Telitacicept(注射用泰它西普)

Introduction of Telitacicept

Telitacicept for Injection has a favorable safety profile, with most adverse reactions being mild in severity. Additionally, its convenient once-weekly administration schedule can effectively improve patients' medication compliance.

Indications

In combination with conventional therapy, this product is indicated for adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who still have high disease activity despite conventional treatment (e.g., positive anti-ds-DNA antibodies, hypocomplementemia, and SELENA-SLEDAI score ≥8).

This indication has been granted conditional approval based on the results of a Phase Ⅱ clinical trial in adult patients with systemic lupus erythematosus who still have high disease activity despite conventional treatment. The full approval of this indication will depend on whether confirmatory randomized controlled clinical trials can verify the clinical benefits of this product in this patient population.

Overview

Dosage and Administration

This product should be used under the guidance of a physician experienced in the diagnosis and treatment of systemic lupus erythematosus.

Administration Method

This product is administered via subcutaneous injection, with the abdomen as the injection site.

This product is a lyophilized powder. Reconstitute each vial (80 mg) with 1 ml of sterile water for injection to obtain a solution with a concentration of 80 mg of Telitacicept per ml. For reconstitution, direct the stream of sterile water for injection towards the side wall of the vial and add it slowly along the wall to minimize foam formation. During reconstitution, place the vial at room temperature, rotate it gently for approximately 60 seconds, and then let it stand until the foam subsides. Do not shake the vial. After the drug dissolves, rotate the vial gently again to ensure the solution is thoroughly mixed. Reconstitution is usually completed within 15 minutes after adding sterile water for injection, but may take up to 30 minutes. The reconstituted solution should be a colorless to pale yellow, clear liquid.

Discard the product if visible particles are observed.

Small air bubbles in the reconstituted solution do not affect the use; however, the bubbles should be expelled after drawing the solution into a sterile syringe.

The total time from reconstitution to completion of subcutaneous injection should not exceed 4 hours.

Dosage

The recommended dosage is 160 mg per administration, once weekly.

During the administration of this product, the physician shall fully evaluate the patient's safety and tolerability to decide whether a dosage reduction is necessary. If dosage reduction is required, the dose can be adjusted to 80 mg per administration.

Contraindications

This product is contraindicated in patients with hypersensitivity to telitacicept or any of the excipients contained in this product.

Adverse Reactions

Infections and Infestations

Very common (≥10%): Upper respiratory tract infection.

Common (≥1% to <10%): Urinary tract infection, herpes zoster, pharyngitis, bronchitis, gastroenteritis, conjunctivitis, nasopharyngitis.

General Disorders and Administration Site Conditions

Very common (≥10%): Various injection site reactions.

Common (≥1% to <10%): Fatigue, pyrexia.

Gastrointestinal Disorders

Common (≥1% to <10%): Diarrhea, nausea, toothache, upper abdominal pain, non-infective gingivitis.

Investigations

Common (≥1% to <10%): Decreased immunoglobulin, decreased lymphocyte count.

Skin and Subcutaneous Tissue Disorders

Common (≥1% to <10%): Rash, pruritus.

Musculoskeletal and Connective Tissue Disorders

Common (≥1% to <10%): Arthralgia, back pain, myalgia.

Respiratory, Thoracic and Mediastinal Disorders

Common (≥1% to <10%): Cough.

Nervous System Disorders

Common (≥1% to <10%): Headache, dizziness, hypoesthesia.

Hepatobiliary Disorders

Common (≥1% to <10%): Abnormal liver function.

Psychiatric Disorders

Common (≥1% to <10%): Insomnia.

Use in Special Populations

Pregnant and lactating women

Pregnancy

No studies have been conducted to evaluate the effects of maternal exposure to telitacicept on mothers and newborns in clinical trials, and there are no adequate and well-controlled study data in pregnant women. Therefore, this product is contraindicated during pregnancy unless the potential benefit to the fetus outweighs the risk.

Lactation

It is unknown whether this product is excreted in human milk, as well as the effects of this product on breastfed infants and milk production. A decision should be made whether to discontinue breastfeeding or discontinue the treatment with this product, taking into account the benefits of breastfeeding to the infant and the benefits of the treatment to the mother.

Contraception

Women of childbearing potential should use effective contraceptive measures during treatment with this product and for at least 4 months after the last administration.

Fertility

No studies have been performed to evaluate the effects of this product on human fertility. The impact of this product on male and female fertility is unknown.

Pediatric Use

The safety and effectiveness of this product in pediatric patients and adolescents under 18 years of age have not been established.

Geriatric Use

There are no clinical study data in geriatric patients aged 65 years and older, and the safety and effectiveness of this product in this population cannot be evaluated at present. Therefore, the use of this product is not recommended for geriatric patients.

For more detailed drug information, please consult the official package leaflet.

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