DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

PEG-Intron (Peginterferon Alfa-2B) - Indications and Dosage

 
 



INDICATIONS AND USAGE

PEG-Intron, peginterferon alfa-2b, is indicated for use alone or in combination with REBETOL (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

DOSAGE AND ADMINISTRATION

There are no safety and efficacy data on treatment for longer than one year. A patient should self-inject PEG-Intron 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 given to him/her. (See illustrated MEDICATION GUIDE for instructions.)

It is recommended that patients receiving PEG-Intron, alone or in combination with ribavirin, be discontinued from therapy if HCV viral levels remain high after 6 months of therapy.

PEG-INTRON MONOTHERAPY

The recommended dose of PEG-Intron regimen is 1.0 µg/kg/week subcutaneously for one year. The dose should be administered on the same day of the week.

The volume of PEG-Intron to be injected depends on the patient weight (see Table 4 below).

TABLE 4. Recommended PEG-Intron Monotherapy Dosing
Body
weight (kg)
PEG-Intron Redipen™
or Vial Strength to Use
Amount of
PEG-Intron (µg) to Administer
Volume (mL) * of
PEG-Intron to Administer
</=45
46-56
50 µg per 0.5 mL   40
  50
0.4
0.5
57-72
73-88
80 µg per 0.5 mL   64
  80
0.4
0.5
89-106
107-136
120 µg per 0.5 mL   96
120
0.4
0.5
137-160 150 µg per 0.5 mL 150 0.5
* When reconstituted as directed

PEG-INTRON/REBETOL COMBINATION THERAPY

When administered in combination with REBETOL, the recommended dose of PEG-Intron is 1.5 micrograms/kg/week. The volume of PEG-Intron to be injected depends on the strength of PEG-Intron and patient's body weight. (See Table 5 below).

TABLE 5. Recommended PEG-Intron Combination Therapy Dosing
Body
weight (kg)
PEG-Intron Redipen™
or Vial Strength to Use
Amount of
PEG-Intron (µg) to Administer
Volume (mL) * of
PEG-Intron to Administer
<40 50 µg per 0.5 mL   50 0.5
40-50
51-60
80 µg per 0.5 mL   64
  80
0.4
0.5
61-75
76-85
120 µg per 0.5 mL   96
120
0.4
0.5
>85 150 µg per 0.5 mL 150 0.5
* When reconstituted as directed

The recommended dose of REBETOL is 800 mg/day in 2 divided doses: two capsules (400 mg) with breakfast and two capsules (400 mg) with dinner. REBETOL should not be used in patients with creatinine clearance <50 mL/min.

DOSE REDUCTION

If a serious adverse reaction develops during the course of treatment (See WARNINGS) discontinue or modify the dosage of PEG-Intron and/or REBETOL until the adverse event abates or decreases in severity. If persistent or recurrent serious adverse events develop despite adequate dosage adjustment, discontinue treatment. For guidelines for dose modifications and discontinuation based on laboratory parameters, see Tables 6 and 7. In the combination therapy trial dose reductions occurred among 42% of patients receiving PEG-Intron 1.5 µg/kg/REBETOL 800 mg daily including 57% of those patients weighing 60 kg or less (see ADVERSE REACTIONS).

TABLE 6. Guidelines for Modification or Discontinuation of PEG-Intron or PEG-Intron/REBETOL and for Scheduling Visits for Patients with Depression
Depression
Severity 1
       
Initial Management (4-8 wks) 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 IFN dose 50% Evaluate once weekly (office visit at least every other week). Consider psychiatric consultation. Continue reduced dosing. If symptoms improve and are stable for 4 wks, may resume normal visit schedule. Continue reducing dosing or return to normal dose. (See severe depression)
Severe Discontinue IFN/R permanently. Obtain immediate psychiatric consultation. Psychiatric therapy necessary
1 See DSM-IV for definitions

