Elzonris PI 1.2019

Question 1

What does erzs at the end of tagraxofusp stand for?

Answer 1

Don’t know

Question 2

What is the indication?

Answer 2

ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.

Question 3

What is the dosage?

Answer 3

Administer ELZONRIS intravenously at 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle

Question 4

Any pre-meds necessary?

Answer 4

Premedicate with an H1-histamine antagonist, acetaminophen, corticosteroid and H2-histamine antagonist prior to each ELZONRIS infusion.

Question 5

In-patient or out patient?

Answer 5

Administer the first cycle of ELZONRIS in the inpatient setting. Subsequent cycles may be administered in the inpatient or appropriate outpatient setting

Question 6

Dosage forms and strengths?

Answer 6

Injection: 1,000 mcg in 1 mL clear colorless solution in a single-dose vial.

Question 7

Contraindications?

Answer 7

None

Question 8

Warnings and Precautions?

Answer 8

Hypersensitivity: Monitor patients for signs/symptoms and treat appropriately. (5.2)
Hepatotoxicity: Monitor ALT and AST. Interrupt ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal.

Question 9

Most common adverse reactions incidence ≥ 30%?

Answer 9

Capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia and weight increase

Question 10

Most common laboratory abnormalities incidence ≥ 50%?

Answer 10

Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST

Question 11

What does serum albumin need to be in order to dose EZ?

Answer 11

≥ 3.2 g/dL

Question 12

What to give pt if serum albumin is < 3.5?

Answer 12

Administer 25g intravenous albumin (q12h or more frequently as practical) until serum albumin is ≥ 3.5 g/dL AND not more than 0.5 g/dL lower than the value measured prior to dosing initiation of the current cycle.

Question 13

What are the signs/symptoms of CLS

Answer 13

Serum albumin < 3.5 g/dL
Serum albumin reduced by ≥ 0.5 g/dL from the albumin value measured prior to ELZONRIS dosing initiation of the current cycle
A predose body weight that is increased by ≥ 1.5 kg over the previous day’s predose weight
Edema, fluid overload and/or hypotension

Question 14

What drugs do give if CLS occurs?

Answer 14

25g intravenous albumin q12h until serum albumin is
≥ 3.5 g/dL AND not more than 0.5 g/dL lower than the value measured prior to dosing initiation
1 mg/kg of methylprednisolone (or an equivalent) per day, until resolution

Question 15

What are the following components required for dose preparation and prior to thawing EZ?

Answer 15

• One empty 10 mL sterile vial
• 0.9% Sodium Chloride Injection, USP (sterile saline)
• Three 10 mL sterile syringes
• One 1 mL sterile syringe
• One mini-bifuse Y-connector
• Microbore tubing
• One 0.2 micron polyethersulfone in-line filter

Question 16

What is the thawed appearance of EZ?

Answer 16

Clear, colorless liquid that may contain a few white to translucent particles.

Question 17

Prior to dose preparation, what are steps you take with the frozen vial of EZ?

Answer 17

Thaw at room temperature, between 15°C and 25°C (59°F and 77°F), for 15 to 30 minutes in original carton, and verify thaw visually. Thawed vials may be held at room temperature for approximately 1 hour prior to dosage preparation. Do not force thaw. Do not refreeze vial once thawed

Question 18

Once thawed, how long do you have to give EZ?

Answer 18

4 hours. During this 4-hour window, the prepared dose should remain at room temperature. Any excess material should be thrown away.

Question 19

How do you administer EZ? what kind of infusion?

Answer 19

Administer the prepared ELZONRIS dose via infusion syringe pump over 15 minutes. The total infusion time will be controlled using a syringe pump to deliver the entire dose and the saline flush over 15 minutes