PEG-Intron

1 What is PEG-Intron?

Brand: PEG-Intron, Peg Intron RP, Sylatron

Generic: Peginterferon Alfa-2b

PEG-Intron injection is a pegylated interferon made up of 165 amino acids used alone or in combination with ribavirin and another drug called a hepatitis C virus NS3/4A protease inhibitor to treat chronic hepatitis C infection.

This drug is used for patients with no history of being with treated by alpha interferons. The combination treatment of peginterferon alfa-2b and ribavirin is used to treat adults and children 3 years of age and older who show symptoms of liver damage.

Malignant melanoma can be prevented from recurring after resection by this drug. This drug should be started within 84 days of surgery to remove lymph nodes containing cancer. This drug requires a prescription.

2 What to Know Before Using

Before using PEG-Intron, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children younger than 3 years of age regarding the correlation of age to the effects of PegintronВ® have not been performed while safety and efficacy have not been established. Studies in children regarding the correlation of age to the effects of Sylatron have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of peginterferon alfa-2b injection. Adjustments in the dose of the elderly may be required since they are more likely to be more sensitive to the effects of this drug, and are more likely to have age-related kidney problems.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Thioridazine
  • Aminophylline
  • Amitriptyline
  • Anagrelide
  • Caffeine
  • Clomipramine
  • Clozapine
  • Desipramine
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Eliglustat
  • Flecainide
  • Imipramine
  • Methadone
  • Nortriptyline
  • Perphenazine
  • Pirfenidone
  • Propranolol
  • Rasagiline
  • Ropivacaine
  • Theophylline
  • Tizanidine
  • Tramadol
  • Trimipramine
  • Warfarin

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

Proper usage of PEG-Intron requires strict adherence to your doctor’s orders. A trained healthcare professional will be the only one to give you this drug. This drug is injected under your skin. You will be educated on how to administer this drug at home.

To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional. Make sure you understand how to prepare, inject, and assess the stability of the drug. The brand of this drug that your healthcare professional prescribed must be used as different brands may not work the same way.

You will be advised to inject the drug at bedtime and to take drugs 30 minutes before the injection if you are using this drug at home to prevent common "flu-like" symptoms such as:

It is recommended to increase fluid intake if you experience these unwanted effects. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. The dose in adults with hepatitis C virus infection is based on body weight and must be determined by your healthcare professional. It is usually between 40 and 150 micrograms injected under the skin once a week.

The dose in children 3 years of age and older is based on body weight and must be determined by your healthcare professional. Use and dose in children younger than 3 years of age must be determined by your healthcare professional.

The dose in adults with hepatitis C virus infection taking combination therapy with ribavirin is based on body weight and must be determined by your healthcare professional. It is usually between 50 and 150 micrograms injected under the skin once a week and should be taken together with ribavirin capsules or solution twice daily. The dose in children 3 years of age and older is based on body surface area and must be determined by your healthcare professional.

The dose is usually 60 micrograms per square meter of body surface area injected under the skin once a week and should be taken together with ribavirin capsules or solution twice daily.

Use and dose in children younger than 3 years of age must be determined by your healthcare professional. The dose in adults with melanoma is based on body weight and must be determined by your healthcare professional. It is usually 6 micrograms per kilogram of body weight injected under the skin once a week for 8 doses.

This should be followed by a dose of 3 mcg/kg of body weight injected under the skin once a week for up to 5 years. Use and dose in children must be determined by your healthcare professional. This drug needs to be given on a fixed schedule. Call your healthcare professional if you miss a dose or forget to use your drug.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using PEG-Intron, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests.

This drug has teratogenic potential when used with ribavirin and can also cause birth defects if the father is using it when his sexual partner becomes pregnant.

Inform your healthcare professional immediately if a pregnancy occurs while you are using these drugs. A negative pregnancy test is required in women who are of childbearing age before starting treatment with this drug and ribavirin. It is recommended to use 2 forms of birth control during therapy and for 6 months after therapy ends for female patients and female partners of male patients.

