Leaflet GEVESLA 150mg soft capsules

Product code:
W70878002
Quantity:
60
Indicated for:
cancer
Route of administration:
oral
Substance:
nintedanib (antineoplastic agent)
ATC
L01EX09 — Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Other protein kinase inhibitors

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.

Nintedanib is a medication used for the treatment of idiopathic pulmonary fibrosis and other progressive interstitial lung diseases. It is a tyrosine kinase inhibitor that works by reducing inflammation and fibrosis in the lungs.

The medication is taken orally, usually twice daily with meals. The dose is adjusted based on the patient's tolerance and any adverse reactions. Common side effects include diarrhea, nausea, vomiting, and decreased appetite.

Nintedanib is contraindicated in patients with hypersensitivity to the active substance or any of its excipients. It should also be used with caution in patients with severe liver impairment.

This medication is an important option for patients with progressive lung diseases, helping to slow disease progression and improve their quality of life.

General data about GEVESLA 150mg

Substance:
nintedanib
Date of latest medicines list:
01-06-2026
Product code:
W70878002
Concentration:
150mg
Pharmaceutical form:
soft capsules
Quantity:
60
Product type:
Generic medicine
Price:
6727.15 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
PHARMADOX HEALTHCARE LIMITED - MALTA
Holder:
SANDOZ PHARMACEUTICALS S.R.L. - ROMANIA
Number:
15788/2025/02
Shelf life:
3 years

Concentrations available for nintedanib

  • 100mg
  • 150mg
  • 25mg

Compensation lists for GEVESLA 150mg Sanpha

G31H (C1) - Chronic lung disease

Price
6727.15 RON
Copayment
4257.24 RON
Patient
2469.91 RON

NHP 6.20 (C2) - Idiopathic pulmonary fibrosis

Price
6727.15 RON
Copayment
4257.24 RON
Patient
2469.91 RON