Description
Xovoltib 50mg (Afatinib Dimaleate) Tablets
Xovoltib 50mg Afatinib contains afatinib dimaleate and belongs to a group of medicines called kinase inhibitors. Healthcare professionals use afatinib for certain types of metastatic non-small cell lung cancer (NSCLC) when the tumor has specific molecular characteristics.
Importantly, afatinib treatment requires medical supervision and appropriate testing. Therefore, patients should use Xovoltib 50mg only according to the instructions of a qualified healthcare professional.
Product information: Xovoltib 50mg is supplied as 28 film-coated tablets (7 x 4) according to the packaging shown on this product page.
Xovoltib 50mg Afatinib Uses
Xovoltib 50mg Afatinib is an afatinib medicine used for certain forms of non-small cell lung cancer. Afatinib blocks signals from specific receptors that can help cancer cells grow and multiply.
In the United States, afatinib tablets are indicated for first-line treatment of metastatic NSCLC with certain non-resistant EGFR mutations detected by an FDA-approved test. Afatinib also has an indication for metastatic squamous NSCLC that has progressed after platinum-based chemotherapy.
Afatinib for Lung Cancer
Afatinib lung cancer treatment focuses on specific types of metastatic NSCLC. Before treatment, the healthcare professional may arrange molecular testing to determine whether the tumor has an EGFR mutation for which afatinib may be appropriate.
Therefore, afatinib should not be used as a general treatment for every type of lung cancer. The cancer type, mutation status, previous treatment, overall health, and other medicines can all affect treatment decisions.
What Is Afatinib Dimaleate?
Afatinib dimaleate is the salt form used to provide afatinib as an oral medicine. Afatinib belongs to the kinase inhibitor class and works by blocking certain signaling pathways involved in cancer-cell growth.
As a result, afatinib can slow or inhibit signaling that contributes to the growth and spread of certain cancer cells. MedlinePlus describes afatinib as a kinase inhibitor used for certain types of metastatic non-small cell lung cancer.
How Does Afatinib Work?
Afatinib blocks the activity of certain proteins involved in cancer-cell signaling. These proteins belong to the epidermal growth factor receptor (EGFR) family and related signaling pathways.
Consequently, blocking these signals can reduce the growth and multiplication of certain cancer cells. However, the medicine works only for appropriate cancer types and molecular profiles.
For this reason, your healthcare professional may use an FDA-approved test to identify relevant EGFR mutations before starting treatment.
How to Take Xovoltib 50mg
Take Xovoltib 50mg exactly as prescribed by your oncologist or other qualified healthcare professional. Do not change the dose, stop treatment, or restart treatment without medical advice.
Afatinib is generally taken once daily on an empty stomach. U.S. prescribing information recommends taking afatinib at least 1 hour before or 2 hours after a meal.
- Take the tablet at approximately the same time each day.
- Swallow the tablet according to your healthcare professional’s instructions.
- Take it on an empty stomach.
- Do not change your prescribed dose yourself.
- Continue treatment only as directed by your healthcare professional.
What If You Miss a Dose?
If you miss a dose, follow your prescription instructions. Current U.S. prescribing information advises that a missed dose should not be taken if the next scheduled dose is within 12 hours. Instead, follow your normal schedule.
Do not take a double dose to make up for a missed tablet.
Afatinib Price
The afatinib price can vary depending on the manufacturer, tablet strength, pack size, availability, pharmacy, and destination country.
Xovoltib 50mg is presented on this page as a 28-tablet pack. However, pricing and availability can change. Therefore, check the current product listing for the latest price and availability information.
You can also browse our online medicine shop or explore our cancer medicine category.
Xovoltib 50mg Side Effects
Like other prescription medicines, afatinib can cause side effects. The type and severity can vary between individuals.
Common Afatinib Side Effects
Commonly reported adverse reactions include:
- Diarrhea
- Skin rash or acneiform dermatitis
- Inflammation or sores in the mouth
- Dry skin
- Decreased appetite
- Nausea
- Vomiting
- Itching
- Nail problems
- Changes around the fingernails or toenails
U.S. prescribing information identifies diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, and pruritus among the most common adverse reactions.
Serious Afatinib Side Effects
Some reactions require prompt medical attention. Therefore, contact your healthcare professional immediately if you experience severe or persistent symptoms.
- Severe or persistent diarrhea
- Severe skin reactions
- Difficulty breathing or new breathing problems
- Severe eye pain, redness, or vision changes
- Yellowing of the skin or eyes
- Unusual bleeding or bruising
- Severe abdominal pain
- Signs of dehydration
- Rapid or irregular heartbeat
Afatinib labeling includes warnings for diarrhea, serious skin reactions, interstitial lung disease, liver toxicity, gastrointestinal perforation, keratitis, and embryo-fetal toxicity.
