Leaflet PROGRAF 5mg capsules

Product code:
W53731001
Quantity:
50
Indicated for:
prevention of transplant rejection
Route of administration:
oral
Substance:
tacrolimus (immunosuppressant)
ATC
L04AD02 — Antineoplastic and immunomodulating agents | Immunosuppressants | Immunosuppressants | Calcineurin inhibitors

Precautions:

Avoid grapefruit

Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Avoid live vaccines

Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Immunosuppression / infection risk

Immunosuppression / infection risk

This medicine may increase the risk of infections.

Narrow therapeutic index

Narrow therapeutic index

The dose must be followed strictly.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Requires periodic laboratory tests

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Breastfeeding warning

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Pregnancy warning

Use during pregnancy only on medical advice.

Tacrolimus is an immunosuppressive medication used to prevent organ rejection in transplant recipients, such as kidney, liver, or heart transplants. It works by inhibiting the activity of T-cells in the immune system, thereby reducing the immune response that could attack the transplanted organ.

Tacrolimus is available in capsules, ointments, and injectable solutions. For transplants, it is administered long-term to ensure the proper functioning of the transplanted organ. Additionally, tacrolimus ointment is used to treat severe atopic dermatitis when other treatments are ineffective.

The medication requires careful monitoring, as high levels can lead to toxicity, while low levels may increase the risk of organ rejection. Common side effects include tremors, headaches, high blood pressure, nausea, and an increased risk of infections.

Tacrolimus should be used as directed by a healthcare provider, and patients are advised to avoid excessive sun exposure, as the medication can increase skin sensitivity.

General data about PROGRAF 5mg

Substance:
tacrolimus
Date of latest medicines list:
01-06-2026
Product code:
W53731001
Concentration:
5mg
Pharmaceutical form:
capsules
Quantity:
50
Product type:
Original
Price:
1089.23 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ASTELLAS IRELAND CO. LTD. - IRLANDA
Holder:
ASTELLAS PHARMA EUROPE B.V. - OLANDA
Number:
8913/2016/01
Shelf life:
3 years-after packing for marketing;after the first opening a pungii din Al-1 year

Concentrations available for tacrolimus

  • 0.03%
  • 0.1%
  • 0.2mg
  • 0.5mg
  • 1mg
  • 2mg
  • 3mg
  • 5mg
  • 5mg/ml

Compensation lists for PROGRAF 5mg Astellas

NHP 9.1 (C2) - Spinal cord transplant

Price
1089.23 RON
Copayment
1089.23 RON
Patient
0.00 RON

NHP 9.2 (C2) - Heart transplant

Price
1089.23 RON
Copayment
1089.23 RON
Patient
0.00 RON

NHP 9.3 (C2) - Liver Transplant

Price
1089.23 RON
Copayment
1089.23 RON
Patient
0.00 RON

NHP 9.4 (C2) - Kidney transplant, combined kidney and pancreas transplant

Price
1089.23 RON
Copayment
1089.23 RON
Patient
0.00 RON

NHP 9.7 (C2) - Outpatient treatment of transplant patients

Price
1089.23 RON
Copayment
1089.23 RON
Patient
0.00 RON