10 Tablets Upadacitinib 15mg Upanib 15 For Adult Patients Active Rheumatoid Arthritis

【Drug Name】
Generic name: Upatinib extended-release tablets

Product name: Ruifu® (English: RINVOQ®)

English name: Upadacitinib Sustained-release Tablets

Chinese Pinyin: Wupatini Huanshipian

【Indications】
atopic dermatitis

This product is suitable for patients with refractory, moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who have not responded well to other systemic treatments (such as hormones or biological agents) or are not suitable for the above treatments.

Limitations of use: Concomitant use of this product with other JAK inhibitors, biological immunomodulators, or other immunosuppressives is not recommended.

Rheumatoid Arthritis

This product is indicated for adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to or are intolerant to one or more TNF inhibitors.

Limitations of use: Concomitant use of this product with other JAK inhibitors, biologic DMARDs, or strong immunosuppressants such as azathioprine and cyclosporine is not recommended.

psoriatic arthritis

This product is indicated for adults with active psoriatic arthritis who have an inadequate response to or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). This product can be used in combination with methotrexate (MTX).

[Dosage of Upatinib]
Upatinib treatment should be initiated by and used under the guidance of a physician with experience in the diagnosis and treatment of indications for this product.

atopic dermatitis

Children 12 years and older weighing ≥40 kg and adults 65 years and younger start with a dose of 15 mg once daily. If response is inadequate, consider increasing dose to 30 mg once daily. If adequate response is not achieved at the 30 mg dose, discontinue this product. The lowest effective dose needed to maintain response should be used. The safety and effectiveness of this product have not been studied in adolescents weighing less than 40 kg.

The recommended dose for adults 65 years and older is 15 mg once daily.

Data are limited in patients aged ≥75 years.

Rheumatoid Arthritis

The recommended dose is 15 mg once daily.

psoriatic arthritis

The recommended dose is 15 mg once daily.

renal impairment

Atopic Dermatitis: No dose adjustment is required in patients with mild or moderate renal impairment. There are limited data on the use of upadatinib in patients with severe renal impairment (see Pharmacokinetics). Upadatinib 15 mg once daily should be used with caution in patients with severe renal impairment. Upadatinib 30 mg once daily is not recommended in patients with severe renal impairment. Upadatinib has not been studied in subjects with end-stage renal disease.

Rheumatoid Arthritis and Psoriatic Arthritis: No dose adjustment is required in patients with mild or moderate renal impairment, upadatinib 15 mg once daily should be used with caution in patients with severe renal impairment.

liver damage

No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment (see Pharmacokinetics). This product should not be used in patients with severe hepatic impairment (Child-Pugh C) (see Contraindications).

[Usage of Upatinib]

This product can be taken with or without food and at any time of day. This product should be swallowed whole and should not be broken, crushed or chewed to ensure a complete dose is given.

Initiate dosing

It is not recommended to initiate treatment in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3, or a hemoglobin level less than 8 g/dL. (See [Precautions] and [Adverse Reactions]).

Suspend dosing

If a patient develops a serious infection, treatment with this product should be suspended until the infection is controlled.

Laboratory abnormalities described in Table 1 may require withholding dosing and management accordingly.

Table 1 Laboratory Inspection and Monitoring Guidelines

Laboratory Inspection Indicators Measures Monitoring Guidelines
Absolute neutrophil count (ANC) If ANC is <1000 cells/mm3, dosing should be suspended until ANC recovers to 1000 cells/mm3 or above, then dosing can be restarted. Assessments were performed at baseline and no later than 12 weeks after initiation of treatment. Thereafter assessment is based on individual patient management.
Absolute Lymphocyte Count (ALC) If ALC is <500 cells/mm3, administration should be suspended until ALC recovers to 500 cells/mm3 or above before administration can be restarted.
Hemoglobin (Hb) If Hb <8 g/dL, administration should be suspended until Hb recovers to 8 g/dL or above, and administration can be restarted.
Liver Aminotransferases If drug-induced hepatic injury is suspected, dosing should be withheld. Assessments should be made at and after baseline in accordance with routine patient management.
Lipids Patients should be managed in accordance with international clinical guidelines for hyperlipidemia. Assess 12 weeks after initiation of treatment and monitor thereafter in accordance with clinical guidelines for hyperlipidemia.
Combined topical treatment (for atopic dermatitis): This product can be used with or without topical corticosteroids. Topical calcineurin inhibitors can be used on sensitive areas such as the face, neck, intertriginous areas, and genitals.

【Adverse reactions】
Laryngitis, viral laryngitis, nasopharyngitis, oropharyngeal pain, pharyngeal abscess, pharyngitis, strep pharyngitis, pharyngeal tonsillitis, respiratory infection, respiratory viral infection, rhinitis, rhinolaryngitis, sinusitis, tonsillitis, bacterial Tonsillitis, upper respiratory tract infection, viral pharyngitis, viral upper respiratory tract infection

Acne and acneiform dermatitis

Genital herpes, genital herpes simplex, dermatitis herpetiformis, ocular herpes, herpes simplex, nasal herpes, ocular herpes simplex, herpes virus infection, oral herpes

Immediate severe allergic reaction, anaphylactic shock, angioedema, systemic exfoliative dermatitis, drug hypersensitivity, eyelid edema, facial edema, hypersensitivity reaction, periorbital swelling, pharyngeal swelling, facial swelling, toxic rash, Type I hypersensitivity reaction, urticaria

Abdominal and epigastric pain

Shingles and chickenpox

[Medicine for pregnant and lactating women]
Women of childbearing age

Women of childbearing potential should be advised to use effective contraception during treatment with upadacitinib and for 4 weeks after the last dose. Female pediatric patients and/or their parents/caregivers should be informed of the need to contact their treating physician should they experience menarche while taking upadatinib.

pregnancy

Data on the use of upadatinib in pregnant women are limited or lacking.

Upadatinib is contraindicated during pregnancy (see Contraindications).

If a patient becomes pregnant while taking upadacitinib, the patient should be informed of the potential harm to the fetus.

breast-feeding

It is unknown whether upadacitinib or its metabolites are excreted in human milk. Existing animal pharmacodynamics/toxicology data indicate that upadatinib is excreted in breast milk (see [Pharmacology and Toxicology]).

Risk to neonates/infants cannot be excluded.

Upadatinib should not be used during breastfeeding. The benefits of breastfeeding to the child and the benefits of this treatment to the mother should be considered when deciding whether to discontinue breastfeeding or discontinue treatment with upadacitinib.

fertility

The effects of upapatinib on human fertility have not been evaluated. Animal studies have not suggested effects on fertility (see [Pharmacology and Toxicology]).

[Medicine for children]
Safety and efficacy in children younger than 12 years with atopic dermatitis are unknown. Data not yet available. Clinical exposure data in adolescents weighing <40 kg are not available (see Pharmacokinetics).

The safety and efficacy of upadatinib in children and adolescents aged 0 to less than 18 years with rheumatoid arthritis and psoriatic arthritis are unknown. Data not yet available.

【Medication for the Elderly】
For atopic dermatitis, doses higher than 15 mg once daily are not recommended in patients 65 years of age and older (see Adverse Reactions).

Data are limited in patients 75 years and older.

【Storage】
Sealed and stored no more than 30℃.