Intron A

Generic Name: interferon alfa-2b (Injection route)

in-ter-FEER-on AL-fa-2b

Commonly used brand name(s):

In the U.S.

• Intron A

Available Dosage Forms:

• Powder for Solution
• Kit
• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interferon, Alfa (class)

Uses For Intron A

Interferon alfa-2b is used to treat hepatitis B and C, lymphoma, skin cancer, genital warts, certain types of leukemia, and Kaposi's sarcoma (in people with AIDS). Interferons are substances naturally produced by cells in the body to help fight infections and tumors. Interferon alfa-2b is a synthetic (man-made) version of these substances .

This medicine is available only with your doctor's prescription .

Before Using Intron A

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of interferon alfa-2b in children 1 to 17 years of age with hepatitis B or children 3 to 16 years of age with hepatitis C .

Appropriate studies have not been performed on the relationship of age to the effects of interferon alfa-2b in children with lymphoma, skin cancer, genital warts, certain types of leukemia, and Kaposi's sarcoma. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of interferon alfa-2b in the elderly. However, elderly patients are more likely to have age-related liver, kidney, bone marrow, or heart problems, which may require an adjustment of dosage in patients receiving interferon alfa-2b .

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ribavirin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Autoimmune disorders (such as lupus, rheumatoid arthritis, psoriasis, or sarcoidosis) or
• Blood clots or
• Bone marrow problems or
• Bowel problems or
• Diabetes or
• Eye problems or
• Heart or blood vessel disease, history of or
• Heart rhythm problems or
• Hypertriglyceridemia (high triglycerides in the blood) or
• Low blood pressure or
• Lung disease (such as COPD), history of or
• Stroke or heart attack, history of or
• Thyroid problems—Use with caution. This medicine may make these conditions worse .

• Autoimmune hepatitis or
• Depression or mental illness, history of or
• Liver disease or
• Weakened immune system—Should not use in patients with these conditions .

Proper Use of Intron A

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin, into a muscle or vein, or directly into a skin lesion .

If you are injecting interferon alfa-2b yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition .

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas .

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way .

Use a new needle and syringe each time you inject your medicine .

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems .

Each package of interferon alfa-2b contains a patient instruction sheet. Read this sheet carefully and make sure you understand:

• How to prepare the injection.
• Proper use of disposable syringes.
• How to give the injection.
• How long the injection is stable .

If you have any questions about any of this, check with your health care professional .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Intron A

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects .

Interferon alfa-2b can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor 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 doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose 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 .

For some children and teenagers, this medicine can increase thoughts of suicide. All of the warnings in this leaflet are true for a child or teenager who is using this medicine. Tell your doctor right away if you start to feel more depressed. Also tell your doctor right away if you have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide .

The powder form of this medicine contains albumin, which is derived from human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns .

Check with your doctor if blurred vision, decreased vision, or any other change in vision occurs during your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

Interferon alfa-2b may cause dryness of the mouth. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections .

Intron A Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Depression
• difficult or labored breathing
• shortness of breath
• swelling or puffiness of face
• tightness in chest
• weight loss
• wheezing