TABLE 7. Guidelines for Dose Modification and Discontinuation of PEG-Intron or PEG-Intron/REBETOL for Hematologic Toxicity
Laboratory Values PEG-Intron REBETOL
Hgb * <10.0 g/dL         ------------------------ Decrease by 200 mg/day  
<8.5 g/dL        Permanently discontinue Permanently discontinue
WBC <1.5 × 109/L        Reduce dose by 50%   ------------------------
<1.0 × 109/L        Permanently discontinue Permanently discontinue
Neutrophils <0.75 × 109/L        Reduce dose by 50%   ------------------------
<0.5 × 109/L        Permanently discontinue Permanently discontinue
Platelets <80 × 109/L        Reduce dose by 50%   ------------------------
<50 × 109/L        Permanently discontinue Permanently discontinue
* For patients with a history of stable cardiac disease receiving PEG-Intron in combination with ribavirin, the PEG-Intron dose should be reduced by half and the ribavirin dose by 200 mg/day if a >2g/dL decrease in hemoglobin is observed during any 4 week period. Both PEG-Intron and ribavirin should be permanently discontinued if patients have hemoglobin levels <12 g/dL after this ribavirin dose reduction.

PREPARATION AND ADMINISTRATION

PEG-INTRON REDIPEN™

PEG-Intron Redipen™ consists of a dual-chamber glass cartridge with sterile, lyophilized peginterferon alfa-2b in the active chamber and Sterile Water for Injection, USP in the diluent chamber. The PEG-Intron in the glass cartridge should appear as a white to off-white tablet shaped solid that is whole or in pieces, or powder. To reconstitute the lyophilized peginterferon alfa-2b in the Redipen™, hold the Redipen™ upright (dose button down) and press the two halves of the pen together until there is an audible click. Gently invert the pen to mix the solution. DO NOT SHAKE. The reconstituted solution has a concentration of either 50 µg per 0.5 mL, 80 µg per 0.5 mL, 120 µg per 0.5 mL, or 150 µg per 0.5 mL for a single subcutaneous injection. Visually inspect the solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and colorless. Do not use if the solution is discolored or cloudy, or if particulates are present.

Keeping the pen upright, attach the supplied needle and select the appropriate PEG-Intron dose by pulling back on the dosing button until the dark bands are visible and turning the button until the dark band is aligned with the correct dose. The prepared PEG-Intron solution is to be injected subcutaneously.

The PEG-Intron Redipen™ is a single use pen and does not contain a preservative. The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2°-8°C (See Storage). DO NOT REUSE THE REDIPEN™. The sterility of any remaining product can no longer be guaranteed. DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.

PEG-INTRON VIALS

Two B-D Safety-Lok™ syringes are provided in the package; one syringe is for the reconstitution steps and one for the patient injection. There is a plastic safety sleeve to be pulled over the needle after use. The syringe locks with an audible click when the green stripe on the safety sleeve covers the red stripe on the needle. Instructions for the preparation and administration of PEG-Intron Powder for Injection are provided below.

Reconstitute the PEG-Intron lyophilized product with only 0.7 mL of 1 mL of supplied diluent (Sterile Water for Injection, USP). The diluent vial is for single use only. The remaining diluent should be discarded. No other medications should be added to solutions containing PEG-Intron, and PEG-Intron should not be reconstituted with other diluents. Swirl gently to hasten complete dissolution of the powder. The reconstituted solution should be clear and colorless. Visually inspect the solution for particulate matter and discoloration prior to administration. The solution should not be used if discolored or cloudy, or if particulates are present.

The appropriate PEG-Intron dose should be withdrawn and injected subcutaneously. PEG-Intron vials are for single use only and do not contain a preservative. The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2°-8°C (See Storage). DO NOT REUSE THE VIAL. The sterility of any remaining product can no longer be guaranteed. DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.

After preparation and administration of the PEG-Intron for injection, it is essential to follow the state and or local procedures for proper disposal of syringes, needles, and the Redipen™. A puncture-resistant container should be used for disposal. Patients should be instructed in how to properly dispose of used syringes, needles, or the Redipen™ and be cautioned against the reuse of these items.

STORAGE

PEG-INTRON REDIPEN™

PEG-Intron Redipen™ should be stored at 2° to 8°C (36° to 46°F). After reconstitution, the solution should be used immediately, but may be stored up to 24 hours at 2° to 8°C (36° to 46°F). The reconstituted solution contains no preservative, and is clear and colorless. DO NOT FREEZE.

