Pegasys

1 What is Pegasys?

Brand: Pegasys, Pegasys Proclick

Generic: Peginterferon Alfa-2a

Pegasys injection is an antiviral drug used alone or in combination with other drugs, such as:

  • Ribavirin
  • Boceprevir
  • Telaprevir for the treatment of chronic hepatitis C infection

Chronic hepatitis B infection can also be treated with this drug. This drug aids the immune system combat hepatitis infections. This drug requires a prescription.

2 What to Know Before Using

Before using Pegasys, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children younger than 5 years of age regarding the correlation of age to the effects of peginterferon alfa-2a injection have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of peginterferon alfa-2a injection. Adjustments in the dose of the elderly may be required since they are more likely to have age-related kidney problems.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects. Inform your healthcare professional if you are taking any other drugs such as Telbivudine, or Methadone.

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

Proper usage of Pegasys requires strict adherence to your doctor’s orders. A trained healthcare professional will be the only one to give you this drug. This drug is injected under your skin. You will be educated on how to administer this drug at home.

To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional. Make sure you understand how to prepare, inject, and assess the stability of the drug.

This drug is available in 3 dosage forms: a vial, a prefilled syringe, or a disposable autoinjector. Double-check that you are giving yourself the correct amount of drug if you switch from using the vial to using the prefilled syringe or autoinjector. Each vial, syringe, or autoinjector must be used only one time. You might not use the entire drug.

Saving an open vial, syringe, or autoinjector is not recommended. Do not use the drug if the vial or syringe has changed color, or if you see particles in it. It is recommended to increase fluid intake to maintain your hydration status, especially during the early part of your treatment.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

The dose in adults with hepatitis B and hepatitis C is based on body weight and must be determined by your healthcare professional. It is usually 180 micrograms injected under the skin once a week for 48 weeks. It is recommended to use this drug on the same day each week and at approximately the same time.

Use and dose in children must be determined by your healthcare professional. The dose in adults with hepatitis C infection taking combination therapy with ribavirin is based on body weight and must be determined by your healthcare professional.

It is usually 180 micrograms injected under the skin once a week together with oral ribavirin twice daily for 24 to 48 weeks. The length of time will be determined by your healthcare professional.

The dose in children 5 years of age and older is based on body weight or body size and must be determined by your healthcare professional. It is usually 180 mcg injected under the skin once a week together with oral ribavirin twice daily for 24 to 48 weeks. The length of time will be determined by your healthcare professional.

Use and dose in children younger than 5 years of age must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Pegasys, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests.

This drug has teratogenic potential when used with ribavirin and can also cause birth defects if the father is using it when his sexual partner becomes pregnant.

Inform your healthcare professional immediately if a pregnancy occurs while you are using these drugs. A negative pregnancy test is required in women who are of childbearing age before starting treatment with this drug and ribavirin.

It is recommended to use 2 forms of birth control during therapy and for 6 months after therapy ends for female patients and female partners of male patients.

Female patients must have regular pregnancy tests during combination therapy. This drug can induce suicidal thoughts in people with or without a history of a mental illness.

This drug may also cause relapse in people with a history of substance abuse. Inform your healthcare professional immediately if you start to feel more depressed, exhibit aggressive behavior, or if you have thoughts of hurting yourself.

Notify your healthcare professional if you have trouble sleeping, get upset easily, have a big increase in energy, start to act reckless, or if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared during treatment with this drug.

Seek immediate medical attention if you have symptoms of anaphylaxis such as:

  • Itching
  • Hives
  • Hoarseness
  • Trouble with breathing
  • Trouble with swallowing
  • or Any swelling of the hands, face, or mouth while you or your child are using this drug

Consult with your healthcare professional if you have symptoms of an allergic reaction such as:

  • Blistering
  • Peeling, or loose skin
  • Fever or chills
  • Hives or welts
  • Red skin lesions
  • Severe acne or skin rash
  • or Sores or ulcers on the skin while you are using this drug

Check with your healthcare professional immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. You may be referred to an ophthalmologist to have your eyes checked.

Peginterferon alfa-2a injection combined with ribavirin can temporarily cause leukopenia and thrombocytopenia which increase your risk of infection or bleeding. It is recommended to avoid people with infections.

Check with your healthcare professional 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 healthcare professional 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 health care professional, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical health care professional before having any dental work done. Touching your eyes or the inside of your nose is not recommended 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 healthcare professional immediately if you have symptoms of a serious liver problem such as:

  • Pain or tenderness in the upper stomach
  • Pale stools
  • Dark urine
  • Loss of appetite
  • Nausea
  • Unusual tiredness or weakness
  • or Yellow eyes or skin

Peginterferon alfa-2a injection, when used together with ribavirin, may cause teeth and gum problems. These drugs may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take these drugs for a long time.

To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

Check with your healthcare professional immediately if you have symptoms of pancreatitis such as:

sudden and severe stomach pain:

Children who use peginterferon alfa-2b and ribavirin combination may have weight loss and slowed growth. Most children have a growth spurt and gain weight after therapy ends.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Pegasys. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • 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 sleeping
  • Trouble with concentrating
  • Ulcers
  • Sores, or white spots in the mouth
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • 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
  • Weight gain

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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