sylatron

Sylatron (peginterferon alfa-2b) is an alpha interferon made from human proteins. It helps the body fight viral infections.

Sylatron is a prescription medicine that is used to prevent malignant melanoma (a kind of skin cancer) from coming back after it has been removed by surgery. It is not known if Sylatron is safe and effective in children less than 18 years of age.

Sylatron may also be used for purposes not listed in this medication guide.

Important information

You should not use Sylatron if you are allergic to peginterferon alfa-2b or other alfa interferons, or if you have autoimmune hepatitis, liver failure, severe kidney disease, or a hemoglobin blood cell disorder.

Before using Sylatron, tell your doctor about all of your medical conditions.

Stop using Sylatron and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to Sylatron, you must never use it again. There are many other medicines that can interact with Sylatron. Tell your doctor about all the prescription and over-the-counter medications you use.

Before using Sylatron

You should not use Sylatron if you are allergic to peginterferon alfa-2b or other alfa interferons (Intron A, Rebetron, Alferon N, Infergen, Pegasys), or if you have:

• autoimmune hepatitis;

• liver failure;

• severe kidney disease;

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

To make sure you can safely use Sylatron, tell your doctor if you have:

• lung disease;

• hepatitis B, or liver problems other than hepatitis C;

• a thyroid disorder;

• uncontrolled diabetes;

• new or worsening problems with your eyes;

• cancer;

• HIV or AIDS;

• pancreatitis or ulcerative colitis;

• heart disease, high blood pressure, high cholesterol or triglycerides, or a history of heart attack, or stroke;

• dental problems or gum disease;

• an allergy causing severe reaction;

• history of organ transplant;

• any blood cell disorder causing bleeding episodes, infections, or fever-related illness;

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

• a history of drug or alcohol addiction, depression, anxiety, or suicidal thoughts or behaviors.

FDA pregnancy category C: Sylatron may be harmful to an unborn baby. Do not use Sylatron without telling your doctor if you are pregnant. Use Sylatron during pregnancy only if the potential benefit justifies the potential risk to the unborn baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether peginterferon alfa-2b passes into breast milk or if it could harm a nursing baby. Because of the potential for adverse reactions from peginterferon alfa-2b in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with Sylatron, taking into account the importance of the therapy to the mother.

How should I use Sylatron?

Sylatron is injected under the skin (subcutaneously). 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.

Sylatron is usually given once per week. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Sylatron is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not shake the medication bottle or you may ruin the medicine. Swirl gently to dissolve the powder. Prepare your dose 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.

To be sure Sylatron is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. You may also need regular eye exams. Do not miss any scheduled appointments.

Store unmixed Sylatron vials at room temperature away from moisture and heat. Do not freeze. Do not reuse a vial. If you do not use the vial of the prepared solution right away, store it in a refrigerator and use within 24 hours. Do not freeze the prepared solution.

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.

Sylatron side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Sylatron: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Sylatron and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to Sylatron, you must never use it again.

Stop using Sylatron and call your doctor at once if you have any of these serious side effects:

• vision problems;

• fast heart rate, feeling like you might pass out;

• fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness, pain or burning when you urinate;

• high fever with severe stomach pain and bloody diarrhea;

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

• cough with mucus, feeling short of breath, chest pain, uneven heartbeats;

• sudden numbness or weakness, problems with speech, or balance; or

• new or worsening liver symptoms (upper stomach pain, dark urine, jaundice).

Common Sylatron side effects may include:

• fever, chills, tired feeling, headache, muscle pain;

• nausea, loss of appetite;

• abnormal liver function tests; or

• pain, redness, swelling, or irritation 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.

See also: Side effects (in more detail)

What other drugs will affect Sylatron?

Many drugs can interact with Sylatron. Below is just a partial list. Tell your doctor if you are using:

• fosphenytoin, methadone, phenytoin, rifampin, telbivudine, voriconazole;

• a blood thinner such as warfarin, Coumadin, Jantoven;

• ADHD medication such as Adderall, Ritalin, and others;

• an antidepressant or anti-psychotic medication;

• cancer medication;

• cough medicine (prescription or over-the-counter);

• diabetes medications you take by mouth;

• heart or blood pressure medication;

• HIV or AIDS medication;

• medicines used to prevent organ transplant rejection; or

• a sulfa drug (Bactrim, Septra, Sulfatrim, SMX-TMP, and others).

This list is not complete and there are many other medicines that can interact with Sylatron. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.