Actemra

Actemra Manufacturers

• Genentech, Inc.
  

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  Actemra | Genentech, Inc.

  

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  2.1 Rheumatoid Arthritis

  ACTEMRA may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an intravenous infusion or as a subcutaneous injection.

  Recommended Intravenous (IV) Dosage Regimen:

  The recommended dosage of ACTEMRA for adult patients given as a 60-minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.

  Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.7), Warnings and Precautions (5.3), and Adverse Reactions (6.1)]. Doses exceeding 800 mg per infusion are not recommended in RA patients [see Clinical Pharmacology (12.3)].

  Recommended Subcutaneous (SC) Dosage Regimen:

  Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response Patients at or above 100 kg weight 162 mg administered subcutaneously every week

  When transitioning from ACTEMRA intravenous therapy to subcutaneous administration administer the first subcutaneous dose instead of the next scheduled intravenous dose.

  Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every other week dosing is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.7), Warnings and Precautions (5.3), and Adverse Reactions (6.2)].

  2.2 Polyarticular Juvenile Idiopathic Arthritis

  ACTEMRA may be used alone or in combination with methotrexate. The recommended dosage of ACTEMRA for PJIA patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:

  Recommended Intravenous PJIA Dosage Every 4 Weeks Patients less than 30 kg weight 10 mg per kg Patients at or above 30 kg weight 8 mg per kg Do not change dose based solely on a single visit body weight measurement, as weight may fluctuate. Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.7)]. Subcutaneous administration is not approved for PJIA. 2.3 Systemic Juvenile Idiopathic Arthritis

  ACTEMRA may be used alone or in combination with methotrexate. The recommended dose of ACTEMRA for SJIA patients given once every 2 weeks as a 60-minute single intravenous drip infusion is:

  Recommended Intravenous SJIA Dosage Every 2 Weeks Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg per kg Do not change a dose based solely on a single visit body weight measurement, as weight may fluctuate. Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.7)]. Subcutaneous administration is not approved for SJIA. 2.4 General Considerations for Administration ACTEMRA has not been studied in combination with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators because of the possibility of increased immunosuppression and increased risk of infection. Avoid using ACTEMRA with biological DMARDs. It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN). 2.5 Preparation and Administration Instructions for Intravenous Infusion

  ACTEMRA for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:

  PJIA and SJIA patients less than 30 kg: use a 50 mL infusion bag or bottle of 0.9% Sodium Chloride, and then follow steps 1 and 2 below. Adult RA, PJIA and SJIA patients at or above 30 kg weight: use a 100 mL infusion bag or bottle, and then follow steps 1 and 2 below. – Step 1. Withdraw a volume of 0.9% Sodium Chloride injection, equal to the volume of the ACTEMRA injection required for the patient's dose from the infusion bag or bottle [see Dosage and Administration (2.1, 2.2, 2.3)]. For Intravenous Use: Volume of ACTEMRA Injection per kg of Body Weight Dosage Indication Volume of ACTEMRA injection per kg of body weight 4 mg/kg Adult RA 0.2mL/kg 8 mg/kg Adult RA
  SJIA and PJIA (≥30 kg of body weight) 0.4mL/kg 10 mg/kg PJIA (< 30 kg of body weight) 0.5 mL/kg 12 mg/kg SJIA (< 30 kg of body weight) 0.6mL/kg – Step 2. Withdraw the amount of ACTEMRA for intravenous infusion from the vial(s) and add slowly into the Sodium Chloride infusion bag or bottle. To mix the solution, gently invert the bag to avoid foaming. The fully diluted ACTEMRA solutions for infusion may be stored at 2° to 8°C (36° to 46°F) or room temperature for up to 24 hours and should be protected from light. ACTEMRA solutions do not contain preservatives; therefore, unused product remaining in the vials should not be used. Allow the fully diluted ACTEMRA solution to reach room temperature prior to infusion. The infusion should be administered over 60 minutes, and must be administered with an infusion set. Do not administer as an intravenous push or bolus. ACTEMRA should not be infused concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of ACTEMRA with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, the product should not be used. Fully diluted ACTEMRA solutions are compatible with polypropylene, polyethylene and polyvinyl chloride infusion bags and polypropylene, polyethylene and glass infusion bottles. 2.6 Preparation and Administration Instructions for Subcutaneous Injection for RA

  ACTEMRA for subcutaneous injection is only indicated in the treatment in patients with adult RA and is not indicated for the treatment of patients with PJIA or SJIA. ACTEMRA for subcutaneous injection is not intended for intravenous drip infusion.

