Sensipar

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cinacalcet hydrochloride 33mg (R - enantiomer, anhydrate, equivalent to 30mg cinacalcet as the free base)

Available from:

Amgen New Zealand Limited

INN (International Name):

Cinacalcet hydrochloride 33 mg (R - enantiomer, anhydrate, equivalent to 30mg cinacalcet as the free base)

Dosage:

30 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Cinacalcet hydrochloride 33mg (R - enantiomer, anhydrate, equivalent to 30mg cinacalcet as the free base) Excipient: Carnauba wax Colloidal silicon dioxide Crospovidone Magnesium stearate Microcrystalline cellulose Opadry Clear YS-1-19025-A Opadry Green Povidone Starch

Units in package:

Blister pack, Aclar blisters, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sumitomo Chemical Company Limited

Therapeutic indications:

Sensipar may be used to treat the biochemical manifestations of secondary hyperparathyroidism in adult patients with end stage renal disease, receiving dialysis. Sensipar should be used as adjunctive therapy.

Product summary:

Package - Contents - Shelf Life: Blister pack, Aclar blisters - 28 tablets - 48 months from date of manufacture stored at or below 30°C

Authorization date:

2003-11-03

Patient Information leaflet

PAGE 1 OF 6
AMGEN (NEW ZEALAND) LIMITED
AMGEN
Sensipar CMI NZ
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-pear-a-THIGH-royd-izm) in
adults with kidney disease who require dialysis treatment.

a condition called primary hyperparathyroidism in adults when surgical
removal of the
parathyroid gland is not a treatment option.

high blood calcium levels in adults 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, 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

Summary of Product characteristics

NEW ZEALAND DATA SHEET
SENSIPAR NZ DATA SHEET CDS V26
PAGE 1 OF 22
1.
PRODUCT NAME
Sensipar

30 mg film coated tablets
Sensipar

60 mg film coated tablets
Sensipar

90 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cinacalcet 30 mg (corresponding to 33 mg as the hydrochloride salt)
Cinacalcet 60 mg (corresponding to 66 mg as the hydrochloride salt)
Cinacalcet 90 mg (corresponding to 99 mg as the hydrochloride salt)
Excipient(s) with known effect
Each 30 mg tablet contains 2.74 mg of lactose
Each 60 mg tablet contains 5.47 mg of lactose
Each 90 mg tablet contains 8.21 mg of lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sensipar 30 mg tablets are formulated as light green, film-coated,
oval-shaped tablets
marked with “AMG” on one side and “30” on the opposite side.
Sensipar 60 mg tablets are formulated as light green, film-coated,
oval-shaped tablets
marked with “AMG” on one side and “60” on the opposite side.
Sensipar 90 mg tablets are formulated as light green, film-coated,
oval-shaped tablets
marked with “AMG” on one side and “90” on the opposite side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sensipar may be used to treat the biochemical manifestations of
secondary
hyperparathyroidism in adult patients with end stage renal disease,
receiving dialysis.
Sensipar should be used as adjunctive therapy.
Sensipar is indicated for the treatment of hypercalcaemia in adult
patients with
parathyroid carcinoma.
NEW ZEALAND DATA SHEET
SENSIPAR NZ DATA SHEET CDS V26
PAGE 2 OF 22
Sensipar may be used to treat the biochemical manifestations of
primary
hyperparathyroidism in adult patients for whom parathyroidectomy is
not a treatment
option.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
_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 m