Friday, September 16, 2016

peginterferon alfa-2a


Generic Name: peginterferon alfa-2a (peg in ter FEER on AL fa 2 a)

Brand Names: Pegasys, Pegasys ProClick Autoinjector


What is peginterferon alfa-2a?

Peginterferon alfa-2a is made from human proteins that help the body fight viral infections.


Peginterferon alfa-2a is used to treat chronic hepatitis B or C. Peginterferon alfa-2a is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab).


Peginterferon alfa-2a may also be used for purposes not listed in this medication guide.


What is the most important information I should know about peginterferon alfa-2a?


Peginterferon alfa-2a is often used together with another medication called ribavirin. Ribavirin is known to cause birth defects or death in an unborn baby. If a man fathers a child while using ribavirin, the baby may have birth defects. You should not use this medication if you are allergic to peginterferon alfa-2a, or if you have autoimmune hepatitis, liver failure, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia, if you are pregnant, or if you are a man and your sexual partner is pregnant.

Before using this medication, tell your doctor about all of your medical conditions. Also tell your doctor if you have ever had a drug or alcohol addiction, or depression, mental illness, or suicidal thoughts.


Using this medication will not prevent you from passing hepatitis.

What should I discuss with my healthcare provider before using peginterferon alfa-2a?


You should not use this medication if you are allergic to peginterferon alfa-2a, or if you have:

  • liver failure or autoimmune hepatitis;




  • a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;




  • if you are pregnant; or




  • if you are a man and your sexual partner is pregnant.



To make sure you can safely use peginterferon alfa-2a, tell your doctor if you have any of these other conditions:



  • anemia (a lack of red blood cells);



  • liver problems other than hepatitis;

  • kidney disease (or if you are on dialysis);


  • HIV or AIDS;




  • diabetes;




  • a thyroid disorder;




  • lung disease;




  • a bleeding or blood clotting disorder;




  • heart disease or prior heart attack;




  • eye problems;




  • problems with your sleep;




  • colitis, or a history of stomach or intestinal bleeding;




  • an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis;




  • a history of cancer;




  • history of liver or other organ transplant;




  • history of depression, anxiety, mental illness, suicidal thoughts, or drug or alcohol addiction;




  • if you have both hepatitis B and hepatitis C; or




  • if you have used interferon alfa in the past and it was not effective.




Peginterferon alfa-2a is often used together with another medication called ribavirin. Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking these two medications together.

  • If you are a woman, do not use peginterferon alfa-2a and ribavirin if you are pregnant.




  • If you are a man, do not use peginterferon alfa-2a and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.




  • Use at least 2 effective forms of birth control while either sexual partner is using peginterferon alfa-2a with ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.




  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using peginterferon alfa-2a together with ribavirin.




It is not known whether peginterferon alfa-2a passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medication.

How should I use peginterferon alfa-2a?


Peginterferon alfa-2a is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Peginterferon alfa-2a is usually given once per week, on the same day each week at about the same time of day. Your doctor may occasionally change your dose to make sure you get the best results.


Do not shake the medication bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


Peginterferon alfa-2a can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.


If you have hepatitis B you may develop liver symptoms while you are using peginterferon alfa-2a, and even after you stop using this medication. Your doctor may want to check your liver function more often if this happens.


If your doctor changes your brand, strength, or type of peginterferon alfa-2a, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of peginterferon alfa-2a you receive at the pharmacy.


Hepatitis is sometimes treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis should remain under the care of a doctor.


Store in the refrigerator, protected from light. Do not freeze.

What happens if I miss a dose?


Use the medicine as soon as you remember the missed dose, then go back to your regular schedule on the day your next dose is due. If you are more than 2 days late in using your injection, call your doctor for instructions. Do not use extra medicine to make up a missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using peginterferon alfa-2a?


Avoid drinking alcohol. It may increase your risk of liver damage. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Using this medication will not prevent you from passing hepatitis. Follow your doctor's instructions about how to prevent passing the disease to another person.