• Absence of or decrease in body movement
• accumulation of pus
• acne or oily skin
• actions that are out of control
• anxiety
• arm or jaw pain
• attack, assault, force
• back, leg, or stomach pains
• belching
• bladder pain
• bleeding after defecation
• bleeding, tender, or enlarged gums
• bloody, black, or tarry stools
• bloody nose
• bloody or cloudy urine
• bluish color of fingernails, lips, skin, palms, or nail beds
• blurred vision
• burning, dry or itching eyes
• burning feeling in chest or stomach
• burning, numbness or tingling in fingers, toes, hands, feet, or face
• burning or stinging of skin
• burning while urinating
• canker sores
• change in color vision
• change in consciousness
• change in hearing
• change in personality
• change in sense of smell
• change in walking and balance
• changes in menstrual periods
• changes in skin color
• changes in vision
• chest pain, discomfort, or heaviness
• chills
• clay-colored stools
• clumsiness
• cold flu-like symptoms
• cold hands and feet
• cold sweats
• collection of blood under skin
• confusion as to time, place, or person
• congestion
• constipation
• continuing ringing or buzzing or other unexplained noise in ears
• cough producing mucus
• coughing or spitting up blood
• cracked lips
• crying
• dark urine
• decreased ability to exercise
• decreased breast size
• decreased sexual ability in males
• decreased urination
• deep, dark purple bruise
• deepening of voice
• delusions
• dementia
• depersonalization
• diarrhea
• difficult or painful urination
• difficulty in speaking
• difficulty seeing at night
• difficulty swallowing
• dilated neck veins
• discharge, excessive tearing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• double vision
• drooling
• drowsiness
• dry eyes
• dry hair
• dry mouth
• dry, puffy skin
• dryness or soreness of throat
• dull ache or feeling of pressure or heaviness in legs
• dysphoria
• earache
• early growth of pubic hair
• enlarging clitoris
• enlarging penis
• euphoria
• excess air or gas in stomach
• excessive muscle tone
• extra heartbeats
• extreme fatigue
• extremely shallow or slow breathing
• eye pain
• fainting
• fast, slow, pounding, irregular, or racing heartbeat or pulse
• feeling cold
• feeling of constant movement of self or surroundings
• feeling of heat
• feeling of warmth
• feeling, seeing, or hearing things that are not there
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• fever
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• full or bloated feeling
• general body swelling
• general physical wasting or malnutrition associated with severe illness
• hallucinations
• headache
• heartburn
• heavier menstrual periods
• hives
• hoarseness or husky voice
• holding false beliefs that cannot be changed by fact
• hyperventilation
• inability to move arms, legs, or facial muscles
• inability to speak
• incoherent speech
• increase in body movements
• increase in heart rate
• increased frequency of erections
• increased hunger
• increased sensitivity of eyes to sunlight
• increased sensitivity to pain
• increased sensitivity to touch
• increased thirst
• increased urge to urinate during the night
• increased urination
• increased volume of pale, dilute urine
• indigestion
• irregular breathing
• irritability
• itching in genital or other skin areas
• itching, pain, redness, or swelling
• itching skin near damaged veins
• lab results that show problems with liver
• lack of feeling or emotion
• large amount of triglyceride in the blood
• light-colored stools
• lightheadedness
• loss of appetite
• loss of balance control
• loss of consciousness
• loss of hearing
• low body temperature
• lower back or side pain
• lump in abdomen
• menstrual irregularities
• mental depression
• metallic taste
• muscle aches
• muscle cramps
• muscle tension or tightness
• muscle trembling, jerking, or stiffness
• muscle weakness
• nausea or vomiting
• nerve pain
• nervousness
• no blood pressure
• no breathing
• no pulse
• noisy breathing
• nosebleeds
• pain or burning in throat
• pain, tenderness, or swelling of foot or leg
• painful blisters on trunk of body
• painful cold sores or blisters on lips, nose, eyes, or genitals
• painful or difficult urination
• pale skin
• paleness or cold feeling in fingertips and toes
• paranoia
• partial or slight paralysis
• passing of gas
• pinpoint red spots on skin
• pounding in the ears
• pressure in the stomach
• problems in urination or increase in amount of urine
• problems with speech or speaking
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• quick to react or overreact emotionally
• rapid, shallow breathing
• rapidly changing moods
• rash
• redness of the face, neck, arms and occasionally, upper chest
• redness or swelling in ear
• redness, pain, swelling of eye, eyelid, or inner lining of eyelid
• restlessness
• scaling
• seeing double
• seizures
• sensation of pins and needles
• sensation of spinning
• sensitivity to heat
• severe mood or mental changes
• severe pain in chest
• severe stomach pain with nausea and vomiting
• shakiness in legs, arms, hands, feet
• sharp pain in either or both sides of the chest
• shivering
• shuffling walk
• skin rash
• sleepiness
• slow speech
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• sneezing
• sore on the edge of the eyelid
• sores, ulcers, or white spots on lips or tongue or inside the mouth
• stabbing pain
• stiffness of limbs
• stomachache
• stomach cramps, tenderness, or discomfort
• stomach pain, continuing
• stomach upset
• sudden onset of severe breathing difficulty
• sudden shortness of breath or troubled breathing
• sudden sweating
• sudden, wide mood swings
• sunken eyes
• sweating
• swelling around the eyes
• swelling of abdominal or stomach area
• swelling of face, fingers, hands, ankles, feet, or lower legs
• swelling of front part of neck
• swelling of scrotum or penis
• swelling of the breasts or breast soreness in both females and males
• swelling or inflammation of the mouth
• swollen, painful, or tender lymph glands in neck, armpit, or groin
• swollen, red, tender area of infection
• talking, feeling, and acting with excitement
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• terrifying dreams causing sleep disturbances
• thickening of bronchial secretions
• thirst
• thoughts of killing oneself changes in behavior
• tingling in the hands and feet
• tingling or pain in fingers or toes when exposed to cold
• trembling or shaking of hands or feet
• trouble in holding or releasing urine painful urination
• trouble sleeping
• troubled breathing with exertion
• twisting movements of body
• twitching
• uncaring
• uncomfortable swelling around anus
• unconsciousness
• uncontrolled eye movements
• uncontrolled movements, especially of face, neck, and back
• unnatural hair growth or loss
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual behavior
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• upper right abdominal pain
• very drowsy or sleepy
• voice changes
• vomiting of blood or material that looks like coffee grounds
• waking to urinate at night
• watery or bloody diarrhea
• weak or feeble pulse
• weakness of the muscles in your face
• weight gain
• wrinkled skin
• yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• bleeding gums
• blistering, crusting, irritation, itching, or reddening of skin
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• change in taste bad unusual or unpleasant (after)taste
• cracked, dry, scaly skin
• hair loss, thinning of hair
• irritation in mouth
• joint pain
• lack or loss of strength
• loss of memory
• muscle or bone pain
• pain or tenderness around eyes and cheekbones
• poor concentration
• problems with memory
• redness and swelling of gums
• stuffy or runny nose
• swollen joints

