Pronunciation:

in-ter-FEER-on GAM-ma-1b

Brand Names:

• Actimmune

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Interferon Gamma

Uses of This Medicine:

Interferon gamma-1b injection is used to lower the frequency and severity of serious infections caused by chronic granulomatous disease (CGD). It is also used to slow down the progression of severe, malignant osteopetrosis (SMO). Interferon gamma-1b is a man-made version of a substance naturally produced by cells in the body to help fight infections and tumors.

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 Actimmune® to treat CGD in children 1 year of age and older, and to treat SMO in children 1 month and older. However, safety and efficacy have not been established in children to treat CGD younger than 1 year of age, and in newborns with SMO.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Actimmune® in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving Actimmune®.

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 taking 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.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

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:

• Arrhythmia (heart rhythm problem) or
• Congestive heart failure or
• Heart disease (eg, ischemia) or
• Nervous system problems, or history of or
• Seizures—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine.

Proper Use of This Medicine:

This medicine is given as a shot under your skin, usually in the right and left upper arms, or thighs.

Each package of interferon gamma-1b 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 doctor.

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. This will help prevent skin problems from the injections.

Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it. Do not shake it.

Do not mix it with other medicines in the same syringe.

You may have fewer side effects (headache, fever, or muscle aches) if you give yourself the shot just before bedtime. Ask your doctor if you can take acetaminophen to prevent or relieve side effects.

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

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.

• For injection dosage form:
  • For chronic granulomatous disease:
    • Adults and children 1 year of age and older—Dose is based on body size and must be determined by your doctor.
      • For patients with more than 0.5 square meter (m[2]) of body size: The dose is 50 microgram (mcg) per square meter (m[2]) of body size injected under your skin 3 times every week.
      • For patients with less than or equal to 0.5 square meter (m[2]) of body size: The dose is 1.50 microgram (mcg) per kilogram (kg) of body size injected under your skin 3 times every week.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.
  • For severe, malignant osteopetrosis:
    • Adults and children 1 month of age and older—Dose is based on body size and must be determined by your doctor.
      • For patients with more than 0.5 square meter (m[2]) of body size: The dose is 50 microgram (mcg) per square meter (m[2]) of body size injected under your skin 3 times every week.
      • For patients with less than or equal to 0.5 square meter (m[2]) of body size: The dose is 1.50 microgram (mcg) per kilogram (kg) of body size injected under your skin 3 times every week.
    • Children up to 1 month of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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.

Store in the refrigerator. Do not freeze.

Throw away any unopened vials that are left at room temperature for more than 12 hours.

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 and urine tests may be needed to check for unwanted effects.

This medicine commonly causes flu-like reactions, with aching muscles, fever and chills, and headache. Follow your doctor's instructions carefully about taking your temperature, and how much and when to take the acetaminophen to treat fever and pain.

This medicine may cause dizziness, decreased mental status, clumsiness, or trouble walking. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Actimmune® 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 right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you change in how much or how often you urinate, lower back or side pain, difficult or painful urination.

The stopper of the vial contains natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

While you are being treated with Actimmune® and after you stop using it, do not have any vaccines without your doctor's approval. Actimmune® may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

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 or nurse immediately if any of the following side effects occur:

More common

Chills

fever

Less common

Black, tarry stools

bleeding gums

blood in the urine or stools

confusion

cough or hoarseness

loss of balance control

lower back or side pain

mask-like face

painful or difficult urination

pinpoint red spots on the skin

shuffling walk

sore throat

stiffness of the arms or legs

trembling and shaking of the hands and fingers

trouble breathing

trouble speaking or swallowing

trouble thinking or concentrating

trouble walking

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Abdominal or stomach pain or tenderness

change in walking and balance

clay colored stools

clumsiness or unsteadiness

dark urine

decreased appetite

decreased frequency or amount of urine

general feeling of discomfort or illness

headache

increased thirst

itching or skin rash

joint or muscle pain

loss of appetite

lower back or side pain

muscle aches and pains

nausea and vomiting

numbness or tingling of the face, hands, or feet

painful or difficult urination

pale skin

redness and soreness of the eyes

runny nose

shivering skin

sweating

swelling of the face, fingers, or lower legs

trouble sleeping

weight gain

yellow 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

Diarrhea

redness or tenderness at the injection site

Less common

Back pain

dizziness

weight loss

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.