Interferon alfa-2b Injection

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze it. Once mixed, use it immediately. It can be stored in the refrigerator for up to 24 hours after mixing. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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 interferon alfa-2b, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to interferon alfa-2b 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 pediatric-specific problems that would limit the usefulness of interferon alfa-2b injection 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 injection in children with lymphoma, malignant melanoma, genital warts, hairy cell leukemia, and Kaposi sarcoma. Safety and efficacy have not been established.

Geriatric

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

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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving interferon alfa-2b, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using interferon alfa-2b with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Pirfenidone

Using interferon alfa-2b 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 interferon alfa-2b. Make sure you tell your doctor if you have any other medical problems, especially:

• Autoimmune disorders (eg, psoriasis, Raynaud disease, rhabdomyolysis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, or vasculitis) or
• Blood clotting problems (eg, pulmonary embolism, thrombophlebitis) or
• Bone marrow problems or
• Bowel problems (eg, colitis) or
• Depression or mental illness, history of or
• Diabetes or
• Diabetic retinopathy (diabetic eye problem) or
• Eye or vision problems (eg, retinopathy, optic neuritis) or
• Heart attack, history of or
• Heart or blood vessel disease, history of or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertensive retinopathy (eye problem caused by high blood pressure) or
• Hypertriglyceridemia (high triglycerides in the blood) or
• Hypotension (low blood pressure) or
• Liver disease (including cirrhosis), severe or
• Lung disease or other breathing problems (eg, COPD), history of or
• Stroke, history of or
• Thyroid problems—Use with caution. May make these conditions worse.

• Autoimmune hepatitis (liver inflammation) or
• Human immunodeficiency virus (HIV) infection or
• Kidney disease, severe or
• Liver or other organ transplant or
• Sickle cell anemia (red blood cell disorder) or
• Thalassemia major (genetic blood disorder) or
• Weakened immune system—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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
• swelling or puffiness of the face
• tightness in the chest
• weight loss

• Back, leg, or stomach pains
• bleeding, tender, or enlarged gums
• bloody, black, or tarry stools
• bloody nose
• bloody or cloudy urine
• blurred vision
• change in personality
• changes in behavior
• chest pain, discomfort, or heaviness
• chills
• clay-colored stools
• confusion as to time, place, or person
• constipation
• cough producing mucus
• coughing or spitting up blood
• dark urine
• decreased urination
• diarrhea
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fainting
• fast, slow, pounding, irregular, or racing heartbeat or pulse
• 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
• hallucinations
• headache
• hearing loss
• heavier menstrual periods
• hives or rash
• hoarseness or husky voice
• inability to speak
• increased thirst
• increased urination
• indigestion
• irritability
• itching, pain, redness, or swelling of the skin
• light-colored stools
• lightheadedness
• loss of appetite
• loss of consciousness
• loss of hearing
• lower back or side pain
• metallic taste
• muscle aches or cramps
• nausea or vomiting
• pale skin
• passing of gas
• pinpoint red spots on the skin
• seizures
• severe mood or mental changes
• severe stomach pain with nausea and vomiting
• slow speech
• sneezing
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stiffness of the limbs
• stomach cramps, tenderness, or discomfort
• stomach pain, continuing
• stomach upset
• sweating
• swelling around the eyes
• swelling of the face, fingers, hands, ankles, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thoughts of hurting or killing oneself
• trouble sleeping
• unusual behavior
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain
• 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 the skin
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste, or bad, unusual, or unpleasant (after) taste
• cracked, dry, or scaly skin
• hair loss or thinning of the hair
• irritation in the mouth
• joint pain
• lack or loss of strength
• loss of memory
• muscle or bone pain
• pain or tenderness around the eyes and cheekbones
• poor concentration
• problems with memory
• redness and swelling of the gums
• stuffy or runny nose
• swollen joints

• Abnormal ejaculation
• absent, missed, or irregular menstrual periods
• bleeding, burning, inflammation, itching, or pain at the injection site
• bone deformity
• burning, itching, and pain in the hairy areas, pus at the root of the 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 with moving or walking
• discoloration of the skin
• inability to have or keep an erection
• increased clear or white vaginal discharge
• increased sensitivity of the 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 the ankles or knees
• pain in the ribs
• pain, inflammation, or swelling in the 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
• red or irritated eyes
• redness or swelling in the arms or legs
• redness, tenderness, itching, burning, or peeling of the skin
• severe sunburn
• shivering
• skin rash, encrusted, scaly, and oozing small lumps under the skin
• small lumps under the skin
• soreness of the muscles
• stopping of menstrual bleeding
• swelling or redness in the joints
• tanning or blue-gray discoloration of the 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.