Advanced Consumer Information

interferon alfacon-1 (Subcutaneous route)

in-ter-FEER-on AL-fa-kon-1

Subcutaneous routeSolution

Alpha interferons, including interferon alfacon-1, 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 Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping interferon alfacon-1 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.

Infergen

Available Dosage Forms:

Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interferon, Alfa (class)

Uses For interferon alfacon-1

Interferon is a substance naturally produced in cells in the body to help fight infections. There also are synthetic (man-made) versions of this substance, such as interferon alfacon-1. Interferon alfacon-1 is used to treat hepatitis C, a type of infection of the liver, in adults who also have other types of liver disease.

interferon alfacon-1 is available only with your doctor's prescription.

Before Using interferon alfacon-1

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 alfacon-1, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to interferon alfacon-1 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

Studies on interferon alfacon-1 have been done only in adult patients, and there is no specific information comparing use of interferon alfacon-1 in children with use in other age groups. However, use in children less than 18 years of age is not recommended.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of interferon alfacon-1 in the elderly with use in other age groups.

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 alfacon-1 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.

Rotavirus Vaccine, Live

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.

Proper Use of interferon alfacon-1

If you are injecting interferon alfacon-1 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.

To help clear up your infection completely, interferon alfacon-1 must be used for the full time of treatment, even if you begin to feel better after a few days or weeks. It is also very important that you receive your injection at the same time for each day of treatment.

Each package of interferon alfacon-1 contains a patient instruction 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 care professional.

Dosing

The dose of interferon alfacon-1 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 alfacon-1. 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.

For injection dosage form:
- For hepatitis C:
  - Adults—9 micrograms per dose, injected under the skin, three times per week at intervals of at least forty-eight hours, for twenty-four weeks.
  - Children—Use is not recommended.

Missed Dose

If you miss a dose of interferon alfacon-1, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Precautions While Using interferon alfacon-1

It is very important that your doctor check your progress at regular visits to make sure that interferon alfacon-1 is working properly and to check for unwanted effects. It is also important that you tell your doctor if you notice any changes in your ability to see clearly.

Do not change to another brand of alpha interferon without checking with your physician. Different kinds of alpha interferon have different doses. If you refill your medicine and it looks different, check with your pharmacist.

interferon alfacon-1 commonly causes a flu-like reaction, with aching muscles, fever and chills, and headache. To prevent problems from your temperature going too high, your doctor may ask you to take acetaminophen before each dose of interferon alfacon-1. You may also need to take acetaminophen after a dose of interferon alfacon-1 to bring your temperature down. Follow your doctor's instructions carefully about taking your temperature, and how much and when to take the acetaminophen.

In some patients, interferon alfacon-1 may cause mental depression. Tell your doctor right away:

if you or anyone else notices unusual changes in your mood.
if you start having early-morning sleeplessness or unusually vivid dreams or nightmares.

Interferon alfacon-1 can lower the number of white blood cells in your blood temporarily, 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 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.

Interferon alfacon-1 may cause some people to become unusually tired or dizzy, or less alert than they are normally. Make sure you know how you react to interferon alfacon-1 before you drive, use machines, or do anything else that could be dangerous if you are dizzy or if you are not alert.

interferon alfacon-1 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 as soon as possible if any of the following side effects occur:

More common

Anxiety
black, tarry stools
blood in urine or stools
confusion
cough or hoarseness
fever or chills
lower back or side pain
mental depression
nervousness
painful or difficult urination
pinpoint red spots on skin
redness at place of injection
trouble in sleeping
trouble in thinking or concentrating
unusual bleeding or bruising

Less common

Chest pain
irregular heartbeat
numbness or tingling of fingers, toes, or face

Rare

Blurred vision or loss of vision
skin rash, hives, or itching

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

Abdominal pain
aching muscles
decreased appetite
diarrhea
dizziness
general feeling of discomfort or illness
headache
heartburn or indigestion
nausea or vomiting
pain in back or joints
sore throat
unusual tiredness or weakness

Interferon alfacon-1 may cause a temporary loss of some hair. After treatment has ended, normal hair growth should return.

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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