TEPEZZA Powder for solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Horizon Therapeutics USA, Inc.

Λέξεις κλειδιά

75987-130

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1. Indications and Usage

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

2. Dosage and Administration

2.1 Recommended Dosing The recommended dose of TEPEZZA is an intravenous infusion of 10 mg/kg for the initial dose followed by an intravenous infusion of 20 mg/kg every three weeks for 7 additional infusions. ...

3. Dosage Forms and Strengths

For injection (intravenous infusion): 500 mg of teprotumumab as a white to off-white lyophilized powder in a single-dose vial for reconstitution and dilution.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Infusion Reactions TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Signs and symptoms of infusion-related reactions ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1)] Exacerbation of Inflammatory Bowel Disease ...

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 ...

6.2. Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. In a placebo-controlled ...

8.1. Pregnancy

Risk Summary Based on findings in animals and its mechanism of action inhibiting insulin-like growth factor 1 receptor (IGF-1R), TEPEZZA may cause fetal harm when administered to a pregnant woman. Adequate ...

8.2. Lactation

Risk Summary There is no information regarding the presence of TEPEZZA in human milk, the effects on the breast-fed infant or the effects on milk production.

8.3. Females and Males of Reproductive Potential

Contraception Females Based on its mechanism of action inhibiting IGF-1R, TEPEZZA may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females ...

8.4. Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

8.5. Geriatric Use

Of the 171 patients in the two randomized trials, 15% were 65 years of age or older; the number of patients 65 years or older was similar between treatment groups. No overall differences in efficacy or ...

10. Overdosage

No information is available for patients who have received an overdosage.

11. Description

Teprotumumab-trbw, an insulin-like growth factor-1 receptor inhibitor (IGF-1R), is a fully human IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO-DG44) cells. It has a molecular weight of ...

12.1. Mechanism of Action

Teprotumumab-trbws mechanism of action in patients with Thyroid Eye Disease has not been fully characterized. Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.

12.2. Pharmacodynamics

No formal pharmacodynamic studies have been conducted with teprotumumab-trbw.

12.3. Pharmacokinetics

The pharmacokinetics of teprotumumab-trbw was described by a two compartment population PK model based on data from 40 patients with Thyroid Eye Disease receiving an initial intravenous infusion of 10 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis The carcinogenic potential of TEPEZZA has not been evaluated in long-term animal studies. Mutagenesis The genotoxic potential of TEPEZZA has not been evaluated. Impairment of Fertility ...

14. Clinical Studies

TEPEZZA was evaluated in 2 randomized, double-masked, placebo-controlled studies in 171 patients with Thyroid Eye Disease: Study 1 (NCT01868997) and Study 2 (NCT03298867). Patients were randomized to receive ...

16.1. How Supplied

TEPEZZA (teprotumumab-trbw) for injection is a sterile, preservative-free, white to off-white lyophilized powder available as follows: Carton containing one 500 mg single-dose vial NDC 75987-130-15 ...

16.2. Storage and Handling

Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton until time of use to protect from light. Do not freeze.

17. Patient Counseling Information

Embryo-Fetal Toxicity: Advise females of reproductive potential that TEPEZZA can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Educate and counsel ...