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Sylatron

Generic Name: peginterferon alfa-2b (peg-IN-ter-FEER-on AL-fa)
Brand Name: Sylatron

Sylatron may increase the risk of serious mental or mood problems, such as depression or suicidal thoughts or actions. Your doctor will monitor you for mental or mood changes while you use Sylatron and for 6 months after you stop using it. Talk with your doctor to be sure that the benefits of using Sylatron outweigh the risks.

Families and caregivers must closely watch patients who use Sylatron. Tell the patient's doctor right away if the patient has symptoms like new or worsened depression, or suicidal thoughts or attempts. Discuss any questions or concerns with the patient's doctor.


Sylatron is used for:

Treating skin cancer (melanoma) in certain patients.

Sylatron is an interferon. Exactly how Sylatron works to treat melanoma is not known.

Do NOT use Sylatron if:

  • you are allergic to any ingredient in Sylatron or to interferon alfa-2b
  • you have hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) or severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Sylatron:

Some medical conditions may interact with Sylatron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of mental or mood problems, suicidal thoughts or actions, or alcohol or other substance abuse or dependence
  • if you have kidney problems or liver problems (eg, cirrhosis)
  • if you have a history of heart problems (eg, fast or irregular heartbeat, heart muscle problems), eye or vision problems, thyroid problems, diabetes or high blood sugar, or lupus

Some MEDICINES MAY INTERACT with Sylatron. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Telbivudine because the risk of burning, numbness, or tingling in the arms or legs may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sylatron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sylatron:

Use Sylatron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Sylatron comes with an additional patient information sheet called a Medication Guide. It also comes with an additional patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Sylatron refilled.
  • Sylatron is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Sylatron at home, a health care provider will teach you how to use it. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Use your dose of Sylatron 1 time per week unless your doctor tells you otherwise. Use it on the same day of each week, at about the same time of day.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
  • Sylatron must be mixed before using. Swirl gently to mix Sylatron. Do not shake.
  • Do not use Sylatron if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use a different injection site (eg, thigh, outer surface of your upper arm, stomach) each time you use Sylatron. Do not inject yourself in the area around your belly button or waistline. If you are very thin, do not inject Sylatron into the stomach area. If you are unsure about where to inject Sylatron, contact your doctor or pharmacist.
  • Do not inject Sylatron into an area that is irritated, bruised, red, infected, scarred, or lumpy, or has stretch marks.
  • Drinking extra fluids while you are taking Sylatron is recommended. Check with your doctor for instructions.
  • Sylatron may cause flu-like side effects (eg, fever, headache, muscle aches, tiredness). Check with your doctor to see if you should use Sylatron at bedtime or take a nonprescription pain/fever reducer (eg, acetaminophen, ibuprofen) to decrease these effects.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Sylatron, check with your doctor about what to do.

Ask your health care provider any questions you may have about how to use Sylatron.

Important safety information:

  • Sylatron may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Sylatron with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT use more than the recommended dose. If you use more than your prescribed dose, contact your doctor right away.
  • Sylatron may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Sylatron may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Sylatron may increase the risk of serious and sometimes fatal liver problems, especially if you already have a certain liver problem (cirrhosis). Contact your doctor right away if you experience symptoms of liver problems (eg, dark urine, pale stools, unusual loss of appetite, nausea, stomach pain, yellowing of the skin or eyes, stomach swelling).
  • Sylatron may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Sylatron may increase the risk of serious mental or mood problems. It may also increase the risk of relapse in recovering addicts. This has been reported up to 6 months after stopping treatment. Contact your doctor at once if you experience new or worsened depression; aggressive, restless, or irritable behavior; thoughts of hurting another person; suicidal thoughts or actions; or any unusual change in mood or behavior while taking Sylatron or within 6 months after stopping treatment.
  • Tell your doctor or dentist that you take Sylatron before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver function, thyroid function, and eye exams, may be performed while you use Sylatron. You will also be monitored for mental or mood changes while you use Sylatron and for 6 months after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sylatron should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Sylatron can cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sylatron while you are pregnant. It is not known if Sylatron is found in breast milk. Do not breast-feed while taking Sylatron.

Possible side effects of Sylatron:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; hair thinning or loss; headache; loss of appetite; mild fever; muscle or joint pain or aches; nausea; taste changes; temporary redness, swelling, or itching at the injection site; tiredness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; butterfly-shaped rash on the face; chest, jaw, or arm pain; confusion; decreased hearing or hearing loss; fainting; fast or irregular heartbeat; fever, chills, cough, or persistent sore throat; hallucinations; memory loss; new or worsening mental or mood problems (eg, aggression or thoughts of hurting others, depression, exaggerated sense of well-being, irritability); new or worsening vision problems (eg, blindness, decrease in vision clearness, blurred vision); one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness or light-headedness; severe or persistent stomach pain; shortness of breath; slurred speech; sudden, severe nausea or vomiting; suicidal thoughts or actions; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting); symptoms of high blood sugar (eg, increased thirst, appetite, or urination; rapid breathing; fruit-like breath; unusual drowsiness); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes, stomach swelling); symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unexplained weight changes); unusual bruising or bleeding; unusual sweating; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms of overdose may include headache; muscle aches or pain; severe tiredness; symptoms of low blood platelets (eg, unusual bruising or bleeding); or symptoms of low white blood cells (eg, fever, chills, sore throat).

Proper storage of Sylatron:

Before mixing Sylatron, store it at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom.

After you mix Sylatron, use it right away. If you do not use it right away, it may be stored for up to 24 hours in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Throw away any mixed medicine that has not been used within 24 hours.

Do not mix more than 1 vial at a time. Do not freeze. Discard any used medicine appropriately. Keep Sylatron out of the reach of children and away from pets.

General information:

  • If you have any questions about Sylatron, please talk with your doctor, pharmacist, or other health care provider.
  • Sylatron is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Sylatron or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sylatron. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sylatron. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Sylatron.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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