Amsalyo 75 mg powder for concentration for solution infusion

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Amsacrine

Disponible depuis:

Eurocept International BV

Code ATC:

L01XX01

DCI (Dénomination commune internationale):

Amsacrine

forme pharmaceutique:

Powder for solution for infusion

Domaine thérapeutique:

amsacrine

Statut de autorisation:

Not marketed

Date de l'autorisation:

2024-01-26

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMSALYO 75 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Amsacrine
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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Amsalyo is and what it is used for
2. What you need to know before you use Amsalyo
3. How to use Amsalyo
4. Possible side effects
5. How to store Amsalyo
6. Contents of the pack and other information
1. WHAT AMSALYO IS AND WHAT IT IS USED FOR
This
medicine
is
an
anticancer
(cytostatic)
agent.
It
is
used
in
combination
with
other
chemotherapeutic (anticancer) agents to treat a form of cancer of the
white cells in your blood, acute
myeloid leukaemia. It prevents the growth of certain cells.
Amsalyo is mainly indicated in case of recurrence or failure of
conventional treatments.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMSALYO
DO NOT USE AMSALYO
-
if you are allergic (hypersensitive) to amsacrine or any of the other
ingredients of this medicine
listed in section 6.
-
if your bone marrow does not produce enough blood cells following the
administration of other
chemotherapy products and/or radiation therapy.
-
during breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Amsalyo:
Your doctor will take special care if any of the following conditions
apply to you.
-
this medicine can cause a decrease in the production of white blood
cells and platelets where
severe infections and haemorrhages may occur. Your doctor will check
this by blood samples
and reduce the dose and interrupt treatment if necessary.
-
there is a risk

Résumé des caractéristiques du produit

Health Products Regulatory Authority
29 January 2024
CRN00CZZW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amsalyo 75 mg powder for concentration for solution infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 75 mg amsacrine.
After reconstitution, each ml of solution contains 1.5 mg amsacrine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Red‐orange lyophilized powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salvage therapy of refractory/relapsed acute myeloid leukaemia (AML)
in adults, in combination with other chemotherapeutic
agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be supervised by a physician experienced in the
management of patients with AML. Before treatment is
started the potassium level in serum must be controlled and corrected.
A serum potassium level >4 mEq/L prior to
administration is recommended. Amsacrine is given in combination with
other cytostatic drugs.
Numerous dose levels and dosing schedules exist and depend on
concomitant therapy, patient and disease characteristics,
bone marrow reserve and hematoxicity, and response to therapy. Refer
to the protocol by which the patient is being treated
and to applicable guidelines. Dosing schedules reported for induction
treatment with combination chemotherapy typically
include doses of 90 to 150 mg/m2 per day, for three to five
consecutive days. For consolidation treatment, lower doses may be
considered.
Renal impairment
Caution is advised when administering amsacrine to patients with renal
impairment, see section 5.2.
In patients with mild
-
renal
dysfunction (GFR 60–89 ml/min/1.73 m
2
), no starting dose
adjustment is recommended.
In patients with moderate or severe
renal impairment (GFR <59 ml/min/1.73 m
2
), a starting dose reduction by approximately 20‐30% should be
considered.
Subsequent dose adjustments may be needed based on clinical toxicity.
Hepatic impairment:
Cau