SAFETY

Jump To Section:

DATROWAY has serious Warnings and Precautions. Click here for more information.

Common adverse reactions in TROPION-Breast02¹

Most ARs were Grade 1 or 2

ARs in ≥10% of patients, %		DATROWAY (n=319)		Chemotherapy (n=309)
ARs in ≥10% of patients, %		All Grades	Grades 3 or 4	All Grades	Grades 3 or 4
Gastrointestinal disorders	Stomatitis*	63	8	14	0.3
	Nausea	48	0.6	22	0.6
	Constipation	40	0.3	17	0
	Vomiting	23	1.6	11	0.6
Skin and subcutaneous tissue disorders	Alopecia	43	0	35	0.3
	Rash^†	16	0.6	10	0.3
	Skin hyperpigment-ation^‡	10	0	0.3	0
General disorders	Fatigue*	36	2.8	32	2.9
Eye disorders	Keratitis^§	26	6	2.8	0.3
Eye disorders	Dry eye	26	1.3	4.9	0
Musculoskeletal and connective tissue disorders	Musculoskeletal pain*	22	0.6	22	1.3
Respiratory, thoracic, and mediastinal disorders	Cough*	19	0	14	0
Metabolism and nutrition disorders	Decreased appetite	19	0.6	8	0.3

ARs in ≥10% of patients, %	DATROWAY (n=319)		Chemotherapy (n=309)
ARs in ≥10% of patients, %	All Grades	Grades 3 or 4	All Grades	Grades 3 or 4
Gastrointestinal disorders
Stomatitis*	63	8	14	0.3
Nausea	48	0.6	22	0.6
Constipation	40	0.3	17	0
Vomiting	23	1.6	11	0.6
Skin and subcutaneous tissue disorders
Alopecia	43	0	35	0.3
Rash^†	16	0.6	10	0.3
Skin hyperpigment-ation^‡	10	0	0.3	0
General disorders
Fatigue*	36	2.8	32	2.9
Eye disorders
Keratitis^§	26	6	2.8	0.3
Dry eye	26	1.3	4.9	0
Musculoskeletal and connective tissue disorders
Musculoskele-tal pain*	22	0.6	22	1.3
Respiratory, thoracic, and mediastinal disorders
Cough*	19	0	14	0
Metabolism and nutrition disorders
Decreased appetite	19	0.6	8	0.3

Events were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.¹

*Includes other related terms.¹

^†Includes rash, erythematous rash, maculo-papular rash, pruritic rash.¹

^‡Includes pigmentation disorder, skin discoloration, skin hyperpigmentation.¹

^§Includes corneal disorder, corneal epithelium defect, corneal erosion, corneal exfoliation, corneal lesion, corneal toxicity, injury corneal, keratitis, keratopathy, punctate keratitis, ulcerative keratitis.¹

Dosage modifications with DATROWAY due to ARs¹

4.7_% discontinuation rate

35_% dosage interruptions

28_% dose reductions

Rates of Grade ≥3 TRAEs and duration of treatment^1,2

DATROWAY:

33% Grade ≥3 TRAEs

8.5 months median treatment duration

Chemotherapy:

29% Grade ≥3 TRAEs

4.1 months median treatment duration

Rates of Grade ≥3 neutropenia and G-CSF use^1,3

3.5% Grade ≥3 neutropenia
7.1% G-CSF use

TRAEs refer to adverse events possibly related to treatment as assessed by the investigator. Adverse reactions refer to the adverse events which have a likely basis for a causal relationship between the drug and the occurrence of the adverse event.^4,5

Warnings and Precautions¹

The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 1365 patients from TROPION-Breast02 and other clinical trials.

