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Managing Common Infusion Issues1

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Managing Common Infusion Issues1 Managing Common Infusion Issues1 Local Reaction • Assess for tape allergy—change to paper/hypoallergenic tape • Assess needle gauge—choose a needle that is consistent with volume being infused • Assess length of needle—may be too short and infusion may be intradermal • Assess site location—may not be penetrating subcutaneous tissue • Choose sites with appropriate amount of subcutaneous tissue • Avoid tracking IgG through intradermal tissue by not allowing drops of IgG on needle tip prior to needle insertion (prime dry) • Assess appropriateness of rotating sites based on previous tolerability • Consider use of topical anesthetic ointment • Avoid infusion into areas where the skin is tender, bruised, red, or hard. Avoid infusing into scars, stretch marks, or tattooed skin Leaking at • Assess needle and catheter—ensure they are affixed securely Infusion Site and fully inserted • Assess placement—may be in location that is subject to movement; advise regarding selection of site • Assess length of subcutaneous needle—may be too short; suggest change • Assess rate of infusion volume—amount per site may be too great; adjust volume • Assess rate of infusion—adjust rate (rate may be too fast) (continued on next page) © 2018 CSL Behring LLC. The product information presented on this site is intended for US residents only. Managing Common Infusion Issues1 (continued) Discomfort • Assess needle length—may be too long and irritating to the infusion site With Needle • Try catheter that allows introducer needle to be removed or try another brand of SCIg set • Consider applying cold pack or topical anesthetic cream prior to insertion Infusion Issues • Assess product storage—Hizentra is ready to use at room temperature; no refrigeration required • Assess volume per site, rate of infusion, and number of sites, or adjust infusion regimen • Check manufacturer’s instructions for pump setting, correct selection of tubing size and length to match infusion rates; check pump function, battery function, etc • Arrange observation of patient technique (specialty pharmacy provider or office visit) Reference: 1. Murphy E, Burton J, Riley P. Nursing approaches to a novel subcutaneous immunoglobulin therapy. Infusion. 2007;13:1-8. © 2018 CSL Behring LLC. The product information presented on this site is intended for US residents only. HIGHLIGHTS OF PRESCRIBING INFORMATION Administration (2.3) These highlights do not include all the information needed to use HIZENTRA • PI: Administer at regular intervals from daily up to every 2 weeks. safely and effectively. See full prescribing information for HIZENTRA. • CIDP: Administer weekly. • Infusion sites – Up to 8 infusion sites are allowed simultaneously, with at least HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid 2 inches between sites. Initial U.S. Approval: 2010 WARNING: THROMBOSIS Administration in PI See full prescribing information for complete boxed warning. Infusion 1st Infusion Subsequent Infusions • Thrombosis may occur with immune globulin products, including Parameters* HIZENTRA. Risk factors may include: advanced age, prolonged Volume (mL/site) ≤15 ≤25 immobilization, hypercoagulable conditions, history of venous or Rate (mL/hr/site) ≤15 ≤25 arterial thrombosis, use of estrogens, indwelling vascular catheters, *As tolerated hyperviscosity, and cardiovascular risk factors. Administration in CIDP • For patients at risk of thrombosis, administer HIZENTRA at the minimum Infusion dose and infusion rate practicable. Ensure adequate hydration in patients 1st Infusion Subsequent Infusions before administration. Monitor for signs and symptoms of thrombosis Parameters* and assess blood viscosity in patients at risk for hyperviscosity. Volume (mL/site) ≤20 ≤50 Rate (mL/hr/site) ≤20 ≤50 ---------------------------------------RECENT MAJOR CHANGES------------------------------ * As tolerated Indications (1.2) 3/2018 ----------------------------DOSAGE FORMS AND STRENGTHS------------------------------ Dosage and Administration (2.2, 2.3) 3/2018 0.2 g per mL (20%) protein solution for subcutaneous infusion. (3) ------------------------------------INDICATIONS AND USAGE--------------------------------- -------------------------------------CONTRAINDICATIONS-------------------------------------- HIZENTRA is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for • Anaphylactic or severe systemic reaction to human immune globulin or inactive the treatment of: ingredients of HIZENTRA, such as polysorbate 80. (4) • Primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. • Hyperprolinemia