(peg in ter feer' on)
P : Caution when used during pregnancy
L : Caution when used during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
Alpha interferons, 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 Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.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 therapy.
Use with Ribavirin
Ribavirin, including COPEGUSÂ®, 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.
|Indication(s) & Dosage||
Chronic hepatitis C
Hepatic impairment: Alanine transaminase (ALT) progressively rising above baseline: Decrease dose to 135 mcg/wk. If ALT continues to rise or is accompanied by increased bilirubin or hepatic decompensation, discontinue immediately.
Hepatic impairment: Alanine transaminase (ALT) >5 times the upper limits of normal: Monitor LFTs more frequently; consider 135 mcg/wk or temporarily discontinuing (may resume after ALT flare subsides). ALT >10 times the upper limits of normal: Consider discontinuing.
Special Populations: Dosage adjustment in end-stage renal disease (ESRD) requiring hemodialysis: 135 mcg/week and monitor for toxicity. Dosage adjustment in hepatic impairment: 135 mcg/week, discontinue therapy immediately if ALT continues to rise or is accompanied by increased bilirubin or hepatic decompensation.
|Overdosage||Fatigue, elevated liver enzymes, neutropenia, thrombocytopenia; treatment is supportive.|
|Contraindications||Autoimmune hepatitis; decompensated liver disease in cirrhotic patients (Child-Pugh score >6); decompensated liver disease (Child-Pugh score â‰¥6, class B and C) in chronic hepatitis C coinfected with HIV; neonates and infants; in combination with ribavirin in pregnant women.|
|Special Precautions||Neuropsychiatric disorders, discontinue treatment with worsening or persistently severe signs/symptoms; myelosuppresion; anemia (spherocytosis, history of GI bleeding); pulmonary disease; autoimmune disease; cardiovascular disease; DM; infectious disorders; ischaemic disorders; renal impairment; thyroid disorders; patients who have failed other alpha interferon therapy, received organ transplants, been coinfected with Hepatis B or C virus or HIV; or with Hepatitis C virus and HIV with a CD4+ cell count <100 cells/microliter, or been treated for >48 wk. Elderly. Safety and efficacy not been established in children. Do not change brands of interferon without the concurrence of healthcare provider (product variability). More frequent monitoring of LFTs and dose reduction in Hepatitis B. Hazardous agent, handle and dispose appropriately. May affect ability to drive or operate machinery.|
|Adverse Drug Reaction(s)||Headache, fatigue, pyrexia, insomnia, depression, dizziness, irritability/anxiety/nervousness, pain; alopecia, pruritus, dermatitis; nausea/vomiting, anorexia, diarrhoea, weight loss, abdominal pain; neutropenia, lymphopenia, anemia; increase in alanine transaminase (ALT); inj site reaction; weakness, myalgia, rigors, arthralgia; dyspneal. Rarely: Impaired concentration, memory or mood; dermatitis, rash, dry skin, eczema; hypothyroidism, hyperthyroidism; xerostomia, dyspepsia, wt loss; thrombocytopenia, lymphopenia, anemia; hepatic decompensation; back pain; blurred vision; cough, dyspnea, exertional dyspnoea; diaphoresis, bacterial infection.
Potentially Fatal: Serious cutaneous reactions, including Stevens-Johnson syndrome; hepatic decompensation.
|Drug Interactions||Increased risk of haemolytic anemia, birth defects and/or foetal mortality, genotoxicity, mutagenicity, and may possibly be carcinogenic with ribavirin; decreases metabolism of theophylline; enhances adverse/toxic effects of zidovudine, decreases metabolism of zidovudine. Avoid ethanol in hepatitis C virus patients.
|Pregnancy Category (FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Subcutaneous: Storage: Store in refrigerator at 2-8Â°C; do not freeze or shake. Protect from light.|
|Pharmacology||Peginterferon alfa-2a are interferon proteins bound to polyethylene glycol (PEG) molecules resulting in higher and more prolonged serum interferon concentrations. It has antiviral, antiproliferative and immune-regulating activity. Interferons are activated when it interacts with cells through high affinity cell surface receptors. The effects of this activation include the induction of gene transcription, inhibition of cellular growth, alteration of cellular differentiation, interference with oncogene expression, alteration of cell surface antigen expression, increase in phagocytic activity of macrophages and augmentation of cytotoxicity of lymphocytes for target cells.
