pms-Erlotinib

Erlotinib hydrochloride.

Each tablet contains 100 mg or 150 mg erlotinib (as erlotinib hydrochloride).
Excipients/Inactive Ingredients: Hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, sodium starch glycolate and titanium dioxide.

pms-ERLOTINIB belongs to a group of medicines called epidermal growth factor receptor tyrosine kinase inhibitors which are used to treat cancer. pms-ERLOTINIB prevents the activity of a protein called epidermal growth factor receptor. This protein is known to be involved in the growth and spread of cancer cells.

pms-ERLOTINIB is prescribed because of non-small cell lung cancer at an advanced stage and: chemotherapy has not helped to stop the disease; or the disease has not worsened after 4 cycles of first line chemotherapy; or a confirmed activating mutation of the Epidermal Growth Factor Receptor tyrosine kinase (EGFR-TK).
pms-ERLOTINIB is NOT indicated for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours DO NOT HAVE an epidermal growth factor receptor (EGFR) activating mutation.

Usual dose: The usual dose is one 150 mg tablet each day.
Take pms-ERLOTINIB tablet: at least 1 hour before eating; or at least 2 hours after eating.
If taking medications which reduce acid in the stomach (such as ranitidine 150 mg twice a day), take pms-ERLOTINIB tablet: 2 hours before the morning dose of the medication; and 10 hours after the evening dose of the medication.
Swallow the tablet with a glass of plain water.
Always take pms-ERLOTINIB exactly as the doctor has instructed. Check with the doctor or pharmacist if unsure.
This medicine has been prescribed for the patient personally and should not be passed on to others. It may harm them even if their symptoms are the same.
Missed Dose: If one or more doses of pms-ERLOTINIB is/are missed, contact the doctor or pharmacist as soon as possible.
Do not take a double dose to make up for forgotten individual doses.

If too much pms-ERLOTINIB has been taken, contact the healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Do not take pms-ERLOTINIB if hypersensitive (allergic) to erlotinib or any of the other ingredients of pms-ERLOTINIB. See Description.

pms-ERLOTINIB should be prescribed and managed only by a doctor who is experienced with anticancer drugs.
The patient must have a confirmed activating mutation of the EGFR-TK prior to starting of first-line pms-ERLOTINIB monotherapy.
Erlotinib has not been studied in patients with severely reduced liver function.
Erlotinib has not been studied in patients with severely reduced kidney function.
Serious side effects that have been reported with erlotinib include: liver failure, including fatal cases; gastrointestinal perforation (a hole through the wall of the stomach or small intestine, or large bowel), including fatal cases.
Before using pms-ERLOTINIB, talk to the doctor or pharmacist if: there are liver problems; there are kidney problems; there are gastrointestinal ulcers (bleeding of the stomach or intestines) or diverticular disease; there are cataracts, there had been cataract surgery, or wearing contact lenses; there is lung disease; smoking tobacco; planning to become pregnant; planning to breastfeed; told by the doctor that some sugars cannot be tolerated.
Smoking tobacco may reduce pms-ERLOTINIB blood level.

Breastfeeding should be avoided while being treated with pms-ERLOTINIB.
Avoid pregnancy while being treated with pms-ERLOTINIB. If the patient is a woman who could become pregnant, adequate contraception must be used during treatment and for at least 2 weeks after taking the last tablet. If the patient becomes pregnant while being treated with pms-ERLOTINIB, the doctor who will decide if the treatment should be continued must be immediately informed.

Like all medicines, pms-ERLOTINIB can have side effects.
The most common side effects (more than 5 out of 10 patients): rash; diarrhea.
If diarrhea occurs, drink plenty of water throughout the day to reduce the risk of dehydration. If having difficulty drinking liquid due to severe nausea/vomiting, please call the doctor immediately to be assessed for possible dehydration, low potassium levels and kidney failure.
Very common side effects (more than 1 out of 10 patients): tiredness, loss of appetite, difficulty in breathing, cough, infection, nausea, vomiting, mouth irritation, stomach pain, itching, dry skin, eye irritation.
Common side effects (less than 1 out of 10 patients): Bleeding from the stomach or the intestines; Abnormal blood tests for the liver function; Headaches and dizziness; Hair and nail changes; Acne or other red or pink little bumps at hair follicles.
Hair and nail changes: They included inflammatory reactions around the fingernail (common), excess body and facial hair of a male distribution pattern (uncommon), eyelash and eyebrow changes (uncommon), and brittle and lose nails (uncommon).
Contact the doctor as soon as possible if suffering from any of the previously mentioned side effects.
Uncommon serious side effects (less than 1 out of 100 patients): Interstitial lung disease, a rare form of lung inflammation and can have a fatal outcome in some cases; Gastrointestinal bleeding or perforation (a hole through the entire wall of stomach, intestine, or bowel); Corneal perforation, the risk is higher in patients who have had cataract surgery or wear contact lenses; severe skin reactions (Stevens-Johnson Syndrome).
Interstitial lung disease: If symptoms such as sudden difficulty of breathing associated with cough or fever have developed, contact the doctor immediately.
If any side effects not mentioned in this monograph are noticed, please inform the doctor or pharmacist.

Tell the doctor if taking other drugs, including non-prescription and natural health products, because they may speed up or slow down the breakdown of pms-ERLOTINIB. For example: Antifungals (such as ketoconazole, fluconazole); Calcium channel blockers (such as diltiazem, verapamil); Macrolide antibiotics (such as erythromycin, clarithromycin); Fluoroquinolone antibiotics (such as ciprofloxacin, norfloxacin); Other antibiotics such as rifampin; Some antivirals (such as ritonavir, indinavir); Grapefruit juice; St. John's Wort; Anticonvulsants such as carbamazepine and phenytoin; Blood thinners such as warfarin; Medications which reduce acid in the stomach (such as omeprazole, ranitidine); Statin drugs to treat high cholesterol.

Store below 25°C.

Targeted Cancer Therapy

L01EB02 - erlotinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

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