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Frequently Asked Questions About INFERGEN® (Interferon alfacon-1)
What is INFERGEN?
How is INFERGEN different from other interferons?
What is the goal of INFERGEN therapy?
How should I take INFERGEN?
Who should not take INFERGEN?
What should I avoid while taking INFERGEN?
What are the possible side effects of INFERGEN?
How do I prepare and inject the INFERGEN dose?
Disposal
How should I store INFERGEN?
How will I know if the therapy is working?
How often should I see my healthcare professional during INFERGEN therapy?
What else do I need to know about INFERGEN therapy?
What is INFERGEN?
INFERGEN is a medicine used to treat adults with chronic HCV infection. Hepatitis C is a liver disease caused by HCV and is spread by contact with the blood of a person carrying HCV. Most people who get hepatitis C carry the virus in their blood for the rest of their lives. Most of these people will have some liver damage, but many do not feel sick from the disease. Some people will develop a badly damaged or scarred liver (cirrhosis). Cirrhosis can cause the liver to stop working.
Your healthcare provider will tell you if the hepatitis C virus you have is resistant (type 1 virus) or easier to treat (type 2 or 3 virus) and the chance of treatments working.
INFERGEN may lower the amount of HCV in the body so that it cannot be measured by blood tests. Your healthcare provider should do regular blood tests to check for side effects and your response to treatment.
INFERGEN therapy alone will not prevent a person with hepatitis C from giving another person the HCV infection.
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How is INFERGEN different from other interferons?
INFERGEN is a bioengineered consensus interferon. This means that it is different from other interferons used to treat hepatitis C because it was made in a laboratory. INFERGEN has been demonstrated to be effective in patients for whom previous interferon treatment has not been effective or who have detectable virus following treatment with other interferons.1
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What is the goal of INFERGEN therapy?
There are two goals of INFERGEN therapy:
- Eradicate HCV from your blood so it can no longer be found
- Reduce or prevent any further damage to your liver
- Your liver damage may improve, and the virus may drop below levels where it can be found in the blood, even after you stop taking INFERGEN. This is called a sustained virologic response (SVR).
- Your liver and the amount of virus may remain the same, with little benefit to you. This is called nonresponse.
- Your liver can improve, and the virus level can drop, but after you stop treatment these signs of hepatitis can come back. This is called a relapse.
How should I take INFERGEN?
Follow your healthcare professional's instructions about how to take INFERGEN.
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Who should not take INFERGEN?
Do not take INFERGEN if you:
- Are pregnant or breast feeding or planning to become pregnant
- Have autoimmune hepatitis (hepatitis caused by your immune system attacking your liver)
- Had an allergic reaction to another alpha-interferon medicine or are allergic to any of the ingredients in INFERGEN. See the ingredient listing in the Full Prescribing Information.
What should I avoid while taking INFERGEN?
While taking INFERGEN you should:
- Avoid becoming pregnant. INFERGEN may cause harm to an unborn child or cause you to lose your baby (miscarry).
- Do not breastfeed your baby.
- Mental health problems
- Blood problems
- Heart problems
- Autoimmune problems
- Hives
- Swelling around your eyes or lips
- Swelling in your mouth or throat
- Trouble breathing
- Flu-like symptoms: INFERGEN causes flu-like symptoms in most patients. Symptoms include headache, muscle aches, tiredness, chills and fever that usually lessen after the first few weeks of therapy. If you inject your INFERGEN dose at bedtime, you may be able to sleep through the symptoms. You may also take a fever and pain reducer such as acetaminophen (Tylenol®*) or ibuprofen, to help relieve or reduce the flu-like symptoms.
- Tiredness (fatigue): INFERGEN causes extreme tiredness in many patients.
- Upset stomach: Nausea, loss of appetite, diarrhea and weight loss may happen.
- Blood sugar problems: INFERGEN may affect blood sugar levels and cause high blood sugar or diabetes.
- Skin reactions at the injection site: Redness, rash, itching, a lump, swelling, or bruising that does not go away may happen at the site of injection. Call your healthcare provider if these symptoms do not go away after several days.
- Hair thinning: Hair thinning may happen during INFERGEN treatment but hair loss stops and hair growth returns after you stop taking INFERGEN.
If you are concerned about side effects or find them troublesome, talk to your healthcare provider.