Female patients must have regular pregnancy tests during combination therapy. This drug can induce suicidal thoughts in people with or without a history of a mental illness. This drug may also cause relapse in people with a history of substance abuse.

Inform your healthcare professional immediately if you start to feel more depressed, exhibit aggressive behavior, or if you have thoughts of hurting yourself.

Notify your healthcare professional if you have:

  • Trouble sleeping
  • Get upset easily
  • Have a big increase in energy
  • Start to act recklessly
  • or If you have sudden or strong feelings such as:
    • Feeling nervous
    • Angry
    • Restless
    • Violent
    • Scared during treatment with this drug

Seek immediate medical attention if you have symptoms of anaphylaxis such as:

  • Itching
  • Hives
  • Hoarseness
  • Trouble with breathing
  • Trouble with swallowing
  • Any swelling of the hands, face, or mouth while you or your child are using this drug

Consult with your healthcare professional if you have symptoms of an allergic reaction such as:

  • Blistering
  • Peeling, or loose skin
  • Fever or chills
  • Hives or welts
  • Red skin lesions
  • Severe acne or skin rash
  • Sores or ulcers on the skin while you are using this drug

Check with your healthcare professional immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. You may be referred to an ophthalmologist to have your eyes checked.

Peginterferon alfa-2b injection combined with ribavirin can temporarily cause leukopenia and thrombocytopenia which increase your risk of infection or bleeding. It is recommended to avoid people with infections. Check with your healthcare professional immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your healthcare professional immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical health care professional, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical health care professional before having any dental work done.

Touching your eyes or the inside of your nose is not recommended unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

Check with your healthcare professional immediately if you have symptoms of a serious liver problem such as:

  • Pain or tenderness in the upper stomach
  • Pale stools
  • Dark urine
  • Loss of appetite
  • Nausea
  • Unusual tiredness or weakness
  • Yellow eyes or skin

Peginterferon alfa-2b injection, when used together with ribavirin, may cause teeth and gum problems. These drugs may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take these drugs for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

Check with your healthcare professional immediately if you have symptoms of pancreatitis such as:

Children who use peginterferon alfa-2b and ribavirin combination may have weight loss and slowed growth. Most children have a growth spurt and gain weight after therapy ends.

Check with your healthcare professional immediately if you have symptoms of peripheral neuropathy such as:

  • Burning
  • Numbness
  • Tingling
  • Painful sensations in the arms, hands, legs, or feet

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with PEG-Intron. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Abdominal or stomach pain
  • Anxiety
  • Black, tarry stools
  • Blood in the urine or stools
  • Bloody diarrhea
  • Chills
  • Cloudy urine
  • Cough or hoarseness
  • Depression
  • Difficult or labored breathing
  • Fever
  • Irritability
  • Lower back or side pain
  • Mood swings
  • Nausea
  • Painful or difficult urination
  • Pale skin
  • Pinpoint red spots on the skin
  • Tightness in the chest
  • Trouble sleeping
  • Troubled breathing with exertion
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • Vomiting
  • Changes in menstrual cycle
  • Constipation
  • Drowsiness
  • Dry hair and skin
  • Sensitivity to cold
  • Weight gain
  • Aching
  • Pain, or stiffness in the joints
  • Aggressive behavior
  • Attempt to kill yourself
  • Backache
  • Chest pain
  • Cool, pale skin
  • Decrease in vision
  • Diarrhea
  • Difficulty with speaking
  • Dizziness
  • Drug addiction or overdose
  • Eye pain
  • Fast or irregular heartbeat
  • Feeling of constant movement of self or surroundings
  • Headache
  • Loss of appetite
  • Muscle weakness
  • Nervousness
  • Numbness or loss of feeling in one or both limbs on the same side of the body
  • Palpitations
  • Paralysis
  • Decrease in the amount of urine
  • Rash, hives, or itching
  • Restlessness
  • Sensation of spinning
  • Sensitivity to heat
  • Sensitivity to sunlight
  • Sweating
  • Thick
  • Scaly skin
  • Thoughts of killing someone
  • Thoughts of killing yourself
  • Warm, smooth, or moist skin
  • or Weight loss

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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