Type I or II (HIZENTRA contains stabilizer L-proline). (4) (1.1) • IgA-deficient patients with antibodies against IgA and a history of hypersensitivity. (4) • Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). (1.2) ---------------------------------WARNINGS AND PRECAUTIONS---------------------------- • IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity ------------------------------DOSAGE AND ADMINISTRATION------------------------------- and anaphylactic reactions. (5.1) For subcutaneous infusion only. • Thrombosis may occur following treatment with immune globulin products, including Dose (2.2) HIZENTRA. (5.2) PI • Aseptic meningitis syndrome has been reported with IGIV or IGSC, including HIZENTRA Before switching to HIZENTRA, obtain the patient’s serum IgG trough level to guide sub- treatment. (5.3) sequent dose adjustments. • Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output • Weekly: Start HIZENTRA 1 week after last Immune Globulin Intravenous (Human) in patients at risk of acute renal failure. (5.4) (IGIV) infusion. • Monitor for clinical signs and symptoms of hemolysis. (5.5) Initial weekly dose = Previous IGIV dose (in grams) x 1.37 • Monitor for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). (5.6) No. of weeks between IGIV doses • HIZENTRA is made from human blood and may contain infectious agents, e.g., viruses, • Biweekly (every 2 weeks): Start HIZENTRA 1 or 2 weeks after the last IGIV infusion or the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt- 1 week after the last weekly IGSC infusion. Administer twice the calculated weekly dose. Jakob disease (CJD) agent. (5.7) • Frequent dosing (2 to 7 times per week): Start HIZENTRA 1 week after the last IGIV or IGSC infusion. Divide the calculated weekly dose by the desired number of times -----------------------------------ADVERSE REACTIONS---------------------------------------- per week. The most common adverse reactions observed in ≥5% of study subjects were local • Adjust the dose based on clinical response and serum IgG trough levels. infusion site reactions, headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, upper respiratory tract infection, rash, pruritus, vomiting, abdominal pain (upper), CIDP migraine, arthralgia, pain, fall and nasopharyngitis. (6) • Initiate therapy with HIZENTRA 1 week after the last IGIV infusion. To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring • Recommended subcutaneous dose is 0.2 g/kg (1 mL/kg) body weight (bw) per week. Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or - In the clinical study after transitioning from IGIV to HIZENTRA, a dose of 0.4 g/kg www.fda.gov/medwatch. (2 mL/kg) bw per week was also safe and effective to prevent CIDP relapse. • If CIDP symptoms worsen, consider re-initiating treatment with an IGIV approved for -----------------------------------DRUG INTERACTIONS--------------------------------------- the treatment of CIDP, while discontinuing HIZENTRA. The passive transfer of antibodies may interfere with the response to live virus vaccines - If improvement and stabilization are observed during IGIV treatment, consider re- (7.1), and lead to misinterpretation of the results of serological testing. (5.8, 7.2) initiating HIZENTRA at 0.4 g/kg bw per week, while discontinuing IGIV. - If CIDP symptoms worsen on 0.4 g/kg bw per week, consider re-initiating therapy with IGIV, while discontinuing HIZENTRA. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. • Monitor patient’s clinical response and adjust duration of therapy based on patient need. Revised: March 2018 FULL PRESCRIBING INFORMATION: CONTENTS* 7 DRUG INTERACTIONS WARNING: THROMBOSIS 7.1 Live Virus Vaccines 1 INDICATIONS AND USAGE 7.2 Serological Testing 1.1 Primary Immunodeficiency (PI) 8 USE IN SPECIFIC POPULATIONS 1.2 Chronic Inflammatory Demyelinating olyneuropathyP (CIDP) 8.1 Pregnancy 2 DOSAGE AND ADMINISTRATION 8.2 Lactation 2.1 Preparation and Handling 8.4 Pediatric Use 2.2 Dose 8.5 Geriatric Use 2.3 Administration 11 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.3 Pharmacokinetics 5.1 Hypersensitivity 13 NONCLINICAL TOXICOLOGY 5.2 Thrombosis 13.2 Animal Toxicology and/or Pharmacology 5.3 Aseptic Meningitis Syndrome (AMS) 14 CLINICAL STUDIES 5.4 Renal Dysfunction/Failure 14.1 Primary Immunodeficiency (PI) 5.5 Hemolysis 14.2 Chronic Inflammatory Demyelinating olyneuropathyP (CIDP) 5.6 Transfusion Related Acute Lung Injury (TRALI) 15 REFERENCES 5.7 Transmissible Infectious Agents 5.8 Laboratory Tests 16 HOW SUPPLIED/STORAGE AND HANDLING 17 ATIENT COUNSELING INFORMATION 6 ADVERSE REACTIONS P 6.1 Clinical Trials Experience * Sections or subsections
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