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The INFERGEN Patient Decision Kit
Sign up to receive a Patient Decision Kit, which includes: A video/DVD
that includes step-by-step instructions on injecting
INFERGEN
Find a clean, comfortable, well-lit place and remove a vial of INFERGEN from the refrigerator and allow it to reach room temperature.
- Assemble the supplies you will need for your injection:
- A vial of INFERGEN
- One sterile disposable syringe and needle
- Several alcohol swabs and
- A puncture-proof container to dispose of the needle and syringe when you are done
- Make sure you have the right syringe to use with INFERGEN. It is important to use a syringe that is marked in tenths of millimeters (mLs), for example, 0.1 mL. Your healthcare provider may refer to a mL as a cc (1 mL = 1 cc). Failure to use the right syringe can lead to a mistake in dosage. You may receive too little or too much INFERGEN.
- Check the date on the vial of INFERGEN and make sure that the date has not passed and look at the liquid inside the vial.
Do not use the INFERGEN if:- The liquid is cloudy
- The liquid is not clear and colorless
- The liquid has particles
- The expiration date has passed
- Wash your hands thoroughly with soap and water.
Select and prepare the injection site on your body - Pick a site for your injection.
- Back of the upper arms (if someone is giving you the injection)
- Upper stomach area (abdomen), except for the belly button (navel) and waist areas
- Upper thighs
- Clean the injection site with an alcohol swab. Use circular motions from the inside to the outside. Keep the used alcohol swab nearby.
Preparing the dose - Remove the colored cap from the vial, exposing the rubber stopper.
- Clean the rubber stopper with a new alcohol swab, and then cover the stopper with the swab.
- Remove the syringe and needle from their packages. If either package looks like it has been opened or damaged, do not use the syringe or needle; dispose of it in the puncture-proof disposal container.
- Remove the needle cover and pull the plunger back and draw air into the syringe. The amount of air you draw into the syringe should be the same amount as the dose of medicine your healthcare provider has prescribed.
- Remove the alcohol wipe from the top of the vial and insert the needle straight through the center of the rubber stopper.
- Push the plunger of the syringe down to inject the air into the air space above the liquid in the vial. The air injected into the vial will allow INFERGEN to be easily withdrawn from the vial into the syringe.
- Keeping the needle in the vial, turn the vial upside down and make sure that the tip of the needle is in the liquid.
- Slowly pull the plunger back and let the medicine enter the syringe, filling it to the line that equals the dose your healthcare provider prescribed.
- Keeping the needle in the vial, check for air bubbles in the syringe. Air bubbles are harmless but can reduce the dose you should be receiving. To remove the air bubbles, gently tap the syringe with your fingers until the bubbles rise to the needle-end of the syringe barrel. Then push the plunger in to force the air out of the syringe.
Make sure the tip of the needle is in the liquid and slowly pull back on the plunger until the liquid in the syringe reaches the mark that correctly matches the amount of your dose. - Take the needle out of the vial and hold the syringe needle facing up in the hand that you will use to inject yourself. Do not lay the syringe down or allow the needle to touch anything.
Injecting the dose - Use the other hand to pinch a fold of skin at the site you cleaned for an injection.
- Hold the syringe the way you would hold a pencil and insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degree angle) to the skin.
- After the needle is in, let go of the skin. Pull the plunger back slightly. If blood appears, do not inject INFERGEN, because the needle has entered a blood vessel. Withdraw the syringe and discard it. Prepare a new syringe and inject at a new site. Repeat this procedure at the second site, checking for blood before injecting.
- If no blood appears, slowly push down on the plunger all the way, until all the medicine is gone from the syringe.
- Pull the needle out of the skin at the same angle you put it in and place an alcohol swab over the injection site, then press for several seconds.
- Promptly place the needle and syringe in the puncture proof disposal container. Never reuse the syringe or needle. Do not recap the needle.
Dispose of syringes and needles as directed by your healthcare provider or pharmacist. There may be special state and local laws.
Place all used needles, needle covers, and syringes in a special container called a Sharps Container or a hard plastic container‚ or a metal container with a plastic lid. Do not use glass or clear plastic containers‚ or any container that will allow the needles to stick through them.
Always keep the container out of the reach of children.
Do not recycle containers or throw full containers into the household trash.
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How should I store INFERGEN?
- Store INFERGEN in the refrigerator at 36° to 46°F (2° to 8°C)‚ but not in the freezer compartment.
