GNH USA

Europe — EMA

Imraldi

GNH USA supplies Imraldi (Adalimumab), a TNF‑alpha inhibitor for rheumatoid arthritis, psoriatic arthritis and related inflammatory diseases.

Adalimumab

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What is Adalimumab?

Adalimumab, the active ingredient in Imraldi, is a TNF‑alpha inhibitor presented as a 40 mg solution for injection for subcutaneous use. It treats autoimmune inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and non‑infectious uveitis in adult patients.

GNH USA supplies Imraldi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Adalimumab used for?

Imraldi is a biologic DMARD that modulates the TNF‑alpha pathway in several chronic inflammatory diseases. - Rheumatoid arthritis: reduces joint pain, swelling and structural damage. - Psoriatic arthritis: improves skin lesions and joint symptoms. - Ankylosing spondylitis: alleviates spinal inflammation and stiffness. - Plaque psoriasis: clears plaques and reduces scaling. - Crohn's disease: induces and maintains remission of intestinal inflammation. - Ulcerative colitis: helps achieve clinical remission and mucosal healing.

What are the side effects of Adalimumab?

Adalimumab may cause a range of adverse reactions, from mild to severe.

Common Side Effects: - Injection site reactions: redness, swelling or pain at the injection site. - Upper respiratory infections: nasopharyngitis, sinusitis. - Headache: mild to moderate intensity. - Nausea: occasional gastrointestinal upset. - Rash: mild skin eruptions.

Serious or Rare Side Effects: - Serious infections: tuberculosis, bacterial, fungal or viral infections. - Malignancies: lymphoma, skin cancers. - Hepatic injury: elevated liver enzymes or hepatitis. - Demyelinating disorders: multiple sclerosis‑like symptoms. - Heart failure exacerbation: worsening of existing cardiac failure.

What precautions apply to Adalimumab?

Before initiating therapy, patients should be evaluated for infection risk and baseline laboratory values. - Screen for latent TB: perform tuberculin skin test or interferon‑gamma release assay. - Monitor for infections: report fever, cough, or unexplained malaise promptly. - Assess liver function: periodic testing of ALT, AST and bilirubin. - Evaluate cardiac status: avoid in uncontrolled heart failure. - Store at 2‑8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Adalimumab interact with?

Adalimumab can interact with other immunomodulatory agents and vaccines.

Major Interactions (Avoid): - Live vaccines: may cause disseminated infection; avoid concurrent administration. - Antifungal agents (e.g., azoles) used for systemic infections: may increase infection risk.

Moderate Interactions (Monitor Closely): - Other biologics (e.g., abatacept, rituximab): increased immunosuppression. - Immunosuppressants (e.g., methotrexate, azathioprine): monitor for additive infection risk. - Cytochrome P450 substrates: may require dose adjustment due to cytokine‑mediated enzyme changes.

Frequently asked questions

What conditions is Imraldi used to treat?+
Imraldi is indicated for several chronic inflammatory disorders, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and non‑infectious uveitis. It works by reducing the inflammatory activity driven by tumor necrosis factor‑alpha.
How does adalimumab work in the body?+
Adalimumab is a monoclonal antibody that specifically binds to both soluble and membrane‑bound TNF‑α. By neutralising this cytokine, it blocks the cascade of inflammatory signals that lead to tissue damage, thereby decreasing pain, swelling and disease progression in affected organs.
What is the usual dose of Imraldi?+
The dosing regimen for Imraldi is determined by the prescribing clinician based on the patient’s condition, weight, and response to therapy. Healthcare professionals follow approved guidelines and adjust the dose as needed; patients should follow the prescriber’s instructions exactly.
Is Imraldi safe to use during pregnancy or breastfeeding?+
The safety of adalimumab in pregnancy and lactation has not been fully established. It is classified as pregnancy category unknown, and clinicians weigh potential benefits against risks. Women who are pregnant, planning pregnancy, or breastfeeding should discuss treatment options with their healthcare provider.
How do I order Imraldi from GNH USA?+
To request Imraldi, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, cold‑chain shipping details and necessary import documentation.
How does Imraldi compare with other TNF‑alpha inhibitors?+
Imraldi contains the same active molecule, adalimumab, as other branded products like Humira. Clinical efficacy and safety are comparable, while differences may exist in formulation, packaging, and pricing. Choice of product often depends on supply chain considerations, regulatory approvals and institutional contracts.
What are the storage requirements for Imraldi?+
Imraldi must be stored refrigerated between 2 °C and 8 °C. Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking. If a temperature excursion occurs, consult the product’s stability guidelines before use.
How is Imraldi administered?+
Imraldi is supplied as a 40 mg solution for subcutaneous injection. The patient or a healthcare professional injects the dose under the skin, typically in the abdomen, thigh or upper arm, following aseptic technique and the prescriber’s dosing schedule.
What are the most serious risks associated with Imraldi?+
Serious risks include severe infections such as tuberculosis or opportunistic fungal infections, possible development of malignancies (e.g., lymphoma, skin cancer), worsening heart failure, and rare demyelinating disorders. Patients should be monitored regularly for signs of infection, malignancy and cardiac symptoms.
Who should not use Imraldi?+
Imraldi is contraindicated in patients with known hypersensitivity to adalimumab or any excipients, and in those with active serious infections. Caution is advised for individuals with uncontrolled heart failure, demyelinating disease, or a history of malignancy. The prescriber must evaluate each patient’s medical history before initiating therapy.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Adalimumab
Route
Subcutaneous Use
Manufacturer
Samsung Bioepis Nl B.V.
Origin
EU

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