Actimmune

Name: Actimmune

Interferon Gamma 1b Dosage

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Interferon gamma-1b is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Use only the type of syringe supplied with this medicine, or recommended by your pharmacist. Do not mix interferon gamma-1b in the same syringe with other injectable medicines.

Do not shake the medication bottle. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Interferon gamma-1b can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

While using interferon gamma-1b, you may need frequent blood tests. Your kidney function may also need to be checked.

Tell your doctor if you have any changes in height or weight. Interferon gamma-1b doses are based on body surface area (height and weight), and any changes may affect your dose.

Store interferon gamma-1b in the refrigerator, do not freeze.

You may take the medicine out of the refrigerator and allow it to reach room temperature before injecting your dose.

Do not leave the medicine at room temperature for longer than 12 hours. Throw the medicine if it has been at room temperature for more than 12 hours. Do not put it back in the refrigerator.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include changes in you mental status, dizziness, loss of balance or coordination, or flu-like symptoms.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Introduction

Biologic response modifier; biosynthetic (recombinant DNA origin) form of endogenous human interferon gamma.1 5 6 7

Uses for Actimmune

Chronic Granulomatous Disease

Reduction of the frequency and severity of serious infections in patients with chronic granulomatous disease (designated an orphan drug by FDA for this use).1 5 10 13 20 21 22 24

Osteopetrosis

Treatment to delay the time to disease progression in patients with severe, malignant osteopetrosis (designated an orphan drug by FDA for this use).1 6 7 13

Idiopathic Pulmonary Fibrosis

Interferon gamma-1b was investigated in patients with idiopathic pulmonary fibrosis† (IPF) with mild-to-moderate lung function impairment in the INSPIRE study; the study was terminated early when interim data analysis indicated lack of benefit in patients receiving the drug.26 Interim analysis also indicated that 14.5% of patients receiving interferon gamma 1-b died compared with 12.7% of those receiving placebo.26

Interferon gamma-1b is not approved for use in patients with IPF.26 FDA suggests that health-care professionals should discuss the results of this trial with their patients receiving the drug for IPF and carefully consider whether they should continue to receive treatment with interferon gamma-1b.26

What do I need to tell my doctor BEFORE I take Actimmune?

  • If you have an allergy to Actimmune (interferon gamma-1b) or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Actimmune with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Actimmune?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have a latex allergy, talk with your doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Actimmune affects you.
  • Talk with your doctor before you drink alcohol.
  • If you have heart disease, talk with your doctor. The flu-like side effects of interferon may be stressful to heart patients.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your urine checked as you have been told by your doctor.
  • Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Actimmune while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Actimmune) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to give closely if you or a family member is giving the shot at home.
  • Move the site where you give the shot with each shot.
  • Wash your hands before and after use.
  • Take at bedtime to help with flu-like signs.
  • Do not shake the solution.
  • Do not mix Actimmune with other drugs in the same syringe.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some other side effects of Actimmune?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where the shot is given.
  • Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating. Mild pain drugs may help.
  • Loose stools (diarrhea).
  • Upset stomach or throwing up.
  • Muscle pain.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Dosage Forms and Strengths

Injection: 100 mcg (2 million International Units) per 0.5 mL solution in a single-use vial. Actimmune (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection.

Use in specific populations

Pregnancy

Risk Summary

There are no adequate and well-controlled studies in pregnant women. Actimmune should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal Data

Actimmune has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. A study in pregnant primates treated with subcutaneous doses 2 – 100 times the human dose failed to demonstrate teratogenic activity for Actimmune.

Female mice treated subcutaneously with recombinant murine IFN-interferon gamma (rmuIFN-gamma) at 280 times the maximum recommended clinical dose of Actimmune from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. The clinical significance of this finding observed following treatment of mice with rmuIFN-gamma is uncertain. For lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity or teratogenicity in preclinical studies.

Lactation

Risk Summary

It is not known whether Actimmune is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Actimmune, a decision should be made whether to discontinue nursing or to discontinue the drug, dependent upon the importance of the drug to the mother.

Females and Males of Reproductive Potential

Infertility

Based on the information available, it cannot be excluded that the presence of higher levels of interferon gamma may impair male fertility and that in certain cases of female infertility increased levels of interferon gamma may have played a role [see Nonclinical Toxicology (13.1)].

In younger patients, the long-term effect on fertility is also not known.

Pediatric Use

The safety and effectiveness of Actimmune has been established in pediatric patients aged 1 year and older in CGD patients and 1 month and older in SMO patients [see Clinical Studies (14)]. There are no data available for pediatric patients below the age of 1 month.

Geriatric Use

Clinical studies of Actimmune did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Actimmune Description

Actimmune (Interferon gamma-1b), an interferon gamma, is a single-chain polypeptide containing 140 amino acids. Production of Actimmune is achieved by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the recombinant protein. Purification of the product is achieved by conventional column chromatography. Actimmune is a highly purified sterile solution consisting of non-covalent dimers of two identical 16,465 Dalton monomers; with a specific activity of 20 million International Units/mg (2 × 106 International Units/0.5 mL) which is equivalent to 30 million units/mg.

Actimmune is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection. Each 0.5 mL of Actimmune contains: 100 mcg (2 million International Units) of interferon gamma-1b formulated in disodium succinate hexahydrate (0.37 mg), mannitol (20 mg), polysorbate 20 (0.05 mg), succinic acid (0.14 mg) and Sterile Water for Injection. Note that the above activity is expressed in International Units (1 million International Units/50 mcg). This is equivalent to what was previously expressed as units (1.5 million units/50 mcg).

