TxIDAnemia

Pharmacological Treatment Options for Anemia, Iron Deficiency Nicholas Tsourounis, PharmD Candidate 2007

Oral Iron Replacemement Therapy

Parenteral Iron Replacement Therapy Erythropoesis Stimulating Factors used in

conjunction with Iron Replacement therapy

Androgens used in conjunction with Iron Replacement therapy

Product AvailabilityGeneric (Brand)

Iron-polysaccharide Complex (Fe-Tinic 150® [OTC], Ferrex 150® [OTC], Hytinic® [OTC], Niferex 150® [OTC], Niferex® [OTC], Nu-Iron 150® [OTC])

Ferrous Fumarate (Femiron® [OTC], Feostat® [OTC], Ferretts® [OTC], Ferro-Sequels® [OTC], Hemocyte® [OTC], Ircon® [OTC], Nephro-Fer® [OTC])

Ferrous gluconate (Fergon® [OTC])

Ferrous sulfate (Feosol® [OTC], Fer-Gen-Sol® [OTC], Fer-In-Sol® [OTC], Fer-Iron® [OTC], Feratab® [OTC], Slow Fe® [OTC])

Ferrous sulfate/ascorbate (Fero-Grad 500® [OTC], Vitelle®, Irospan® [OTC])

Ferric Gluconate (Ferrlecit®) Iron sucrose (Venofer®) Iron dextran (Dexferrum®, INFeD®)

Epoetin Alfa (Epogen®, Procrit®)

Darbepoetin alfa (Aranesp®)

Nandrolone (Durabolin®, Deca-Durabolin®)

Oxymetholone (Anadrol®)

Student Name, PharmD Candidate 2007 Pharmacotherapy Presentation – Pharmaceutical Care RotationUniversity of Maryland School of Pharmacy Happy Harry’s Pharmacy Patient Care Center, Perryville, MD

Mechanismof Action

All aforementioned products are iron salts, which get incorporated into hemoglobin and increase the oxygen-carrying capacity of the blood.

All aforementioned products are iron salts, which get incorporated into hemoglobin and increase the oxygen-carrying capacity of the blood.

Both Epoetin-alfa and Darbepoetin-alfa cause erythropoesis by stimulating the division and differentiation of erythroid progenitor cells

Both Nandrolone and Oxymetholone promote anabolism, and promote the production of erythropoetin and IGF1. The end result is an increase in hemoglobin and RBC volume.

EFFICACY

(Indication/Use, Clinical Data Support)

These products are indicated for use in the prevention and treatment of iron-deficiency anemias.

All these products are inidcated for use in the treatment of microcytic, hypochromic anemia due to iron deficiency or blood loss, when oral therapy for these conditions proves ineffective, or in dialysis patients.

Both Epoetin-alfa and Darbepoetin-alfa are indicated for use in the treatment of anemia in patients with CRF, with or without dialysis. These drugs are being included since there drugs are usually given in conjunction with iron replacement therapy if serum ferritin is <100mcg/mL and transferrin saturation <20%

Both Nandrolone and Oxymetholone are indicated for use in the treatment of anemia in of renal insufficiency, with or without dialysis. These drugs are being included since there drugs are usually given in conjunction with iron replacement therapy.

SAFETY

(Major Drug Interactions,Pre-cautions, Contra-indications,Adverse Effects,Pregnancy Risk Category)

Interactions: False positive on fecal

occult blood test Increased

absorption/effect when co-administered with >200mg vitamin C per 30 mg elemental iron

Co-administration of iron and tetracyclines decreases absorption of both drugs

Iron decreases the absorption of fluoroquinolones, levodopa, methyldopa, and penecillamine

Concurrent administration of antacids, dairy products, H2 blockers, and PPI’s may decrease iron absorption

Chloramphenicol may delay response to iron

Interactions: Chloramphenicol may delay response to iron

therapy

Precautions: Use with caution in asthmatics, people with

hepatic impairment, or rheumatoid arthritis Not recommended for children <4months old Anaphylaxis can occur following

administration, possibly resulting in death A test dose is needed to determine whether

anaphylaxis will occur

Contraindications: Hypersensitivity to any component of the

formulation Hemochromatosis Hemolytic anemia Anemias that are not due to iron deficiency

