Injectable Iron Products

Transcription

1 Injectable Iron Products Allyson Gabbard, Pharm.D. PGY1 Pharmacy Specialist Resident INTEGRIS Baptist Medical Center 1 Learning Objectives Compare and contrast the different injectable iron products. List the labeled and, if applicable, off-label indications for each injectable iron product. Identify contraindications and warnings/precautions associated with each injectable iron product. Describe appropriate administration methods and monitoring parameters for each injectable iron product. 2 Anemia: A Brief Background Definition Decreased number of red blood cells (RBC) in the blood Symptoms Weakness and fatigue Chest pain and palpitations Shortness of breath Vertigo 3 1

2 Iron Deficiency Anemia (IDA) Causes Blood loss Decreased iron intake and/or absorption Increased RBC production Lab Tests Serum iron Serum ferritin Total iron-binding capacity (TIBC) Red blood cell distribution width (RDW) Transferrin saturation 4 Injectable Iron Products Feraheme (ferumoxytol) Ferrlecit (ferric gluconate) Infed (iron dextran complex) Injectafer (ferric carboxymaltose) Venofer (iron sucrose) 5 Feraheme (ferumoxytol) FDA-Labeled Indication IDA in patients > 18 years old with chronic kidney disease (CKD) Serious hypersensitivity/anaphylaxis reactions Hypersensitivity to Feraheme or any components History of allergic reactions to any injectable iron product 6 2

3 Feraheme (ferumoxytol) Warning/Precautions Hypotension Iron overload MRI result alteration Common Adverse Effects Diarrhea or constipation Nausea Dizziness Hypotension Peripheral edema 7 Feraheme (ferumoxytol) Administration Two 510 mg doses Separate by 3-8 days ml IV 0.9% sodium chloride or 5% dextrose Infuse over > 15 minutes 8 Feraheme (ferumoxytol) Monitor during Monitor for 30 minutes following Monitor at least 1 month after second dose Pulse Blood pressure Pulse Blood pressure Serum ferritin Serum iron Transferrin saturation Hemoglobin 9 3

4 Ferrlecit (ferric gluconate) FDA-Labeled Indication IDA in patient > 6 years old with CKD on hemodialysis and receiving epoetin Off-Label Indication Chemotherapy-associated anemia None Hypersensitivity to Ferrlecit or any components 10 Ferrlecit (ferric gluconate) Warning/Precautions Hypersensitivity reactions Hypotension Iron overload Benzyl alcohol toxicity Common Adverse Effects Diarrhea Nausea/vomiting Hypotension Cramps Flushing Pruritus 11 Ferrlecit (ferric gluconate) Administration (Adults) One 125 mg dose per dialysis session Most patients require 8 doses (1,000 mg total) 100 ml IV 0.9% sodium chloride Infuse over 60 minutes Undiluted IV Infuse at < 12.5 mg/minute 12 4

5 Ferrlecit (ferric gluconate) Monitor during Monitor for 30 minutes following Monitor monthly Serum ferritin Transferrin saturation Hemoglobin/hematocrit 13 Infed (iron dextran complex) FDA-Labeled Indication IDA in patients > 4 months old who cannot take oral iron or who have failed oral iron therapy Anaphylactic-type reactions Hypersensitivity to Infed or any components Anemia not caused by iron deficiency Infed (iron dextran complex) Warning/Precautions Delayed reactions Caution in patients with underlying conditions Carcinogenesis Laboratory interactions Common Adverse Effects Hypotension Pain at injection site Brown staining at injection site Flushing Fever/chills Myalgia 15 5

6 Infed (iron dextran complex) Administration (Adults) Dose depends on lean body weight and hemoglobin levels Use package insert dosing chart or provided formula Undiluted IV Test dose of 0.5 ml given over > 30 seconds Divide remaining dose in volumes of < 2 ml per day Infuse at < 1 ml/minute Undiluted IM injection Test dose of 0.5 ml into upper outer quadrant of buttock Give remaining dose divided in volumes of < 2 ml per day 16 Infed (iron dextran complex) Monitor during test and therapeutic dose Anaphylaxis Monitor for 1 hour following therapeutic dose Anaphylaxis Monitor monthly Serum ferritin Serum iron TIBC Hemoglobin/hematocrit 17 Injectafer (ferric carboxymaltose) FDA-Labeled Indication IDA in patients > 18 years old who failed oral iron therapy or have non-dialysis dependent CKD None Hypersensitivity to Injectafer or any components American-Regent-Expands-Promotional-Campaign-Iron-Deficiency 18 6

