Intermune, Inc.

Intermune, Inc. Drugs

• Esbriet
  

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  Esbriet

  

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  2.1 Testing Prior to ESBRIET Administration

  Conduct liver function tests prior to initiating treatment with ESBRIET [see Warnings and Precautions (5.1)].

  2.2 Recommended Dosage

  The recommended daily maintenance dosage of ESBRIET is 801 mg (three 267 mg capsules) three times a day with food for a total of 2403 mg/day. Doses should be taken at the same time each day.

  Upon initiation of treatment, titrate to the full dosage of nine capsules per day over a 14-day period as follows:

  Table 1. Dosage Titration for ESBRIET in Patients with IPF Treatment days Dosage  Days 1 through 7  1 capsule three times a day with food  Days 8 through 14  2 capsules three times a day with food  Days 15 onward  3 capsules three times a day with food

  Dosages above 2403 mg/day (9 capsules per day) are not recommended for any patient.

  2.3 Dosage Modifications due to Adverse Reactions

  Patients who miss 14 or more days of ESBRIET should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage [see Dosage and Administration (2.2)]. For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed.

  If patients experience significant adverse reactions (i.e., gastrointestinal, photosensitivity reaction or rash), consider temporary dosage reductions or interruptions of ESBRIET to allow for resolution of symptoms [see Warnings and Precautions (5.1, 5.2, 5.3)].

  Dosage Modification due to Elevated Liver Enzymes Dosage modifications or interruptions may also be necessary when liver enzyme and bilirubin elevations are exhibited. For liver enzyme elevations, modify the dosage as follows:

  If a patient exhibits >3 but ≤5 × the upper limit of normal (ULN) ALT and/or AST without symptoms or hyperbilirubinemia after starting ESBRIET therapy:

  Discontinue confounding medications, exclude other causes, and monitor the patient closely. Repeat liver chemistry tests as clinically indicated. The full daily dosage may be maintained, if clinically appropriate, or reduced or interrupted (e.g., until liver chemistry tests are within normal limits) with subsequent re-titration to the full dosage as tolerated.

  If a patient exhibits >3 but ≤5 × ULN ALT and/or AST accompanied by symptoms or hyperbilirubinemia:

  Permanently discontinue ESBRIET. Do not rechallenge patient with ESBRIET.

  If a patient exhibits >5 × ULN ALT and/or AST:

  Permanently discontinue ESBRIET. Do not rechallenge patient with ESBRIET.

  2.4 Dosage Modification due to Drug Interactions

  Strong CYP1A2 Inhibitors (e.g., fluvoxamine, enoxacin) Reduce ESBRIET to one capsule three times a day.

  Moderate CYP1A2 Inhibitors (e.g., ciprofloxacin) With use of ciprofloxacin at a dosage of 750 mg twice daily, reduce ESBRIET to two capsules three times a day.

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• Amphotec
  

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  Amphotec

  

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  The recommended dose for adults and pediatric patients is 3 - 4 mg/kg as required, once a day.

  AMPHOTEC, reconstituted in Sterile Water for Injection, is administered diluted in 5% Dextrose for Injection by intravenous infusion at a rate of 1 mg/kg/hour. A test dose immediately preceding the first dose is advisable when commencing all new courses of treatment. A small amount of drug (e.g., 10 mL of the final preparation containing between 1.6 to 8.3 mg) should be infused over 15 to 30 minutes and the patient carefully observed for the next 30 minutes.

  The infusion time may be shortened to a minimum of 2 hours for patients who show no evidence of intolerance or infusion-related reactions. If the patient experiences acute reactions or cannot tolerate the infusion volume, the infusion time may be extended.

  Directions for reconstitution and preparation of infusion admixture

  AMPHOTEC must be reconstituted by addition of Sterile Water for Injection. Using sterile syringe and a 20-gauge needle, rapidly add the following volumes to the vial to provide a liquid containing 5 mg of amphotericin B per mL. Shake gently by hand, rotating the vial until all solids have dissolved. Note that the fluid may be opalescent or clear.

  50 mg/vial add 10 mL Sterile Water for Injection 100 mg/vial add 20 mL Sterile Water for Injection

  For infusion, further dilute the reconstituted liquid to a final concentration of approximately 0.6 mg/mL (range 0.16 mg/mL to 0.83 mg/mL). The following table provides dilution recommendations:

  Dose ofAMPHOTEC Volume of ReconstitutedAMPHOTEC Infusion Bag Size for5% Dextrose for Injection 10 – 35 mg 2 – 7 mL 50 mL 35 – 70 mg 7 – 14 mL 100 mL 70 – 175 mg 14 – 35 mL 250 mL 175 – 350 mg 35 – 70 mL 500 mL 350 – 1000 mg 70 – 200 mL 1000 mL

  Do not reconstitute the lyophilized powder with saline or dextrose solutions, or admix the reconstituted liquid with saline or electrolytes.

  The use of any solution other than those recommended, or the presence of a bacteriostatic agent (e.g., benzyl alcohol) in the solution may cause precipitation of AMPHOTEC. Do not filter or use an in-line filter with AMPHOTEC.

  Do not mix the infusion admixture with other drugs. If administered through an existing intravenous line, flush with 5% Dextrose for Injection prior to, and following, infusion of AMPHOTEC, otherwise administer via a separate line.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if a precipitate or foreign matter is present, or if the seal is not intact. Strict aseptic technique always should be observed during reconstitution and dilution since no preservatives are present in the lyophilized drug or in the solutions used for reconstitution and dilution.

  After reconstitution, the drug should be refrigerated at 2-8°C (36-46°F) and used within 24 hours. Do not freeze. After further dilution with 5% Dextrose for Injection, the infusion should be stored in a refrigerator (2-8°C) and used within 24 hours. Partially used vials should be discarded.

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• Actimmune
  

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  Actimmune

  

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  The recommended dosage of ACTIMMUNE  for the treatment of patients with Chronic Granulomatous Disease and severe, malignant osteopetrosis is 50 mcg/m2 (1 million IU/m2) for patients whose body surface area is greater than 0.5 m2 and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m2. Note that the above activity is expressed in International Units (1 million IU/50mcg). This is equivalent to what was previously expressed as units (1.5 million U/50mcg). Injections should be administered subcutaneously three times weekly (for example, Monday, Wednesday, Friday). The optimum sites of injection are the right and left deltoid and anterior thigh. ACTIMMUNE  can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  The formulation does not contain a preservative. A vial of ACTIMMUNE  is suitable for a single use only. The unused portion of any vial should be discarded. Higher doses are not recommended. Safety and efficacy has not been established for ACTIMMUNE  given in doses greater or less than the recommended dose of 50 mcg/m2. The minimum effective dose of ACTIMMUNE  has not been established.

  ACTIMMUNE  should not be mixed with other drugs in the same syringe.

  Dose Modification

  If severe reactions occur, the dosage should be reduced by 50 percent or therapy should be interrupted until the adverse reaction abates.

  ACTIMMUNE  may be administered using either sterilized glass or plastic disposable syringes.

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