IRESSA (GEFITINIB)

Iressa is a brand name for a generic, anti-cancer drug called gefitinib, supplied by AstraZeneca company. This prescription medicine got FDA approval in 2015 for the first-line monotherapy of metastatic non-small cell lung cancer (NSCLC) with tumors having epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test, in adults. Doctors give it to reduce the growth and spread of cancer cells that have locally advanced or turned metastatic within the body.

Iressa tablets contain gefitinib as its active ingredient and the following inactive ingredients at its core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, and povidone. The composition of brown film-coating of the tablets includes polyethylene glycol 300, hypromellose, red ferric oxide, titanium dioxide, and yellow ferric oxide. Gefitinib is a free base, a kinase inhibitor, chemically designated as 4-Quinazolinamine N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl) propoxy].

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Iressa belongs to the pharmacological class: Epidermal Growth Factor Receptor Inhibitor. Epidermal growth factor receptor inhibitors are drugs that bind to certain portions of the EGFR protein found on the surface of some cells causing cells to divide on binding of EGFR to it. Iressa is a tyrosine kinase inhibitor that goes and unites the tyrosine kinase domain in the epidermal growth factor receptor to make it inactive.

Iressa tablets come in single strength: 250 mg. These tablets are round, biconvex, brown film-coated with debossing of “Iressa 250” on one side.

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Iressa is given by doctors to treat non-small cell lung cancer (NSCLC) with EGFR mutations. It is the most common lung cancer type. Its subtypes are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. The signs and symptoms of this condition are persistent cough or hoarseness; coughing up rust-colored mucus or blood; and angina that gets worse when taking deep breaths, laughing, or coughing.

The suggested dosage for Iressa is 250 mg once a day, taken through the mouth, with or without food, until disease progression or intolerable toxicity. It is also advised to follow the healthcare provider's instructions to gain optimal therapeutic outcomes. One must take Iressa consistently at the same time daily. If the patient misses a dose, then don't double up; resume with the regular schedule.

Iressa is available in the form of tablets for oral administration. Swallow the tablet as a whole with a glass of water. If having trouble swallowing, dissolve the tablet in half a glass of water and drink it as soon as it completely dissolves. Oral administration avoids the discomfort associated with certain invasive procedures, enhancing the overall patient experience. It is important to consult a healthcare professional to determine the most suitable form of administration for a given medication based on individual circumstances.

Commonly reported side effects of taking Iressa include:

• Diarrhea
• Vomiting
• Nausea or sick feeling.
• Reduced appetite.
• Nail disorders.
• Weakness, fatigue, or difficulty sleeping.
• Inflamed mouth lining (Stomatitis).
• Dry eye, skin, or mouth.
• Swelling of the eyelids.
• Skin reactions like weakness and pustular rash.
• Increased level of a liver enzyme (alanine aminotransferase) in the blood.

Seek immediate medical care if experience any of the following side effects:

• Abnormal bleeding- coughing up blood or blood in the urine.
• Pain or irritation in the eyes.
• Swollen feet or ankles.
• Allergic reactions.
• Stomach bleeding.
• Sudden or ongoing diarrhea.
• Liver issues.
• Serious eye and heart symptoms.
• Severe skin reaction.

Some of the drugs known to interact with Iressa include:

• Tricyclic Antidepressants
• Rifampicin
• Histamine H2 receptor agonists
• Antacids
• Azole antifungals
• Phenytoin
• Proton pump inhibitors
• Warfarin.

Iressa is not safe for intake by:

• Anyone having known hypersensitivity to gefitinib or any other component of Iressa tablets.
• Breastfeeding mothers
• Pregnant women.
• People who are suffering from liver disease, kidney disease, breathing issues long-term disease, or vision problems.
• Those who are taking blood thinners.
• Small children.

If taking Iressa tablets, it is important to take the following precautions:

• Avoid intake of antacids or stomach acid reducers such as Nexium, Prilosec, Pepcid, Zantac, Prevacid, and others within 6-12 hours beforehand or after taking the dose.
• Avoid intake of grapefruit or grapefruit juice throughout the treatment course as it can raise Gefitinib in the blood to a harmful level.
• Inform the doctor beforehand about the current intake of medications and supplements and if having any illnesses.
• Tell the doctor if you intend to get pregnant or nurse the child while taking this medication. Conceiving a child or breastfeeding must be avoided during the treatment course.
• Discuss with the doctor about fertility preservation that can be taken before starting taking the medication as Gefitinib may have an antifertility effect.
• Avoid doubling or skipping doses. A missed dose can be taken within 12 hours of missing the dose or else skipped and taken on the usual dose timing.

• Store Iressa tablets at a controlled room temperature of 20-25°C in a dry, cool place.
• Keep Iressa away from heat, moisture, and direct sunlight.

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