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Injecting INFERGEN® (Interferon alfacon-1)
A step-by-step guide
Beginning INFERGEN therapyThe good news is that you, a family member, or a friend, can inject INFERGEN. This gives you the freedom to take injections in the privacy and comfort of your own home. You can also travel during your treatment period as long as your INFERGEN is stored and handled properly.
No matter where you are, follow the injection schedule your healthcare professional has set up for you. Many people prefer to inject INFERGEN before bedtime. This may help to decrease the impact of any treatment-related side effects.
Each vial of INFERGEN is meant to be used only once. Do not reuse opened vials, even if there is some INFERGEN left in the vial. Do not use a vial if the contents are cloudy, or if you see particles or discoloration in it.
Get INFERGEN at a pharmacy or specialty pharmacy
Your healthcare professional will give you a prescription for INFERGEN and syringes. It can be filled at most pharmacies. If your pharmacy does not have access to syringes, ask your healthcare professional how you should get them.
Storing INFERGEN
INFERGEN should always be stored in the refrigerator, but not in the freezer. Do not leave it in direct sunlight. If you think your INFERGEN has been frozen or left in direct sunlight—or if it is past the expiration date stamped on the label—do not use it.
When you get your INFERGEN, be sure to:
- Check the label
Always check to make sure that the name INFERGEN is on the carton and vial. Make sure to use the vial before the expiration date stamped on the vial label. - Check the contents
INFERGEN should always be clear and colorless. Do not use it if the contents of the vial look discolored or cloudy, or contain lumps, flakes, or particles. - Use the correct syringe
Your healthcare professional will tell you how many milliliters (mL) you will need in the syringe for the correct dose. Your healthcare professional may refer to mL as cc (cubic centimeters). The two terms mean the same thing. It is important to use a syringe that is marked in tenths of milliliters (such as 0.1 mL). Using an improperly marked syringe can lead to a mistake in dosage, and failure to achieve the desired treatment results. Use disposable syringes and needles since they do not require sterilization. Ask your healthcare professional which syringe you should use. - Store INFERGEN and supplies safely
Always store your INFERGEN container, and all supplies for injection, out of the reach of children.
Getting ready
Before you start, make sure you have:- An INFERGEN single-use vial (keep refrigerated prior to use)
- Sterile disposable syringe with needle
- Alcohol swabs
- Adhesive bandages
- Needle disposal container
- Injection instructions
Once these items are assembled, follow these simple steps:
- Choose a clean, private, well-lit area.
- Wash hands thoroughly with soap and water.
- Remove the INFERGEN vial from the refrigerator. Check the date to make sure it has not expired. Allow time for the vial to reach room temperature. Use this time to assemble your other supplies. DO NOT SHAKE THE VIAL VIGOROUSLY.
Choosing and preparing an injection site
- Choose an injection site from these areas:
- Upper thighs
- Abdomen
- Back of arms (if someone else is giving you the injection)
Best areas for injection are areas that are more fatty. There are fewer nerves in fatty areas, so there will be less pain, or no pain at all, during injection.
Rotate the site each time you inject to avoid soreness (injection-site reactions). Always remember to record each injection site to help remind you to rotate sites properly. Occasionally, a problem may develop at the injection site. If you notice a lump, swelling, or bruising that does not go away, contact your healthcare professional. - Clean the injection site with an alcohol swab using a circular motion moving from the center to the outside. Allow alcohol to dry completely before giving yourself the injection.
Preparing the INFERGEN dose
- Remove the plastic cap from the vial so you see the rubber stopper.
- Clean the rubber stopper with a fresh alcohol swab. Cover the stopper with the swab to keep it sterile until you use it.
- Remove a syringe from its packaging. Do not use a syringe if the packaging has been opened or removed. Dispose of such syringes in your needle disposal container.
- With the needle cover on, pull back the syringe plunger until its tip is at the dose amount your healthcare professional has prescribed for you.
- Carefully remove the needle cover. Do not replace the cover on the needle.
- Set the INFERGEN vial upright on a flat surface. Insert the syringe needle straight through the rubber stopper.
- Push in the syringe plunger to inject air into the vial. Injecting air allows easier withdrawal of INFERGEN from the vial into the syringe.
- Keeping the needle in the rubber stopper, lift and turn both so that the vial is upside down above the syringe. Make sure the needle tip is in the liquid.
- Slowly pull the plunger back to draw INFERGEN into the syringe, filling it up to the dosage amount your healthcare professional has prescribed for you.
Your healthcare professional may refer to mL (milliliter) as cc (cubic centimeter). The two terms refer to the same amount. - Before removing the syringe from the vial, check the syringe for air bubbles. They are harmless, but can reduce the amount of INFERGEN you receive. To remove air bubbles, follow these steps:
- Gently tap the syringe until the bubbles rise to the top of the barrel.
- Push the plunger to force the bubbles out of the syringe.
- Pull the plunger back to the mL mark that matches your prescribed dose.
- Double-check to make sure you have withdrawn the correct amount of INFERGEN.
- Remove the needle from the rubber stopper. Hold the syringe in the hand you will use when injecting yourself.
Do not put the syringe down or allow the needle to touch anything.
Injecting INFERGEN
- Use your free hand to pinch a fold of skin at the previously prepared injection site (see step 5).
- Hold the syringe as you would hold a pencil. Insert the needle at either a straight up-and-down (90-degree angle) or at a 45-degree angle to the skin.
- After you have inserted the needle:
- Let go of the adjacent 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 retry in a different area of the prepared injection site, rechecking for the appearance of blood.
- When you find a site where no blood appears, slowly push the plunger down all the way until all the INFERGEN has been pushed out of the syringe.
- After you remove the needle, place the alcohol swab over the injection site. Press for several seconds to prevent bleeding.
- Use the disposable syringe only once—this will help make sure that the syringe is sterile (not contaminated by germs) and that you are giving yourself the proper dose. Carefully place the used syringe in your needle disposal container. NEVER attempt to put the cap back on the needle.
Always remember to- Discard all hazardous materials—such as used syringes and alcohol swabs—in your needle disposal container. Use the INFERGEN Treatment Diary to keep track of the exact body site where you gave yourself the injection.
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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