CEENU 10mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lomustine, Quantity: 10 mg

Available from:

Bristol-Myers Squibb Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: mannitol; Gelatin; titanium dioxide; magnesium stearate; indigo carmine; butan-1-ol; Shellac; iron oxide black

Administration route:

Oral

Units in package:

20 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

(1) Brain tumours (primary and secondary). (2) Hodgkin's disease (as secondary therapy). Lomustine is used in addition to appropriate surgical and/or radiotherapeutic procedures or as a component of various chemotherapeutic regimens in the palliative treatment of primary and metastatic brain tumours. CeeNU containing combinations should be used as alternative therapy in the treatment of disseminated Hodgkin's Disease in patients refractory to other established treatment regimens.

Product summary:

Visual Identification: Capsule, white, marked in black with "CPL" above "3030" on the cap and "10MG" on the body; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

CEENU
®
_Lomustine (low-MUSS-teen)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CeeNU. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking CeeNU
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CEENU IS USED
FOR
CeeNU is used to treat brain cancer.
It may also be used to treat another
type of cancer called Hodgkin's
Disease.
CeeNU belongs to a group of
medicines called cytotoxic
medicines. You may also hear of
these being called chemotherapy
medicines.
CeeNU works by killing cancer cells.
CeeNU is often used in combination
with other medicines to treat your
cancer.
Your doctor may have prescribed
CeeNU for another reason. Ask your
doctor if you have any questions
about why CeeNU has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
Safety and effectiveness in children
have not been established.
BEFORE YOU TAKE
CEENU
DO NOT TAKE CEENU IF YOU HAVE A
SEVERE ALLERGY TO CEENU OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET,
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching, hives or flushed, red
skin
•
dizziness or light headedness
DO NOT TAKE CEENU IF YOU HAVE, OR
HAVE HAD, ANY OF THE FOLLOWING
MEDICAL CONDITIONS, UNLESS YOU
HAVE DISCUSSED IT WITH YOUR DOCTOR:
•
blood disorder with a reduced
number of red or white blood
cells
•
liver problems
•
kidney problems
•
lung disease (including asthma)
•
heart problems (including a heart
attack)
•
any other cancer
•
lowered immunity due to
treatment with medicines such as
cort

Summary of Product characteristics

AU_PI_CeeNU_V9.0
1
AUSTRALIAN PRODUCT INFORMATION – CEENU
®
(LOMUSTINE)
1
NAME OF THE MEDICINE
Lomustine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules containing 10 mg and 40 mg of lomustine.
Lomustine (CeeNU) is an antitumour agent, cancer chemotherapeutic
agent, cytotoxic agent and
alkylating agent. Lomustine is a yellow powder, very slightly soluble
in water (0.5mg/mL); slightly
soluble in propylene glycol (0.7mg/mL) and polysorbate 80 (2.5mg/mL);
soluble in absolute alcohol
(70mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Capsule containing 10mg lomustine are white, marked CPL 3030/10mg.
Capsule containing 40mg lomustine are white/dark green, marked CPL
3031/40mg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CeeNU may be used for the treatment of:
1.
Brain tumours (primary and secondary).
2.
Hodgkin's disease (as secondary therapy).
Lomustine is used in addition to appropriate surgical and/or
radiotherapeutic procedures or as a
component of various chemotherapeutic regimens in the palliative
treatment of primary and metastatic
brain tumours.
CeeNU containing combinations should be used as alternative therapy in
the treatment of disseminated
Hodgkin's disease in patients refractory to other established
treatment regimens.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of CeeNU is 130mg/m
2
as a single dose by mouth every 6 weeks.
In individuals with compromised bone marrow function, the dose should
be reduced to 100mg/m
2
every
six weeks.
A repeat course of CeeNU should not be given until circulating blood
elements have returned to
acceptable levels (platelets above 100,000/mm
3
, leucocytes above 4,000/mm
3
). Blood counts should
be
monitored
weekly
and
repeat
courses
should
not
be
given
before
six
weeks
because
the
haematological toxicity is delayed and cumulative.
Doses subsequent to the initial dose should be adjusted according to
the haematologic response of the
patient to the preceding dose. The hematologic response s