Fertility warning
This medicine may affect fertility.
Leaflet OGSIVEO 150mg film-coated tablets
- Product code:
- W72069001
- Quantity:
- 56
- Indicated for:
- desmoid tumors
- Route of administration:
- oral
- Substance:
- nirogacestat (antineoplastic agent)
- ATC
- L01XX81 — Antineoplastic and immunomodulating agents | Other antineoplastic agents
Nirogacestat is an oral medicine used in adults with progressing desmoid tumours when systemic treatment is needed. Desmoid tumours usually do not spread like many cancers, but they can grow locally and cause pain, reduced movement, or pressure on nearby organs. Treatment aims to slow the disease and improve symptoms.
The medicine inhibits gamma-secretase, an enzyme involved in signalling pathways that may support tumour growth. It is generally taken twice daily, with or without food, and tablets should be swallowed whole. Do not crush, break or chew them. Tell your doctor about all prescription, over-the-counter and herbal medicines, because important interactions can occur.
Common side effects include diarrhoea, nausea, tiredness, rash, mouth inflammation, headache, abdominal pain, hair loss and blood test changes such as low phosphate or increased liver enzymes. In women who could become pregnant, ovarian function may be affected, sometimes causing menstrual changes or symptoms similar to menopause.
Clinical monitoring and blood tests are needed during treatment. Contact your healthcare team quickly if you develop severe diarrhoea, dehydration, fever, widespread rash, strong abdominal pain, or major menstrual changes. Nirogacestat can harm an unborn baby; use effective contraception and discuss fertility preservation before starting treatment.
The medicine inhibits gamma-secretase, an enzyme involved in signalling pathways that may support tumour growth. It is generally taken twice daily, with or without food, and tablets should be swallowed whole. Do not crush, break or chew them. Tell your doctor about all prescription, over-the-counter and herbal medicines, because important interactions can occur.
Common side effects include diarrhoea, nausea, tiredness, rash, mouth inflammation, headache, abdominal pain, hair loss and blood test changes such as low phosphate or increased liver enzymes. In women who could become pregnant, ovarian function may be affected, sometimes causing menstrual changes or symptoms similar to menopause.
Clinical monitoring and blood tests are needed during treatment. Contact your healthcare team quickly if you develop severe diarrhoea, dehydration, fever, widespread rash, strong abdominal pain, or major menstrual changes. Nirogacestat can harm an unborn baby; use effective contraception and discuss fertility preservation before starting treatment.
General data about OGSIVEO 150mg
- Substance:
- nirogacestat
- Date of latest medicines list:
- 01-09-2026
- Product code:
- W72069001
- Concentration:
- 150mg
- Pharmaceutical form:
- film-coated tablets
- Quantity:
- 56
- Product type:
- Generic medicine
- Price:
- 111976.12 RON
- Prescription status:
- P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.
Concentrations available for nirogacestat
- 100mg
- 150mg
- 50mg
Precautions:
Dose adjustment in hepatic impairment
Dose adjustment may be needed in liver disease.
Cytotoxic / special handling
Handle with special care.
Contraception required
Effective contraception is required during treatment.
Contraindicated during breastfeeding
Do not use this medicine while breastfeeding.
Contraindicated during pregnancy
Do not use this medicine during pregnancy.
Hepatotoxicity
This medicine may affect the liver.
Major drug interactions
This medicine may have important interactions with other medicines.
Myelosuppression / agranulocytosis
This medicine may lower blood cell counts.
Additional monitoring
This medicine is subject to additional monitoring.
Requires periodic laboratory tests
Periodic laboratory tests may be required during treatment.
Severe skin reactions
Stop taking the medicine and seek urgent medical help if a severe rash occurs.