Erlotinib (Alchemy)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Erlotinib hydrochloride 109.27mg equivalent to Erlotinib 100mg

Available from:

Alchemy Health Limited

Dosage:

100 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Erlotinib hydrochloride 109.27mg equivalent to Erlotinib 100mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white 200F280000 Sodium starch glycolate

Prescription type:

Prescription

Therapeutic indications:

Erlotinib is indicated for the first-line and maintenance treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. Erlotinib is also indicated for the treatment of patients with locally advanced or metastatic NSCLC who have previously received chemotherapy.

Product summary:

Package - Contents - Shelf Life: Blister pack, Aluminium - OPA/Alu/PVC - 30 tablets - 48 months from date of manufacture stored at or below 30°C

Authorization date:

2021-01-27

Patient Information leaflet

Erlotinib CMI 28-03-2023
1
New Zealand Consumer Medicine Information
ERLOTINIB
_ERLOTINIB _
100 mg and 150 mg Film-coated tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Erlotinib.
This leaflet answers some common questions about Erlotinib. 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 using
Erlotinib against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT ERLOTINIB IS USED FOR
Erlotinib is used for the treatment of non-small cell lung cancer
(NSCLC). It can be
given before or after initial chemotherapy if your cancer has specific
mutations in a
protein called epidermal growth factor receptor (EGFR). It can also be
given later on
when initial chemotherapy has not worked.
Erlotinib is also used in combination with gemcitabine for the
treatment of pancreatic
cancer.
Erlotinib belongs to a group of medicines called anti-neoplastic (or
anti-cancer)
agents which are used to treat cancer.
Erlotinib prevents the activity of the EGFR protein. This protein is
known to be
involved in the growth and spread of cancer cells.
Your doctor may have prescribed Erlotinib for another reason.
Ask your doctor if you have any questions about why Erlotinib has been
prescribed
for you.
Erlotinib is not addictive.
Erlotinib CMI 28-03-2023
2
This medicine is available only with a doctor's prescription.
BEFORE YOU USE ERLOTINIB
_WHEN YOU MUST NOT USE IT _
Do not use Erlotinib if:
•
YOU HAVE HAD AN ALLERGIC REACTION TO ERLOTINIB OR ANY INGREDIENTS
LISTED AT THE
END OF THIS LEAFLET
Some symptoms of an allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
•
rash, itching or hives on the skin
�

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Erlotinib (Alchemy) 28-03-2023
Page 1 of 19
1. ERLOTINIB 25 mg, 50 mg, 100 mg and 150 mg film coated tablets
Erlotinib 25 mg, 50 mg, 100 mg and 150 mg film coated tablets
_The 25 mg and 50 mg strengths are currently not available in New
Zealand. _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Erlotinib film coated tablets come in 4 dosage strengths containing
erlotinib hydrochloride equivalent
to 25 mg, 50 mg, 100 mg or 150 mg of erlotinib.
Excipients with known effect
Each 25 mg film-coated tablet contains 23.98 mg Lactose monohydrate.
Each 50 mg film-coated tablet contains 43.97 mg Lactose monohydrate.
Each 100 mg film-coated tablet contains 95.93 mg Lactose monohydrate.
Each 150 mg film-coated tablet contains 143.90 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Erlotinib 25 mg film-coated tablets are round, biconvex, white to
yellowish tablets marked with “25”
engraved on one side. The diameter of the tablet is 6.1 mm

5%.
Erlotinib 50 mg film-coated tablets are round, biconvex, white to
yellowish tablets marked with “50”
engraved on one side. The diameter of the tablet is 7.6 mm

5%.
Erlotinib 100 mg film-coated tablets are round, biconvex, white to
yellowish tablets marked with
“100” engraved on one side. The diameter of the tablet is 8.9 mm

5%.
Erlotinib 150 mg film-coated tablets are round, biconvex, white to
yellowish tablets marked with
“150” engraved on one side. The diameter of the tablet is 10.5 mm

5%.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
Erlotinib is indicated for the first-line and maintenance treatment of
patients with advanced (Stage
IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with
activating EGFR mutations.
Erlotinib is also indicated for the treatment of patients with locally
advanced or metastatic NSCLC
who have previously received chemotherapy.
PANCREATIC CANCER
Erlotinib in combination with gemcitabine is indicated for the
treatm