Anzupgo (delgocitinib)

No dosing information is available for this tab.

Delgocitinib is administered topically as a 2% cream. Prior to application, the affected areas should be clean and dry.

Delgocitinib is for topical use only and is not for oral, ophthalmic, or intravaginal use. Patients should avoid contact with the eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, the area should be rinsed thoroughly with water.

Store delgocitinib cream at 20--25degreesC; excursions permitted between 15--30degreesC. Do not freeze.

No dosing information is available for this tab.

Drug interaction studies with delgocitinib have not been performed.

Delgocitinib does not inhibit or induce cytochrome P-450 (CYP) enzymes or inhibit transporter systems such as P-glycoprotein (P-gp), breast cancer resistance protein (BRCP), organic anion transporter polypeptide (OATP), organic anion transporters (OAT), organic cation transporters (OCT), or multidrug and toxin extrusion (MATE) at clinically relevant concentrations.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

• Herpes zoster
• Inactive tuberculosis
• Infection
• Opportunistic fungal infection
• Opportunistic viral infection
• Viral hepatitis B
• Viral hepatitis C

• Basal cell carcinoma of skin
• Squamous cell carcinoma

The most common adverse effects of delgocitinib cream (<=1% of patients) are application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia.

Less Frequent

• Hypoglycemic disorder

Less Frequent

• Application site skin reactions
• Bacterial skin and skin structure infection
• Erythema
• Leukopenia
• Neutropenic disorder
• Paresthesia
• Pruritus of skin

No enhanced messaging available.

The safety and efficacy of delgocitinib have not been established in pediatric patients.

There is insufficient evidence with delgocitinib in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

In animal reproduction studies, oral administration of delgocitinib to pregnant rats and rabbits during the period of organogenesis did not result in adverse developmental effects at doses 120 or 193 times, respectively, the maximum recommended human dose (MRHD) based on AUC comparison. In embryofetal development studies, delgocitinib was administered during the period of organogenesis at dosages of 3, 10, and 30 mg/kg per day in pregnant rats and 1, 3, and 10 mg/kg per day in rabbits. In rats, no maternal toxicity was noted at dosages up to 30 mg/kg per day (1446 times the MRHD based on AUC comparison). Decreases in fetal weight and skeletal variations were observed at dosages >=10 mg/kg per day (512 times the MRHD based on AUC comparison). An increase in post-implantation loss was observed at 30 mg/kg per day (1446 times the MRHD based on AUC comparison). No embryofetal toxicity was noted at dosages of 3 mg/kg per day. In rabbits, no significant maternal toxicity was noted at dosages up to 10 mg/kg per day (992 times the MRHD based on AUC comparison). An increase in post-implantation loss, reduced number of live fetuses, and decrease in fetal weights were observed at 10 mg/kg per day (992 times the MRHD based on AUC comparison). No embryofetal toxicity was noted at 3 mg/kg per day.

There are no data on the presence of delgocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. After oral administration, delgocitinib was present in the milk of lactating rats. When a drug is present in animal milk, it is likely that to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for delgocitinib and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. To minimize potential infant exposure, advise breastfeeding women to avoid direct contact with the nipple and surrounding area immediately after applying delgocitinib to the hands and/or wrists.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Of the 691 subjects exposed to delgocitinib in clinical trials, 59 subjects (8.5%) were >=65 years of age and 10 subjects (1.4%) were >=75 years of age. No overall differences in safety or effectiveness were observed between subjects >=65 years of age and younger adult subjects.