ACTEMRA (Page 3 of 15)

2.9 Preparation and Administration Instructions for Subcutaneous Injection

  • ACTEMRA for subcutaneous injection is not intended for intravenous drip infusion.
  • Assess suitability of patient for subcutaneous home use and instruct patients to inform a healthcare professional before administering the next dose if they experience any symptoms of allergic reaction. Patients should seek immediate medical attention if they develop symptoms of serious allergic reactions. 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. PJIA and SJIA patients may self-inject with the ACTEMRA prefilled syringe or ACTPen® autoinjector, or the patient’s caregiver may administer ACTEMRA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate [see Use in Specific Populations (8.4)]. 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) or prefilled ACTPen® autoinjectors 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 or ACTPen® autoinjector appears to be damaged.
  • Patients using ACTEMRA for subcutaneous administration should be instructed to inject the full amount in the syringe (0.9 mL) or full amount in the ACTPen® autoinjector (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.

2.10 Dosage Modifications due to Serious Infections or Laboratory Abnormalities

Serious Infections

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

Laboratory Abnormalities

Rheumatoid Arthritis, Giant Cell Arteritis and Systemic Sclerosis-Associated Interstitial Lung Disease

Liver Enzyme Abnormalities [see Warnings and Precautions (5.3, 5.4)]
Lab Value Recommendation for RA and SSc-ILD Recommendation for GCA
Greater than 1 to 3× ULN Dose modify concomitant DMARDs if appropriateFor 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
Dose modify immunomodulatory agents if appropriateFor persistent increases in this range:
  • For patients receiving intravenous ACTEMRA, 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(confirmed by repeat testing) Hold ACTEMRA dosing until less than 3× ULN and follow recommendations above for greater than 1 to 3× ULNFor persistent increases greater than 3× ULN, discontinue ACTEMRA Hold ACTEMRA dosing until less than 3x ULN and follow recommendations above for greater than 1 to 3x ULNFor persistent increases greater than 3x ULN, discontinue ACTEMRA
Greater than 5× ULN Discontinue ACTEMRA Discontinue ACTEMRA
Low Absolute Neutrophil Count (ANC) [see Warnings and Precautions (5.4)]
Lab Value(cells per mm3) Recommendation for RA and SSc-ILD Recommendation for GCA
ANC greater than 1000 Maintain dose Maintain dose
ANC 500 to 1000 Hold ACTEMRA dosingWhen 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
Hold ACTEMRA dosingWhen ANC greater than 1000 cells per mm3:
  • For patients receiving intravenous ACTEMRA, resume ACTEMRA at 6 mg per kg
  • 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 Discontinue ACTEMRA
Low Platelet Count [see Warnings and Precautions (5.4)]
Lab Value(cells per mm3) Recommendation for RA and SSc-ILD Recommendation for GCA
50,000 to 100,000 Hold ACTEMRA dosingWhen 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
Hold ACTEMRA dosingWhen platelet count is greater than 100,000 cells per mm3:
  • For patients receiving intravenous ACTEMRA, resume ACTEMRA at 6 mg per kg
  • 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 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 and GCA. 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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