Peginterferon alfa-2b

What is Peginterferon alfa-2b?

• Peginterferon alfa-2b (Sylatron) is an alpha interferon used to treat melanoma, as an adjuvant therapy to surgery.
• Peginterferon alfa-2b is also approved to treat chronic hepatitis C. This use is approved for the PEG-Intron brand of peginterferon alfa-2b.

Peginterferon alfa-2b

What are the uses of this medicine?

• Peginterferon alfa-2b (Sylatron) is used to prevent malignant melanoma (a kind of skin cancer) from coming back after it has been removed by surgery.
• Sylatron should be started within 84 days of surgery to remove lymph nodes containing cancer.

How does this medicine work?

• Peginterferon alfa-2b is a form of interferon alfa (a substance normally made by cells in the immune system) linked to a substance called PEG, which makes the drug stay in the body longer.
• Peginterferon alfa-2b is made in the laboratory.
• It is a type of cytokine and a type of biological response modifier.
• Also called SCH 54031.
• Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a serious allergic reaction to peginterferon alfa-2b or to interferon alfa-2b
• have certain types of hepatitis
• have severe liver damage

What drug interactions can this medicine cause?

Tell your doctor and pharmacist 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:

• amitriptyline, aripiprazole (Abilify), celecoxib (Celebrex), clomipramine (Anafranil), codeine, desipramine (Norpramin), dextromethorphan (in cough and cold medications, in Nuedexta), diclofenac ( Cambia, Cataflam, Flector, Voltaren, others), duloxetine (Cymbalta), flecainide (Tambocor), fluvastatin (Lescol), glipizide (Glucotrol), haloperidol (Haldol), ibuprofen (Motrin), imipramine (Tofranil), irbesartan (Avapro), losartan (Cozaar), mexiletine, naproxen (Anaprox, Naprosyn), ondansetron (Zofran), paroxetine (Paxil, Pexeva), phenytoin (Dilantin), piroxicam (Feldene), propafenone (Rhythmol), risperidone (Risperdal), rosiglitazone (Avandia), sulfamethoxazole (in Bactrim, in Septra), tamoxifen, thioridazine, timolol, tolbutamide, torsemide, tramadol (Conzip, Ultram, Ryzolt), venlafaxine (Effexor), and warfarin (Coumadin, Jantoven).

Is this medicine FDA approved?

• Sylatron was Approved for medical use in the United States in 2001.

How should this medicine be used?

• Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of Sylatron and as needed for subsequent doses.

Recommended dosage:

• The recommended starting dose is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years.

Administration:

• Inject Sylatron one time each week unless instructed differently by your healthcare provider. Call your healthcare provider for instructions if you miss a dose.
• Sylatron is given as an injection under your skin (subcutaneous injection). Your healthcare provider should show you how to prepare and measure your dose of Sylatron, and how to inject yourself before you use Sylatron for the first time.
• To help reduce flu-like symptoms:
• You should take 500 mg to 1,000 mg of acetaminophen 30 minutes before your first dose of Sylatron.
• Follow your healthcare provider's instructions about taking acetaminophen before future doses of Sylatron.
• Inject Sylatron at bedtime to help reduce flu-like symptoms.
• Drink plenty of fluids.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 200 mcg of deliverable lyophilized powder per single-use vial
• 300 mcg of deliverable lyophilized powder per single-use vial
• 600 mcg of deliverable lyophilized powder per single-use vial

This medicine is available in fallowing brand namesː

• Sylatron

What side effects can this medication cause?

The most common side effects of this medicine include:

• flu-like symptoms, which may include fever, headache, tiredness, muscle or joint aches, chills, nausea, or loss of appetite
• feeling sad or depressed
• redness, swelling, or itching around the injection site
• changes in blood tests measuring how your liver works

Sylatron can cause serious side effects or worsen existing problems, including:

• serious mental health problems
• Heart problems
• Serious eye problems
• Severe or worsening liver problems
• Thyroid problems
• High blood sugar (diabetes)

What special precautions should I follow?

• Peginterferon alfa-2b can cause life-threatening or fatal neuropsychiatric reactions. These include suicide, suicidal and homicidal ideation, depression, and an increased risk of relapse of recovering drug addicts. Permanently discontinue Sylatron for suicidal or homicidal ideation, aggressive behavior towards others, or other severe or persistent psychiatric symptoms; institute psychiatric intervention and follow-up as appropriate.
• Cardiac adverse reactions, including myocardial infarction, bundle-branch block, ventricular tachycardia, and supraventricular arrhythmia occurred in 4% of Sylatron-treated patients. Permanently discontinue Sylatron for new onset of ventricular arrhythmia or cardiovascular decompensation.
• Peginterferon alfa-2b can cause decrease in visual acuity or blindness due to retinopathy. Perform an eye examination that includes assessment of visual acuity and indirect ophthalmoscopy or fundus photography at baseline in patients with preexisting retinopathy and at any time during Sylatron treatment in patients who experience changes in vision. Permanently discontinue Sylatron in patients who develop new or worsening retinopathy.
• Peginterferon alfa-2b, increases the risk of hepatic decompensation and death in patients with cirrhosis. Permanently discontinue Sylatron for evidence of severe (Grade 3) hepatic injury or hepatic decompensation.
• Peginterferon alfa-2b can cause new onset or worsening of hypothyroidism, hyperthyroidism, and diabetes mellitus. Permanently discontinue Sylatron in patients who develop hypothyroidism, hyperthyroidism or diabetes mellitus that cannot be effectively managed.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe fatigue
• headache
• myalgia
• neutropenia
• thrombocytopenia

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Sylatron in pregnant women.
• Use Sylatron during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in patients below the age of 18 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: peginterferon alfa-2b
• Inactive ingredients: dibasic sodium phosphate anhydrous, monobasic sodium phosphate dihydrate, polysorbate 80, sucrose, sterile water for injection is supplied as a diluent.

Who manufactures and distributes this medicine?

Manufactured by:

• Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ , USA

What should I know about storage and disposal of this medication?

• Store Sylatron vials in the carton at 59°F to 86°F (15°C to 30°C).
• After mixing, use Sylatron right away or store it in the refrigerator for no longer than 24 hours at 36°F to 46°F (2°C to 8°C).
• Do not freeze Sylatron.

• Dailymed label info on Peginterferon alfa-2b
• FDA Peginterferon alfa-2b

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