  ACTEMRA subcutaneous injection is intended for use under the guidance of a healthcare practitioner. After proper training in subcutaneous injection technique, a patient may self-inject ACTEMRA or the patient's caregiver may administer ACTEMRA if a healthcare practitioner determines that it is appropriate. Patients, or patient caregivers, should be instructed to follow the directions provided in the Instructions for Use (IFU) for additional details on medication administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use ACTEMRA prefilled syringes (PFS) exhibiting particulate matter, cloudiness, or discoloration. ACTEMRA for subcutaneous administration should be clear and colorless to pale yellow. Do not use if any part of the PFS appears to be damaged. Patients using ACTEMRA for subcutaneous administration should be instructed to inject the full amount in the syringe (0.9 mL), which provides 162 mg of ACTEMRA, according to the directions provided in the IFU. Injection sites should be rotated with each injection and should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact. 2.7 Dosage Modifications due to Serious Infections or Laboratory Abnormalities

  Hold ACTEMRA treatment if a patient develops a serious infection until the infection is controlled.

  Rheumatoid Arthritis

  Liver Enzyme Abnormalities [see Warnings and Precautions (5.3)]: Lab Value Recommendation Greater than 1 to 3× ULN Dose modify concomitant DMARDs if appropriate For persistent increases in this range: For patients receiving intravenous ACTEMRA, reduce dose to 4 mg per kg or hold ACTEMRA until ALT or AST have normalized For patients receiving subcutaneous ACTEMRA, reduce injection frequency to every other week or hold dosing until ALT or AST have normalized. Resume ACTEMRA at every other week and increase frequency to every week as clinically appropriate. Greater than 3 to 5× ULN Hold ACTEMRA dosing until less than 3× ULN and follow recommendations above for greater than 1 to 3× ULN (confirmed by repeat testing) For persistent increases greater than 3× ULN, discontinue ACTEMRA Greater than 5× ULN Discontinue ACTEMRA Low Absolute Neutrophil Count (ANC) [see Warnings and Precautions (5.3)]: Lab Value
  (cells per mm3) Recommendation ANC greater than 1000 Maintain dose ANC 500 to 1000 Hold ACTEMRA dosing When ANC greater than 1000 cells per mm3: For patients receiving intravenous ACTEMRA, resume ACTEMRA at 4 mg per kg and increase to 8 mg per kg as clinically appropriate For patients receiving subcutaneous ACTEMRA, resume ACTEMRA at every other week and increase frequency to every week as clinically appropriate ANC less than 500 Discontinue ACTEMRA Low Platelet Count [see Warnings and Precautions (5.3)]: Lab Value
  (cells per mm3) Recommendation 50,000 to 100,000 Hold ACTEMRA dosing When platelet count is greater than 100,000 cells per mm3: For patients receiving intravenous ACTEMRA, resume ACTEMRA at 4 mg per kg and increase to 8 mg per kg as clinically appropriate For patients receiving subcutaneous ACTEMRA, resume ACTEMRA at every other week and increase frequency to every week as clinically appropriate Less than 50,000 Discontinue ACTEMRA

  Polyarticular and Systemic Juvenile Idiopathic Arthritis:

  Dose reduction of ACTEMRA has not been studied in the PJIA and SJIA populations. Dose interruptions of ACTEMRA are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelet counts in patients with PJIA and SJIA at levels similar to what is outlined above for patients with RA. If appropriate, dose modify or stop concomitant methotrexate and/or other medications and hold ACTEMRA dosing until the clinical situation has been evaluated. In PJIA and SJIA the decision to discontinue ACTEMRA for a laboratory abnormality should be based upon the medical assessment of the individual patient.

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