Cosmegen dactinomycin (actinomycin D) 0.5mg injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dactinomycin, Quantity: 500 microgram

Available from:

Recordati Rare Diseases Australia Pty Ltd

INN (International Name):

dactinomycin (actinomycin D)

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol

Administration route:

Intravenous

Units in package:

500 microgram of powder

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Wilm's Tumour; Rhabdomyosarcoma; Carcinoma of the Testes and Uterus. Other Neoplasms: Actinomycin D given IV or by regional perfusion, either alone or with other antineoplastic compounds or with X-ray therapy in the palliative treatment of Ewing's sarcoma and sarcoma botryoides; non-metastatic Ewing's carcinoma. Actinomyin D and Radiation therapy; Actinomycin D in various types of sarcoma, carcinoma and adenocarcinoma using isolation-perfusion technique. FOR FULL LIST OF INDICATIONS REFER TO APPROVED PI DOCUMENT.

Product summary:

Visual Identification: Yellow lyophilized powder; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-22

Patient Information leaflet

COSMEGEN
®
1
COSMEGEN
®
_DACTINOMYCIN (ACTINOMYCIN D) _
_(PRONOUNCED DAK-TI-NOE-MYE-SIN DI) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COSMEGEN. 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 COSMEGEN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT COSMEGEN IS
USED FOR
COSMEGEN is used alone, or in
combination with other
chemotherapy or radiotherapy, to
treat certain types of cancers,
including:

Wilms’ tumour, a type of kidney
cancer

Rhabdomyosarcoma, a cancer of
the muscle

Nonseminomatous testicular
carcinoma, a cancer of the testis

Choriocarcinoma, a cancer of the
uterus

Ewing’s sarcoma, a type of bone
cancer

Sarcoma botryoides, a cancer of
the female reproductive tract.
COSMEGEN may also be used to
treat the symptoms of certain
cancers, or to treat tumours that are
not responding to radiotherapy. It
may also be used in people who are
having a tumour surgically removed.
COSMEGEN belongs to a group of
medicines called antineoplastics. It
works by interfering with the growth
of cancer cells, which are eventually
killed.
Your doctor may have prescribed
COSMEGEN for another reason.
Ask your doctor if you have any
questions about why COSMEGEN
has been prescribed for you.
COSMEGEN is not addictive.
BEFORE YOU ARE GIVEN
COSMEGEN
_WHEN YOU MUST NOT BE GIVEN _
_COSMEGEN _
DO NOT USE COSMEGEN IF YOU
HAVE AN ALLERGY TO COSMEGEN OR
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
DO NOT USE COSMEGEN IF YOU
HAVE RECENTLY HAD OR ARE CURRENTLY
INFECTED WITH CHICKEN POX OR
HERPES ZOSTER (SHINGLES).
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START RECEIVING
COSMEGEN, TALK TO YOUR DOCTOR.
DO NOT USE COSMEGEN IF YOU ARE
BREA

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - COSMEGEN
® DACTINOMYCIN (ACTINOMYCIN D)
1.
NAME OF THE MEDICINE
Dactinomycin (Actinomycin D)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
COSMEGEN contains 500 micrograms (0.5 milligrams) of dactinomycin and
20.0 milligrams of
mannitol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
COSMEGEN is a sterile, yellow lyophilised powder for injection by the
intravenous route or by
regional perfusion after reconstitution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
WILMS’ TUMOUR
The neoplasm responding most frequently to COSMEGEN is Wilms’
tumour. With low doses of
both dactinomycin and radiotherapy, temporary objective improvement
may be as good as and
may last longer than with higher doses of each given alone. In the
National Wilms’ Tumour
study, combination therapy with dactinomycin and vincristine together
with surgery and
radiotherapy, was shown to have significantly improved the prognosis
of patients in groups II
and III. Dactinomycin and vincristine were given for a total of seven
cycles, so that maintenance
therapy continued for approximately 15 months.
Postoperative radiotherapy in group I patients and optimal combination
chemotherapy for those
in group IV are unsettled issues. About 70 percent of lung metastases
have disappeared with an
appropriate combination of radiation, dactinomycin and vincristine.
RHABDOMYOSARCOMA
Temporary regression of the tumour and beneficial subjective results
have occurred with
dactinomycin in rhabdomyosarcoma which, like most soft tissue
sarcomas, is comparatively
radio-resistant.
Several groups have reported successful use of cyclophosphamide,
vincristine, dactinomycin and
doxorubicin hydrochloride in various combinations. Effective
combinations have included
vincristine and dactinomycin; vincristine, dactinomycin and
cyclophosphamide (VAC therapy)
and all four drugs in sequence. At present, the most effective
treatment for children with
inoperable or metastatic rhabdomyosarcoma has been