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interferon alfa-2a (Subcutaneous route)

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

Subcutaneous routeKit

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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 .

Commonly used brand name(s):

In the U.S.

  • Roferon-A

Available Dosage Forms:

  • Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interferon, Alfa (class)

Uses For interferon alfa-2a

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.

interferon alfa-2a 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This product was withdrawn from the U.S. market by Roche on October 1, 2007.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 interferon alfa-2a

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-2a, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to interferon alfa-2a 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-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.

Geriatric

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.

Interactions with Medicines

Using interferon alfa-2a 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 interferon alfa-2a 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

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-2a. 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 interferon alfa-2a

A nurse or other trained health professional may give you interferon alfa-2a. interferon alfa-2a is given as a shot under your skin. You may be taught how to give interferon alfa-2a 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 interferon alfa-2a 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 interferon alfa-2a. This will keep your kidneys working well and help prevent kidney problems.

Dosing

The dose of interferon alfa-2a 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 interferon alfa-2a. 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

interferon alfa-2a 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 interferon alfa-2a

It is very important that your doctor check your progress at regular visits to make sure that interferon alfa-2a is working properly. Blood tests may be needed to check for unwanted effects.

interferon alfa-2a 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 interferon alfa-2a. 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 interferon alfa-2a.

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).

interferon alfa-2a may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to interferon alfa-2a 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.

interferon alfa-2a 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:

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.

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