Peginterferon alfa-2a side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • confusion, severe depression, thoughts of hurting yourself or others;




  • unusual thoughts or behaviors, feeling anxious or aggressive;




  • sudden weakness, loss of balance or coordination, or problems with speech;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • numbness, burning, pain, or tingly feeling;




  • fever, chills, body aches, flu symptoms;




  • easy bruising or bleeding, feeling very tired;




  • sores in your mouth, nose or eyes;




  • redness, crusting, or drainage in your eyes;




  • worsening of psoriasis;




  • cough, stabbing chest pain, feeling short of breath;




  • severe pain in your upper stomach spreading to your back, fast heart rate;




  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);




  • low blood sugar (headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating);




  • vision changes, headache or pain behind your eyes; or




  • fever with severe stomach pain and bloody diarrhea.



Less serious side effects may include:



  • vomiting, upset stomach, loss of appetite, mild diarrhea;




  • weight changes, feeling very hot or cold;




  • headache, muscle or joint pain;




  • sleep problems (insomnia);




  • temporary hair loss, mild skin rash; or




  • itching, redness, dryness, or swelling where the medicine was injected.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Peginterferon alfa-2a Dosing Information


Usual Adult Dose for Chronic Hepatitis C:

Peginterferon alfa-2a may be used alone or in combination with ribavirin tablets. However, peginterferon alfa-2a monotherapy is not recommended unless a patient has a contraindication to or significant intolerance to ribavirin.

Monotherapy: 180 mcg subcutaneously once a week for 48 weeks

Combination therapy:
Genotypes 1, 4:
Less than 75 kg: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 1000 mg/day orally in 2 divided doses for 48 weeks

75 kg or more: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 1200 mg/day orally in 2 divided doses for 48 weeks

Genotypes 2, 3: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 800 mg/day orally in 2 divided doses for 24 weeks

Genotype 5, 6: Insufficient data to make a recommendation

Patients coinfected with HIV:
Monotherapy: 180 mcg subcutaneously once a week for 48 weeks

Combination therapy: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 800 mg/day orally in 2 divided doses for 48 weeks, regardless of genotype

Usual Adult Dose for Chronic Hepatitis B:

180 mcg subcutaneously once a week for 48 weeks

Usual Pediatric Dose for Chronic Hepatitis C:

5 years or older:
Combination therapy:
Peginterferon alfa-2a: 180 mcg/1.73 m2 x body surface area (BSA) subcutaneously once a week
Maximum dose: 180 mcg

plus

Ribavirin tablets:
23 to 33 kg: 400 mg/day orally in 2 divided doses
34 to 46 kg: 600 mg/day orally in 2 divided doses
47 to 59 kg: 800 mg/day orally in 2 divided doses
60 to 74 kg: 1000 mg/day orally in 2 divided doses
75 kg or more: 1200 mg/day orally in 2 divided doses

Duration:
Genotype 2 and 3: 24 weeks
Other genotypes: 48 weeks


What other drugs will affect peginterferon alfa-2a?


Tell your doctor about all other medicines you use, especially:



  • azathioprine (Azasan, Imuran);




  • telbivudine (Tyzeka);




  • theophylline (Slo-Bid, Theobid, Theo-Dur, and others);




  • methadone (Diskets, Dolophine, Methadose); or




  • HIV or AIDS medication such as abacavir (Ziagen), didanosine (Videx), emtricitabine (Atripla, Emtriva, Truvada), lamivudine (Epivir, Combivir), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).



This list is not complete and other drugs may interact with peginterferon alfa-2a. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More peginterferon alfa-2a resources


  • Peginterferon alfa-2a Side Effects (in more detail)
  • Peginterferon alfa-2a Use in Pregnancy & Breastfeeding
  • Peginterferon alfa-2a Drug Interactions
  • Peginterferon alfa-2a Support Group
  • 9 Reviews for Peginterferon alfa-2a - Add your own review/rating


  • peginterferon alfa-2a Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Peginterferon Alfa-2a Professional Patient Advice (Wolters Kluwer)

  • Peginterferon Alfa-2a MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pegasys Prescribing Information (FDA)

  • Pegasys Consumer Overview



Compare peginterferon alfa-2a with other medications


  • Hepatitis B
  • Hepatitis C


Where can I get more information?


  • Your pharmacist can provide more information about peginterferon alfa-2a.

See also: peginterferon alfa-2a side effects (in more detail)


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