Imraldi SPC: Essential Guide for Biosimilar Treatment

Imraldi SPC (Summary of Product Characteristics) provides healthcare professionals with vital information about this adalimumab biosimilar medication. Understanding the Imraldi SPC is crucial for proper prescription, administration, and monitoring of this treatment option for inflammatory conditions.

What Is Imraldi and Its Summary of Product Characteristics

Imraldi is a biosimilar medication containing the active substance adalimumab, developed by Samsung Bioepis and marketed by Biogen. As a biosimilar to the reference product Humira, Imraldi has been approved by the European Medicines Agency (EMA) for treating various inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and psoriasis.

The Imraldi Summary of Product Characteristics (SPC) is an official document that contains comprehensive information about the medication's composition, pharmaceutical form, therapeutic indications, posology, method of administration, contraindications, special warnings, and precautions. This document serves as the authoritative reference for healthcare professionals when prescribing and administering Imraldi to patients. The SPC is regularly updated based on new clinical data and safety information to ensure that healthcare providers have access to the most current guidance.

Key Components of the Imraldi SPC Document

The Imraldi SPC follows a standardized format required by regulatory authorities and contains several critical sections that healthcare professionals must understand. The qualitative and quantitative composition section details that each pre-filled syringe or pen contains 40 mg of adalimumab in 0.8 ml solution. The clinical particulars section covers therapeutic indications, specifying the exact conditions for which Imraldi has been approved.

Dosage recommendations in the SPC vary by indication, age group, and patient weight. For example, adult rheumatoid arthritis patients typically receive 40 mg every other week, while dosing for pediatric patients with juvenile idiopathic arthritis is weight-based. The SPC also contains detailed information about contraindications, including active tuberculosis or other severe infections, moderate to severe heart failure, and hypersensitivity to the active substance.

Special warnings highlight the importance of tuberculosis screening before initiating treatment, monitoring for infections during therapy, and potential risks related to concurrent use of biological DMARDs or TNF-antagonists. The SPC also includes information on interactions with other medications, fertility, pregnancy and lactation considerations, effects on driving ability, and undesirable effects ranging from common injection site reactions to rare serious adverse events.

Comparing Imraldi with Other Adalimumab Biosimilars

The adalimumab biosimilar market has expanded significantly in recent years, offering healthcare systems and patients more treatment options. When comparing Imraldi with other adalimumab biosimilars, several factors should be considered including efficacy, safety profile, administration devices, and cost-effectiveness.

Below is a comparison of Imraldi with other available adalimumab biosimilars:

Biosimilar	Manufacturer	Presentation	Citrate-Free
Imraldi	Samsung Bioepis/Biogen	Pre-filled syringe, pre-filled pen	No
Amgevita	Amgen	Pre-filled syringe, pre-filled pen	No
Hyrimoz	Sandoz	Pre-filled syringe, pre-filled pen	No
Hulio	Viatris	Pre-filled syringe, pre-filled pen	No

Clinical studies have demonstrated that Imraldi has comparable efficacy, safety, and immunogenicity to the reference product Humira. A phase III study in rheumatoid arthritis patients showed equivalent ACR20 response rates at week 24. The pharmacokinetic profile, including absorption, distribution, and elimination characteristics documented in the Imraldi SPC, is also comparable to the reference product.

Benefits and Limitations Outlined in Imraldi SPC

The Imraldi SPC details both the benefits and limitations of this adalimumab biosimilar. Key benefits include demonstrated efficacy across multiple inflammatory conditions, with clinical response rates comparable to the reference product. The availability of both pre-filled syringe and pen devices offers flexibility in administration methods based on patient preference and capability.

However, the SPC also clearly outlines important limitations and risks. These include potential serious infections such as tuberculosis, invasive fungal infections, and other opportunistic infections. The SPC notes that treatment should be discontinued if a patient develops a new serious infection until the infection is controlled. There is also an increased risk of lymphomas and other malignancies in patients treated with TNF antagonists like Imraldi, particularly in those with highly active inflammatory disease and/or prolonged exposure to immunosuppressant therapies.

Neurological events, including demyelinating disorders, have been rarely reported with TNF antagonist use. The SPC advises caution when considering Imraldi treatment for patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. According to the European Medicines Agency, healthcare professionals should carefully weigh these potential risks against the expected benefits before initiating treatment and monitor patients closely throughout therapy.

Administration and Storage Guidelines from the SPC

The Imraldi SPC provides detailed instructions for proper administration and storage of the medication. Imraldi is administered via subcutaneous injection, with recommended injection sites including the thigh, abdomen (except the area around the navel), and the outer upper arm. Injection sites should be rotated, and new injections should be given at least 3 cm from previous sites.

Patients may self-inject after proper training in injection technique and with medical follow-up as necessary. The SPC specifies that Imraldi pre-filled syringes and pens should be stored in a refrigerator at 2°C to 8°C and should not be frozen. The pre-filled syringe or pen should be kept in the outer carton to protect from light.

For patient convenience, the SPC notes that a single Imraldi pre-filled syringe or pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The product must be protected from light and discarded if not used within the 14-day period. The Biogen patient support materials include detailed instructions with visual aids to assist patients with proper self-administration techniques. The SPC also addresses special precautions for disposal, noting that any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Conclusion

The Imraldi SPC provides essential guidance for healthcare professionals prescribing this adalimumab biosimilar. As biosimilar medications continue to expand treatment options for inflammatory conditions, understanding the detailed information in the SPC is crucial for optimizing patient outcomes while managing potential risks. Healthcare providers should regularly review the most current version of the Imraldi SPC available from EMA or Biogen to ensure treatment decisions are based on the latest safety and efficacy data. While Imraldi offers a valuable treatment option with demonstrated efficacy comparable to the reference product, careful patient selection, monitoring, and education remain essential components of successful therapy.

Citations

This content was written by AI and reviewed by a human for quality and compliance.