Elzonris

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

tagraxofusp

Disponibil de la:

Stemline Therapeutics B.V.

Codul ATC:

L01XX67

INN (nume internaţional):

tagraxofusp

Grupul Terapeutică:

Antineoplastic agents

Zonă Terapeutică:

Lymphoma

Indicații terapeutice:

Elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Rezumat produs:

Revision: 6

Statutul autorizaţiei:

Authorised

Data de autorizare:

2021-01-07

Prospect

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELZONRIS 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
tagraxofusp
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ELZONRIS is and what it is used for
2.
What you need to know before you are given ELZONRIS
3.
How ELZONRIS is given
4.
Possible side effects
5.
How to store ELZONRIS
6.
Contents of the pack and other information
1.
WHAT ELZONRIS IS AND WHAT IT IS USED FOR
ELZONRIS contains the active substance tagraxofusp. Tagraxofusp, an
anti-cancer medicine, is made
from two proteins from different sources. One of the proteins can kill
cancer cells. This protein is
delivered to the cancer cell by the second protein.
ELZONRIS is used to treat adult patients with blastic plasmacytoid
dendritic cell neoplasm (BPDCN).
BPDCN is a cancer of a rare type of immature immune cells called
‘plasmacytoid dendritic cells’. It
can affect many organs including the skin, bone marrow, and lymph
nodes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ELZONRIS
DO NOT USE ELZONRIS
-
if you are allergic to tagraxofusp or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using ELZONRIS and during treatment if you:
-
suddenly gain weight after starting treatment, have new or worsening
swelling of your face, limbs
or joints (oedema) or dizziness (a symptom of low blood pressure).
These may be signs of a
potentially life-

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
ELZONRIS 1 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of concentrate for solution for infusion contains 1 mg
tagraxofusp. Each vial contains 1 mg of
tagraxofusp.
Tagraxofusp is a diphtheria toxin-interleukin-3 (IL-3) fusion protein
produced by recombinant DNA
technology in
_ Escherichia coli_
.
Excipient with known effect
Each vial contains 50 mg of sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless liquid. A few white to translucent particles may be
present.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELZONRIS is indicated as monotherapy for the first-line treatment of
adult patients with blastic
plasmacytoid dendritic cell neoplasm (BPDCN) (see section 5.1).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ELZONRIS should be administered under the supervision of a physician
experienced in the use of
anti-cancer agents. Appropriate resuscitation equipment should be
available.
Posology
The recommended dose is 12 mcg/kg tagraxofusp administered as an
intravenous infusion over
15 minutes, once daily, on days 1-5 of a 21-day cycle. The dosing
period may be extended for dose
delays up to day 10 of the cycle. Treatment should be continued until
disease progression or
unacceptable toxicity (see section 4.4).
_ _
_First treatment cycle _
The first cycle of ELZONRIS should be administered in the in-patient
setting. Patients should be
monitored for signs and symptoms of hypersensitivity or capillary leak
syndrome (see section 4.4)
until at least 24 hours after the last infusion.
_ _
_Subsequent treatment cycles _
3
ELZONRIS