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ACTIMMUNE- interferon gamma-1b injection, solution

Patient 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[seeAdverse 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

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