Pepaxti

Valsts: Eiropas Savienība

Valoda: angļu

Klimata pārmaiņas: EMA (European Medicines Agency)

Aktīvā sastāvdaļa:

Melphalan flufenamide hydrochloride

Pieejams no:

Oncopeptides AB

ATĶ kods:

L01AA10

SNN (starptautisko nepatentēto nosaukumu):

melphalan flufenamide

Ārstniecības grupa:

Antineoplastic agents

Ārstniecības joma:

Multiple Myeloma

Ārstēšanas norādes:

Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.4).

Produktu pārskats:

Revision: 3

Autorizācija statuss:

Authorised

Autorizācija datums:

2022-08-17

Lietošanas instrukcija

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PEPAXTI 20 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
melphalan flufenamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Pepaxti is and what it is used for
2.
What you need to know before you are given Pepaxti
3.
How Pepaxti is given
4.
Possible side effects
5.
How to store Pepaxti
6.
Contents of the pack and other information
1.
WHAT PEPAXTI IS AND WHAT IT IS USED FOR
Pepaxti belongs to a group of cancer medicines called alkylating
agents. It works by attaching to DNA
(the genetic instruction needed for cells to survive and multiply) and
damaging it, thereby helping to
stop the cancer cells from growing.
Pepaxti is given with the steroid dexamethasone, to treat adults with
the blood cancer multiple
myeloma. It is used when the disease does not respond to at least
three types of cancer medicines. If
you have been treated with a blood stem cell transplant (a procedure
where the cells that make your
blood are cleared out and replaced), the time to when the multiple
myeloma came back after
transplantation should be at least 3 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PEPAXTI
_ _
DO NOT USE PEPAXTI
-
if you are allergic to melphalan flufenamide or any of the other
ingredients of this medicine
(listed in section 6).
-
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Pepaxti.
Abnormal bleeding and bruising and low number of platelets (blood
cells)
Pepaxti can lower the number of blood cells called platelets that help
to clot your blood. Tell your
doctor or nurse immediately if you start bleeding e.g. a nosebleed or
get

Produkta apraksts

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pepaxti 20 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 20 mg melphalan flufenamide (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
Lyophilised white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pepaxti is indicated, in combination with dexamethasone, for the
treatment of adult patients with
multiple myeloma who have received at least three prior lines of
therapies, whose disease is refractory
to at least one proteasome inhibitor, one immunomodulatory agent, and
one anti-CD38 monoclonal
antibody, and who have demonstrated disease progression on or after
the last therapy.
For patients with a prior autologous stem cell transplantation, the
time to progression should be at least
3 years from transplantation (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Pepaxti must be initiated and supervised by physicians
experienced in the treatment of
multiple myeloma.
Posology
The recommended starting dose of Pepaxti is 40 mg on Day 1 of each
28-day treatment cycle. For
patients with a body weight of 60 kg or less the recommended starting
dose is 30 mg on Day 1 of each
28-day cycle. It is recommended that treatment should be continued
until disease progression or
unacceptable toxicity (see section 5.1).
The recommended dose of dexamethasone is 40 mg orally on Days 1, 8, 15
and 22 of each 28-day
treatment cycle. For patients 75 years of age and older the
recommended dose of dexamethasone is
20 mg. For additional information regarding administration of
dexamethasone, see section 5.1 and the
corresponding Summary of Product Characteristics.
_Dose modification for adverse reactions _
Pepaxti must be withheld if the neutrophil count is less than 1 × 10
9
/L or the platelet count is less than
50 × 10
9