How Supplied/Storage and Handling

How Supplied

Actimmune (interferon gamma-1b) is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection. Each vial permits the extraction of up to 0.5 mL of Actimmune with additional volume to facilitate solution withdrawal. Each 0.5 mL of Actimmune contains: 100 mcg (2 million International Units) of interferon gamma-1b.

NDC Number Size
75987-111-10 One vial
75987-111-11 Cartons of 12 vials

Storage and Handling

Store vials in the refrigerator at 2 to 8 °C (36 °F – 46 °F). Do Not Freeze. Avoid excessive or vigorous agitation. Do Not Shake. An unused vial of Actimmune can be stored at room temperature up to 12 hours prior to use. Discard vials if not used within the 12 hour period. Do not return to the refrigerator.

Information for the Patient/Caregiver Actimmune® (Interferon gamma-1b)

DO NOT ADMINISTER Actimmune UNTIL YOUR PHYSICIAN HAS THOROUGHLY TRAINED YOU IN THE PROPER TECHNIQUES.

Actimmune is supplied in single-use vials. The unused portion of each vial should be disposed of as instructed by your physician. DO NOT SHAKE.

Your physician will tell you what size needle and syringe to use and also give you instructions on sterile technique. Keep all used syringes and needles out of the reach of children. Follow your physician's instructions on the safe disposal of used syringes and needles.

MEASURING THE DOSE

In measuring the correct dose for injection, be sure to check that the Actimmune solution is clear. If the solution is cloudy or hazy, do not inject it, but return the Actimmune vial to your pharmacist or prescribing physician.

1.
Wash your hands thoroughly with soap and water before preparing the medication. This helps prevent infection.
2.
Check the date on the Actimmune vial to be sure the drug has not expired.
3.
Remove the protective plastic cap and wipe the rubber stopper located on top of the Actimmune vial with an alcohol swab.
4.
Draw air into the syringe by pulling back on the plunger. The amount of air should be equal to the Actimmune dose.
5.
Remove and save the needle guard. Slowly insert the needle straight through the center of the rubber stopper into the Actimmune vial.
6.
Gently push the plunger to discharge the air into the vial.
7.
Turn the vial upside down with the syringe needle still in it and hold it in one hand. Be sure the tip of the needle is in the solution. Using your other hand slowly pull back on the plunger in a continuous motion until the correct amount of Actimmune solution is in the syringe. Each vial contains enough Actimmune for removal of up to 0.5 mL, with a small additional amount present for ease of withdrawal.
8.
Remove the needle from the Actimmune vial and replace the needle guard until time of administration or injection. Administration should be as soon after filling the syringe as possible; do not store Actimmune in the syringe.
SELECTING THE INJECTION SITE
Your doctor or nurse will teach you how to locate appropriate injection sites. It is very important that you rotate the site of an injection each time you give the medication. Even if you or your child develop a preference for one site – as often happens – you still should rotate the injection site.
Following are the injection sites most often recommended:
  • Upper Arm
  • Abdomen
  • Thigh
GIVING THE MEDICATION
Your doctor or nurse will provide you with hands-on training on how to give an injection. Needles and syringes should be used only once to insure sterility of both the needle and the syringe. The following is a review of the steps involved in giving the medication:
1.
Cleanse the injection site with an alcohol-saturated cotton ball or cotton swab.
2.
Remove the needle guard from the syringe filled with the proper dose of solution and hold the syringe the way you would hold a pencil. Double check that the correct amount of Actimmune solution is in the syringe.
3.
Squeeze the skin between your fingers before and during the injection. Insert the needle into the skin at a 45° angle with a quick, firm motion. This hurts less than pushing the needle in slowly.
4.
After the needle is in, pull back very slightly with one hand on the plunger to see if blood comes into the syringe. This is to be sure that the needle has not entered a blood vessel. If blood does come into the syringe, do not inject the Actimmune solution. Withdraw the needle and insert at another location.
5.
If blood does not come into the syringe, slowly (within a few seconds) inject the solution by gently pushing the plunger until the syringe is empty.
6.
Withdraw the needle quickly, pulling it straight out, and apply pressure over the injection site with a dry gauze pad or cotton ball. A drop of blood may appear. Put a Band-Aid® on the injection site if desired.
7.
To prevent injury, safely dispose of all used needles and syringes after a single use as instructed by your physician by following these simple steps:
  • Place all used needles and syringes in a hard, plastic container with a screw-on cap, or a metal container with a plastic lid, such as a coffee can properly labeled as to content. If a metal container is used, cut a small hole in the plastic lid and tape the lid to the metal container. When the metal container is full, cover the hole with tape and throw it away. If a hard, plastic container is used, always screw the cap on tightly after each use. When the plastic container is full, tape around the cap and throw it away.
  • Do not use glass or clear, plastic containers, or any container that will be recycled or returned to a store.
  • Always store the container out of the reach of children.
  • Please check with your doctor, nurse or pharmacist for other suggestions. There may be special state and local laws that they will discuss with you.
8.
Occasionally a problem may develop at the injection site. If you notice any of the following signs or symptoms, contact your doctor or nurse:
  • A lump or swelling that doesn't go away
  • Bruising that doesn't go away
  • Any signs of infection or inflammation at an injection site (pus, persistent redness, surrounding skin that is hot to the touch, persistent pain after the injection)

Interferon gamma-1b Pregnancy Warnings

Interferon gamma-1b has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of abortifacient properties in primates at 100 times the human dose. There are no controlled data in human pregnancy. The manufacturer recommends using interferon gamma-1b with caution during pregnancy when potential benefit outweighs fetal risk.

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