Vitigo Cream
Ruxolitinib topical
1.5%
Incepta Pharmaceuticals Ltd.
| Pack size | 10 gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 2200.00 AED |
Indications
Vitigo Cream is used for:
Atopic Dermatitis, Vitiligo
Adult Dose
Atopic Dermatitis
Indicated for topical short-term and noncontinuous long-term treatment of mild-to-moderate atopic dermatitis in nonimmunocompromised adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Apply a thin layer of cream to affected areas BID of up to 20% body surface area;
not to exceed >60 g/week or one 100-gram tube/2 weeks
If signs and symptoms do not improve within 8 weeks, re-examine the patient
Vitiligo
Indicated for topical treatment of nonsegmental vitiligo
Apply a thin layer to affected areas twice daily of up to 10% body surface area; not to exceed >60 g/week or one 100-gram tube/2 weeks
Satisfactory patient response may require treatment for >24 weeks
If no meaningful repigmentation is observed by 24 weeks, re-evaluate the patient
Child Dose
Atopic Dermatitis
Indicated for topical short-term and noncontinuous long-term treatment of mild-to-moderate atopic dermatitis in nonimmunocompromised patients aged ?12 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
<12 years: Safety and efficacy not established
>12 years
Apply thin layer of cream to affected areas twice daily of up to 20% body surface area; not to exceed >60 g/week or one 100-gram tube/2 weeks
Stop using when signs and symptoms (eg, itch, rash, redness) of atopic dermatitis resolve
If signs and symptoms do not improve within 8 weeks, re-examine the patient
Vitiligo
Indicated for topical treatment of nonsegmental vitiligo vitiligo in adolescents aged ?12 years
<12 years: Safety and efficacy not established
>12 years
Apply thin layer to affected areas BID of up to 10% body surface area; not to exceed >60 g/week or one 100-gram tube/2 weeks
Satisfactory patient response may require treatment for >24 weeks
If no meaningful repigmentation observed by 24 weeks, re-evaluate the patient
Renal Dose
Administration
For topical use only
Not for ophthalmic, oral, or intravaginal use
Contra Indications
Precautions
Serious Infections: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Regularly monitor patients for infection and
manage it promptly.
Non-melanoma Skin Cancers. Basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during treatment and
the following treatment as appropriate.
Thrombosis. Thromboembolic events have occurred.
Thrombocytopenia, Anemia, and Neutropenia: Thrombocytopenia, anemia, and neutropenia have occurred. Perform CBC monitoring as clinically
indicated
Pregnancy-Lactation
Lactation
Advise a patient not to breastfeed during treatment with Ruxolitinib and for about four weeks after the last dose
Risk Summary
There are no data on the presence of ruxolitinib in human milk, the effects on the breastfed child, or the effects on milk production. Ruxolitinib was present in the milk of lactating rats.
When a drug is present in animal milk, it is likely that the drug will be present in human milk.
Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with Ruxolitinib and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).
Data
Lactating rats were administered a single dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13 times the maternal plasma AUC.
Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma.
Interactions
Adverse Effects
Side effects of Ruxolitinib topical :
1-10%
Nasopharyngitis (3%)
Bronchitis (1%)
Ear infection (1%)
Eosinophil count increased (1%)
Urticaria (1%)
Diarrhea (1%)
Folliculitis (1%)
Tonsillitis (1%)
Rhinorrhea (1%)
<1%
Neutropenia
Allergic conjunctivitis
Pyrexia
Seasonal allergy
Herpes zoster
Otitis externa
Staphylococcal infection
Acneiform dermatitis
Mechanism of Action
Janus kinase (JAK) pathways inhibitor; JAK consists of a group of intracellular tyrosine kinases that transmit signals from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function, including inflammation associated with atopic dermatitis
JAKs phosphorylate and recruit signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression
JAK inhibitors modulate the JAK signaling pathway, which in turn prevents the phosphorylation and activation of STATs
Note
Vitigo 1.5% Cream manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Ruxolitinib topical. Vitigo is availble in Bangladesh.
Farmaco BD drug index information on Vitigo Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.