Leaflet MUSTOPHORAN 208mg powder and solvent for solution for infusion

Product code:
W03251001
Quantity:
1
Indicated for:
cancer
Route of administration:
infusion
Substance:
fotemustine (antineoplastic agent)
ATC
L01AD05 — Antineoplastic and immunomodulating agents | Alkylating agents | Nitrosoureas

Precautions:

Fertility warning

Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling

Cytotoxic / special handling

Handle with special care.

Contraception required

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Fotemustine is a cytostatic medication used in the treatment of certain types of cancer, especially advanced malignant melanoma and some brain tumors. It works by inhibiting the division of cancer cells, slowing down or stopping their growth in the body.

Fotemustine is administered intravenously under strict medical supervision, usually in a hospital or oncology center. The dose and treatment schedule are determined by the doctor based on the type and stage of cancer, as well as the patient's general condition.

Side effects may include a decrease in blood cell counts, nausea, vomiting, fatigue, infections, or impaired liver function. In some cases, allergic reactions or lung problems may occur. Careful monitoring is essential throughout the treatment.

Fotemustine is an effective medication for certain forms of cancer, but its use involves risks and requires continuous medical supervision. Follow your doctor's instructions closely and report any unusual symptoms to prevent complications.

General data about MUSTOPHORAN 208mg

Substance:
fotemustine
Date of latest medicines list:
01-07-2025
Product code:
W03251001
Concentration:
208mg
Pharmaceutical form:
powder and solvent for solution for infusion
Quantity:
1
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
CENEXI - LABORATOIRES THISSEN S.A. - BELGIA
Holder:
LES LABORATOIRES SERVIER - FRANTA
Number:
12574/2019/01
Shelf life:
2 years; after reconstitution-sol. trebuie utilizata imediat