- Do not let INFERGEN freeze and do not leave it in direct sunlight.
- Do not use a vial of INFERGEN that has been frozen or past the expiration date stamped on the label. If you think that the INFERGEN has been frozen or left in direct sunlight‚ do not use it‚ and call your healthcare provider for instructions.
- To transport INFERGEN‚ keep the vials cool and avoid extreme temperature changes.
- Do not shake INFERGEN. If INFERGEN is shaken too hard, it will not work properly.
- Keep INFERGEN and all medicines out of the reach of children.
How will I know if the therapy is working?
There are certain blood tests (ALT and HCV RNA) that your healthcare professional uses to see if you have hepatitis C. These same tests can also tell if INFERGEN is working. Your healthcare professional knows if INFERGEN is working if the blood tests show a lowering of your ALT level to normal, and if the HCV RNA particles have decreased or are no longer found in your blood.
Your healthcare professional may want to perform these same tests at different times during and after your therapy. It is important to continue to perform certain laboratory tests to see if the therapy is working. These tests are also used after therapy has stopped to see if the HCV has returned. The HCV may decrease as you keep taking INFERGEN, but it is important to stay with the injection schedule just as your healthcare professional prescribes.
Your healthcare professional may also perform a liver biopsy to make sure that disease activity (such as inflammation) is decreasing.
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How often should I see my healthcare professional during INFERGEN therapy?
Your healthcare professional will schedule regular office visits for you before you start therapy and during your therapy to keep track of your progress. After you stop taking INFERGEN, you will continue to see your healthcare professional to make sure that no problems arise after therapy.
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What else do I need to know about INFERGEN therapy?
It is important to know how much INFERGEN to use, how and when to inject it, and how to dispose of the materials after they have been used. This is important so that the people around you, such as your family, are not put at risk for developing hepatitis C.
Your healthcare professional will give you complete instructions on your therapy, including:
- Correct dosing
- How to safely and effectively inject INFERGEN
- How to dispose of contaminated materials safely
- How to prevent the spread of the disease to others.
Learn more about the INFERGEN® AspireSM Program
Find out about a live support program that's there for you 24/7.
Find out about a live support program that's there for you 24/7.
* Tylenol is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Data on file. Three Rivers Pharmaceuticals.
INFERGEN® (Interferon alfacon-1) is indicated for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA. Other causes of hepatitis, such as viral hepatitis B or autoimmune hepatitis, should be ruled out prior to initiation of therapy with INFERGEN. The most commonly reported adverse events during initial and subsequent treatment were headache, fatigue, fever, myalgia, rigors, body pain, arthralgia, and nausea.
Important Safety Information:
INFERGEN is contraindicated in patients with known hypersensitivity to alpha interferons or to any component of the product, in patients with decompensated hepatic disease and autoimmune hepatitis. Development of or exacerbation of autoimmune disorders (e.g. autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis) have been reported in patients receiving alpha interferon therapies, including INFERGEN.
Treatment with INFERGEN should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse experiences requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.
Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including INFERGEN. Depression, suicidal ideation, suicide attempt, and suicide may occur. Other prominent psychiatric adverse events may also occur, including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction. INFERGEN should be used with extreme caution in patients who report a history of depression. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted.
Bone Marrow Toxicity: Alpha interferons suppress bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts be obtained pretreatment and monitored routinely during therapy. Alpha interferon therapy should be discontinued in patients who develop severe decreases in neutrophil (<0.5 x 109/L) or platelet counts (<50 x 109/L).
Hypertension, tachycardia, palpitation, and tachyarrhythmias have been reported in patients treated with INFERGEN. INFERGEN should be administered with caution to patients with preexisting cardiac disease. Supraventricular arrhythmias, chest pain, and myocardial infarction have been associated with alpha interferon therapies.
Pneumonia and interstitial pneumonitis, some resulting in respiratory failure and/or patient deaths, have been induced or aggravated by alpha interferon therapy, including INFERGEN. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with INFERGEN.
Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with alpha interferons, including INFERGEN. During treatment, patients' clinical status and hepatic function should be closely monitored, and INFERGEN treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed.
Ophthalmologic Disorders: Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema are induced or aggravated by treatment with INFERGEN or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. INFERGEN therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Ischemic and hemorrhagic cerebrovascular events including hemorrhagic stroke have been observed in patients being treated with INFERGEN. In addition, transient ischemic attack has been reported in young patients being treated with INFERGEN without other reported risk factors.
