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Giotrif Information

Giotrif (afatinib dimaleate) tablets are used for the treatment of non-small cell lung cancer (NSCLC). It is specifically indicated for:
• First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations as detected by an FDA-approved test.
• Patients with metastatic squamous NSCLC who have progressed after platinum-based chemotherapy.

Afatinib is a kinase inhibitor that works by irreversibly binding to and inhibiting the activity of the ErbB family of receptors, including EGFR (ErbB1), HER2 (ErbB2), and ErbB4 (ErbB4). In NSCLC, particularly in patients with specific EGFR mutations, these receptors can become overactive, resulting in uncontrolled growth and survival of cancer cells. By blocking these receptors, Giotrif helps to inhibit the signalling pathways that promote cancer cell proliferation. This leads to a reduction in tumour size and progression of cancer. Giotrif delivers the active substance afatinib, which specifically targets these ErbB family receptors, helping to manage NSCLC in patients with specific mutations or after prior chemotherapy.

Giotrif Side Effects

The most common side effects of Giotrif may include diarrhea, rash or acne, stomatitis (mouth sores), paronychia (nail inflammation), cheilitis (lip inflammation), indigestion, dehydration, dry skin, decreased appetite, weight loss, pruritus (itching), fatigue, and nausea. Call your doctor right away if you have any of the serious side effects, such as:

• Bloody diarrhea
• Chest pain
• Interstitial Lung Disease (ILD)/Pneumonitis (lung problems): new or worsening cough, shortness of breath, fever, difficulty breathing
• Keratitis (eye inflammation): eye pain, blurred vision, dry eyes, eye irritation, or sensitivity to light
• Kidney problems (renal impairment): changes in the amount of urine, swelling in your ankles or feet, confusion, fatigue
• Liver problems: yellowing of your skin or the whites of your eyes, dark urine, unusual tiredness, loss of appetite, nausea or vomiting, pain on the upper right side of your stomach area, bleeding or bruising more easily than normal
• Serious cardiovascular events, including stroke and heart attack (rare but serious)
• Severe diarrhea, especially if accompanied by dehydration or kidney problems. This can be severe and require immediate medical attention.
• Severe Rash/Acne: widespread skin redness, peeling skin, blistering, or severe itching.
• Signs of an allergic reaction, such as rash, breathing difficulties, itching or swelling of the face, tongue, or throat

Giotrif Precautions

Do not use Giotrif if you are allergic to afatinib or other ingredients in this medication. Before you start using this medication, tell your doctor about your medical history, including if you have liver problems, kidney problems, lung or breathing problems (other than lung cancer), heart problems, eye problems, or a history of severe skin reactions. Tell your doctor about all your medications, including prescription, OTC, herbal supplements, and vitamins. There may be a drug interaction between Giotrif and other medications, such as P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine A, ketoconazole, erythromycin, verapamil, quinidine, ritonavir) which can increase afatinib exposure, and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort) which can decrease afatinib exposure. These interactions can significantly alter the levels of Giotrif in your body. Inform your doctor if you are pregnant or planning to become pregnant before using Giotrif. Based on findings from animal studies and its mechanism of action, Giotrif can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment and for at least 1 month after the final dose. Inform your doctor if you are breastfeeding or planning to breastfeed before using Giotrif. The safety of afatinib in breastfeeding is unknown. Do not breastfeed during treatment with Giotrif and for 1 month after the last dose due to the potential for severe adverse reactions in breastfed infants. Do not use this medicine in children without talking to your doctor. The safety and effectiveness of Giotrif in children have not been established.

Use your medicine exactly as prescribed by your doctor. Giotrif comes as a tablet. Swallow the tablet whole; do not chew or crush it. You must take Giotrif at least 1 hour before or 2 hours after a meal. The recommended dosage is 40 mg orally once daily. If a dose of Giotrif is missed, it should be taken as soon as possible on the same day. If vomiting occurs after taking a dose, do not take an additional dose; instead, continue with the next scheduled dose. Take Giotrif at the same time(s) each day to help you remember. Your doctor may order regular blood tests to monitor your liver function, kidney function, and other parameters and adjust your dosage as needed based on side effects. Your doctor may also monitor for skin reactions, diarrhea, and lung symptoms. Your doctor may withhold, reduce the dose, or permanently discontinue Giotrif based on the severity of adverse reactions. Continue treatment until disease progression or unacceptable toxicity. Store Giotrif at room temperature, away from moisture and heat. Keep all medicines out of reach of children.

Do I need a prescription to order Giotrif?

Yes, a prescription is required from your physician to order Giotrif.