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Drugs reference index «Pegasys»

Pegasys

Generic Name: peginterferon alfa-2a (Subcutaneous route)

peg-in-ter-FEER-on AL-fa-2a

Subcutaneous routeSolution
  • Alpha interferons, including peginterferon alfa-2a, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping peginterferon alfa-2a therapy.
  • Use with Ribavirin
    • Ribavirin may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen .

Alpha interferons may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely with periodic clinical and laboratory evaluations. Discontinue therapy with persistently severe or worsening signs or symptoms of these conditions. When used with ribavirin, may cause birth defects and/or death of the fetus and extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia that may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen .

Commonly used brand name(s):

In the U.S.

  • Pegasys

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Interferon, Alfa (class)

Uses For Pegasys

Peginterferon alfa-2a is a synthetic (man-made) version of a substance that is normally produced in the body to fight infection. Peginterferon alfa-2a is used alone or together with ribavirin to treat chronic hepatitis C infection. It is used for patients who have never been treated by alpha interferons. Peginterferon alfa-2a is also used to treat adult patients with HBeAg positive and negative chronic hepatitis B. It is used in patients who have liver disease and evidence of viral replication and liver inflammation.

This medicine is available only with your doctor's prescription.

Before Using Pegasys

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of peginterferon alfa-2a in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of peginterferon alfa-2a in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving peginterferon alfa-2a.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Autoimmune hepatitis (serious liver disease) or
  • Heart disease (unstable), history of or
  • Kidney disease, severe or
  • Liver disease, severe or
  • Sickle-cell anemia (red blood cell disorder) or
  • Thalassemia major (genetic blood disorder)—Should not be used in patients with these conditions.
  • Bleeding problems, history of or
  • Bone marrow problems (e.g., aplastic anemia) or
  • Breathing problems or lung diseases or
  • Chest pain or
  • Depression, history of or
  • Diabetes mellitus or
  • Diabetic retinopathy (eye problem caused by diabetes) or
  • Eye or vision problems or
  • Heart or blood vessel disease or
  • Heart rhythm problems, history of or
  • High blood pressure or
  • Hyperglycemia (high blood sugar) or
  • Hypoglycemia (low blood sugar) or
  • Interstitial nephritis (kidney disease) or
  • Manic episodes (bipolar depression), history of or
  • Myositis (muscle pain) or
  • Psoriasis (skin disease) or
  • Rheumatoid arthritis or
  • Stroke, history of or
  • Systemic lupus erythematosus (SLE) (immune system disorder) or
  • Thyroid disease—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.
  • Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Pegasys

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin. You may also be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

Use a new needle and syringe each time you inject your medicine.

Each package of peginterferon alfa-2a contains a Medication Guide. Read the guide carefully and make sure you understand the information. If you have any questions, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For hepatitis B and hepatitis C:
      • Adults—180 micrograms (mcg) injected under the skin once a week for 48 weeks. The medicine should be used on the same day each week and at approximately the same time.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use your medicine and you are 1 or 2 days late, use it as soon as you can. If it has been more than 2 days since you were supposed to use the medicine, call your doctor for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Pegasys

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using peginterferon alfa-2a together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking this medicine with ribavirin.

A negative pregnancy test is needed for women who are of childbearing age before starting treatment with this medicine and ribavirin. Two forms of birth control must be used during treatment and for six months after treatment ends. You will need to have pregnancy tests done every month while you receive these medicines and for 6 months after your treatment ends.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Serious allergic reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; fever or chills; hives or welts; red skin lesions; a severe skin rash or acne; or sores or ulcers on the skin while you are using this medicine.

This medicine can temporarily lower the number of white blood cells in your blood, which will increase the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy and not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pegasys Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • chills
  • cough
  • discouragement
  • feeling sad or empty
  • fever
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • shortness of breath
  • sore throat
  • tiredness
  • trouble with concentrating
  • trouble with sleeping
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Bone pain
  • chest pain or discomfort
  • confusion
  • constipation
  • depressed mood
  • dizziness
  • dry skin and hair
  • fainting
  • fast heartbeat
  • feeling cold
  • hair loss
  • headache
  • heart murmur
  • hives
  • hoarseness or husky voice
  • lightheadedness
  • muscle cramps and stiffness
  • pale skin
  • rapid, shallow breathing
  • slowed heartbeat
  • sneezing
  • stomach pain
  • tightness in the chest
  • troubled breathing with exertion
  • wheezing
  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry scaly skin
  • diarrhea
  • dry mouth
  • fear
  • feeling unusually cold, shivering
  • hair loss or thinning of the hair
  • muscle or joint pain
  • nervousness
  • numbness
  • pain
  • rash
  • redness
  • scarring
  • soreness
  • stinging
  • stomach pain
  • swelling
  • tenderness
  • tingling
  • ulceration
  • vomiting
  • warmth
Less common
  • Acid or sour stomach
  • belching
  • blurred vision
  • heartburn
  • indigestion
  • memory problems
  • stomach discomfort upset or pain
Incidence not known
  • Change of hearing
  • loss of hearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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  • Pegasys Prescribing Information (FDA)
  • Pegasys Consumer Overview
  • Pegasys Detailed Consumer Information (PDR)
  • Pegasys MedFacts Consumer Leaflet (Wolters Kluwer)
  • Peginterferon Alfa-2a Professional Patient Advice (Wolters Kluwer)