INFERGEN should be discontinued immediately and appropriate medical treatment instituted if hypersensitivity reactions occur. INFERGEN should be administered with caution to patients with a history of endocrine disorders and should be discontinued immediately in patients who develop signs and symptoms of colitis. In addition, INFERGEN should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.
The most common adverse events reported for INFERGEN during clinical studies were headache (82%), fatigue (69%), fever (61%), myalgia (58%), rigors (57%), body pain (54%), arthralgia (51%), nausea (40%), insomnia (39%), pharyngitis (34%), nervousness (31%), infection upper respiratory (31%), diarrhea (29%), depression (26%), anorexia (24%), injection site erythema (23%), granulocytopenia (23%), dizziness (22%), cough (22%), dyspepsia (21%), thrombocytopenia (19%), anxiety (19%), sinusitis (17%), influenza-like symptoms (15%) and leucopenia (15%).
For U.S. residents only. The products discussed herein may have different product labeling in different countries. Please see Important Safety Information (including Boxed Warning) as well as the Full Prescribing Information and the INFERGEN Medication Guide.
Important Safety Information:
Alpha interferons, including Interferon alfacon-1, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.
Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping Interferon alfacon-1 therapy.
See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in the Full Prescribing Information.
Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping Interferon alfacon-1 therapy.
See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in the Full Prescribing Information.
INFERGEN is contraindicated in patients with known hypersensitivity to alpha interferons or to any component of the product, in patients with decompensated hepatic disease and autoimmune hepatitis. Development of or exacerbation of autoimmune disorders (e.g. autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis) have been reported in patients receiving alpha interferon therapies, including INFERGEN.
Treatment with INFERGEN should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse experiences requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.
Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including INFERGEN. Depression, suicidal ideation, suicide attempt, and suicide may occur. Other prominent psychiatric adverse events may also occur, including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction. INFERGEN should be used with extreme caution in patients who report a history of depression. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted.
Bone Marrow Toxicity: Alpha interferons suppress bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts be obtained pretreatment and monitored routinely during therapy. Alpha interferon therapy should be discontinued in patients who develop severe decreases in neutrophil (<0.5 x 109/L) or platelet counts (<50 x 109/L).
Hypertension, tachycardia, palpitation, and tachyarrhythmias have been reported in patients treated with INFERGEN. INFERGEN should be administered with caution to patients with preexisting cardiac disease. Supraventricular arrhythmias, chest pain, and myocardial infarction have been associated with alpha interferon therapies.
Pneumonia and interstitial pneumonitis, some resulting in respiratory failure and/or patient deaths, have been induced or aggravated by alpha interferon therapy, including INFERGEN. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with INFERGEN.
Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with alpha interferons, including INFERGEN. During treatment, patients' clinical status and hepatic function should be closely monitored, and INFERGEN treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed.
Ophthalmologic Disorders: Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema are induced or aggravated by treatment with INFERGEN or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. INFERGEN therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Ischemic and hemorrhagic cerebrovascular events including hemorrhagic stroke have been observed in patients being treated with INFERGEN. In addition, transient ischemic attack has been reported in young patients being treated with INFERGEN without other reported risk factors.
INFERGEN should be discontinued immediately and appropriate medical treatment instituted if hypersensitivity reactions occur. INFERGEN should be administered with caution to patients with a history of endocrine disorders and should be discontinued immediately in patients who develop signs and symptoms of colitis. In addition, INFERGEN should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.
The most common adverse events reported for INFERGEN during clinical studies were headache (82%), fatigue (69%), fever (61%), myalgia (58%), rigors (57%), body pain (54%), arthralgia (51%), nausea (40%), insomnia (39%), pharyngitis (34%), nervousness (31%), infection upper respiratory (31%), diarrhea (29%), depression (26%), anorexia (24%), injection site erythema (23%), granulocytopenia (23%), dizziness (22%), cough (22%), dyspepsia (21%), thrombocytopenia (19%), anxiety (19%), sinusitis (17%), influenza-like symptoms (15%) and leucopenia (15%).
For U.S. residents only. The products discussed herein may have different product labeling in different countries. Please see Important Safety Information (including Boxed Warning) as well as the Full Prescribing Information and the INFERGEN Medication Guide.
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