Yes, PROCRIT contains human albumin
PROCRIT, the brand name for the medication epoetin alfa, is used to treat anemia by stimulating the production of red blood cells. A common question that arises for patients is regarding the composition of the injectable solution. The answer is yes, specific formulations of PROCRIT contain Albumin (Human). Albumin is included as a stabilizer to maintain the epoetin alfa protein's integrity and effectiveness.
The role of albumin as a stabilizing excipient
In the context of drug manufacturing, an excipient is an inactive substance used as a vehicle for the active drug. In PROCRIT's case, human albumin performs a crucial function: protein stabilization. As a large, abundant protein in human plasma, albumin helps prevent the active ingredient, epoetin alfa, from adhering to surfaces within the vial or syringe and from degrading. This ensures that the patient receives a consistent and effective dose of the medication.
Key functions of albumin in drug formulations include:
- Stabilizing the active ingredient: It prevents the epoetin alfa protein from losing its shape or function, which could reduce its therapeutic effect.
- Preventing adhesion: It coats surfaces, such as the inside of the vial, to stop the medication from sticking and ensures the full dosage is delivered.
- Increasing solubility and half-life: As a natural carrier protein, albumin can help improve a drug's solubility and prolong its half-life in the body.
Formulations of PROCRIT with and without preservatives
It is important for patients and healthcare providers to understand that PROCRIT is available in different formulations, distinguished primarily by their dose, whether they are single-use or multi-use, and the inclusion of a preservative. This difference can impact certain patient populations, particularly neonates, infants, and pregnant or lactating women, for whom preservative-containing products are contraindicated.
Common formulations and their excipients:
- Single-dose, preservative-free vials: These are available in various strengths and contain Albumin (Human) along with other ingredients like sodium citrate, sodium chloride, and citric acid. They are free of benzyl alcohol.
- Multiple-dose vials: These formulations contain benzyl alcohol as a preservative, in addition to Albumin (Human) and other buffers. Benzyl alcohol has been associated with serious, sometimes fatal, side effects in premature infants, making these vials inappropriate for certain uses.
Table of PROCRIT Formulations: Albumin and Preservative Content
| Formulation | Contains Albumin (Human)? | Contains Preservative (Benzyl Alcohol)? | Primary Use | Relevant Patient Considerations |
|---|---|---|---|---|
| Single-dose Vials (e.g., 2,000-10,000 Units/mL) | Yes | No | Wide range of patients | Suitable for neonates, infants, and pregnant women |
| Single-dose Vials (e.g., 40,000 Units/mL) | Yes | No | Often used for weekly dosing | Suitable for neonates, infants, and pregnant women |
| Multiple-dose Vials (e.g., 10,000 Units/mL, 20,000 Units/mL) | Yes | Yes | For patients requiring multiple doses from one vial | Contraindicated in neonates, infants, pregnant, or lactating women |
Potential risks and safety considerations
While the inclusion of human albumin is generally safe, it carries certain risks and requires specific safety precautions. These are important for patients and clinicians to be aware of, especially concerning potential allergies or hypersensitivity.
Allergic reactions: Some individuals may have a known hypersensitivity to human albumin or products derived from mammalian cells. Allergic reactions can range from mild symptoms like rash and hives to severe reactions, including anaphylaxis. Patients with a history of such reactions should not use PROCRIT.
Theoretical risk of infectious diseases: Since the albumin is a derivative of human blood, there is an extremely remote theoretical risk for the transmission of viral diseases, though manufacturing processes are designed to mitigate this risk. The official FDA label notes that based on effective donor screening and product manufacturing, the risk is extremely remote and no cases of viral transmission have been identified. A theoretical, also extremely remote, risk of Creutzfeldt-Jakob disease (CJD) transmission is also mentioned.
Other considerations for administration: Patients receiving PROCRIT for reasons other than standard indications (e.g., pre-operatively to reduce red blood cell transfusions) must be monitored carefully, especially regarding the risk of deep venous thrombosis. For patients receiving PROCRIT pre-operatively, prophylactic anticoagulation is often recommended.
Comparison with alternative formulations
Not all erythropoiesis-stimulating agents (ESAs) contain human albumin. Some alternative formulations, including biosimilars or other brand-name versions of epoetin alfa, may use different stabilizers. For example, some epoetin alfa products use polysorbate 80 instead of albumin. The use of alternative excipients is a deliberate choice in drug development to potentially avoid risks associated with blood-derived products or to suit specific patient needs, such as those with allergies to albumin. However, it is critical to consult the specific prescribing information for any medication, as the excipients can vary by manufacturer and product.
Conclusion
In summary, PROCRIT does contain human albumin in its various single-dose and multiple-dose formulations, as confirmed by its prescribing information. The albumin is a vital inactive ingredient, functioning primarily as a stabilizer to ensure the drug's integrity and efficacy. While the safety record is excellent due to rigorous screening and manufacturing processes, awareness of the albumin content is important for patients with hypersensitivity to blood-derived products. Different formulations also vary in their preservative content, which carries additional considerations, especially for sensitive populations. For these reasons, patients should always review the specific formulation with their healthcare provider to ensure it is appropriate for their individual needs and medical history.