• Abnormal ejaculation
• absent, missed, or irregular menstrual periods
• bleeding, burning, inflammation, itching, or pain at site
• bone deformity
• burning, itching, and pain in hairy areas, pus at root of hair
• burning, numbness, pain, or tingling in all fingers except smallest finger
• cold and clammy skin
• decrease in height
• decreased interest in sexual intercourse
• degenerative disease of the joint
• difficulty in moving or walking
• discoloration of skin
• inability to have or keep an erection
• increased clear or white vaginal discharge
• increased sensitivity of skin to sunlight
• itching or pain of the genital area
• leg cramps
• longer menstrual periods
• loss in sexual ability, desire, drive, or performance
• multiple swollen and inflamed skin lesions
• pain in ankles or knees
• pain in ribs
• pain, inflammation, or swelling in calves, shoulders, or hands
• painful, red lumps under the skin, mostly on the legs
• pelvic pain
• rash with flat lesions or small raised lesions on the skin
• severe sunburn
• skin rash, encrusted, scaly and oozing small lumps under the skin
• small lumps under the skin
• swelling, or redness in joints
• red or irritated eyes
• redness or swelling in arms or legs
• redness, tenderness, itching, burning, or peeling of skin
• shivering
• soreness of muscles
• stopping of menstrual bleeding
• tanning or blue-gray discoloration of skin
• tearing of the eyes
• underactive reflexes
• unexpected menstrual bleeding

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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