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U.S. Food and Drug Administration (FDA) – Afatinib Prescribing Information
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201292s019lbl.pdf -
European Medicines Agency (EMA) – Afatinib Product Information
https://www.ema.europa.eu -
National Cancer Institute – Afatinib Drug Information
https://www.cancer.gov -
Drugs.com – Afatinib Drug Information
https://www.drugs.com -
ClinicalTrials.gov – Afatinib Clinical Studies
https://clinicaltrials.gov
Written by:
Dr. Sophie Reynolds
Dr. Sophie Reynolds is a board-certified medical doctor specializing in internal medicine. With over a decade of experience in patient care and medical writing
Xovoltib 40 mg Tablet
Brand Name:   Xovoltib
Molecule:   Afatinib
Strength:   40 mg
Quantity:   28 Tablets
Form:   Tablet
Packaging Type:   Strip
Manufacturer/Marketed By:   Boehringer Ingelheim India Private Limited
Country of Origin:   Germany
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Description
Xovoltib 40 mg Tablets are manufactured by Boehringer Ingelheim India pvt ltd in Germany and contain 40 mg of Afatinib per tablet. Each Blister pack includes 28 tablets per bottle, making Xovoltib 40 mg Tablets an effective option for Lung Cancer . Prescription Required from your healthcare provider to purchase Afatinib medicine. Indogenmed deals in all type of generic Afatinib medicine.
Benefits
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Targets EGFR signaling pathways involved in cancer cell growth
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Precision oncology therapy guided by genetic mutation testing
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Oral targeted treatment suitable for outpatient use
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May help slow disease progression in certain patients with EGFR-mutated NSCLC
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Part of modern targeted therapy strategies for lung cancer
Indications and Usage
Xovoltib (afatinib) may be prescribed for:
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Metastatic non-small cell lung cancer (NSCLC) with EGFR mutation
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Patients with tumors confirmed to have EGFR exon 19 deletion or exon 21 (L858R) substitution mutations
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First-line treatment of EGFR mutation–positive advanced lung cancer
Treatment decisions are based on molecular diagnostic testing and clinical evaluation.
How it Works
Afatinib works by inhibiting the tyrosine kinase activity of the epidermal growth factor receptor (EGFR) and other members of the ErbB receptor family. These receptors regulate signaling pathways that control cell growth, division, and survival.
In certain lung cancers, mutations in the EGFR gene cause these pathways to remain continuously active, leading to uncontrolled tumor growth. Afatinib blocks these receptors and disrupts abnormal signaling, which may help reduce cancer cell proliferation and slow disease progression when used as prescribed and monitored by an oncology specialist.
Dosage & Administration
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Xovoltib tablets are taken orally once daily, unless directed otherwise by a healthcare professional.
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Tablets should be taken on an empty stomach (at least 1 hour before or 2 hours after meals).
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Tablets should be swallowed whole with water.
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Dose adjustments may be required depending on treatment tolerance and side effects.
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Treatment duration is determined by the oncologist based on response and clinical condition.
Side Effects
Common side effects
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Diarrhea
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Skin rash or acne-like rash
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Mouth sores (stomatitis)
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Dry skin
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Decreased appetite
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Nail infections or nail changes
Serious side effects
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Severe diarrhea and dehydration
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Lung inflammation (interstitial lung disease)
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Liver function abnormalities
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Severe skin reactions
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Eye problems such as keratitis
Patients should contact their healthcare provider if severe symptoms occur.
Warning and Precaution
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Risk of severe diarrhea, which may lead to dehydration
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Possible interstitial lung disease (lung inflammation)
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Liver function abnormalities may occur
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Skin reactions and photosensitivity
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Eye disorders such as keratitis
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Inform healthcare providers about all medications and supplements being used
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Pregnancy should be avoided during treatment
Patient Guidance
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Take the medicine exactly as prescribed by your oncologist
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Attend scheduled medical monitoring and laboratory tests
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Report symptoms such as severe diarrhea, breathing difficulty, or skin reactions
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Maintain proper hydration during treatment
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Inform your doctor about all medications and supplements you take
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Do not stop treatment without consulting your healthcare provider
Clinical Trial & Approvals
Afatinib has been evaluated in multiple clinical trials for patients with EGFR mutation–positive non-small cell lung cancer. The LUX-Lung clinical trials demonstrated improved progression-free survival in certain patients compared with earlier therapies. Based on these results, afatinib received approvals from regulatory agencies including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for specific lung cancer indications.
References
Prescription & documentation note
Xovoltib 40 mg Tablet is typically supplied against a valid prescription. For international orders, patients may need to provide documentation such as a licensed physician’s prescription, identification, and country-specific import documentation, depending on destination regulations. MedsMonk may assist with documentation guidance where applicable.
FAQ
What is Xovoltib 40 mg Tablet used for?+
It is used in the treatment of EGFR mutation–positive non-small cell lung cancer.
What is the active ingredient in Xovoltib?+
The active ingredient is afatinib, a tyrosine kinase inhibitor.
Is genetic testing required before using afatinib?+
Yes. Treatment usually requires confirmation of EGFR mutation in the tumor.
How is Xovoltib taken?+
It is typically taken once daily on an empty stomach, unless directed otherwise by a doctor.
Can Xovoltib cause diarrhea?+
Yes. Diarrhea is a common side effect and should be monitored during treatment.
Is Xovoltib chemotherapy?+
No. It is a targeted cancer therapy, not traditional chemotherapy.
Is a prescription required for Xovoltib?+
Yes. It is a prescription-only oncology medicine.
How should Xovoltib tablets be stored?+
Store at room temperature, away from moisture and excessive heat.
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