7 Injectafer (ferric carboxymaltose) Warning/Precautions Hypersensitivity reactions Hypertension Laboratory interactions Common Adverse Effects Nausea Dizziness Hypertension Flushing Decreased phosphorous levels 19 Injectafer (ferric carboxymaltose) Administration Dose depends on body weight < 50 kg: two doses of 15 mg/kg separated by > 7 days > 50 kg: two doses of 750 mg separated by > 7 days Undiluted IV Slow IV push at < 100 mg/minute (< 2 ml/minute) Diluted IV 0.9% sodium chloride Infuse over > 15 minutes 20 Injectafer (ferric carboxymaltose) Monitor during Hypertension Extravasation Monitor for 30 minutes following Hypertension Monitor every 1-3 months Serum ferritin Transferrin saturation Hemoglobin/hematocrit 21 7

8 Venofer (iron sucrose) FDA-Labeled Indication IDA in patients > 2 years old with CKD Off-Label Indication Chemotherapy-associated anemia None Hypersensitivity to Venofer or any components 22 Venofer (iron sucrose) Warning/Precautions Hypersensitivity reactions Hypotension Iron overload Common Adverse Effects Diarrhea Nausea/vomiting Dizziness Hypotension Muscle cramps Injection site reactions 23 Venofer (iron sucrose) Administration (Adults) Dose depends on dialysis status Non-dialysis-dependent CKD 5 doses of 200 mg each within 14 days 2 doses of 500 mg each separated by 12 days Peritoneal-dialysis-dependent CKD Two doses of 300 mg each separated by 14 days followed by one 400 mg dose 14 days later Hemodialysis-dependent CKD 100 mg per dialysis session for a total treatment dose of 1,000 mg Undiluted IV : only for doses < 200 mg Slow IV push over 2-5 minutes Diluted IV 0.9% sodium chloride Volume and rate depend on dose 24 8

9 Venofer (iron sucrose) Monitor during dose administration Hypotension Monitor for 30 minutes following dose Hypotension Monitor > 48 hours following dose Serum ferritin Transferrin saturation Hemoglobin/hematocrit 25 Injectable Iron Products: Data Synthesis Feraheme Ferrlecit Infed Injectafer Venofer Labeled Indications IDA with CKD IDA with CKD on HD and on IDA if cannot take PO iron or IDA with CKD (non-dialysis IDA with CKD epoetin failed PO iron dependent) therapy or if failed PO iron therapy Off-Label Indications Approved Ages > 6 years > 4 months > 18 years > 18 years > 2 years 26 Injectable Iron Products: Data Synthesis Feraheme Ferrlecit Infed Injectafer Venofer Hypersensitivity None Anaphylactic None None Anaphylaxis type reactions None Chemotherapy- None None Chemotherapyassociated associated anemia anemia Allergic None Anemia not None None reaction to any caused by iron injectable iron deficiency anemia products Warnings/ Precautions Hypotension Iron overload Hypotension Iron overload Delayed reactions Underlying Hypertension Lab interactions Hypotension Iron overload MRI alteration Benzyl alcohol conditions toxicity Carcinogenesis Lab interactions 27 9

10 Injectable Iron Products: Data Synthesis Feraheme Ferrlecit Infed Injectafer Venofer Administration Diluted IV Diluted IV Undiluted IV Test dose Undiluted IM injection Undiluted IV Diluted IV Undiluted IV Diluted IV Undiluted IV Diluent Monitoring Parameters 0.9% sodium 0.9% sodium None 0.9% sodium 0.9% sodium chloride chloride chloride chloride 5% dextrose Vital signs Vital signs Anaphylaxis Vital signs Vital signs Pulse Hypersensitivity Hypersensitivity Hypertension Hypotension Blood pressure Iron studies Iron studies Extravasation Hypersensitivity Hypersensitivity CBC CBC Hypersensitivity Iron studies Iron studies Iron studies CBC CBC CBC 28 Injectable Iron Products Allyson Gabbard, Pharm.D. PGY1 Pharmacy Specialist Resident INTEGRIS Baptist Medical Center 29 References Feraheme [package insert]. New York, NY: Darke-Davis Division of Pfizer Inc.; Available at: a739-11dc-a a5d5c51b. Accessed February 11, Ferrlecit [package insert]. New York, NY: Darke-Davis Division of Pfizer Inc.; Available at: 42ac-4329-b1a5-a9dadfcb79f6. Accessed February 11, Infed [package insert]. New York, NY: Darke-Davis Division of Pfizer Inc.; Available at: eeac8ca2a. Accessed February 11, Injectafer [package insert]. New York, NY: Darke-Davis Division of Pfizer Inc.; Available at: Accessed February 11, Venofer [package insert]. New York, NY: Darke-Davis Division of Pfizer Inc.; Available at: c6b4-4f9c-9bf4-774fd3ae619a. Accessed February 11, Feraheme. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Minneapolis, MN. Available at: Accessed February 12, Ferrlecit. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Minneapolis, MN. Available at: Accessed February 12, Infed. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Minneapolis, MN. Available at: February 12, Injectafer. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Minneapolis, MN. Available at: February 12, Venofer. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Minneapolis, MN. Available at: February 12,