ILD/pneumonitis (unresectable or metastatic breast cancer)^¶

DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. In the pooled safety population of 841 patients with breast cancer from TROPION-Breast01, TROPION-Breast02, TROPION-PanTumor01, and TROPION-PanTumor02, ILD/pneumonitis occurred in 3% of patients treated with DATROWAY, including 0.4% of patients with Grade 3. There were two fatal cases (0.2%). The median time to onset was 5.3 months (range: 1.1-19.3 months) with a median duration of 1.2 months (range: 0.3-5.2 months). Eight patients (1%) had DATROWAY withheld and 10 patients (1.2%) permanently discontinued due to ILD/pneumonitis. Systemic corticosteroids were required in 64% (16/25) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 40% of patients

Ocular adverse reactions (unresectable or metastatic breast cancer and other solid tumors)

DATROWAY can cause ocular ARs including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision
In the pooled safety population, ocular ARs occurred in 38% of patients treated with DATROWAY. Forty-two patients (3.1%) experienced Grade 3 ocular ARs, which included keratitis and dry eye, and 4 patients (0.3%) experienced a Grade 4 ocular AR of keratitis, corneal epithelium defect, corneal lesion, and conjunctival hemorrhage. The most common (≥5%) ocular ARs were dry eye (18%), keratitis (16%), increased lacrimation (6%), and conjunctivitis (5%). The median time to onset was 2.3 months (range: 0.03-30 months) with a median duration of 2.3 months (range: 0.03-19.5 months). Of the patients who experienced ocular ARs, 39% had complete resolution, and 8% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow-up). Ocular ARs led to dosage interruption in 4.3%, dosage reductions in 2.8%, and permanent discontinuation in 0.9% of patients

Stomatitis (unresectable or metastatic breast cancer and other solid tumors)

DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis
In the pooled safety population, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to onset was 0.5 months (range: 0.03-19.8 months) with a median duration of 1.1 months (range: 0.03-33.2 months). Stomatitis led to dosage interruption in 5%, dosage reductions in 11%, and permanent discontinuation in 0.4% of patients

Embryo-fetal toxicity

DATROWAY can cause embryo-fetal harm

^¶ A higher incidence of ILD/pneumonitis has been observed in patients with creatinine clearance (CLcr) 30 to <90 mL/min (estimated by Cockcroft Gault).¹

Additional safety data for DATROWAY¹
The safety of DATROWAY was evaluated in 319 patients with triple-negative breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast02.

Median duration of treatment

8.5 months (range: 0.7-38 months)

Serious adverse reactions (>1% of patients)

Pneumonia (2.2%), vomiting (1.9%), COVID-19 (1.6%), and anemia (1.3%). Fatal adverse reaction occurred in one patient (0.3%) and was due to ILD/pneumonitis

Adverse reactions associated with discontinuation and dose modifications

Discontinuation (>0.5% of patients) included ILD/pneumonitis (0.9%) and keratitis (0.9%)

Dosage interruption (>1% of patients) included stomatitis (5%), increased amylase (4.1%), keratitis (3.4%), neutropenia (3.1%), COVID-19 (2.8%), pneumonia (2.2%), dry eye (1.9%), upper respiratory tract infection (1.6%), anemia (1.3%), leukopenia (1.3%), IRR (1.3%), and ILD/pneumonitis (1.3%)

Dose reduction (>1% of patients) included stomatitis (11%), keratitis (4.1%), fatigue (3.8%), increased amylase (2.8%), and pneumonia (1.3%)

Other clinically relevant adverse reactions in <10% of patients

Infusion-related reactions, including anaphylactic reaction, diarrhea, conjunctivitis, lacrimation increased, dry mouth, dry skin, pruritus, rhinorrhea, blepharitis, meibomian gland dysfunction, blurred vision, ILD/pneumonitis, visual impairment, photophobia, and madarosis

Select TRAEs in TROPION-Breast02^2,3,6,7

The majority of select TRAEs with DATROWAY were Grade 1 or 2^2,6

Select TRAEs, %	DATROWAY (n=319)				Chemotherapy (n=309)
Select TRAEs, %	Grade 1	Grade 2	Grade ≥3	Discontinuation rate	Grade 1	Grade 2	Grade ≥3	Discontinuation rate
Oral mucositis/ stomatitis*	24	27	8	0	7	3	0	0
Keratitis	7	4	2	<1	<1	0	0	0
Dry eye	16	7	1	0	2	1	0	0
Adjudicated drug-related ILD^†‡	<1	2	<1	<1	<1	<1	0	<1
Alopecia	26	14	NA	0	15	16	NA	0

Select TRAEs, %	DATROWAY (n=319)
Select TRAEs, %	Grade 1	Grade 2	Grade ≥3	Discontinuation rate
Oral mucositis/stomatitis*	24	27	8	0
Keratitis	7	4	2	<1
Dry eye	16	7	1	0
Adjudicated drug-related ILD^†‡	<1	2	<1	<1
Alopecia	26	14	NA	0