Absorption: Time to peak (serum): 72-96 hr.
Excretion: Half-life elimination (terminal): 50-160 hr; increased with renal dysfunction.
|ATC Classification||L03AB11 - peginterferon alfa-2a; Belongs to the class of interferons. Used as immunostimulants.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|OPTIPEG-A 135||Incepta Pharmaceuticals Limited||Pegylated Interferon alfa-2a BP 135mcg/0.5ml pre-filled syringe||Injection||135mcg: 8,800 MRP|
|OPTIPEG-A 180||Incepta Pharmaceuticals Limited||Pegylated Interferon alfa-2a BP 180mcg/0.5ml pre-filled syringe||Injection||180mcg: 9,800 MRP|
|PEGIN||Beacon Pharmaceuticals Limited||Peginterferon alfa-2a 180mcg/0.5ml vial for S/C injection||Injection||180mcg/0.5ml: 9,800.00 MRP|
|PEGINTRON||Schering Plough/Janata Healthcare||Peginterferon alfa-2b 50, 80, 120 &150mcg/0.5ml||Injection||80mcg vial: 17,728.90 MRP|
Peginterferon alfa-2a may cause or worsen the following conditions which may be serious or cause death: infections; mental illness including depression, mood and behavior problems, or thoughts of hurting or killing yourself; starting to use street drugs again if you used them in the past; ischemic disorders (conditions in which there is poor blood supply to an area of the body) such as angina (chest pain), heart attack, or colitis (inflammation of the bowels); and autoimmune disorders (conditions in which the immune system attacks one or more parts of the body) that may affect the blood, joints, kidneys, liver, lungs, muscles, skin, or thyroid gland.Tell your doctor if you have an infection; or if you have or have ever had an autoimmune disease; atherosclerosis (narrowing of the blood vessels from fatty deposits); cancer; chest pain; colitis; diabetes; heart attack; high blood pressure; high cholesterol; HIV (human immunodeficiency virus) or AIDS (acquired immunodeficiency syndrome); irregular heartbeat; mental illness including depression, anxiety, or thinking about or trying to kill yourself; liver disease other than hepatitis B or C; or heart, kidney, lung or thyroid disease. Also tell your doctor if you drink or have ever drunk large amounts of alcohol, or if you use or have ever used street drugs or have overused prescription medications. If you experience any of the following symptoms, call your doctor immediately: bloody diarrhea or bowel movements; stomach pain, tenderness or swelling; chest pain; irregular heartbeat; changes in your mood or behavior; depression; irritability; anxiety; thoughts of killing or hurting yourself ; hallucinating (seeing things or hearing voices that do not exist); frenzied or abnormally excited mood; loss of contact with reality; aggressive behavior; difficulty breathing; fever, chills, cough, sore throat, or other signs of infection; unusual bleeding or bruising; dark-colored urine; light colored bowel movements; extreme tiredness; yellowing of the skin or eyes; severe muscle or joint pain; or worsening of an autoimmune disease.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to peginterferon alfa-2a.
Read the manufacturer's patient information sheet (Medication Guide) carefully and ask your doctor if you have any questions. You can also visit the US Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using peginterferon alfa-2a.
Use with ribavirin (Copegus, Rebetol):
You may take peginterferon with another medication called ribavirin (Copegus). Ribavirin may help peginterferon work better to treat your condition, but it may also cause serious side effects. The rest of this section tells about the risks of taking ribavirin. Your doctor and pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ribavirin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the US Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Ribavirin may cause anemia (condition in which there is a decrease in the number of red blood cells). Tell your doctor if you have ever had a heart attack and if you have or have ever had high blood pressure, breathing problems, any condition that affects your blood such as sickle cell anemia (inherited condition in which the red blood cells are abnormally shaped and cannot bring oxygen to all parts of the body) or thalassemia (Mediterranean anemia; a condition in which the red blood cells do not contain enough of the substance needed to carry oxygen), or heart disease. If you experience any of the following symptoms, call your doctor immediately: excessive tiredness, pale skin, headache, dizziness, confusion, fast heartbeat, weakness, shortness of breath, or chest pain.
