ACTIMMUNE® (Interferon gamma-1b) therapy for Severe, Malignant Osteopetrosis (SMO)

ACTIMMUNE® has been shown to delay disease progression in patients with severe, malignant osteopetrosis (SMO)

In a controlled clinical trial, 16 patients were chosen at random to receive either ACTIMMUNE® with calcitriol (a special form of vitamin D) or calcitriol alone. The age of patients ranged from 1 month to 8 years; average age was 1.5 years.1

  • The average time to progression in the ACTIMMUNE® plus calcitriol arm was at least 165 days vs 65 days in the calcitriol only group1

This means that ACTIMMUNE® delays time to disease progression by over 3 months, compared with calcitriol alone.

SMO Chart

In an analysis which combined data from a second study, 19 of 24 patients treated with ACTIMMUNE® (± calcitriol) for at least 6 months had reduced trabecular bone volume compared to baseline.1 Trabecular bone is a type of tissue that helps form bone.

Safety and side effects of ACTIMMUNE®

The safety profile of ACTIMMUNE® in patients with SMO was found to be similar to patients with CGD treated with ACTIMMUNE®.1,2

The most common side effects seen with ACTIMMUNE® are “flu-like” symptoms such as fever, headache, chills, myalgia (muscle pain), or fatigue, which may reduce in severity as treatment continues. Administering ACTIMMUNE® at bedtime may also help minimize some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.

ACTIMMUNE® can cause severe allergic reactions and/or rash; flu-like symptoms, which may worsen pre-existing heart conditions; reversible changes to the nervous system (such as decreased mental status, walking disturbances, and dizziness); reversible severe bone marrow toxicity; decreased production of important cells in the body; and reversible changes to liver function (particularly in patients less than 1 year old).

If you develop a serious reaction discontinue immediately; call your doctor or seek medical help. Tell your doctor if you have any allergies to interferon-gamma or E coli-derived products; a cardiac condition (such as irregular heartbeat, heart failure, or decreased blood flow to your heart); history of seizures or other neurologic disorders; or reduced bone marrow function.

If you are pregnant or plan to become pregnant or plan to nurse, you should consult your doctor.

For a full list of side effects with ACTIMMUNE®, please see Full Prescribing Information.

Common adverse events in patients with CGD1

Adverse Events Box

This chart demonstrates side effects in patients with Chronic Granulomatous Disease taking ACTIMMUNE® injections or placebo, as directed during a clinical trial.1,2

*Serious infection was defined as a clinical event requiring hospitalization and the use of intravenous (IV) antibiotics.2

Important tips for managing flu-like side effects2

  • Taking ACTIMMUNE® at bedtime may help reduce some of the ‘‘flu-like” symptoms
  • Acetaminophen may be used to prevent or reduce fever and headache
  • Side effects may decrease as treatment continues

If you have concerns regarding side effects or if severe reactions occur, call your healthcare provider immediately.

References: 1. ACTIMMUNE® (Interferon gamma-1b) Full Prescribing Information. Roswell, GA: Horizon Pharma, Inc; 2015. 2. The International Chronic Granulomatous Disease Cooperative Study Group. A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease. N Engl J Med. 1991;324(8):509-516.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

Important Information About ACTIMMUNE

What is ACTIMMUNE® (Interferon gamma 1-b) used for?

ACTIMMUNE® (Interferon gamma 1-b) is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body’s ability to fight infections effectively. CGD is often treated (though not cured) with antibiotics, antifungals, and ACTIMMUNE.

ACTIMMUNE is also used to slow the worsening of severe, malignant osteopetrosis (SMO). SMO is a genetic disorder that affects normal bone formation and is usually diagnosed in the first few months after birth.

When should I not take ACTIMMUNE?

Don’t use ACTIMMUNE if you are allergic to interferon-gamma, E coli-derived products, or any ingredients contained in the product.

What warnings should I know about ACTIMMUNE?

At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions.

ACTIMMUNE may cause decreased mental status, walking disturbances, and dizziness, particularly at very high doses. These symptoms are usually reversible within a few days upon dose reduction or discontinuation of therapy.

Bone marrow function may be suppressed with ACTIMMUNE, and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced.

Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than 1 year old. Your doctor should monitor your liver function every 3 months, and monthly in children under 1 year.

In rare cases, ACTIMMUNE can cause severe allergic reactions and/or rash. If you experience a serious reaction to ACTIMMUNE, discontinue it immediately and contact your doctor or seek medical help.

What should I tell my healthcare provider?

Be sure to tell your doctor about all the medications you are taking.

Tell your doctor if you:

  • are pregnant or plan to become pregnant or plan to nurse
  • have a cardiac condition such as irregular heartbeat, heart failure, or decreased blood flow to your heart
  • have a history of seizures or other neurologic disorders
  • have, or have had, reduced bone marrow function. Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3-month intervals on ACTIMMUNE therapy
What are the side effects of ACTIMMUNE?

The most common side effects with ACTIMMUNE are “flu-like” symptoms such as fever, headache, chills, muscle pain, or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may help reduce some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.

What other medications might interact with ACTIMMUNE?

Some drugs may interact with ACTIMMUNE to potentially increase the risk of damage to your heart or nervous system, such as certain chemotherapy drugs. Tell your doctor about all other medications you are taking.

Avoid taking ACTIMMUNE at the same time as a vaccination.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact the Horizon Pharma Medical Information Department toll-free at 1-866-479-6742 or medicalinformation
@horizonpharma.com
.

The risk information provided here is not comprehensive. To learn more, talk about ACTIMMUNE with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at http://www.ACTIMMUNE.com or 1-866-479-6742.