HOW SHOULD I DISPOSE OF MATERIALS USED TO INJECT PEGASYS?

There may be special state and local laws for disposal of used needles and syringes. Your healthcare provider or pharmacist should provide you with instructions on how to properly dispose of your used syringes and needles. Always follow these instructions.

The instructions below should be used as a general guide for proper disposal:

  • The needles and syringes should never be reused.
  • Place all used needles and syringes in a puncture-proof disposable container that is available through your pharmacy or healthcare provider (Sharp's container).
  • DO NOT use glass or clear plastic containers for disposal of needles and syringes.
  • Dispose of the full container as instructed by your healthcare provider or pharmacist.

DO NOT throw the container in your household trash. DO NOT recycle. Keep the container out of the reach of children.

Appendix revision date: December 2003

Hoffmann-La Roche Inc., Nutley, New Jersey 07110-1199

U.S. Govt. Lic. No. 0136

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