anzupgo
Anzupgo (Delgocitinib) is a janus kinase inhibitor used to treat Eczema.
Delgocitinib · by Leo Pharma As
Key facts
- Active ingredient
- Delgocitinib
- Drug class
- Janus Kinase Inhibitor
- Form
- Topical
- Strength
- Delgocitinib 2%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- eczema
- Manufacturer
- Leo Pharma As
- FDA application
- NDA219155
What is Anzupgo?
From the FDA label:ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C 16 H 18 N 6 O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula: Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water. Image
How to use
See the full prescribing information for recommended immunizations prior to treatment. ( 2.1 ) Do not use more than 30 grams per 2 weeks or 60 grams per month. Apply twice daily to skin of the affected areas only on the hands and wrists. ( 2.2 ) For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2.2 ) 2.1 Recommended Immunizations Prior to Treatment Initiation Complete any necessary immunizations, including herpes zoster vaccinations, according to current immunization guidelines prior to ANZUPGO treatment [see Warnings and Precautions (5.3) ] . 2.2 Recommended Dosage and Administration Do not use more than 30 grams per 2 weeks or 60 grams per month. Prior to applying ANZUPGO, clean and dry affected areas. Apply a thin layer of ANZUPGO, twice daily, to the affected areas only on the hands and wrists. ANZUPGO is for topical use only. Not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.
Side effects
Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ANZUPGO was evaluated in two randomized, double-blind, multicenter, vehicle-controlled clinical trials (TRIAL 1 and TRIAL 2), in which 959 adults with moderate to severe CHE received ANZUPGO or vehicle cream topically twice daily for 16 weeks. A total of 638 subjects were treated with ANZUPGO [see Clinical Studies (14) ] . In TRIAL 1 and TRIAL 2, adverse reactions that were reported in ≤ 1% of subjects in the ANZUPGO group were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. In an open label extension trial (TRIAL 3), 801 subjects were treated for up to an…
Warnings
Important safety information
Serious Infections : ANZUPGO may increase the risk of infection. Eczema herpeticum was observed in a subject treated topically with ANZUPGO. Avoid use of ANZUPGO in patients with an active or serious infection. If a serious infection develops, discontinue ANZUPGO until the infection resolves. ( 5.1 ) Non-melanoma Skin Cancers: Non-melanoma skin cancers including basal cell carcinoma have been reported in subjects treated with ANZUPGO. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. ( 5.2 ) Immunizations: Avoid vaccination with live vaccines immediately prior to, during, and immediately after ANZUPGO treatment. ( 5.3 ) Potential Risks Related to JAK Inhibition: It is not known whether ANZUPGO may be associated with the observed or potential adverse reactions of JAK inhibition. Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis (RA) patients. ANZUPGO is not approved for use in RA. Treatment with oral and topical JAK inhibitors has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Treatment with oral JAK inhibitors has been associated with hypoglycemia in patients with diabetes. ( 5.4 ) 5.1 Serious Infections ANZUPGO may increase the risk of infections. Eczema herpeticum was observed in a subject treated with ANZUPGO [see Adverse Reactions (6.1) ] . Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving oral or topical JAK inhibitors. [see Adverse Reactions (6.1) ] . Avoid use of ANZUPGO in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating ANZUPGO in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an opportunistic infection with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ANZUPGO. A patient who develops a new infection during treatment with ANZUPGO should undergo prompt and complete diagnostic testing; appropriate antimicrobial therapy should be initiated; and the patient should be closely monitored. Interrupt treatment with ANZUPGO if a patient develops a serious infection. Do not resume ANZUPGO until the infection resolves or is adequately treated. Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with ANZUPGO. If a patient develops herpes zoster, consider interrupting ANZUPGO treatment until the episode resolves. The impact of ANZUPGO on chronic viral hepatitis reactivation is unknown. Patients with active hepatitis B or C infection were excluded from clinical trials with ANZUPGO. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with ANZUPGO. If signs of reactivation occur, consult a hepatitis specialist. ANZUPGO is not recommended for use in patients with active hepatitis B or hepatitis C. 5.2 Non-melanoma Skin Cancers Non-melanoma skin cancers including basal cell carcinoma have been reported in subjects treated with ANZUPGO. Periodic skin examinations of the application sites are recommended for all patients, particularly those with risk factors for skin cancer. Advise patients to avoid sunlamps and minimize exposure to sunlight by wearing sun-protective clothing or using broad-spectrum sunscreen. 5.3 Immunizations Prior to ANZUPGO treatment, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during, and immediately after ANZUPGO treatment. 5.4 Potential Risks Related to JAK Inhibition It is not known whether ANZUPGO may be associated with the observed or potential adverse reactions of JAK inhibition. In a large, randomized, postmarketing safety trial of an oral JAK inhibitor in combination with methotrexate in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events (MACE), overall thrombosis, deep venous thrombosis (DVT), pulmonary embolism (PE), and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. ANZUPGO is not indicated for use in RA. Treatment with oral and topical JAK inhibitors has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Treatment with oral JAK inhibitors has been associated with hypoglycemia in patients with diabetes.
Who should not take Anzupgo
None None. ( 4 )
Drug class
How this class works, per Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach - PMC, NCBI.
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Anzupgo treat?
- Anzupgo (Delgocitinib) may be used to treat eczema, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Anzupgo work?
- Anzupgo is a janus kinase inhibitor. JAK inhibitors block Janus kinase enzymes inside immune cells. These enzymes normally pass along messages from inflammatory signals (cytokines) to relay proteins that switch on genes, so blocking them turns down the overactive immune signaling that drives diseases like rheumatoid arthritis.
- Is there a coupon or discount for Anzupgo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Anzupgo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Anzupgo?
- Anzupgo is marketed by Leo Pharma As. You can see Leo Pharma As's full profile, rating, and other products on pharmaranks.
- Is Anzupgo a brand-name or generic drug?
- Anzupgo is a brand-name product with the active ingredient Delgocitinib.
- Is Anzupgo available over the counter?
- No. Anzupgo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Anzupgo come in?
- Anzupgo is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Anzupgo?
- Anzupgo is classified as janus kinase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Anzupgo FDA-registered?
- Anzupgo is on record with the U.S. FDA under application number NDA219155. You can verify this on its official FDA label.
- Is Anzupgo safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Anzupgo. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Anzupgo?
- Anzupgo's side effects are taken directly from its FDA label. From the label: Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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