PEG-INTRON VIALS

PEG-Intron should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. After reconstitution with supplied Diluent the solution should be used immediately, but may be stored up to 24 hours at 2° to 8°C (36° to 46°F). The reconstituted solution contains no preservative, is clear and colorless. DO NOT FREEZE.

HOW SUPPLIED

PEG-INTRON REDIPEN™

PEG-Intron Redipen™ contains a dual-chamber glass cartridge with a white to off-white lyophilized powder active chamber and a sterile diluent chamber with Sterile Water for Injection, USP for subcutaneous use.

Each PEG-Intron Redipen™ Package Contains:      
A box containing one 50 µg per 0.5 mL PEG-Intron Redipen™ and 1 B-D needle and 2 alcohol swabs. (NDC 0085-1323-01)
A box containing one 80 µg per 0.5 mL PEG-Intron Redipen™ and 1 B-D needle and 2 alcohol swabs. (NDC 0085-1316-01)
A box containing one 120 µg per 0.5 mL PEG-Intron Redipen™ and 1 B-D needle and 2 alcohol swabs. (NDC 0085-1297-01)
A box containing one 150 µg per 0.5 mL PEG-Intron Redipen™ and 1 B-D needle and 2 alcohol swabs. (NDC 0085-1370-01)

PEG-INTRON VIALS

PEG-Intron is a white to off-white lyophilized powder supplied in 2-mL vials. The PEG-Intron Powder for Injection should be reconstituted with 0.7 mL of the supplied Diluent (Sterile Water for Injection, USP) prior to use.

Each PEG-Intron Package Contains:
A box containing one 50 µg per 0.5 mL vial of PEG-Intron Powder for Injection and one 1 mL vial of Diluent (Sterile Water for Injection, USP), 2 B-D Safety-Lok™ * syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-1368-01)
A box containing one 80 µg per 0.5 mL vial of PEG-Intron Powder for Injection and one 1 mL vial of Diluent (Sterile Water for Injection, USP), 2 B-D Safety-Lok™ * syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-1291-01)
A box containing one 120 µg per 0.5 mL vial of PEG-Intron Powder for Injection and one 1 mL vial of Diluent (Sterile Water for Injection, USP), 2 B-D Safety-Lok™ * syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-1304-01)
A box containing one 150 µg per 0.5 mL vial of PEG-Intron Powder for Injection and one 1 mL vial of Diluent (Sterile Water for Injection, USP), 2 B-D Safety-Lok™ * syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-1279-01)

Schering Corporation

Kenilworth, NJ 07033 USA

Copyright © 2003, Schering Corporation. All rights reserved.

                                                         Rev. 10/03 27664407T


*Safety-Lok is a trademark of Becton Dickinson and Company.

MEDICATION GUIDE
PEG-INTRON® REDIPEN™

Single-dose

Delivery System

(Peginterferon alfa-2b)

Including appendix with instructions for using PEG-Intron® Redipen™ Single-dose Delivery System

Read this Medication Guide carefully before you start taking PEG-Intron (Peg In-tron) or PEG-Intron/REBETOL (REB-eh-tole) combination therapy. Read the Medication Guide each time you refill your prescription because there may be new information. The information in this Medication Guide does not take the place of talking with your doctor.

If you are taking PEG-Intron/REBETOL combination therapy, also read the Medication Guide for REBETOL (ribavirin, USP) Capsules.

What is the most important information I should know about PEG-Intron and PEG-Intron/REBETOL combination therapy?

PEG-Intron (peginterferon) is a treatment for some people who are infected with hepatitis C virus. However, PEG-Intron and PEG-Intron/ REBETOL combination therapy can have serious side effects that may cause death in rare cases. Before you decide to start treatment, you should talk to your doctor about the possible benefits and side effects of PEG-Intron or PEG-Intron/REBETOL combination therapy. If you begin treatment you will need to see your doctor regularly for medical examinations and lab tests to make sure your treatment is working and to check for side effects.