Select TRAEs, %	Chemotherapy (n=309)
Select TRAEs, %	Grade 1	Grade 2	Grade ≥3	Discontinuation rate
Oral mucositis/stomatitis*	7	3	0	0
Keratitis	<1	0	0	0
Dry eye	2	1	0	0
Adjudicated drug-related ILD^†‡	<1	<1	0	<1
Alopecia	15	16	NA	0

TRAEs refer to adverse events possibly related to treatment as assessed by the investigator.⁵

*Includes aphthous ulcer, mouth ulceration, oral pain, oropharyngeal pain, pharyngeal inflammation, and stomatitis.⁶

^†Includes pneumonitis⁶

^‡One patient had an adjudicated drug-related Grade 5 ILD event with DATROWAY.⁶

51% used a steroid-containing mouthwash for management or prophylaxis of stomatitis at any time during treatment with DATROWAY¹

Defining Grade 1 to 2 select adverse reactions
Oral mucositis/stomatitis^1,7§

Grade 1: Asymptomatic or mild symptoms

Grade 2: Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated

Keratitis^1,7§

Grade 1: Asymptomatic; clinical or diagnostic observations only

Grade 2: Symptomatic; moderate decrease in visual acuity^||

Dry eye^7¶

Grade 1: Asymptomatic; clinical or diagnostic observations only; symptoms relieved by lubricants

Grade 2: Symptomatic; moderate decrease in visual acuity^||

Adjudicated drug-related ILD^1,7§

Grade 1: Asymptomatic; consider corticosteroid treatment

Grade 2: Symptomatic; promptly initiate corticosteroid treatment; limiting instrumental activities of daily living

Alopecia^7¶

Grade 1: Hair loss of <50%^#

Grade 2: Hair loss of ≥50% normal for individual; readily apparent to others**

^§Grades are based on both the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and the full Prescribing Information for DATROWAY.

^||Best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline.⁷

^¶Grades are based on NCI CTCAE version 5.0.⁷

^#A different hair style may be required to cover the hair loss but does not require a wig or hairpiece to camouflage.⁷

**A wig or hairpiece is necessary if the patient desires to completely camouflage the hair loss; associated with psychological impact.⁷

Grades shown here do not encompass all grades included in NCI CTCAE. Please refer to guidance on DATROWAY dosing modifications and adverse reaction management.

See additional guidance for select adverse reactions

Select laboratory abnormalities in TROPION-Breast02¹

The majority of select laboratory abnormalities were Grade 1 or 2

Select laboratory abnormalities (≥20%), %		DATROWAY*		Chemotherapy*
Select laboratory abnormalities (≥20%), %		All Grades	Grades 3 or 4	All Grades	Grades 3 or 4
Hematology	Decreased hemoglobin	43	3.8	63	6
	Decreased white blood cells	41	0.9	58	10
	Decreased lymphocytes	36	6	46	7
	Decreased neutrophils	35	3.5	48	14
Chemistry	Increased amylase	54	38	8	0
	Decreased calcium	39	1.9	44	1
	Increased ALT	28	1.6	26	1.3
	Increased AST	27	1.6	26	1.3
	Decreased albumin	25	1	20	0.3
	Decreased sodium	21	3.5	18	2.7
	Increased blood alkaline phosphatase	20	0.3	15	0

Select laboratory abnormalities (≥20%), %	DATROWAY *		Chemotherapy *
Select laboratory abnormalities (≥20%), %	All Grades	Grades 3 or 4	All Grades	Grades 3 or 4
Hematology
Decreased hemoglobin	43	3.8	63	6
Decreased white blood cells	41	0.9	58	10
Decreased lymphocytes	36	6	46	7
Decreased neutrophils	35	3.5	48	14
Chemistry
Increased amylase	54	38	8	0
Decreased calcium	39	1.9	44	1
Increased ALT	28	1.6	26	1.3
Increased AST	27	1.6	26	1.3
Decreased albumin	25	1	20	0.3
Decreased sodium	21	3.5	18	2.7
Increased blood alkaline phosphatase	20	0.3	15	0

Frequencies were based on NCI CTCAE version 5.0 grade-derived laboratory abnormalities.¹

*The denominator used to calculate the rate varied from 235 to 317 based on the number of patients with a baseline value and at least one post-treatment value.¹

ADC, antibody-drug conjugate; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; G-CSF, granulocyte colony-stimulating factor; ILD, interstitial lung disease; IRR, infusion-related reaction; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q3W, once every 3 weeks; TRAE, treatment-related adverse event; Trop-2, trophoblast cell surface antigen 2.

