ENHERTU Powder for solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Daiichi Sankyo Inc.

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1. Indications and Usage

ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. ...

2. Dosage and Administration

2.1 Recommended Dosage and Schedules Do not substitute ENHERTU for or with trastuzumab or ado-trastuzumab emtansine. The recommended dosage of ENHERTU is 5.4 mg/kg given as an intravenous infusion ...

3. Dosage Forms and Strengths

For injection: 100 mg of fam-trastuzumab deruxtecan-nxki as a white to yellowish white lyophilized powder in a single-dose vial for reconstitution and further dilution

4. Contraindications

None.

5. Warnings and Precautions

5.1 Interstitial Lung Disease/Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU [see Adverse Reactions ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease / Pneumonitis [see Warnings and Precautions (5.1)] Neutropenia [see ...

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 a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

8.1. Pregnancy

Risk Summary Based on its mechanism of action, ENHERTU can cause fetal harm when administered to a pregnant woman. There are no available data on the use of ENHERTU in pregnant women. In postmarketing ...

8.2. Lactation

Risk Summary There is no data regarding the presence of fam-trastuzumab deruxtecan-nxki in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception Females ENHERTU can cause fetal harm when administered to a pregnant woman ...

8.4. Pediatric Use

Safety and effectiveness of ENHERTU have not been established in pediatric patients.

8.5. Geriatric Use

Of the 234 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 26% were 65 years or older and 5% were 75 years or older. No overall differences in efficacy were observed between patients ...

8.6. Renal Impairment

No dose adjustment of ENHERTU is required in patients with mild (creatinine clearance (CLcr) ≥60 and <90 mL/min) or moderate (CLcr ≥30 and <60 mL/min) renal impairment [see Clinical Pharmacology (12.3)] ...

8.7. Hepatic Impairment

No dose adjustment of ENHERTU is required in patients with mild (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST) or moderate (total bilirubin >1.5 to 3 times ULN ...

11. Description

Fam-trastuzumab deruxtecan-nxki is a HER2-directed antibody and topoisomerase inhibitor conjugate. Fam-trastuzumab deruxtecan-nxki is an antibody-drug conjugate (ADC) composed of three components: 1) a ...

12.1. Mechanism of Action

Fam-trastuzumab deruxtecan-nxki is a HER2-directed antibody-drug conjugate. The antibody is a humanized anti-HER2 IgG1. The small molecule DXd, is a topoisomerase I inhibitor attached to the antibody by ...

12.2. Pharmacodynamics

Cardiac Electrophysiology The administration of multiple doses of ENHERTU (6.4 mg/kg every 3 weeks, which is 1.2 times the recommended dosage) did not show large mean effect (i.e. >20 ms) on the QTc interval ...

12.3. Pharmacokinetics

The pharmacokinetics of fam-trastuzumab deruxtecan-nxki was evaluated in patients with cancer. Following a single dose, exposures (Cmax and AUC) of fam-trastuzumab deruxtecan-nxki and released ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with fam-trastuzumab deruxtecan-nxki. The topoisomerase inhibitor component of fam-trastuzumab deruxtecan-nxki, DXd, was clastogenic in both an in vivo rat ...

14. Clinical Studies

14.1 Metastatic Breast Cancer The efficacy of ENHERTU was evaluated in study DESTINY-Breast01 (NCT03248492), a multicenter, single-arm, trial that enrolled 184 female patients with HER2-positive, unresectable ...

15. References

1 OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16.1. How Supplied

ENHERTU (fam-trastuzumab deruxtecan-nxki) for injection is a white to yellowish white lyophilized powder supplied as: Carton Contents NDC One 100 mg single-dose vial NDC 65597-406-01

16.2. Storage and Handling

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not freeze. Do not shake the reconstituted or diluted solution ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Interstitial Lung Disease: Inform patients of the risks of severe or fatal ILD. Advise patients to contact their ...

BOXED WARNING SECTION

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly ...