INTERFERONS,ALPHA (Systemic)

Some commonly used brand names are:

In the U.S.?

• Alferon N ⁴
• Roferon-A ¹
• Intron A ²

In Canada?

• Roferon-A ¹
• Intron A ²
• Wellferon ³

Category

• Antineoplastic?Interferon Alfa-2a, Recombinant; Interferon Alfa-2b, Recombinant; InterferonAlfa-n1 (lns); Interferon Alfa-n3
• Biological response modifier?Interferon Alfa-2a, Recombinant; InterferonAlfa-2b, Recombinant; Interferon Alfa-n1(lns); Interferon Alfa-n3

Description

Interferons (in-ter-FEER-ons)are substances naturally produced by cells in the body to help fight infectionsand tumors. They may also be synthetic (man-made) versions of these substances.Alpha interferons are used to treat hairy cell leukemia, malignant melanoma,and AIDS-related Kaposi's sarcoma. They are also used to treat laryngeal papillomatosis(growths in the respiratory tract) in children, genital warts, and some kindsof hepatitis.

Alpha interferons may also be used for other conditions as determined byyour doctor.

Alpha interferons are available only with your doctor's prescription, inthe following dosage form:

Parenteral
• Interferon Alfa-2a, Recombinant
  • Injection (U.S. and Canada)
• Interferon Alfa-2b, Recombinant
  • Injection (U.S. and Canada)
• Interferon Alfa-n1 (lns)
  • Injection (Canada)
• Interferon Alfa-n3
  • Injection (U.S.)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to alpha interferon or to proteins, such as egg white orimmunoglobulin.

Pregnancy?Alpha interferons have not been shown to cause birthdefects or other problems in humans. However, in monkeys given 20 to 500 timesthe human dose of recombinant interferon alfa-2a or given 90 to 180 timesthe usual dose of recombinant interferon alfa-2b, there was an increase indeath of the fetuses.

Breast-feeding?It is not known whether alpha interferons passinto breast milk. However, because this medicine may cause serious side effects,breast-feeding may not be recommended while you are receiving it. Discusswith your doctor whether or not you should breast-feed while you are receivingalpha interferon.

Children?There is no specific information comparing use ofalpha interferon for cancer or genital warts in children with use in otherage groups.

Alpha interferons may cause changes in the menstrual cycle. Discuss thispossible effect with your doctor.

Older adults?Some side effects of alpha interferons(chest pain, irregular heartbeat, unusual tiredness, confusion, mental depression,trouble in thinking or concentrating) may be more likely to occur in the elderly,who are usually more sensitive to the effects of alpha interferons.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of alpha interferons. Make sure you tell yourdoctor if you have any other medical problems, especially:

• Bleeding problems?May be worsened by recombinant interferonalfa-2b

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

• Convulsions (seizures) or
• Mental problems (or history of)?Risk of problems affectingthe central nervous system may be increased

• Diabetes mellitus (sugar diabetes) or
• Heart attack (recent) or
• Heart disease or
• Infections or
• Kidney disease or
• Lack of blood supply to any part of the body or
• Liver disease or
• Lung disease?May be worsened by alpha interferons

• Problems with overactive immune system?Alpha interferons makethe immune system even more active

• Thyroid disease?Recombinant interferon alfa-2b can cause thyroidproblems when it is used to treat hepatitis

Proper Use of This Medicine

If you areinjecting this medicine yourself, use it exactly as directedby your doctor. Do not use more or less of it, and do not use it moreoften than your doctor ordered. The exact amount of medicine you need hasbeen carefully worked out. Using too much will increase the risk of side effects,while using too little may not improve your condition.

Each package of alpha interferon contains a patientinstruction 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 careprofessional.

While you are using alpha interferon, your doctor may want you to drinkextra fluids. This will help prevent low blood pressure due to loss of toomuch water.

Alpha interferons often cause unusual tiredness, which can be severe. Thiseffect is less likely to cause problems if you inject your interferon at bedtime.