Adverse Effects: Flushing Dizziness Fever N/V Metallic taste

Interactions: EtOH consumption

decreases the effect of these drugs

Precautions: Use with caution in

patients with a history of seizures, HTN, angina, or CHF

Use with caution in patients with porphyria

Discontinue use within 2 weeks of a successful renal allograft

Use with caution in patients at risk for thrombosis

Iron stores must be monitored during therapy

Contraindications: Hypersensitivity to

Interactions: may increase the effects of

oral anticoagulants may increase the effects of

insulin and oral antidiabetics

may increase the effects of ACTH and other adrenal steroids

increased hepatotoxicity of cyclosporine

Precautions: monitor DM patients

closely may cause peliosis

hepatitis, hepatocellular carcinoma, changes in blood lipids, and increase the risk of atherosclerosis

use in caution in elderly patients, they may be at a greater risk of prostatic


therapy

Precautions: Avoid in patients with

peptic ulcer disease, ulcerative colitis, or enteritis

Avoid administering continuously for >6 months unless patient is continuously bleeding

Avoid using in patients receiving frequent blood transfusions

Avoid use in premature infants until vitamin E stores are repleted to avoid increase hemolysis

Contraindications Hypersensitivity to any

active or inactive ingredient in the formualtion

Hemochromatosis Hemolytic anemia

Adverse Effects: Stomach cramps Nausea/vomiting Dark stools Constipation Heartburn Discolored urine Stained teeth

Pregnancy Risk category: A

HA Staining of skin at site of injection chills Diaphoresis Athralgia Urticaria

-these last 6 effects may be delayed up to 48 hours after IV administration, or 3-4 days after IM administration

Anaphylaxis

Pregnancy Risk category: C

human albumin, mammalian cell-derived products, or polysorbate 80 (Darbepoetin)

Uncontrolled HTN

Adverse Effects: HTN HA Fever Fatigue Nausea Athralgia Chest pain Asthenia Injection site pain MI CVA TIA Epoetin-alfa - seizure Darbepoetin –

preipheral edema, fluid overload,

Pregnancy Risk category: C

hyperplasia use with caution in

patients with epilepsy or cardiac, renal, or hepatic disease

may accelerate bone maturation, decreasing height potential

Contraindications: Those who have a

hypersensitivity to the drug or any component of the formulation

Pregnant women Infants Those with carcinoma

of the breast or prostate

Patients with nephrosis

Adverse Effects: Acne Gynocomastia Priapism Nausea Diarrhea Virilism Prostatic hyperplasia Peliosis hepatitis Hepatic necrosis Hepatocellular

carcinoma Suppression of clotting

factors CAD Peripheral edema Electrolyte

abnormalities Impotence Testicular

atrophy/dysfunction Clitoromegaly Dyslipidemia


Menstrual irregularity jaundice

Pregnancy Risk category: X

Therapeutic Class/Agents Therapeutic Class/Agents Therapeutic Class/Agents Therapeutic Class/Agents

Dosage & Administration

(Include renal and/or hepatic adjustments)

Iron-polysaccharide1. tablets or elixir –

50 to 100mg BID2. capsules – 150 to

300 mg QD Ferrous Fumarate

1. prophylaxis - 60 to 100mg QDay

2. In elderly – up to 200mg 3-4x/Day

3. Pediatrics – 4 to 6 mg/kg/day in 3 divided doses

Ferrous gluconate 1. prophylaxis –

60mg QDay2. Treatment - adults

- 60mg BID to QID

3. Treatment – pediatrics, severe – 4 to 6 mg/kg/day in 3 divided doses

4. Treatment – pediatrics, mild to moderate – 3 mg/kg/day QDay or in 2 divided doses

Ferrous sulfate 1. Prophylaxis –

Ferric Gluconate1. Adults – Test dose of 2mL diluted in

NS 50mL over 60 minutes, 125mg elemental iron/10mL by IV infusion or slow injection

2. Pediatrics – 1.5mg/kg (max 125mg) diluted in 25mL NS infused over 60 minutes

Iron sucrose 1. during dialysis – 100mg 1-3x/week2. PD patients – two 300mg infusions

over 1.5 hours 14 days apart with one 400mg infusion 14days later

3. non-dialysis – 200mg slow infusion on 5 different days during a 2 week period

Iron dextran - administered IV bolus of <1mL/min or diluted in 250-1000mL NS infused over 1-6 hours

1. 0.5mL test dose should be given in adults, 0.25mL test dose in pediatrics

2. Fe Deficiency – Dose=0.0476*LBW(kg)*(normal Hgb – observed Hgb)+(1mL/5kgLBW up to 14mL)

3. Blood loss – Replacement Iron (mg) = blood loss mL’s * Hct

4. Max dose – Pediatrics <10kg, 1mL.Pediatrics 10-50kg, 2mL. Adults >50kg, 2mL.

Epoetin-alfa – IV or SQ1. Pedicatrics – 50

Units/kg 3x/week2. Adults – 50 to 100

Units/kg 3x/week3. Adjustments –

Increase dose 25% if Hgb does not increase by 2g/dL within 8 weeks. Decrease dose 25% if Hgb increases 1g/dL within a 2 week period.

