From the Guidelines
Prolastin C has been associated with fatigue as a potential side effect, though extreme fatigue is not commonly reported as a primary concern. Prolastin C (alpha-1 proteinase inhibitor) is used to treat alpha-1 antitrypsin deficiency, and while fatigue is listed among its possible side effects, it's generally considered mild to moderate when it occurs. Other more commonly reported side effects include headache, dizziness, nausea, and injection site reactions. If a patient experiences severe or persistent fatigue while using Prolastin C, they should consult their healthcare provider, as it could potentially indicate an adverse reaction or might be related to the underlying condition rather than the medication itself. The fatigue mechanism may be related to the body's immune response to the infused protein or as part of a mild hypersensitivity reaction.
Key Considerations
- Fatigue is a common symptom in various medical conditions, including cancer and inflammatory rheumatic and musculoskeletal diseases, as noted in studies such as 1 and 1.
- The management of fatigue often involves addressing underlying causes, such as anemia, sleep disturbances, pain, and emotional distress, as outlined in guidelines like those found in 1 and 1.
- Regular follow-up appointments with a healthcare provider are essential to monitor for side effects and ensure optimal management of the condition, as suggested by the general principles of managing fatigue in the context of chronic diseases.
Recommendations for Patients Experiencing Fatigue
- Patients should report any severe or persistent fatigue to their healthcare provider.
- A thorough evaluation, including assessment for comorbid conditions and other treatable contributing factors, should be conducted, as recommended in guidelines such as 1 and 1.
- Management strategies may include lifestyle modifications, treatment of underlying conditions, and potentially referral to specialists for further evaluation and support, as discussed in studies like 1 and 1.
Conclusion is not allowed, so the answer ends here.
From the FDA Drug Label
The following adverse reactions have been identified during post-approval use of GLASSIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure General Disorders and Administration Site Conditions: Fatigue
Alpha-1 antitrypsin (A1AT) (Prolastin C) is associated with fatigue as reported in the postmarketing experience section of the drug label 2.
From the Research
Association of Alpha-1 Antitrypsin (A1AT) with Extreme Fatigue
- There is limited direct evidence linking alpha-1 antitrypsin (A1AT) or Prolastin C to extreme fatigue 3, 4, 5, 6.
- A study on the pharmacokinetic comparability of Prolastin-C to Prolastin in alpha₁-antitrypsin deficiency found that adverse events were similar for both treatments, but it did not specifically mention fatigue as a common side effect 3.
- Another study on the effects of Prolastin C on the acute inflammatory response in patients with ST-segment elevation myocardial infarction did not report fatigue as a side effect 4.
- However, a study on the safety and pharmacokinetics of Alpha-1 MP (Prolastin-C) in Japanese patients with alpha1-antitrypsin deficiency reported two treatment-emergent adverse events of fatigue in one subject, which were considered to be possibly related to the treatment 5.
- A review of alpha 1-antitrypsin augmentation therapy did not mention fatigue as a side effect of Prolastin treatment 6.
- It is worth noting that fatigue is a common symptom in many diseases and conditions, and it may not be directly related to A1AT or Prolastin C treatment.
- In contrast, a study on treatment-associated fatigue in cancer patients treated with immune checkpoint inhibitors found that fatigue is a prominent side-effect of immune checkpoint inhibition, but this is not directly related to A1AT or Prolastin C 7.