REBETOL capsules may cause birth defects and/or death of an unborn child. If you are pregnant, you or your male partner must not take PEG-Intron/ REBETOL combination therapy. You must not become pregnant while either you or your partner are being treated with the combination PEG-Intron/ REBETOL therapy, or for 6 months after stopping therapy. Men and women should use birth control while taking the combination therapy and for 6 months afterwards. If you or your partner are being treated and you become pregnant either during treatment or within 6 months of stopping treatment, call your doctor right away.

If you are taking PEG-Intron or PEG-Intron/REBETOL therapy you should call your doctor immediately if you develop any of these symptoms:

New or worsening mental health problems such as thoughts about killing or hurting yourself or others, trouble breathing, chest pain, severe stomach or lower back pain, bloody diarrhea or bloody bowel movements, high fever, bruising, bleeding, or decreased vision.

The most serious possible side effects of PEG-Intron and PEG-Intron/REBETOL therapy include:

Problems with Pregnancy. Combination PEG-Intron/REBETOL therapy can cause death, serious birth defects, or other harm to your unborn child. If you are a woman of childbearing age you must not become pregnant during treatment and for 6 months after you have stopped therapy. You must have a negative pregnancy test immediately before beginning treatment, during treatment, and for 6 months after you have stopped therapy. Both male and female patients must use effective forms of birth control during treatment and for the 6 months after treatment is completed. Male patients should use a condom. If you are a female, 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 doctor about birth control for you and your partner.

Mental health problems and suicide. PEG-Intron and PEG-Intron/REBETOL therapies may cause patients to develop mood or behavioral problems. These can include irritability (getting easily upset) and depression (feeling low, feeling bad about yourself, or feeling hopeless). Some patients may have aggressive behavior. Former drug addicts may fall back into drug addiction or overdose. Some patients think about hurting or killing themselves or other people and some have killed (suicide) or hurt themselves or others. You must tell your doctor if you are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior. You should tell your doctor if you have ever been addicted to drugs or alcohol.

Heart problems. Some patients taking PEG-Intron or PEG-Intron/REBETOL therapy may develop problems with their heart, including low blood pressure, fast heart rate, and very rarely, heart attacks. Tell your doctor if you have had any heart problems in the past.

Blood problems. PEG-Intron and PEG-Intron/REBETOL therapies commonly lower two types of blood cells (white blood cells and platelets). In some patients, these blood counts may fall to dangerously low levels. If your blood counts become very low, this could lead to infections or bleeding.

REBETOL therapy causes a decrease in the number of red blood cells you have (anemia). This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. Talk with your doctor before taking combination PEG-Intron/REBETOL therapy if you have or have ever had any cardiovascular problems.

Body organ problems. Certain symptoms like severe stomach pain may mean that your internal organs are being damaged.

For other possible side effects, see "What are the possible side effects of PEG-Intron and PEG-Intron/REBETOL" in this Medication Guide.

What is PEG-Intron and PEG-Intron/REBETOL combination therapy?

The PEG-Intron product 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.

PEG-Intron/REBETOL combination therapy consists of two medications also used to treat hepatitis C infection. Patients with hepatitis C have the virus in their blood and in their liver. PEG-Intron reduces the amount of virus in the body and helps the body's immune system fight the virus. REBETOL (ribavirin) is a drug that helps to fight the viral infection but does not work when used by itself to treat chronic hepatitis C.

It is not known if PEG-Intron or PEG-Intron/REBETOL therapies 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 PEG-Intron or PEG-Intron/REBETOL combination therapy will prevent one infected person from infecting another person with hepatitis C.

Who should not take PEG-Intron or PEG-Intron/REBETOL therapy?

Do not take PEG-Intron or PEG-Intron/REBETOL 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 REBETOL 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 PEG-Intron or REBETOL Capsules. If you have any doubts, ask your doctor.
  • Do not take PEG-Intron/REBETOL combination therapy if you have abnormal red blood cells such as sickle-cell anemia or thalassemia major.

If you have any of the following conditions or serious medical problems, discuss them with your doctor before taking PEG-Intron or PEG-Intron/REBETOL therapy:

  • depression or anxiety
  • sleep problems
  • high blood pressure
  • previous heart attack, or other heart problems
  • liver problems (other than hepatitis C infection)
  • any kind of autoimmune disease (where the body's immune system attacks the body's own cells), such as psoriasis, systemic lupus erythematosus, rheumatoid arthritis
  • thyroid problems
  • diabetes
  • colitis (inflammation of the bowels)
  • cancer
  • hepatitis B infection
  • HIV infection
  • kidney problems
  • bleeding problems
  • alcoholism
  • drug abuse or addiction
  • body organ transplant and are taking medicine that keeps your body from rejecting your transplant (suppresses your immune system).

How should I take PEG-Intron or PEG-Intron/REBETOL?

Your doctor will decide whether you will take PEG-Intron therapy alone or the combination of PEG-Intron/REBETOL, as well as the correct dose (based on your weight). PEG-Intron and PEG-Intron/REBETOL are given for one year. Take your prescribed dose of PEG-Intron once a week, on the same day of each week and at approximately the same time. Take the medicine for the full year and do not take more than the prescribed dose. REBETOL Capsules should be taken with food. When you take REBETOL with food, more of the medicine (70% more on average) is taken up by your body. You should take REBETOL the same way every day (twice a day with food) to keep the medicine in your body at a steady level. This will help your doctor to decide how your treatment is working and how to change the number of REBETOL capsules you take if you have side effects from REBETOL. Be sure to read the Medication Guide for REBETOL (ribavirin, USP) for complete instructions on how to take the REBETOL capsules.

You should be completely comfortable with how to prepare PEG-Intron; how to set the dose you take; and how to inject yourself before you use PEG-Intron for the first time. PEG-Intron comes in two different forms, a powder in a single-use vial and a Redipen™ single-use delivery system. See the attached appendix for detailed instructions for preparing and giving a dose of PEG-Intron.

If you miss a dose of the PEG-Intron product, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule. If several days go by after you miss a dose, check with your doctor about what to do. Do not double the next dose or take more than one dose a week without talking to your doctor. Call your doctor right away if you take more than your prescribed PEG-Intron dose. Your doctor may wish to examine you more closely, and take blood for testing.

If you miss a dose of REBETOL capsules, take the missed dose as soon as possible during the same day. If an entire day has gone by, check with your doctor about what to do. Do not double the next dose.

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

Tell your doctor if you are taking or planning to take other prescription or non-prescription medicines, including vitamin and mineral supplements and herbal medicines.

What should I avoid while taking PEG-Intron or PEG-Intron/REBETOL therapies?

  • If you are pregnant do not start taking PEG-Intron/REBETOL combination therapy.
  • Avoid becoming pregnant while taking PEG-Intron or PEG-Intron/REBETOL.

PEG-Intron and PEG-Intron/REBETOL 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 treatment or during the 6 months after treatment with PEG-Intron/REBETOL combination therapy, immediately report the pregnancy to your doctor. You or your doctor should call (800) 727-7064. By calling this number, information about you and/or your partner will be added to a pregnancy registry that will be used to help you and your doctor make decisions about your treatment for hepatitis in the future. You, your partner and/or your physician will be asked to provide follow-up information on the outcome of the pregnancy.

  • Do not breast-feed your baby while taking PEG-Intron.

What are the possible side effects of PEG-Intron and PEG-Intron/REBETOL combination therapy?

Possible, serious side effects include:

Mental health problems including suicide, blood problems, heart problems, body organ problems. See "What is the most important information I should know about PEG-Intron and PEG-Intron/REBETOL combination therapy?"

Other body organ problems. A few patients have lung problems (such as pneumonia or inflammation of the lung tissue), inflammation of the kidney, and eye disorders.

New or worsening autoimmune disease. Some patients taking PEG-Intron or PEG-Intron/REBETOL develop autoimmune diseases (a condition where the body's immune cells attack other cells or organs in the body), including rheumatoid arthritis, systemic lupus erythematosus, and psoriasis. In some patients who already have an autoimmune disease, the disease worsens on PEG-Intron and PEG-Intron/REBETOL combination therapy.

