Actimmune (interferon gamma-1b,recomb.)

Dosage and potency of interferon gamma-1b have been expressed in terms of mg or international units (IU) and were formerly expressed in units. Each mg of interferon gamma-1b is approximately equivalent to 20 million international units (equivalent to the amount that formerly was expressed as 30 million units).

Safety and efficacy of interferon gamma-1b dosages exceeding 50 mcg/m2 3 times weekly for the treatment of chronic granulomatous disease or osteopetrosis have not been established. If a severe adverse reaction to interferon gamma-1b occurs, dosage should be reduced by 50% or the drug discontinued until the adverse reaction abates. The fact that the minimum effective dosage of interferon gamma-1b has not been established should be considered.

Interferon gamma-1b is administered by subcutaneous injection. The drug also has been administered IM+ and IV+, but dosage forms for these routes of administration are not commercially available.

The optimum sites for subcutaneous injection of interferon gamma-1b are the right and left deltoid and the anterior thigh. Administering the drug in the evening may make some adverse effects associated with the drug (e.g., flu-like syndrome) more tolerable since this avoids peak serum interferon concentrations during the day.

Interferon gamma-1b is intended for use under the guidance and supervision of a clinician. However, the drug may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up. Patients and/or caregivers who administer interferon gamma-1b in a home setting should be trained on proper injection techniques and cautioned against reuse of syringes and needles and should be supplied with a puncture-resistant container and instructions for the proper, safe disposal of such equipment after use.

Commercially available interferon gamma-1b is intended to be administered by subcutaneous injection as supplied using a sterile glass or plastic syringe; no dilution is necessary. Because interferon gamma-1b does not contain a preservative, vials containing the drug are designed for single use only and any residual solution remaining in the vial after administration of the dose should be discarded.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies have not been performed to date with interferon gamma-1b. Preclinical studies in rodents using species-specific interferon gamma have demonstrated a decrease in hepatic microsomal cytochrome P-450 (CYP) concentrations, and it has been suggested that this potentially could lead to a decrease in the hepatic metabolism of certain drugs that are metabolized by this pathway.

Interferon gamma-1b should be used with caution in patients receiving myelosuppressive agents. (See Cautions: Precautions and Contraindications.)

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Interferon gamma-1b should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Interferon gamma-1b was not teratogenic in a primate study using subcutaneous dosages of the drug 2-100 times the usual human dosage; however, there are no adequate and controlled studies to date using interferon gamma-1b in pregnant women and it is not known if teratogenic effects would be observed in humans. Interferon gamma-1b has been shown to be associated with an increased incidence of abortions in primates given dosages approximately 100 times the usual human dosage. In addition, decreased body weight was observed during the lactation period in neonates of female mice who had been given subcutaneous dosages of recombinant murine interferon gamma 280 times the maximum recommended human dosage from shortly after birth through puberty (but not during the pregnancy). The clinical importance of these effects in humans is uncertain.

It is not known whether interferon gamma-1b is distributed into milk. Because of the potential for serious adverse reactions to interferon gamma-1b in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced messaging available.