What is the rate of deterioration of Humira (adalimumab) at room temperature?

Deterioration of Humira at Room Temperature

Humira (adalimumab) should be stored at 2-8°C (36-46°F) as it will deteriorate more rapidly at room temperature, with significant loss of potency occurring if left at room temperature for extended periods. 1

Storage Requirements and Stability Data

Humira is a thermolabile biologic medication that requires refrigeration to maintain its potency and effectiveness. According to guidelines, the storage of adalimumab should follow these principles:

• Adalimumab should be stored at 4°C (refrigerated) to reduce the rate of potency loss 1
• Exposure to room temperature (20-25°C or 68-77°F) accelerates deterioration
• The medication's stability is affected by several factors including:
  • Temperature
  • Time of exposure
  • Concentration
  • Presence of stabilizers and preservatives

Rate of Deterioration

While the exact rate of deterioration is not precisely quantified in the available guidelines, the evidence suggests:

• More dilute concentrations of biologics deteriorate more rapidly than concentrated forms 1
• Proteins in biologics like adalimumab can lose their structural integrity when exposed to higher temperatures
• Room temperature storage significantly shortens the shelf life compared to refrigerated storage

Practical Implications

For patients and healthcare providers handling Humira:

• Brief exposure to room temperature (such as during administration) is acceptable
• Longer exposures will progressively reduce potency
• The medication should be returned to refrigeration as soon as possible after use

Common Pitfalls to Avoid

1. Home storage issues: A study found that 58.3% of patients stored thermolabile medications like adalimumab outside the correct temperature range in their home refrigerators 2
2. Older refrigerators: Refrigerators older than 5 years represent a risk factor for inadequate storage (RR = 1.68) 2
3. Leaving medication out: Forgetting to return the medication to the refrigerator after administration can significantly reduce its potency
4. Transportation without proper cooling: When transporting the medication, it should be kept cool using appropriate cooling methods

Best Practices for Handling

• Always store Humira in the refrigerator at 2-8°C (36-46°F)
• Avoid freezing the medication
• Protect from light exposure
• Return to refrigeration promptly after use
• When traveling, use appropriate cooling containers
• Check the appearance of the solution before administration (it should be clear and colorless)
• Discard medication that has been left at room temperature for extended periods

Proper storage of Humira is essential to maintain its effectiveness and ensure optimal treatment outcomes for patients with conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.