For female patients who are taking ribavirin:
Do not take ribavirin if you are pregnant or plan to become pregnant. You should not start taking ribavirin until a pregnancy test has shown that you are not pregnant. You must use two forms of birth control and be tested for pregnancy every month during your treatment and for 6 months afterward. Call your doctor immediately if you become pregnant during this time. Ribavirin may cause harm or death to the fetus.
For male patients who are taking ribavirin:
Do not take ribavirin if your partner is pregnant or plans to become pregnant. If you have a partner who can become pregnant, you should not start taking ribavirin until a pregnancy test shows that she is not pregnant. You must use two forms of birth control, including a condom with spermicide during your treatment and for 6 months afterward. Your partner must be tested for pregnancy every month during this time. Consult your doctor immediately if your partner becomes pregnant. Ribavirin may cause harm or death to the fetus.
Why is Peginterferon prescribed?
Peginterferon alfa-2a is used alone or in combination with ribavirin (a medication) to treat chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in people who show signs of liver damage and who have not been treated with interferon alpha (medication similar to peg-interferon alfa-2a) in the past. Peginterferon alfa-2a is also used to treat chronic hepatitis B infection (swelling of the liver caused by a virus) in people who show signs of liver damage. Peginterferon alfa-2a is in a class of medications called interferons. Peginterferon is a combination of interferon and polyethylene glycol, which helps the interferon stay active in your body for a longer period of time. Peginterferon works by decreasing the amount of hepatitis C virus (HCV) or hepatitis B virus (HBV) in the body. Peginterferon alfa-2a may not cure hepatitis C or hepatitis B or prevent you from developing complications of hepatitis C or hepatitis B such as cirrhosis (scarring) of the liver, liver failure, or liver cancer. Peginterferon alfa-2a may not prevent the spread of hepatitis C or hepatitis B to other people.
How should Peginterferon be used?
Peginterferon alfa-2a comes as a solution (liquid) in a vial and/or a prefilled syringe to inject subcutaneously (into the fatty layer just under the skin). It is usually injected once a week, on the same day of the week, and at around the same time of day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Use peginterferon alfa-2a exactly as directed. Do not use more or less of Peginterferon or use it more often than prescribed by your doctor.
Your doctor will probably start you on an average dose of peginterferon alfa-2a. Your doctor may decrease your dose if you experience serious side effects of the medication. Be sure to tell your doctor how you are feeling during your treatment and ask your doctor or pharmacist if you have questions about the amount of medication you should take.
Continue to use peginterferon alfa-2a even if you feel well. Do not stop using peginterferon alfa-2a without talking to your doctor.
Only use the brand and type of interferon that your doctor prescribed. Do not use another brand of interferon or switch between peginterferon alfa-2a in vials and prefilled syringes without talking to your doctor. If you switch to a different brand or type of interferon, your dose may need to be changed.
You can inject peg-interferon alfa-2a yourself or have a friend or relative give you the injections. Before you use peg-interferon alfa-2a for the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. If another person will be injecting the medication for you, be sure that he or she knows how to avoid accidental needlesticks to prevent the spread of hepatitis.
You can inject peginterferon alfa-2a anywhere on your stomach or thighs, except your navel (belly button) and waistline. Use a different spot for each injection. Do not use the same injection spot two times in a row. Do not inject peginterferon alfa-2a into an area where the skin is sore, red, bruised, scarred, infected, or abnormal in any way.
Never reuse syringes, needles, or vials of peginterferon alfa-2a. Throw away used needles and syringes in a puncture resistant container, and throw away used vials of medication in the trash. Talk to your doctor or pharmacist about how to dispose of the puncture resistant container.
Before you use peginterferon alfa-2a, look at the solution in the vial or the prefilled syringe closely. It should be clear and free of floating particles. Check the vial or syringe to make sure there are no leaks and check the expiration date. Do not use the solution if it is expired, discolored, cloudy, contains particles, or is in a leaky vial or syringe. Use a new solution, and show the damaged or expired one to your doctor.
To prepare peginterferon alfa-2a in vials for injection, follow these steps:
Find a clean, comfortable area and collect the supplies you will need: unused syringe, unused needle, and several alcohol pads.
Remove a vial of peginterferon alfa-2a from the refrigerator.
Warm the vial of peginterferon alfa-2a by rolling it gently in the palms of your hands for about 1 minute. Do not shake the vial.
Wash your hands with soap and warm water. Dry your hands with a paper towel and use the towel to turn off the faucet.
Flip off the plastic top covering the vial opening and clean the rubber stopper with an alcohol pad.
Remove the needle and syringe from their packaging. If the needle and syringe were packaged separately, attach the needle to the end of the syringe. Remove the clear protective needle cap from the end of the needle. If there is an orange cap attached to the end of the syringe above the needle, do not remove it. This is to protect you from accidental needle sticks.
Pull the syringe plunger back so that the end of it is lined up with the mark on the syringe barrel that matches your prescribed dose. If you are not sure which mark on the syringe matches your dose, stop and call your doctor or pharmacist before you inject any medication.
Hold the syringe straight up and down and push the needle down through the center of the medication vial stopper.
Be sure that the tip of the needle is in the empty space above the liquid in the vial. Push down slowly on the plunger to inject all the air from the syringe into the vial .
Keep the needle inside the vial and turn both the vial and the needle upside down. Hold the vial and syringe straight up. Make sure the needle tip is in the medication liquid, not in the space above it, to prevent bubbles from forming in the syringe.
Slowly pull back on the plunger to fill the syringe with medication up to the mark that matches your dose.
Pull the syringe straight out of the vial. Do not touch the needle to anything.
Remove air bubbles from the syringe by holding the syringe with the needle pointing up to the ceiling. Use your thumb and finger to gently tap the syringe to bring air bubbles to the top. Push the plunger slightly to push air bubbles out of the syringe without squirting out any liquid.
- Keep the syringe pointing up until you are ready to give your dose. See below for injection instructions.
To prepare a pre-filled syringe (if available) of peginterferon alfa-2a, follow these steps:
Find a clean comfortable area and collect the supplies you will need: prefilled syringe, needle with needle guard, and several alcohol pads.
Remove a prefilled syringe from the refrigerator and warm it by gently rolling it in your hands for 1 minute. Be careful not to shake the syringe.
Wash your hands with soap and warm water. Dry your hands with a paper towel and use the towel to turn off the faucet.
Remove the needle from the package, but keep the plastic cap on the needle until you are ready to inject the medication.
Remove the rubber cap on the tip of the syringe and throw it away.
Put the needle on the end of the syringe barrel so that it fits tightly. Keep the syringe in a horizontal position until you are ready to use it. If you need to set the syringe down, make sure the plastic needle cap (shield) is covering the needle. Do not touch the needle to anything.
Remove the plastic cap from the needle shield, but do not remove the orange needle guard attached to the syringe above the needle.
Hold the syringe with the needle pointing toward the ceiling. Using your thumb and finger, tap the syringe to bring any air bubbles to the top. Press the plunger in slightly to push any air bubbles out of the syringe.
Slowly and carefully push down on the plunger rod until the edge of the plunger is lined up with the mark on the syringe barrel that matches your dose. If you are not sure which mark on the syringe matches your dose, stop and call your doctor or pharmacist before you inject any medication. Do not save or reuse any medication that you squirt out of the syringe.
- Do not let the needle touch any surface. See below for injection instructions.
To inject a dose of peginterferon alfa-2a, follow these steps:
Gently tap the skin in the place where you plan to inject peginterferon alfa-2a. Use an alcohol pad to clean the skin in the injection spot and allow it to air dry for 10 seconds.
