Rofusis Cream
Roflumilast topical
0.3%
Opsonin Pharma Limited
| Pack size | 30 gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 250.00 AED |
Indications
Rofusis Cream is used for:
Plaque psoriasis
Adult Dose
Topical
Plaque Psoriasis
Indicated for plaque psoriasis, including intertriginous areas
Apply once daily to affected areas and rub in completely
Hepatic impairment
Contraindicated with moderate-to-severe impairment (Child-Pugh B or C)
No studies were conducted with topical roflumilast in patients with hepatic impairment; however, oral roflumilast 250 mcg/day for 14 days was studied in mild-to-moderate hepatic impairment (Child-Pugh A and B)
AUC of roflumilast and roflumilast N-oxide were increased by 51% and 24%, respectively, in Child-Pugh A and by 92% and 41%, respectively, in Child-Pugh B, as compared to age-, weight-, and gender-matched healthy individuals
Peak plasma concentration of roflumilast and roflumilast N-oxide were increased by 3% and 26%, respectively, in Child-Pugh A and by 26% and 40%, respectively, in Child-Pugh B, as compared to healthy individuals
Child Dose
Topical
Plaque Psoriasis
Indicated for plaque psoriasis, including intertriginous areas, in patients aged >12 years
<12 years: Safety and efficacy not established
>12 years
Apply once daily to affected areas and rub in completely
Hepatic impairment
Contraindicated with moderate-to-severe impairment (Child-Pugh B or C)
No studies were conducted with topical roflumilast in patients with hepatic impairment; however, oral roflumilast 250 mcg/day for 14 days was studied in mild-to-moderate hepatic impairment (Child-Pugh A and B)
AUC of roflumilast and roflumilast N-oxide were increased by 51% and 24%, respectively, in Child-Pugh A and by 92% and 41%, respectively, in Child-Pugh B, as compared to age-, weight-, and gender-matched healthy individuals
Peak plasma concentration of roflumilast and roflumilast N-oxide were increased by 3% and 26%, respectively, in Child-Pugh A and by 26% and 40%, respectively, in Child-Pugh B, as compared to healthy individuals
Renal Dose
Administration
For topical use only
Not for ophthalmic, oral, or intravaginal use
Wash hands after application, unless application is for treatment of hands
Contra Indications
Moderate-to-severe liver impairment (Child-Pugh B or C)
Precautions
Hepatic impairment
Contraindicated with moderate-to-severe impairment (Child-Pugh B or C)
Pregnancy-Lactation
Pregnancy
There are no randomized clinical trials of oral or topical roflumilast in pregnant females
Animal studies
Oral administration to pregnant rats and rabbits during organogenesis produced no fetal structural abnormalities at doses up to 9 and 8 times the maximum recommended human dose (MRHD), respectively
Roflumilast induced post-implantation loss in rats at oral doses >3x MRHD
Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 5x and 15x MRHD, respectively
Shown to adversely affect pup post-natal development when dams were treated with oral dose 15x MRHD during pregnancy and lactation periods in mice
Clinical considerations
Do not use during labor and delivery
There are no human studies that have investigated effects on preterm labor or labor at term; however, animal studies showed roflumilast PO disrupted labor and delivery process in mice
Lactation
Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production
Roflumilast and/or its metabolites are excreted into the milk of lactating rats; when a drug is present in animal milk, it is likely that to be present in human milk
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for treatment and any potential adverse effects on the breastfed infant
Clinical considerations
Minimize potential exposure to breastfeeding infants via breast milk by applying to smallest area of skin and for the shortest duration possible
Advise breastfeeding women not to apply cream directly to the nipple and areola to avoid direct infant exposure
Interactions
Coadministration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (eg, erythromycin, ketoconazole, fluvoxamine, cimetidine) may increase roflumilast systemic exposure.
Coadministration of roflumilast with oral contraceptives containing ethinyl estradiol may increase roflumilast systemic exposure.
Adverse Effects
Side effects of Roflumilast topical :
-10%
Diarrhea (3.1%)
Headache (2.4%)
Insomnia (1.4%)
Nausea (1.2%)
Application site pain (1%)
Upper respiratory tract infection (1%)
Urinary tract infection (1%)
Mechanism of Action
Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of phosphodiesterase (PDE)-4
Inhibition of PDE4 (a major cyclic 3′,5′-adenosine monophosphate (cyclic AMP) metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP
Specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined
Note
Rofusis 0.3% Cream manufactured by Opsonin Pharma Limited. Its generic name is Roflumilast topical. Rofusis is availble in Bangladesh.
Farmaco BD drug index information on Rofusis Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.