Dosing?The dose of alpha interferons will be differentfor different patients. The dose that is used may depend on a number of things,including what the medicine is being used for, the patient's size, and whetheror not other medicines are also being taken. If you arereceiving alpha interferons at home, follow your doctor's orders or the directionson the label. If you have any questions about the proper dose of alphainterferons, ask your doctor.

Missed dose?If you miss a dose of this medicine, do not injectthe missed dose at all and do not double the next one. Check with your doctorfor further instructions.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.

Do not change to another brand of alpha interferonwithout checking with your physician. Different kinds of alpha interferonhave different doses. If you refill your medicine and it looks different,check with your pharmacist.

This medicine will add to the effects of alcohol and other CNS depressants(medicines that slow down the nervous system, possibly causing drowsiness).Some examples of CNS depressants are antihistamines or medicine for hay fever,other allergies, or colds; sedatives, tranquilizers, or sleeping medicine;prescription pain medicine or narcotics; barbiturates; medicine for seizures;muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before drinking alcohol or taking anyof the above while you are using this medicine.

Alpha interferon may cause some people to become unusually tired or dizzy,or less alert than they are normally. Make sure you knowhow you react to this medicine before you drive, use machines, or do anythingelse that could be dangerous if you are dizzy or if you are not alert.

This medicine commonly causes a flu-like reaction, with aching muscles,fever and chills, and headache. To prevent problems from your temperaturegoing too high, your doctor may ask you to take acetaminophen (e.g., Anacin-3, Tylenol) before each dose of interferon. Youmay also need to take it after a dose to bring your temperature down. Follow your doctor's instructions carefully about taking yourtemperature, and how much and when to take the acetaminophen.

Alpha interferon can lower the number of white blood cells in your bloodtemporarily, increasing the chance of getting an infection. It can also lowerthe number of platelets, which are necessary for proper blood clotting. Ifthis occurs, there are certain precautions you can take, especially when yourblood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid being close to people with infections. Check with your doctor immediately if you think you are getting aninfection or if you get a fever or chills, cough or hoarseness, lower backor side pain, or have painful or difficult urination.
• Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

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 mayneed medical attention.

Because this medicine is used for many different conditions and in manydifferent doses, the actual frequency of side effects may vary. In general,side effects are less common with low doses than with high doses. Also, whenalpha interferon is used for genital warts, very little of it gets into therest of the body, so side effects are generally less common than in otherconditions.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Less common

Confusion; mental depression; nervousness; numbness or tingling offingers, toes, and face; trouble in sleeping; trouble in thinking or concentrating

Rare

Black, tarry stools; blood in urineor stools; chest pain; cough or hoarseness accompanied by fever or chills; fever or chills (beginning after 3 weeks of treatment); headache; irregular heartbeat; lower back or side pain accompanied by fever or chills; muscle pain; numbness or tingling in the legs; pain, swelling or redness in the joints; painful or difficult urination accompanied by fever or chills; pinpoint red spots on skin; troublespeaking; unusual bleeding or bruising

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Aching muscles; change in taste or metallictaste; fever and chills (should lessen after thefirst 1 or 2 weeks of treatment); general feelingof discomfort or illness; headache; loss of appetite; nausea and vomiting; skin rash; unusual tiredness

Less common or rare

Back pain; blurred vision; diarrhea; dizziness; dryness of mouth; dry skin or itching; increased sweating; joint pain; leg cramps; sores in mouth and on lips; weight loss

Alpha interferon may cause a temporary loss of some hair. After treatmenthas ended, normal hair growth should return.

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, alpha interferons are used in certain patients with the followingmedical conditions:

• Bladder cancer
• Carcinoid tumors
• Chronic myelocytic leukemia
• Kidney cancer
• Laryngeal papillomatosis (growths on larynx)
• Lymphomas, non-Hodgkin's
• Multiple myeloma
• Mycosis fungoides
• Ovarian cancer
• Polycythemia vera (a type of cancer of the blood)
• Skin cancer
• Thrombocytosis

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.