Pronunciation:

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

Brand Names:

• Roferon-A

Dosage Forms:

• Solution

Warnings:

Alpha-interferons, including interferon alfa-2a, 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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-2a therapy .

May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely with periodic clinical and laboratory evaluations. Discontinue therapy with persistently severe or worsening signs or symptoms of these conditions .

Classifications:

Therapeutic

Immunological Agent

Pharmacologic

Interferon, Alfa (class)

Uses of This Medicine:

Interferon alfa-2a is used to treat chronic hepatitis C and certain types of leukemia (such as hairy cell leukemia and Philadelphia chromosome positive chronic myelogenous leukemia [CML]). Interferons are substances naturally produced by cells in the body to help fight infections and tumors. Interferon alfa-2a is a synthetic (man-made) version of these substances.

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

This product was withdrawn from the U.S. market by Roche on October 1, 2007. This action was not due to safety or efficacy concerns .

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-2a in children with chronic myelogenous leukemia.

Appropriate studies have not been performed on the relationship of age to the effects of interferon alfa-2a in children with chronic hepatitis C and hairy cell leukemia. 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-2a in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving interferon alfa-2a.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

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.

• Autumn Crocus
• Captopril
• Colchicine
• Enalaprilat
• Enalapril Maleate

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.

• Theophylline

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 (e.g., systemic lupus erythematosus, psoriasis, Raynaud's phenomenon, rheumatoid arthritis, or vasculitis) or
• Bleeding problems or
• Bone marrow problems (e.g., aplastic anemia) or
• Breathing problems or other lung diseases or
• Depression, history of or
• Diabetes or
• Diabetic retinopathy (eye problem caused by diabetes) or
• Eye or vision problems or
• Heart attack, history of or
• Heart disease, or history of or
• Heart or blood vessel disease or
• Hyperglycemia (high blood sugar level) or
• Hypertriglyceridemia (high triglyceride levels in the blood) or
• Seizures, history of or
• Thyroid disease or
• Weakened immune system Use with caution. May make these conditions worse.

• Autoimmune hepatitis (liver inflammation) or
• Liver disease, severe Should not be used in patients with these conditions.

• Colitis (inflammation of the bowel) or
• Pancreatitis (inflammation of the pancreas) Interferon alfa-2a should be stopped in patients with these conditions.

• Human immunodeficiency virus (HIV) infection or
• Liver or other organ transplant It is not known if interferon alfa-2a will work 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 may give you this medicine. This medicine is given as a shot under your skin. You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

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.

Each package of interferon alfa-2a contains a Medication Guide. Read the guide 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 doctor.

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.

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.

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 that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine contains benzyl alcohol which may cause serious reactions to newborn or premature infants. Discuss this with your doctor if you are concerned.

Interferon alfa-2a may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Serious allergic reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; fever or chills; hives or welts; red skin lesions; severe acne or skin rash; or sores or ulcers on the skin while you are using this medicine.

Interferon alfa-2a 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.

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

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and not able to see well.

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

Blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

chills

cough

depression

diarrhea

discouragement

dizziness

dry skin

fainting

fast, slow, or irregular heartbeat

feeling sad or empty

fever or chills

general feeling of discomfort or illness

headache

irritability

itching

joint pain

lack of appetite

loss of interest or pleasure

muscle aches and pains

nausea

nervousness

pounding in the ears

rash

runny nose

shivering

shortness of breath

sneezing

sore throat

sweating

thickening of bronchial secretions

tightness in the chest

tiredness

trouble with concentrating

trouble with sleeping

troubled breathing

unusual tiredness or weakness

vomiting

weight loss

wheezing

Less common

Back, leg, or stomach pains

black, tarry stools

bladder pain

bleeding gums

bloating

bloody nose

bloody or cloudy urine

changes in skin color

chest discomfort

cold feeling

collection of blood under the skin

confusion

constipation

convulsions

darkened urine

deep, dark purple bruise

difficult or labored breathing

difficult, burning, or painful urination

difficulty with breathing

difficulty with moving

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

eye pain

fear

feeling cold

feeling of constant movement of self or surroundings

frequent urge to urinate

general body swelling

hair loss

hoarseness or husky voice

increased sweating

indigestion

itching, pain, redness, or swelling

loss of bladder control

lower back or side pain

muscle cramps and stiffness

muscle spasm or jerking of all extremities

noisy breathing

nosebleeds

pain

pain, swelling, or redness in the joints

pain, tenderness, or swelling of the foot or leg

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

poor concentration

redness, soreness, or itching skin

sensation of spinning

shaking

sores, ulcers, or white spots on the lips or in the mouth

sores, welting, or blisters

stomach cramps

stuffy nose

sudden loss of consciousness

swelling or inflammation of the mouth

swollen or painful glands

tenderness

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

vomiting of blood or material that looks like coffee grounds

watery or bloody diarrhea

weakness in the arms or legs

weight gain

yellow eyes or skin

Rare

Agitation

bluish color of the fingernails, lips, skin, palms, or nail beds

change in consciousness

changes in the patterns and rhythms of speech

coma

dandruff

decreased vision

double vision

drowsiness

earache

feeling of warmth

generalized slowing of mental and physical activity

inability to move the arms, legs, or facial muscles

inability to speak

lack of feeling or emotion

light-colored stools

loss of ability to use or understand speech or language

loss of consciousness

loss of memory

oily skin

pain or discomfort in the arms, jaw, back, or neck

pain or tenderness around the eyes and cheekbones

paleness or cold feeling in the fingertips and toes

problems with memory

problems with speech or speaking

rapid, shallow breathing

red, scaling, or crusted skin

red, sore eyes

redness of the face, neck, arms, and occasionally, upper chest

restlessness

seeing, hearing, or feeling things that are not there

sensation of pins and needles

shakiness and unsteady walk

skin rash, encrusted, scaly, and oozing

slow speech

slurred speech

stabbing pain

stiff neck

sudden sweating

tingling or pain in the fingers or toes when exposed to cold

trouble sitting still

uncaring

unsteadiness, trembling, or other problems with muscle control or coordination

upper right abdominal pain

Incidence not known

Blindness

change in ability to see colors, especially blue or yellow

coughing that sometimes produces a pink frothy sputum

difficult, fast, or noisy breathing, sometimes with wheezing

heavier menstrual periods

migraine headache

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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

hair loss or thinning of the hair

lack or loss of strength

sleeplessness

unable to sleep

Less common

Abnormal ejaculation

change in taste or bad unusual or unpleasant (after) taste

decreased interest in sexual intercourse

decreased sexual performance or desire

excess air or gas in the stomach or intestines

full feeling

inability to have or keep an erection

irregular menstrual period

loss in sexual ability, desire, drive, or performance

passing gas

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