Hold the needle with the point facing up. Use your thumb and forefinger to pinch up a fold of skin at the injection spot.
Hold the syringe like a pencil at a 45 or 90 degree angle to your skin. In one quick motion, insert the needle as far as it will go into the pinched area of skin. Pull back slightly on the syringe plunger. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject. Pull out the needle and throw away the syringe and needle in a puncture proof container. Choose a different spot to inject your medication and start the injection process over using new supplies. If no blood appears, let go of the pinched skin and slowly push the plunger all the way down so that all of the medication is injected.
Pull the needle out at the same angle you put it into your skin. Wipe the injection spot with an alcohol pad.
If you used a syringe with an orange needle-stick protection device, put the free end of the orange needle guard on a flat surface and push down on it until it clicks and covers the needle.
- Throw away your syringe and needle in a puncture-proof container right away. If you used a vial of peginterferon alfa-2a, throw it away. Each vial can only be used once.
Other uses for Peginterferon
Peginterferon may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions to follow?
Before using peginterferon alfa-2a,
- tell your doctor if you are allergic to peginterferon alfa-2a, other alpha interferons, any other medications, benzyl alcohol, or polyethylene glycol (PEG).Ask your doctor if you are not sure if a medication you are allergic to is an alpha interferon.
- tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: clozapin; cyclobenzaprine; imipramine (Tofranil); certain medications for HIV or AIDS such as abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zalcitabine, and zidovudine; methadone; mexilitene; naproxen; riluzole; tacrine; and theophyilline. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have ever had an organ transplant (surgery to replace an organ in the body). Also tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or any of the following: anemia (red blood cells do not bring enough oxygen to other parts of the body), or problems with your eyes or pancreas.
- tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding. Peginterferon alfa-2a may harm the fetus or cause you to miscarry (lose your baby). Talk to your doctor about using birth control while you are taking Peginterferon. You should not breastfeed while you are taking Peginterferon.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking peginterferon alfa-2a.
- you should know that peginterferon alfa-2a may make you dizzy, confused, or drowsy. Do not drive a car or operate machinery until you know how Peginterferon affects you.
- you should know that you may experience flu-like symptoms such as headache, fever, chills, tiredness, muscle aches, and joint pain during your treatment with peginterferon alfa-2a. If these symptoms are bothersome, ask your doctor if you should take an over-the-counter pain and fever reducer before you inject each dose of peginterferon alfa-2a. You may want to inject peginterferon alfa-2a at bedtime so that you can sleep through the symptoms.
What special dietary instructions to follow?
Drink plenty of fluids while you are taking Peginterferon.
What to do if I forget a dose?
If you remember the missed dose no longer than 2 days after you were scheduled to inject it, inject the missed dose as soon as you remember it. Then inject your next dose on your regularly scheduled day the following week. If more than 2 days have passed since the day you were scheduled to inject the medication, ask your doctor or pharmacist what you should do. Do not use a double dose or use more than one dose in 1 week to make up for a missed dose.
What side effects can Peginterferon cause?
Peginterferon alfa-2a may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
bruising, pain, redness, swelling, or irritation in the place you injected peginterferon alfa-2a
change in the way things taste
loss of appetite
dry or itchy skin
difficulty falling asleep or staying asleep
difficulty concentrating or remembering
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
blurred vision ,vision changes, or loss of vision
lower back pain
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
Peginterferon alfa-2a may cause other side effects. Call your doctor if you have any unusual problems while taking Peginterferon.
What to know about storage and disposal of Peginterferon?
Keep Peginterferon in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze it. Do not leave peginterferon alfa-2a outside of the refrigerator for more than 24 hours (1 day). Keep peginterferon alfa-2a away from light. Throw away any medication that is outdated or no longer needed.
What other information to know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Peginterferon.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref. US Natl. Library of Medicine
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
|| See FDA approved Prescribing Information from Manufacturer | PEGASYS |
| | Latest mph edition: 09 Dec 2013 |
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