WARNING: INTERSTITIAL LUNG DISEASE AND EMBRYO-FETAL TOXICITY

Severe and fatal cases of ILD/pneumonitis have been reported with DATROWAY. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
Exposure to DATROWAY during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease/Pneumonitis

DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.

Unresectable or Metastatic Breast Cancer

In the pooled safety population of 841 patients with breast cancer from TROPION-Breast01, TROPION-Breast02, TROPION-PanTumor01 and TROPION-PanTumor02, ILD/pneumonitis occurred in 3.0% of patients treated with DATROWAY, including 0.4% of patients with Grade 3. There were two fatal cases (0.2%). The median time to first onset for ILD was 5.3 months (range: 1.1 months to 19.3 months) and with a median duration of 1.2 months (range: 0.3 months to 5.2 months). Eight patients (1.0%) had DATROWAY withheld and 10 patients (1.2%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 64% (16/25) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 40% of patients.

Patients were excluded from clinical studies for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis.

Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if ≥Grade 2 ILD/pneumonitis is confirmed.

Ocular Adverse Reactions

DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision.

In patients with unresectable or metastatic breast cancer and other solid tumors, ocular adverse reactions occurred in 38% of patients treated with DATROWAY. Forty-two patients (3.1%) experienced Grade 3 ocular adverse reactions, which included keratitis and dry eye, and four patients (0.3%) experienced a Grade 4 ocular adverse reaction of keratitis, corneal epithelium defect, corneal lesion, and conjunctival hemorrhage. The most common (≥5%) ocular adverse reactions were dry eye (18%), keratitis (16%), increased lacrimation (6%), and conjunctivitis (5%). The median time to first onset for ocular adverse reactions was 2.3 months (range: 0.03 months to 30 months) and with a median duration of 2.3 months (range: 0.03 months to 19.5 months). Of the patients who experienced ocular adverse reactions, 39% had complete resolution, and 8% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to dosage interruption in 4.3% of patients, dosage reductions in 2.8% of patients, and permanent discontinuation of DATROWAY in 0.9% of patients.

Patients with clinically significant corneal disease were excluded from clinical studies.

Advise patients to use preservative-free lubricant eye drops at least four times daily and as needed for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, at end of treatment, and as clinically indicated. While on treatment, conduct visual acuity testing and slit lamp examination every 3 cycles.

Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, withhold, reduce the dose, or permanently discontinue DATROWAY based on severity.

Stomatitis

DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis.

In patients with unresectable or metastatic breast cancer and other solid tumors, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to first onset of stomatitis was 0.5 months (range: 0.03 months to 19.8 months) and with a median duration of 1.1 months (range: 0.03 months to 33.2 months). Stomatitis led to dosage interruption in 5% of patients, dosage reductions in 11% of patients, and permanent discontinuation of DATROWAY in 0.4% of patients.

In patients who received DATROWAY in TROPION-Breast01 and TROPION-Breast02, 39% and 51% respectively used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during the treatment.

Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY.

Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue DATROWAY.

Embryo-Fetal Toxicity

Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells.

Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose.

ADVERSE REACTIONS

Unresectable or Metastatic Breast Cancer and Other Solid Tumors

The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY as a single agent at 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in 1365 patients in TROPION-Breast01, TROPION-Breast02, TROPION-PanTumor01, TROPION-PanTumor02 and other clinical trials. Among the 1365 patients who received DATROWAY, 48% were exposed for greater than 6 months and 22% were exposed for greater than one year. In this pooled safety population, the most common (≥20%) adverse reactions were stomatitis (63%), nausea (51%), fatigue (42%), alopecia (38%), constipation (30%), vomiting (23%), decreased appetite (22%), and rash (20%). In this pooled safety population, the most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (8%), decreased hemoglobin (3.7%), decreased sodium (3.0%), and decreased blood potassium (2.3%).

Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)
TROPION-Breast02

The safety of DATROWAY was evaluated in 319 patients with triple-negative breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast02. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 8.5 months (range: 0.7 months to 38.0 months) for patients who received DATROWAY.

Serious adverse reactions occurred in 17% of patients who received DATROWAY. Serious adverse reactions in >1% of patients who received DATROWAY were pneumonia (2.2%), vomiting (1.9%), COVID-19 (1.6%), and anemia (1.3%). Fatal adverse reactions occurred in one patient (0.3%) who received DATROWAY and was due to ILD/pneumonitis.

Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 4.7% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD/pneumonitis (0.9%) and keratitis (0.9%).

Dosage interruptions of DATROWAY due to an adverse reaction occurred in 35% of patients. Adverse reactions which required dosage interruption in >1% of patients included stomatitis (5%), increased amylase (4.1%), keratitis (3.4%), neutropenia (3.1%), COVID-19 (2.8%), pneumonia (2.2%), dry eye (1.9%), upper respiratory tract infection (1.6%), anemia (1.3%), leukopenia (1.3%), IRR (1.3%), and ILD/pneumonitis (1.3%).

Dose reductions of DATROWAY due to an adverse reaction occurred in 28% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (11%), keratitis (4.1%), fatigue (3.8%), increased amylase (2.8%), and pneumonia (1.3%).

The most common (≥20%) adverse reactions, including laboratory abnormalities in patients receiving DATROWAY, were stomatitis (63%), increased amylase (54%), nausea (48%), alopecia (43%), decreased hemoglobin (43%), decreased white blood cells (41%), constipation (40%), decreased calcium (39%), decreased lymphocytes (36%), fatigue (36%), decreased neutrophils (35%), increased ALT (28%), increased AST (27%), dry eye (26%), keratitis (26%), decreased albumin (25%), vomiting (23%), musculoskeletal pain (22%), decreased sodium (21%), and increased blood alkaline phosphatase (20%).

Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions including anaphylactic reaction, diarrhea, conjunctivitis, lacrimation increased, dry mouth, dry skin, pruritus, rhinorrhea, blepharitis, meibomian gland dysfunction, blurred vision, ILD/pneumonitis, visual impairment, photophobia, and madarosis.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus.
Lactation: There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose.
Females and Males of Reproductive Potential: Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiation of DATROWAY Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Males: Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. Infertility: Based on findings in animal toxicity studies, DATROWAY may impair male and female reproductive function and fertility. The effects on reproductive organs in animals were irreversible.
Pediatric Use: Safety and effectiveness of DATROWAY have not been established in pediatric patients.
Geriatric Use: Of the 841 patients with breast cancer in TROPION-Breast01, TROPION-Breast02, TROPION-PanTumor01, and TROPION-PanTumor02 treated with DATROWAY 6 mg/kg, 23% were ≥65 years of age and 4.5% were ≥75 years of age. Grade ≥3 and serious adverse reactions were more common in patients ≥65 years (45% and 22%, respectively) compared to patients <65 years (38% and 16%, respectively). No other meaningful differences in efficacy and safety were observed between patients ≥65 years of age versus younger patients.
Renal Impairment: Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. A higher incidence of ILD/pneumonitis has been observed in patients with creatinine clearance (CLcr) 30 to <90 mL/min (estimated by Cockcroft Gault). No dosage adjustment is recommended in patients with CLcr 30 to <90 mL/min. The pharmacokinetics of datopotamab deruxtecan-dlnk or DXd in patients with CLcr <30 mL/min is unknown.
Hepatic Impairment: Monitor patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST) for increased adverse reactions. Limited data are available in patients with moderate hepatic impairment. No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST). The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

INDICATION

DATROWAY^® (datopotamab deruxtecan-dlnk) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Please see Prescribing Information and Medication Guide for additional Important Safety Information.

INDICATION

Common adverse reactions in TROPION-Breast021

Most ARs were Grade 1 or 2

Dosage modifications with DATROWAY due to ARs1

Rates of Grade ≥3 TRAEs and duration of treatment1,2

Rates of Grade ≥3 neutropenia and G-CSF use1,3

Select TRAEs in TROPION-Breast022,3,6,7

The majority of select TRAEs with DATROWAY were Grade 1 or 22,6

Select laboratory abnormalities in TROPION-Breast021