Actimmune

Name: Actimmune

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

What is Actimmune (interferon gamma-1b)?

Interferon gamma-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon gamma-1b is used to prevent serious infections in people with a condition called chronic granulomatous disease. Interferon gamma-1b is also used to slow the progression of a bone disorder called malignant osteopetrosis.

Interferon gamma-1b may also be used for purposes not listed in this medication guide.

Actimmune (interferon gamma-1b) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • confusion, hallucinations;

  • a seizure (convulsions);

  • low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding; or

  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Your doses may be delayed or reduced if you have certain side effects.

Common side effects may include:

  • fever, chills;

  • diarrhea;

  • headache;

  • feeling tired;

  • rash; or

  • redness or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses For Actimmune

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.

Precautions While Using Actimmune

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.

Drug Interactions

Myelosuppressive Agents

When administering Actimmune in combination with other potentially myelosuppressive agents, monitor neutrophil and platelet counts [see Warnings and Precautions (5.3)].

Drugs with Neurotoxic, Hematoxic or Cardiotoxic Effects

The concurrent use of drugs having neurotoxic (including effects on the central nervous system), hematotoxic, or cardiotoxic effects may increase the toxicity of interferons in these systems. It is theoretically possible that hepatotoxic and/or nephrotoxic drugs might have an effect on the clearance of Actimmune.

Immunological Preparations

Simultaneous administration of Actimmune with other heterologous serum protein preparations or immunological preparations (e.g., vaccines) should be avoided due to the risk of an unexpected, or amplified, immune response.

Effects on Cytochrome P-450 Pathways

Preclinical studies in rodents using species-specific interferon gamma have demonstrated a decrease in hepatic microsomal cytochrome P-450 concentrations. This could potentially lead to a depression of the hepatic metabolism of certain drugs that utilize this degradative pathway.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: Actimmune has not been tested for its carcinogenic potential.

Mutagenesis: Ames tests using five different tester strains of bacteria with and without metabolic activation revealed no evidence of mutagenic potential. Actimmune was tested in a micronucleus assay for its ability to induce chromosomal damage in bone marrow cells of mice following two intravenous doses of 20 mg/kg. No evidence of chromosomal damage was noted.

Impairment of Fertility: Female cynomolgus monkeys treated with daily subcutaneous doses of 30 or 150 mcg/kg Actimmune (approximately 20 and 100 times the human dose) exhibited irregular menstrual cycles or absence of cyclicity during treatment. Similar findings were not observed in animals treated with 3 mcg/kg Actimmune.

Female mice receiving recombinant murine IFN-interferon gamma (rmuIFN-gamma) at 32 times the maximum recommended clinical dose of Actimmune for 4 weeks via intramuscular injection exhibited an increased incidence of atretic ovarian follicles.

Male cynomolgus monkeys treated intravenously for 4 weeks with 8 times the maximum recommended clinical dose of Actimmune exhibited decreased spermatogenesis. Male mice receiving rmuIFN-gamma at 32 times the maximum recommended clinical dose of Actimmune for 4 weeks via intramuscular injection exhibited decreased spermatogenesis. The impact of this finding on fertility is not known.

Male mice treated subcutaneously with rmuIFN-gamma from shortly after birth through puberty, with 280 times the maximum recommended clinical dose of Actimmune exhibited profound yet reversible decreases in sperm counts and fertility, and an increase in the number of abnormal sperm.

The clinical significance of these findings observed following treatment of mice with rmuIFN-gamma is uncertain.

Patient Counseling Information

Advise the patient and/or their parents or caregivers to read the FDA-approved patient labeling (Information for Patient/Caregiver).

  • Inform patients and/or their parents or caregiver regarding the potential benefits and risks associated with treatment. If home use is determined to be desirable by the physician, instructions on appropriate use should be given, including review of the contents of the Information for Patient/ Caregiver. This information is intended to aid in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects.
  • If home use is prescribed, a puncture resistant container for the disposal of used syringes and needles should be used by the patient and/or parents or caregivers. Instruct patients thoroughly on the importance of proper disposal and caution the patient and/or patient or caregiver against any reuse of needles and syringes. The full container should be disposed of according to the directions provided by the physician.
  • Advise the patients and/or their parents or caregivers that the most common adverse reactions occurring with Actimmune therapy are "flu-like" or constitutional symptoms such as fever, headache, chills, myalgia or fatigue [see Adverse Reactions (6.1)] which may decrease in severity as treatment continues. Some of the "flu-like" symptoms may be minimized by bedtime administration of Actimmune. Acetaminophen may also be used to prevent or partially alleviate the fever and headache.
  • Advise patients and/or their parents or caregivers that they may experience undesirable effects such as fatigue, convulsion, confusional state, disorientation or hallucination during treatment. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience any of these events, they should avoid potentially hazardous tasks such as driving or operating machinery. This effect may be enhanced by alcohol.

Manufactured by:
Horizon Pharma Ireland Ltd.
Dublin, Ireland
U.S. License No. 2022

Distributed by:
Horizon Pharma USA, Inc.
Lake Forest, IL 60045

Storage

Actimmune (Interferon gamma-1b) must be refrigerated immediately. Refrigerate at 36° to 46° Fahrenheit (2° to 8° Centigrade). DO NOT FREEZE.

Actimmune is supplied in single-use vials. The unused portion of each vial should be disposed of according to state and local regulations as instructed by your physician. If you have any questions, contact your physician.

May 2017

Manufactured by:
Horizon Pharma Ireland Ltd.
Dublin, Ireland
US License No. 2022

Distributed by:
Horizon Pharma USA, Inc.
Lake Forest, IL 60045

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

KEEP REFRIGERATED

NDC 75987-111-11

Actimmune®
(Interferon gamma-1b)

How supplied: Each carton contains 12 single-use
vials of Interferon gamma-1b, Actimmune.

Contents: Each 0.5 mL vial of Actimmune contains
100 mcg (2 million IU) Interferon gamma-1b formulated
in 20 mg mannitol, 0.37 mg disodium succinate
hexahydrate, 0.14 mg succinic acid, 0.05 mg polysorbate
20 and Sterile Water for Injection for subcutaneous injection.
Actimmune contains no preservatives.

Dosage and administration: See
package insert for full prescribing
information. Actimmune is
suitable for single-use only.
DO NOT SHAKE.

Storage: Refrigerate at
2° to 8°C/36° to 46°F.
DO NOT FREEZE.

Actimmune 
interferon gamma-1b injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75987-111
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Interferon gamma-1b (Interferon gamma-1b) Interferon gamma-1b 100 ug  in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
mannitol 20 mg  in 0.5 mL
sodium succinate hexahydrate 0.37 mg  in 0.5 mL
succinic acid  
polysorbate 20 0.05 mg  in 0.5 mL
water  
Packaging
# Item Code Package Description
1 NDC:75987-111-11 12 VIAL, SINGLE-USE in 1 CARTON
1 NDC:75987-111-10 0.5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103836 12/01/2013
Labeler - Horizon Pharma Inc. (964613413)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH & Co KG 340700520 MANUFACTURE(75987-111)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim RCV GmbH & Co KG 300010883 API MANUFACTURE(75987-111)
Revised: 05/2017   Horizon Pharma Inc.

In Summary

Common side effects of Actimmune include: fever, flu-like symptoms, headache, chills, erythema at injection site, and tenderness at injection site. See below for a comprehensive list of adverse effects.

Administrative Information

LactMed Record Number

580

Last Revision Date

20140708

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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