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MAR-AFATINIB is a brand name for Afatinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................ 3 CONTRAINDICATIONS ..................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions • MAR-AFATINIB should be administered under the supervision of a qualified health professional who is experienced in the treatment and management of patients with cancer. The following are clinically significant and/or life-threatening adverse events: • Diarrhea which can result in acute renal insufficiency and severe electrolyte imbalance (see Gastrointestinal section below, DOSAGE AND ADMINISTRATION).
• Gastrointestinal perforation, including fatal cases (see Gastrointestinal section below) • Severe skin toxicities (see Skin section below) • Interstitial Lung Disease (ILD) or ILD-like events, including fatalities (see Respiratory section below) • Hepatotoxicity, including uncommon events of hepatic failure with fatalities (see Hepatotoxicity section below) General MAR-AFATINIB contains lactose.
Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Ocular adverse reactions, including blurred vision and keratitis, have been reported in patients treated with afatinib and may impact patients’ ability to drive or operate machines.
Carcinogenesis and Mutagenesis Carcinogenicity studies have not been conducted with afatinib. Afatinib demonstrated no significant mutagenic or genotoxic potential in vitro or in vivo under biological conditions (see TOXICOLOGY, Genotoxicity).
Cardiovascular Left ventricular function Afatinib inhibits HER2 and left ventricular dysfunction has been associated with HER2 inhibition. In the pivotal trial, all patients in the afatinib arm were measured for left ventricular ejection fraction (LVEF) at baseline and during the study; however routine LVEF monitoring was not compulsory for patients in the chemotherapy arm.
9%) patients had LVEF decrease greater than 20%, among which 3 patients experienced LVEF decrease below the lower limit of normal for the particular study site. Afatinib has not been studied in patients with abnormal LVEF or those with significant cardiac history.
In patients with cardiac risk factors and those with conditions that can affect left ventricular function, cardiac monitoring, including an assessment of LVEF at baseline and during MAR-AFATINIB treatment, should be considered. In patients who develop relevant cardiac signs/symptoms during treatment or an ejection fraction below the institution’s lower limit of normal, cardiac consultation as well as MAR-AFATINIB treatment interruption or discontinuation should be considered.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Afatinib in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Gastrointestinal Diarrhea Diarrhea, including severe diarrhea, has been reported during treatment with afatinib (see ADVERSE REACTIONS). Diarrhea has resulted in dehydration, clinically significant hypokalemia and/or renal impairment, and in rare cases fatal outcomes (see ADVERSE REACTIONS).
8% were CTCAE Grade 3 diarrhea. Diarrhea usually occurred within the first 2 weeks of treatment. Grade 3 diarrhea most frequently occurred within the first 6 weeks of treatment. 6% of patients. 1% of patients, respectively. 7%) were treated with anti-propulsives.
Close monitoring and proactive management of diarrhea is essential for successful MAR- AFATINIB treatment. Early and appropriate intervention can prevent the development of more severe diarrhea. In the protocol of LUX-Lung 3 study, it was recommended that loperamide should be made available at the start of MAR-AFATINIB therapy and kept with the patient at all times.
, 20 mg loperamide. • Patients should be advised to avoid lactose-containing products or any foods known to aggravate diarrhea. 5 L/m2/day plus equivalent of actual fluid loss) and electrolyte replacement has to be ensured for CTCAE Grade 2 and 3 diarrhea.
• For CTCAE Grade 3 diarrhea or CTCAE Grade 2 diarrhea lasting ≥ 48 hours despite adequate anti-diarrheal treatment, MAR-AFATINIB must be paused until recovery to CTCAE Grade ≤ 1. Upon recovery, MAR-AFATINIB should be resumed at a reduced dose according to the dose reduction scheme.
PrMAR-AFATINIB Product Monograph Page 6 of 35 • If diarrhea does not resolve to CTCAE ≤ 1 within 14 days despite optimal supportive care and MAR-AFATINIB treatment interruption, the patient must not receive further MAR- AFATINIB treatment.
, loperamide) is essential for successful MAR-AFATINIB treatment of patients. Antidiarrheal agents should be readily available to the patients so that treatment can be initiated at first signs of diarrhea and if necessary, their dose should be escalated to the highest recommended approved dose.
Antidiarrheal agents should be continued until loose bowel movements cease for 12 hours. Patients with severe diarrhea will require interruption and dose reduction or discontinuation of MAR-AFATINIB therapy (see DOSAGE AND ADMINISTRATION).
Patients should also be advised to drink an adequate amount of fluids to make up for the fluid lost through diarrhea. Patients who become dehydrated may require hospitalization and administration of intravenous […]