Test Dose Requirements for Iron Dextran
A test dose is required only once before the first therapeutic dose of iron dextran, not with every subsequent administration, unless the patient has had a previous reaction or there has been a prolonged gap in therapy. 1
Initial Test Dose Protocol
For iron dextran specifically:
- Administer a one-time test dose of 25 mg IV in adults before initiating therapy 1
- Pediatric dosing: 10 mg for patients <10 kg; 15 mg for patients 10-20 kg 1
- Observe the patient for at least 60 minutes after the test dose before proceeding with therapeutic dosing 1, 2
- If no immediate allergic reaction occurs, subsequent routine doses can be given without repeating the test dose 1
Critical Safety Considerations
The test dose has significant limitations that clinicians must understand:
- Most severe anaphylactic reactions to iron dextran occur in patients who previously tolerated both test doses and multiple therapeutic doses 1
- The test dose does not predict or prevent severe reactions to subsequent doses 1
- Fatal reactions have occurred even after uneventful test doses 2
- Severe reactions requiring resuscitative medications occur in approximately 0.035% of iron-naïve patients, and all documented cases occurred after either the test dose or first therapeutic dose 3
When to Consider Repeat Test Dosing
Although not routinely required, consider a repeat test dose in these specific scenarios:
- Patient has a history of multiple drug allergies (associated with increased risk of iron dextran reactions) 1, 2
- Previous reaction to any IV iron preparation 4
- Prolonged gap since last iron dextran administration (clinical judgment required)
- Switching between different iron dextran products, as they are not clinically interchangeable 2
Mandatory Safety Measures for Every Administration
Regardless of test dose history, every iron dextran administration requires:
- Personnel trained in emergency treatment immediately available 1, 2
- Resuscitation equipment and medications (epinephrine, diphenhydramine, corticosteroids) at bedside 1, 2
- Patient observation for at least 15-60 minutes after administration 1
- Maximum rate not exceeding 50 mg per minute for undiluted iron dextran 1
Comparison with Other IV Iron Preparations
Iron dextran is unique in requiring a test dose:
- Iron sucrose does NOT require a test dose 1, 4, 5
- Iron gluconate does NOT require a test dose 1, 4
- Ferumoxytol does NOT require a test dose 1
- Iron dextran carries a black-box warning for anaphylaxis risk that other formulations do not 4, 2
Common Clinical Pitfalls
Avoid these errors:
- Do not assume a negative test dose guarantees safety for future doses—remain vigilant with every administration 1, 2
- Do not use test doses from one iron preparation to justify safety of another preparation 1
- Do not administer iron dextran during acute infectious kidney disease or active bacteremia 2
- Do not exceed 2 mL (100 mg) undiluted iron dextran as maximum daily dose 2
- Do not forget that patients on ACE inhibitors may have increased risk of reactions 2
- Do not assume patients on beta-blockers will respond adequately to epinephrine; have isoproterenol available 2
Delayed Reactions
Be aware of delayed reaction syndrome: