interferon gamma-1b

Therapeutic Classification: immune modifiers

Pharmacologic Classification: interferons

Indications ⬆ ⬇

REMS

Diminished severity and frequency of infectious complications of chronic granulomatous disease.
Slow disease progression in severe, malignant osteopetrosis.

Action ⬆ ⬇

A protein produced by recombinant DNA technology that is capable of activating phagocytes, enhancing their ability to kill pathogens, including:
- Staphylococcus aureus,
- Toxoplasma gondii,
- Leishmania donovani,
- Listeria monocytogenes,
- Mycobacterium avium intracellulare.
Interferon gamma has antiproliferative effects superior to interferon alpha and beta.

Therapeutic effects:

Decreased incidence and severity of infection in patients with chronic granulomatous disease.
Slowed disease progression of severe, malignant osteopetrosis.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed after SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 5.9 hr.

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	4 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to interferon gamma, Escherichia coli–derived products, mannitol, or polysorbate.

Use Cautiously in:

cardiovascular disease;
Bone marrow depression;
Pregnancy, lactation, or children <1 yr (safety not established).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

GI: nausea, vomiting, abdominal pain

Hemat: neutropenia, thrombocytopenia

Local: edema or tenderness at injection site

MS: arthralgia, myalgia, back pain

Neuro: headache, decreased mental status, dizziness, gait disturbances

Misc: chills, fever

Interactions ⬆ ⬇

Drug-drug:

May have additive bone marrow–depressing effects with antineoplastics or radiation therapy.

Route/Dosage ⬆ ⬇

Body Surface Area >0.5 m2

SC (Children ): 50 mcg/m² (1 million units/m²) 3 times weekly.

Body Surface Area 0.5 m2

SC (Children >1 yr): 1.5 mcg/kg 3 times weekly.

Availability ⬆ ⬇

Injection: 100 mcg (3 million units)/vial

Assessment ⬆ ⬇

Assess patient for signs and symptoms of infection before and throughout therapy. Flu-like syndrome (fever, headache, chills, myalgia, fatigue) is a frequent side effect that may decrease in severity as treatment continues. Side effects may be minimized by administering at bedtime. Headache and fever may be treated with acetaminophen. If adverse reactions are severe, dose may be reduced by 50% or discontinued.

Lab Test Considerations:

Monitor CBC with differential, platelet count, blood chemistries including liver and kidney function, and urinalysis before and every 3 mo throughout therapy.

Implementation ⬆ ⬇

Vial must be refrigerated; do not freeze. If vial is left at room temperature for more than 12 hr, discard vial. Vials do not contain a preservative and are for single use only. Do not shake.
SC: Administer in the right or left arm or anterior thigh.

Patient/Family Teaching ⬆ ⬇

Home Care Issues: Instruct patient or family on proper technique for administering injection and care and disposal of equipment. Provide a puncture-proof container for disposal of needles.
- Advise patient of the need for contraception throughout therapy.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in frequency and severity of infections in patients with chronic granulomatous disease.
Slowed disease progression in severe, malignant osteopetrosis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

17089- Guna spa
- 17089-378- GUNA-INF GAMMA
  - 17089-378-18- 1 BOTTLE, DROPPER in 1 BOX (17089-378-18) / 30 mL in 1 BOTTLE, DROPPER

75987- Horizon Therapeutics USA, Inc.
- 75987-111- ACTIMMUNE
  - 75987-111-11- 12 VIAL, SINGLE-DOSE in 1 CARTON (75987-111-11) / .5 mL in 1 VIAL, SINGLE-DOSE (75987-111-10)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