Common but less serious side effects include:

Flu-like symptoms. Most patients who take PEG-Intron or PEG-Intron/REBETOL therapy have "flu-like" symptoms (headache, muscle aches, tiredness and fever). Some of these symptoms (fever, headache) usually lessen after the first few weeks of therapy. You can reduce some of these symptoms by injecting your PEG-Intron dose at bedtime. Over-the-counter pain and fever reducers, such as acetaminophen or ibuprofen, can be used to prevent or reduce the fever and headache.

Extreme fatigue (tiredness). Many patients become extremely tired while on PEG-Intron or PEG-Intron/REBETOL combination therapy.

Appetite problems. Nausea, loss of appetite, and weight loss, occur commonly.

Thyroid problems. Some patients develop changes in the function of their thyroid. Symptoms of thyroid changes include the inability to concentrate, feeling cold or hot all the time, a change in your weight and changes to your skin.

Blood sugar problems. Some patients develop problems with the way their body controls their blood sugar and may develop high blood sugar or diabetes.

Skin reactions. Redness, swelling, and itching are common at the site of injection. If after several days these symptoms do not disappear contact your doctor. You may get a rash during therapy. If this occurs, your doctor may recommend medicine to treat the rash.

Hair thinning. Hair thinning is common during PEG-Intron and PEG-Intron/ REBETOL treatment. Hair loss stops and hair growth returns after therapy is stopped.

These are not all of the side effects of PEG-Intron or PEG-Intron/REBETOL combination therapy. Your doctor or pharmacist can give you a more complete list.

General advice about prescription medicines:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns about PEG-Intron, ask your doctor. Your doctor or pharmacist can give you information about PEG-Intron that was written for health care professionals. Do not use PEG-Intron for a condition for which it was not prescribed. Do not share this medication with other people.

If you are taking PEG-Intron/REBETOL combination therapy, also read the Medication Guide for REBETOL (ribavirin, USP) Capsules.

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

How do I prepare and inject the PEG-Intron Redipen™ Dose?

The PEG-Intron Redipen™ system is for a single use, by one person only. The Redipen™ must not be shared. Use only the injection needle provided in the packaging for the PEG-Intron Redipen™ system. If you have problems with the Redipen™ system or the PEG-Intron solution, you should contact your nurse, doctor, or pharmacist.

The following instructions explain how to prepare and inject yourself with the PEG-Intron Redipen™ system. Please read the instructions carefully and follow them step by step. Your health care provider will instruct you on how to self-inject with the PEG-Intron Redipen™. Do not attempt to inject yourself unless you are sure you understand the procedure and requirements for self-injection.

How to use the PEG-Intron Redipen™ single-dose delivery system.

Storing PEG-Intron

PEG-Intron Redipen™ should be stored in the refrigerator at 2° to 8°C (36° to 46°F); avoid exposure to heat. After mixing, the PEG-Intron solution should be used immediately but may be stored in the refrigerator up to 24 hours at 2° to 8°C (36° to 46°F). The solution contains no preservatives. DO NOT FREEZE.

I: Preparation

  1. Find a clean, well-lit, non-slip flat working surface and assemble all of the supplies you will need for an injection. All of the supplies you will need are in the PEG-Intron Redipen™ package. The package contains:
    • a PEG-Intron Redipen™ single-dose delivery system
    • one disposable needle
    • alcohol swabs, and
    • dose tray (the dose tray is the bottom half of the Redipen™ package)
  2. Take the PEG-Intron Redipen™ system out of the refrigerator to allow the medicine to come to room temperature. Before removing the Redipen™ from the carton, check the expiration date printed on the PEG-Intron Redipen™ carton to make sure that the expiration date has not passed. Do not use if the expiration date has passed.
  3. After taking the PEG-Intron Redipen™ system out of the carton, look in the window of the Redipen™ and make sure the PEG-Intron in the cartridge holder chamber is a white, to off-white tablet that is whole or in pieces or powder.
  4. Wash your hands thoroughly with soap and water, rinse and towel dry. It is important to keep your work area, your hands, and injection site clean to minimize the risk of infection.
    II: Mixing
    Key points:
    Before you mix the PEG-Intron, make sure it is at room temperature. It is important that you keep the PEG-Intron Redipen™ system UPRIGHT (dosing button down) as shown in Figure 1.
  5. Hold the PEG-Intron Redipen™ system UPRIGHT (Figure 1) in the dose tray or on a flat non-slip surface with the dosing button down. You may want to hold the Redipen™ using the grip.
    • To mix the powder and the liquid, press the two halves of the pen together firmly until you hear the click.
    • Wait several seconds for the powder to completely dissolve.

