SENSIPAR cinacalcet 90mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cinacalcet hydrochloride, Quantity: 99.18 mg (Equivalent: cinacalcet, Qty 90 mg)

Available from:

Amgen Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; pregelatinised maize starch; Carnauba Wax; crospovidone; povidone; colloidal anhydrous silica; hypromellose; macrogol 400; titanium dioxide; lactose monohydrate; indigo carmine; triacetin; iron oxide yellow

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SENSIPAR may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see CLINICAL TRIALS). SENSIPAR should be used as adjunctive therapy. SENSIPAR is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma. SENSIPAR may be used to treat the biochemical manifestations of primary hyperparathryoidism in patients for whom parathryoidectomy is not a treatment option.

Product summary:

Visual Identification: Light green, film-coated, oval shaped tablets marked with "AMG" on one side and "90" on the opposite side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Patient Information leaflet

SENSIPAR
®
_Cinacalcet hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sensipar. It does not
contain all the available information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Sensipar
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING SENSIPAR, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU START SENSIPAR AND KEEP IT WITH
THE MEDICINE. YOU MAY NEED TO
READ IT AGAIN.
WHAT SENSIPAR IS USED
FOR
Sensipar is used to treat:
•
a condition called secondary
hyperparathyroidism (high-per-
para-THIGH-royd-izm) in people
with kidney disease who require
dialysis treatment.
•
a condition called primary
hyperparathyroidism when
surgical removal of the
parathyroid gland is not a
treatment option.
•
high blood calcium levels in
people with cancer of the
parathyroid gland.
SECONDARY HYPERPARATHYROIDISM
Kidney disease can cause a condition
called secondary
hyperparathyroidism, which can have
a big impact on your health. Four
small glands located behind the
thyroid gland in your neck are called
parathyroid glands. They make a
hormone called parathyroid hormone
(PTH). Normally, PTH makes sure
you have just enough calcium and
phosphorus in your blood to keep
your bones, heart, muscles, nerves
and blood vessels working well.
When your kidneys are working
properly, PTH keeps your calcium
and phosphorus levels normal by
moving the right amounts of calcium
and phosphorus in and out of your
bones.
When your kidneys aren't working
properly, the calcium and phosphorus
balance in your body is upset, and
your parathyroid glands send out too
much PTH to your body. This
condition is called secondary
hyperparathyroidism, and it can
cause bone disease and also may be a
risk factor for heart disease and
abnormal calcium deposits in blood
vessels and other parts of the body.
Sensipar

Summary of Product characteristics

PRODUCT INFORMATION – SENSIPAR
SENSIPAR AU PI CDS V26
PAGE 1 OF 24
AUSTRALIAN PRODUCT INFORMATION – SENSIPAR
®
(CINACALCET HYDROCHLORIDE) FILM COATED
TABLETS
1.
NAME OF THE MEDICINE
Cinacalcet hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains either 30 mg, 60 mg or 90 mg of cinacalcet as the
free base
equivalent (corresponding to 33 mg, 66 mg and 99 mg as the
hydrochloride salt,
respectively).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Sensipar 30 mg tablets: light green, film-coated, oval-shaped tablets
marked with “AMG”
on one side and “30” on the opposite side.
Sensipar 60 mg tablets: light green, film-coated, oval-shaped tablets
marked with “AMG”
on one side and “60” on the opposite side.
Sensipar 90 mg tablets: light green, film-coated, oval-shaped tablets
marked with “AMG”
on one side and “90” on the opposite side, packaged in blister
packs of 28 tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sensipar may be used to treat the biochemical manifestations of
secondary
hyperparathyroidism (HPT) in patients with end stage renal disease,
receiving dialysis
(see section 5.1 Pharmacodynamic properties, Clinical trials).
Sensipar should be used
as adjunctive therapy.
Sensipar is indicated for the treatment of hypercalcaemia in patients
with parathyroid
carcinoma.
Sensipar may be used to treat the biochemical manifestations of
primary HPT in patients
for whom parathyroidectomy is not a treatment option.
PRODUCT INFORMATION – SENSIPAR
SENSIPAR AU PI CDS V26
PAGE 2 OF 24
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage (dose and interval)
_Patients with end stage renal disease receiving dialysis _
Sensipar reduces parathyroid hormone (PTH) while simultaneously
lowering Ca x P,
calcium and phosphorus levels in patients receiving dialysis.
The recommended starting dose for adults is 30 mg once per day.
Sensipar should be titrated every 2 to 4 weeks to a maximum dose of
180 mg once dail