Darbepoetin-alfa – IV or SQ 0.45mcg/kg Qweek or 0.75mcg/kg QOweek, titrate to response.

Nandrolone 1. Women, 50-100mg

Qweek2. Men, 100-200mg

Qweek 3. Pediatrics, 25-50mg

Qweek

Oxymetholone – 1 to 5 mg/kg/day in one dose, max dose 100mg/Day


300mg QDay2. Treatment –

300mg BID to QID, or 250mg ER Qday to BID

Ferrous sulfate/ascorbate - One 525mg FeS/500mg Vit C tablet QDay

Monitoring

(Efficacy and Toxicity Parameters)

o Efficacy – Monitor Hct, Hgb, serum Fe, TIBC, reticulocyte count, transferrin saturation, serum ferritin, and patient specific signs and symptoms of anemia

o Toxicity - Gi irritation, stomach ulcers, hematemesis, lethargy, acidosis, hepatic or renal impairment, and coma

o Efficacy – Monitor Hct, Hgb, serum Fe, TIBC, reticulocyte count, transferrin saturation, serum ferritin, and patient specific signs and symptoms of anemia

o Toxicity – anaphylaxis, pulmonary edema, convulsions, tachycardia, hematemesis, hepatic and renal impairment, acidosis, lethargy, coma

o Efficacy – Monitor Hct, Hgb, CBC with differential, reticulocyte count, transferrin saturation, serum ferritin, and patient specific signs and symptoms of anemia (2x weekly, then 2-4x monthly)

o Toxicity – BP, polycythemia, MI, CVA, TIA, seizures, peripheral edema, fluid overload

o Efficacy – Hgb, Hct, reticulocyte count Q3months

o Toxicity – LFT’s, BG, jaundice, and blood lipids Q6months, prostate exam Qyear

Patient Education

Do not take within 2 hours before or 4 hours after taking an antacid

Do not take with cereals, fiber-containing foods, tea, coffee, eggs, or milk

Take with water or juice on an empty stomach

To enhance absorption, try to take with a glass of orange juice

You will need frequent blood tests while on this medication

If you have RA, you may have an increase in swelling or pain in your joints

Exercise caution while driving after treatment because of some side effects

Small meals, proper oral hygeine, and lozenges or chewing gum may help with nausea or metallic taste

With any respiratory difficulty, acute GI problems, rapid heartbeat, yellowing of the skin, or swelling of hands and feet, consult physician

Do not take any new medications without consulting prescriber

If self-administering, follow exact directions for use

You will require frequent blood tests to determine appropriate dosage

Do not change intake of dietary iron without consulting physician

Do not take any new medications unless approved by prescriber

Do not donate blood for at least 1 month following use

Take as directed May cause nausea,

vomiting, and diarrhea May cause a myriad of

side effects (see above)


This medication will cause a false positive on a fecal occult blood test, which is a test used to screen for colon cancer. Before taking an FOBT, inform your physician that you are on an iron supplement.

Report signs/symptoms of edema, swollen extremities, respiratory difficulty, or rapid weight gain

If you experience severe HA, acute back pain, chest pain, tremors, or seizure, contact 911

Cost (1-month)

Iron-polysaccharide – o Capsules - $8.93 -

$17.86o Elixir – $21.91

Ferrous Fumarate – $24.99

Ferrous gluconate - $5.99

Ferrous sulfate - $18.99

Ferrous sulfate/ascorbate - all brands DC’ed

Ferric Gluconate - $688.00 Iron sucrose - $688.00 Iron dextran - $452.40

Epoetin-alfa - $2,123.88Darbepoetin - $3,584.36

Oxymetholone - $1,178.45Nandrolone - $83.96

References(Guidelines, Drug Info Sources)

LexicompWalgreens.com

Lexicomphttp://uuhsc.utah.edu/pharmacy/bulletins/venofer.html




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