  6. Gently turn the PEG-Intron Redipen™ system upside down twice (Figure 2). To avoid excessive foaming, DO NOT SHAKE.
    • Keeping the PEG-Intron Redipen™ system UPRIGHT, check through the Redipen™ window to see if the mixed PEG-Intron solution is completely dissolved. If there is still foam, wait until it settles. The solution should be clear, colorless, and without particles before use. It is normal to see some small bubbles near the top of the solution. Do not use if the solution is not clear, or if you see particles.

  7. Place the PEG-Intron Redipen™ system into the dose tray provided in the packaging (Figure 3). The dosing button will be on the bottom.
    • Wipe the rubber membrane of the PEG-Intron Redipen™ system with one alcohol swab.
    • Remove the protective paper tab from the injection needle. Keeping the PEG-Intron Redipen™ system UPRIGHT in the dose tray, gently push the injection needle straight onto the Redipen™ system and screw it securely in place.
    • Keep the PEG-Intron Redipen™ system pointed up and keep the outer needle cap on.
    • You may see some liquid trickle out from under the cap for a few seconds after screwing the injection needle onto the Redipen™. Wait until this stops before going to the next step.


    III: Setting the Dose
  8. Remove the PEG-Intron Redipen™ system from the dose tray (Figure 4). Holding the PEG-Intron Redipen™ system firmly, pull the dosing button out as far as it will go, until you see the dark bands below the dosing button.
    Do not push the dosing button in until you are ready to self-inject the PEG-Intron dose.

  9. Turn the dosing button until your prescribed dose is lined up with the dosing tab (Figure 5).
    IV: Injecting the PEG-Intron Dose
    Choosing an Injection Site
    The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, and abdomen. Do not inject yourself in the area near your navel or waistline. If you are very thin, you should only use the thigh or outer surface of the arm for injection.
    You should use a different site each time you inject PEG-Intron to avoid soreness at any one site. Do not inject PEG-Intron into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
  10. Clean the skin where the injection is to be given with an alcohol swab, and wait for the area to dry.
  11. Remove the outer cap from the needle (Figure 6). There may be some liquid around the inner needle cap. This is normal. Once the injection site is dry pull off the inner needle cap.
  12. Hold the PEG-Intron Redipen™ system with your fingers wrapped around the pen body barrel and your thumb on the dosing button (Figure 7).
    • With your other hand, pinch the skin in the area you have cleaned for injection.
    • Insert the needle into the pinched skin at an angle of 45° to 90°.
    • Press the dosing button down slowly and firmly until you can't push it any further.
    • Keep your thumb pressed down on the dosing button for an additional 5 seconds to ensure that you get the complete dose.
    • Remove the needle from your skin.

  13. Gently press the injection site with a small bandage or sterile gauze if necessary for a few seconds but do not massage the injection site. If there is bleeding, cover with an adhesive bandage. Discard the PEG-Intron Redipen™ system with the needle still attached. DO NOT RECAP THE NEEDLE and DO NOT REUSE the Redipen™.
    • After 2 hours, check the injection site for redness, swelling, or tenderness. If you have a skin reaction and it doesn't clear up in a few days, contact your health care provider.

How do I dispose of the Redipen™?

Discard the Redipen™ system and needle and any solution remaining in the Redipen™ in a Sharps container or other puncture-proof container like a coffee can. DO NOT use glass or clear plastic containers. Your doctor or nurse will tell you how to dispose of a full container. Always keep the container out of reach of children.

Manufactured by:

Schering Corporation

Kenilworth, NJ 07033 USA

10/03               27662404T

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012