Horizon Pharma plc Announces Collaboration With Fox Chase Cancer Center to Study ACTIMMUNE(R) (interferon gamma-1b) in Combination With PD-1/PD-L1 Inhibitors in Various Forms of Cancer - Seite 2

Indications and Usage
Chronic Granulomatous Disease (CGD)
ACTIMMUNE is approved by the US Food and Drug Administration to reduce the frequency and severity of serious infections associated with Chronic Granulomatous Disease. CGD is a genetic disorder that affects the functioning of some cells of the immune system.

Severe, Malignant Osteopetrosis (SMO)
ACTIMMUNE is approved by the US Food and Drug Administration to slow the worsening of severe, malignant osteopetrosis. SMO is also a genetic disorder that affects normal bone formation.

Important Safety Information (ISI)
The most common side effects with ACTIMMUNE are "flu like" symptoms, such as fever, headache, chills, myalgia (muscle pain), or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may minimize these symptoms. Acetaminophen may be helpful in preventing fever and headache.

ACTIMMUNE can cause severe allergic reactions and/or rash. Do not use ACTIMMUNE if you are allergic to interferon-gamma, E. col-derived products, or any component of the product. (See Full Prescribing Information for a list of components). If you develop a serious reaction to ACTIMMUNE discontinue it immediately and contact your doctor or seek medical help.

At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions. Tell your doctor if you have a cardiac condition, such as irregular heartbeat, heart failure, or decreased blood flow to your heart.

ACTIMMUNE may cause reversible changes to your nervous system, including decreased mental status, walking disturbances, and dizziness. Tell your doctor if you have a history of seizures or other neurological disorders.

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. Tell your doctor if you 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 thereafter.

Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than one year old. Your doctor will monitor your liver function at the beginning of therapy and at 3 month intervals thereafter.