Aregen

Uses

Aregen Cream is used for second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

Aregen Cream is not used for use in children less than 2 years of age

Aregen is also used to associated treatment for these conditions: Vitiligo, Intertriginous psoriasis, Mild Atopic dermatitis, Moderate Atopic dermatitis, Refractory Atopic dermatitis

How Aregen works

Aregen binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T cells. Also, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/lgE.

Dosage

Aregen dosage

Apply a thin layer of Aregen Cream, 1% to the affected skin twice daily. The patient should stop using Aregen Cream, 1% when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.

If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis ofatopicdermatitis.

Continuous long-term use of Aregen Cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis

The safety of Aregen Cream, 1% underocclusion, which may promote systemic exposure, has not been evaluated. Avoid use of Aregen Cream, 1% with occlusive dressings.

Side Effects

Common side effects include headache, common cold or stuffy nose, sore throat, cough flu (influenza), fever, viral infection. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Toxicity

Side effects include burning sensation, irritation, pruritus, erythema, and skin infections, at the application site.

Precaution

Avoid use in areas affected by active, cutaneous viral infections. Avoid contact with the eyes and mucous membranes. Immunosuppression may increase risk of lymphoma and other malignancies. Limit exposure to sunlight or other UV light. Mild to moderate sensation of warmth and/or burning may occur at the treatment site within 1-5 days of initiation. Safety of usage beyond 1 yr is not established. Renal or hepatic impairment. Monitor renal, hepatic, cardiac and visual functions, BP, serum glucose and electrolytes regularly. Pregnancy, lactation.

Interaction

Potential interactions between Aregen Cream, 1% and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Food Interaction

Elimination Route

Because of the low systemic absorption of pimecrolimus following topical application the calculation of standard pharmacokinetic measures such as AUC, C_max, half-life, etc. cannot be reliably done.

Elimination Route

80% of the drug is excreted in the feces.

Pregnancy & Breastfeeding use

Pregnancy Category C. There are no adequate and well-controlled studies with Aregen Cream, 1% in pregnant women. Therefore, Aregen Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Contraindication

Aregen Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.

Special Warning

Renal Impairment: Dosage reduction is necessary.

Hepatic Impairment: Dosage reduction is necessary.

Storage Condition

Store Aregen Cream at room temperature between 20° to 25°C. Do not freeze

Innovators Monograph

You find simplified version here Aregen