Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Training > Package Insert > Flashcards

Package Insert Flashcards

1
Q

What type of approval do mBC have for enhertu?

A

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What type of breast cancer patients is enhertu approved for?

A

ENHERTU is indicated for the treatment of:

  1. adult patients
  2. Unresectable or metastatic HER2-positive breast cancer
  3. who have received two or more prior anti-HER2-based regimens in the metastatic setting.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Describe the enhertu approval for gastric cancer?

A

ENHERTU is indicated for the treatment of:

  1. Adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
  2. Who have received a prior trastuzumab-based regimen.
  3. Standard approval, not accelerated approval
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What are the boxed warnings for enhertu?

A

Warning: Interstitial Lung Disease and Embryo-fatal toxicity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What are the contraindications for enhertu?

A

None

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

How long is the initial infusion time? The subsequent infusion time?

A 
Initial = 90 minutes
Subsequent = 30 minutes
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

How long should patients be on enhertu?

A

Continue until disease progression or unacceptable toxicity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is the enhertu dose for breast and gastric/gej patients?

A 
Breast = 5.4 mg/kg
Gastric/gej = 6.4 mg/kg
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What are the dose modifications for breast cancer?

A

Initial = 5.4 mg/kg
1st reduction = 4.4 mg/kg
2nd reduction = 3.2 mg/kg
3rd = discontinue

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What conditions does table 2 list dose modifications for? (4 total)

A

ILD, neutropenia, thrombocytopenia, left ventricular dysfunction

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is the corticosteroid treatment that should be considered for grade 1 ILD?

A

Per §5.1, ≥ 0.5 mg/kg/day prednisolone or equivalent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What is the corticosteroid treatment that should be promptly initiated for grade 2 and above ILD?

A

Per §5.1, ≥ 1 mg/kg/day prednisolone or equivalent and continue for at least 14 days followed by gradual taper for at least 4 weeks

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What metrics are used to diagnose neutropenia?

A

Neutrophil count less than 1.0 to 0.5 x 109/L = grade 3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is the definition of febrile neutropenia? What is the treatment modification?

A

Absolute neutrophil count of less than 1 x109/L and temperature greater than 38.3°C or a sustained temperature of 38°C or greater for more than one hour.

Interrupt until resolved, then reduce by one dose level.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What are the treatment modifications for thrombocytopenia?

A

Grade 3 (platelets less than 50 to 25 x 109/L)= interrupt dose until grade 1 or less then maintain dose

Grade 4 (platelets less than 25 x 109/L)= interrupt dose until grade 1 or less than reduce dose by one level

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What are the treatment modifications for neutropenia?

A

Grade 3 (less than 1.0 to 0.5 x 109/L) = interrupt dose until resolved to grade 2 or less then maintain dose

Grade 4 (less than 0.5 x 109/L)= interrupt dose until resolved to grade 2 or less then reduce dose by one level

17
Q

What is the full name for enhertu that is listed on the vial?

A

ENHERTU (fam-trastuzumab deruxtecan-nxki)

18
Q

What form does enhertu come in and how does a provider prepare it for a patient?

A
  • Comes in lyophilized powder
  • Reconstituted in 5 mL sterile water
  • If not used immediately, store the reconstituted vials in a refrigerator at 2˚C to 8˚C (36˚F to 46˚F) for up to 24 hours
19
Q

What cohort of patients was examined for safety for breast cancer patients? How many?

A

234 patients, pooled analysis from DB-01 and J101 patients that received at least one dose of 5.4 mg/kg enhertu

20
Q

How many patients experienced ILD? How many were fatal?

A

9% had ILD, 2.6% had fatal ILD

21
Q

How long was the median time to onset for ILD? What was the range?

A

Median time = 4.1 months

Range = 1.2 - 8.3 months

22
Q

How many patients experienced a neutrophil count decrease?

A

62%

23
Q

What percent of patients experienced grade 3 or 4 neutropenia? How many experienced febrile neutropenia?

A

16% grade 3 or 4.

1.7% febrile

24
Q

What percent of patients experienced LVEF decrease?

A

2 patients, 0.9% (both asymptomatic)

25
Q

What was the median and range for duration of treatment?

A

Median duration = 7 months

Range = 0.7 - 31 months

26
Q

What percent of patients had a dose interruption? (pooled data)

A

33%

27
Q

What percent had a dose reduction?

A

18%

28
Q

What percent of patients had a permanent discontinutation?

A

9%

29
Q

What percent of patients were over age 65? Over the age of 75? (pooled)

A 
65 = 26%
75 = 5%
30
Q

Use of enhertu in patients with renal impairment?

A

No data available for severe impairment.

No dose adjustment required for patients with mild or moderate impairment

31
Q

Use in hepatic impaired patients?

A

Mild does not need dose adjustment,

Moderate should be closely monitored due to possible toxicity of payload

No data on severe impairment

32
Q

How is enhertu metabolized in the body?

A

The humanized HER2 IgG1 monoclonal antibody is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG

33
Q

How was enhertu metabolized in vitro?

A

In vitro, DXd is primarily metabolized by CYP3A4

34
Q

What % of patients had received prior pertuzumab in DB-01?

A

66%

35
Q

What % of patients had HR+ disease in DB-01?

A

53%

36
Q

Confirmed ORR in DB-01?

A

60.3%

37
Q

% CR

% PR

A

4.3%,

56%

38
Q

Median DOR in DB-01?

A

14.8 months

Training (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions