Pronunciation:

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

Brand Names:

• Intron A

Warnings:

Alpha interferons, including interferon alfa-2b, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping interferon alfa-2b therapy .

Classifications:

Pharmacologic—

Interferon, Alfa (class)

Uses of This Medicine:

Interferon alfa-2b injection is used to treat hepatitis B and C, lymphoma (lymph node cancer), malignant melanoma (skin cancer), genital warts, hairy cell leukemia (blood cell cancer), and Kaposi sarcoma (AIDS-related tumor). Interferons are substances 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 This Medicine:

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.

Children—

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.

Older adults—

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.

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.

Other 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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Fezolinetant

Using this medicine 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.

• Bendamustine
• Clozapine
• Pirfenidone
• Triclabendazole

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

Other interactions—

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 (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.

Proper Use of This Medicine:

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.

This medicine comes in a vial (glass container) or prefilled syringe. You might not use all of the medicine in each vial or syringe. Use them only one time and do not save an open vial or syringe. If the medicine has changed color or has particles in it, do not use it.

The solution in the vial or prefilled syringe should be allowed to warm to room temperature before injecting it.

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.

This medicine comes with a Medication Guide. Read this information carefully and make sure you understand:

• How to prepare the injection.
• The 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 information, talk with your doctor.

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.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

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.

Using interferon alfa-2b injection together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

A negative pregnancy test is required for women who are of childbearing age before starting combination therapy with interferon alfa-2b injection and ribavirin. Female patients and female partners of male patients must use 2 forms of birth control during therapy and for 6 months after therapy ends. Female patients must have regular pregnancy tests during combination therapy.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat.

Interferon alfa-2b injection 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 the 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.

This medicine can increase thoughts of suicide in people with or without a history of a mental illness. This medicine may also cause relapse in people with a history of substance abuse. Tell your doctor right away if you start to feel more depressed or exhibit aggressive behavior. Also tell your doctor right away if you have thoughts of hurting yourself or others. 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. If you, your child, or your caregiver notice any of these side effects during treatment and up to 6 months after treatment, tell your doctor right away.

The powder form of this medicine contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you have questions.

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).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make you tired or unable to concentrate. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Interferon alfa-2b injection and ribavirin combination may cause a dry 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.

Some patients who have used this medicine with ribavirin have had vomiting. If you vomit during or after your treatment, rinse your mouth out with water. This may also help prevent damage to your teeth and gums.

Children who use interferon alfa-2b and ribavirin combination may have weight loss and slowed growth. Most children have a growth spurt and gain weight after therapy ends. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Depression

difficult or labored breathing

swelling or puffiness of the face

tightness in the chest

weight loss

Less common

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:

More common

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

Less common

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.