CINACALCET ACCORD

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CINACALCET

Available from:

Accord Healthcare Limited

ATC code:

H05BX01

INN (International Name):

CINACALCET

Dosage:

60 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

cinacalcet

Authorization status:

Not Marketed

Authorization date:

2016-12-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET ACCORD 30 MG FILM-COATED TABLETS
CINACALCET ACCORD 60 MG FILM-COATED TABLETS
CINACALCET ACCORD 90 MG FILM-COATED TABLETS
cinacalcet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cinacalcet Accord is and what it is used for
2.
What you need to know before you take Cinacalcet Accord
3.
How to take Cinacalcet Accord
4.
Possible side effects
5.
How to store Cinacalcet Accord
6.
Contents of the pack and other information
1.
WHAT CINACALCET ACCORD IS AND WHAT IT IS USED FOR
Cinacalcet Accord works by controlling the levels of parathyroid
hormone (PTH), calcium and phosphorus
in your body. It is used to treat problems with organs called
parathyroid glands. The parathyroids are four
small glands in the neck, near the thyroid gland, that produce
parathyroid hormone (PTH).
Cinacalcet Accord
is used:
•
to treat secondary hyperparathyroidism in patients with serious kidney
disease who need dialysis to clear
their blood of waste products.
•
to reduce high levels of calcium in the blood (hypercalcaemia) in
patients with parathyroid cancer.
•
to reduce high levels of calcium in the blood (hypercalcaemia) in
patients with primary
hyperparathyroidism when removal of the gland is not possible.
In primary and secondary hyperparathyroidism too much PTH is produced
by the parathyroids glands.
“Primary” means that the hyperparathyroidism is not caused by any
other condition and “secondary” means
that the hyperparathyroidism is cau

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cinacalcet Accord 60 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg cinacalcet (as hydrochloride).
Excipient(s) with known effect:
Each film coated tablet contains 134.3 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light green, oval, biconvex film-coated tablet of 12.3-12.7 mm length
debossed ‘C’ on one side and ‘60’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of secondary hyperparathyroidism (HPT) in patients with
end-stage renal disease (ESRD) on maintenance
dialysis therapy.
Cinacalcet Accord may be used as part of a therapeutic regimen
including phosphate binders and/or Vitamin D sterols,
as appropriate (see section 5.1).
Reduction of hypercalcaemia in patients with:
parathyroid carcinoma.
primary HPT for whom parathyroidectomy would be indicated on the basis
of serum calcium levels (as defined
by relevant treatment guidelines), but in whom parathyroidectomy is
not clinically appropriate or is
contraindicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Secondary hyperparathyroidism
_Adults and elderly (> 65 years)_
The recommended starting dose for adults is 30 mg once per day.
Cinacalcet Accord should be titrated every 2 to 4
weeks to a maximum dose of 180 mg once daily to achieve a target
parathyroid hormone (PTH) in dialysis patients of
between 150-300 pg/ml (15.9-31.8 pmol/l) in the intact PTH (iPTH)
assay. PTH levels should be assessed at least 12
hours after dosing with Cinacalcet Accord. Reference should be made to
current treatment guidelines.
PTH should be measured 1 to 4 weeks after initiation or dose
adjustment of Cinacalcet Accord. PTH should be
monitored approximately every 1-3 months during maintenance. Either
the intact PTH (iPTH) or bio-intact PTH
(biPTH) may be used to measure PTH levels; treatment with cinacalcet
does not alter the relationship betwe