NITYR nitisinone 2 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitisinone, Quantity: 2 mg

Available from:

Orpharma Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; glycerol dibehenate

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NITYR Tablets (nitisinone) are indicated for the treatment of patients with hereditary tyrosinaemia type 1 in combination with dietary restriction of tyrosine and phenylalanine.

Product summary:

Visual Identification: Immediate-release dosage form, which presents as white to beige, round, flat tablets, which may display light yellow to brown speckles, marked with "2" on one side and "L" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-06-08

Patient Information leaflet

NITYR Tablets_CMI_V7_March 2019
1 of 7
NITYR
™
(NITISINONE) TABLETS
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NITYR tablets.
It does not contain all of the
available information. Some of the
information it contains may not
apply to you. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and risks.
In deciding to give you NITYR, your
doctor has weighed the risks of you
taking NITYR against the expected
benefits it will have for you.
Always follow the instructions that
your doctor and pharmacist give you
about NITYR.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT NITYR ARE USED
FOR
NITYR CONTAINS THE MEDICINE
NITISINONE. NITISINONE BELONGS TO
A GROUP OF MEDICINES CALLED
‘OTHER ALIMENTARY AND
METABOLISM PRODUCTS’.
NITYR is used for the treatment of a
disease called hereditary tyrosinaemia
type 1. In this disease the body is
unable to completely break down the
amino acid tyrosine. Harmful
substances will be formed and
accumulated in the body.
NITYR block the breakdown of
tyrosine and by doing so the harmful
substances are not formed.
HOWEVER,
TYROSINE WILL REMAIN IN THE BODY
AND THEREFORE A SPECIAL DIET (WITH
LOW TYROSINE AND PHENYLALANINE
CONTENT) MUST BE FOLLOWED WHEN
TAKING NITYR.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
NITYR is not addictive.
NITYR is only available on a
doctor's prescription
BEFORE YOU TAKE NITYR
YOU SHOULD NOT TAKE NITYR IF:
•
YOU ARE ALLERGIC TO NITISINONE OR
ANY OF THE INGREDIENTS LISTED
UNDER 'PRODUCT DESCRIPTION' AT
THE END OF THIS LEAFLET. SIGNS OF
ALLERGIC REACTIONS MAY INCLUDE
ITCHY SKIN, RASH, SHORTNESS OF
BREATH AND SWELLING OF THE FACE
OR TONGUE.
•
YOU ARE BREASTFEEDING
•
THE PACKAGING SHOWS SIGNS OF
TAMPERING.
•
THE EXPIRY DATE ON THE PACK HAS
PASSED.
BEFORE YOU START TO TAKE
NITYR
YOU MUST TELL YOUR DOCTOR IF:
YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT

Summary of Product characteristics

NITYR tablets PI V7 March 2019
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION –
NITYR™ NITISINONE TABLETS
1. NAME OF THE MEDICINE
Nitisinone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg, 5 mg or 10 mg nitisinone.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
NITYR tablets are white to beige, round, flat tablets, which may
display light yellow to brown
speckles, marked with the strength “2”, “5” or “10” on one
side and “L” on the other side.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
N
ITYR
tablets
(nitisinone)
are
indicated
for
the
treatment
of
patients
with
hereditary
tyrosinaemia type 1 in
combination with dietary restriction of tyrosine and phenylalanine.
4.2
DOSE AND METHOD OF ADMINISTRATION
Nitisinone treatment should be initiated and supervised by a physician
experienced
in the treatment of HT-1 patients. Treatment of all genotypes of the
disease should be
initiated as early as possible to increase overall survival and avoid
complications such as
liver failure, liver
cancer and renal disease. Adjunct to the nitisinone treatment, a diet
deficient in phenylalanine
and tyrosine is mandatory. The patient should be provided
with clear instructions on the restricted diet and on the importance
of adherence to the
restricted diet. The patient’s
compliance to the diet should be checked regularly by
monitoring plasma tyrosine levels.
The dose of nitisinone should be adjusted individually.
NITYR tablets PI V7 March 2019
Page 2 of 17
The
recommended
initial
dose
is
1
mg/kg
body
weight/day
divided
in
2
doses
administered orally.
NITYR tablets may be taken with or without food.
For infants, tablets may be crushed between two spoons and mixed with
apple sauce for
administration. Administration of NITYR tablets with other liquids or
foods has not been
studied and is not recommended. Tablets may also be disintegrated in
water inside an
oral syringe by following the instruction described below. Do not
administer the
suspension