Xovoltib 50mg Precautions
Before starting afatinib, tell your healthcare professional about your complete medical history and all medicines you take.
- Tell your healthcare professional if you have liver disease.
- Tell them if you have kidney problems.
- Report previous lung or breathing problems.
- Tell them about existing eye problems, including dry eyes.
- Tell them if you have heart problems.
- Tell them about all prescription and non-prescription medicines.
- Tell them about vitamins, supplements, and herbal products.
- Tell them if you are pregnant, planning a pregnancy, or could become pregnant.
- Tell them if you are breastfeeding.
In addition, afatinib can make the skin more sensitive to sunlight. Therefore, healthcare professionals may recommend limiting unnecessary sun exposure and using appropriate sun protection.
Afatinib Drug Interactions
Afatinib can interact with other medicines. Therefore, provide your doctor or pharmacist with a complete medication list before starting treatment.
Medicines That May Interact With Afatinib
- P-glycoprotein (P-gp) inhibitors
- P-glycoprotein (P-gp) inducers
- St. John’s wort
- Other prescription medicines
- Over-the-counter medicines
- Vitamins and supplements
- Herbal products
Current U.S. prescribing information explains that P-gp inhibitors can increase afatinib exposure, while chronic oral P-gp inducers can decrease afatinib exposure. Therefore, healthcare professionals may adjust treatment when necessary.
Do not start, stop, or change another medicine without discussing it with your healthcare professional.
Afatinib Warnings
Prescription medicine: Xovoltib 50mg should be used only under appropriate medical supervision.
Diarrhea: Severe diarrhea can cause dehydration and may require treatment interruption or dose adjustment. Contact your healthcare professional if diarrhea becomes severe or persistent.
Lung warning: Afatinib can cause serious lung inflammation. Seek urgent medical attention if you develop new or worsening breathing problems, cough, or shortness of breath.
Skin warning: Severe blistering, peeling, or other serious skin reactions require immediate medical evaluation.
Eye warning: Eye inflammation and keratitis can occur. Report eye pain, redness, excessive tearing, or vision changes promptly.
Liver warning: Afatinib can cause liver toxicity. Your healthcare professional may order blood tests to monitor liver function.
Pregnancy warning: Afatinib can harm a developing fetus. People who are pregnant or may become pregnant should discuss effective contraception and pregnancy risks with their healthcare professional before treatment.
Breastfeeding: Do not breastfeed during afatinib treatment and for the period recommended by your healthcare professional after treatment.
Xovoltib 50mg and U.S. FDA Information
Important for U.S. customers: Afatinib is an FDA-approved medicine for specific indications. However, FDA approval of afatinib does not automatically mean that every brand, manufacturer, or strength has FDA approval in the United States.
Current U.S. labeling for afatinib tablets lists 20mg, 30mg, and 40mg tablet strengths. The recommended starting dosage in the current U.S. labeling is 40mg once daily for the indicated patients. Therefore, this page does not represent Xovoltib 50mg as an FDA-approved U.S. strength.
In July 2026, the FDA announced approval of the first generic versions of Gilotrif (afatinib) tablets for specified metastatic NSCLC indications. The FDA announcement also emphasizes the importance of appropriate EGFR mutation testing for the relevant indication.
For authoritative U.S. information, review the MedlinePlus Afatinib Drug Information and the current U.S. afatinib prescribing information on DailyMed.
You can also review the FDA announcement regarding generic afatinib tablets.
Xovoltib 50mg Substitutes
Afatinib substitutes should only be considered by a qualified healthcare professional. The appropriate alternative depends on the cancer type, EGFR mutation status, previous treatment, medical history, and other medicines.
Other targeted cancer medicines may contain different active ingredients and may work through different mechanisms. Therefore, do not replace afatinib with another cancer medicine without advice from your oncologist.
For other oncology products, visit our cancer medicines collection or shop.
Frequently Asked Questions About Xovoltib 50mg
What is Xovoltib 50mg?
Xovoltib 50mg is a product containing afatinib dimaleate. Afatinib belongs to the kinase inhibitor class and is used for certain types of metastatic non-small cell lung cancer.
What is Xovoltib 50mg used for?
Xovoltib 50mg contains afatinib, which may be used for certain forms of metastatic NSCLC when the patient meets the appropriate clinical and molecular criteria. A healthcare professional should determine whether afatinib is appropriate.
What is afatinib used for in lung cancer?
Afatinib can treat certain metastatic NSCLC cases, including tumors with specified non-resistant EGFR mutations. It also has a U.S. indication for certain metastatic squamous NSCLC cases after platinum-based chemotherapy.
What are the most common afatinib side effects?
Common side effects include diarrhea, rash, acneiform dermatitis, mouth inflammation, dry skin, decreased appetite, nausea, vomiting, itching, and nail problems.
How should afatinib be taken?
Afatinib is generally taken once daily on an empty stomach. U.S. prescribing information recommends taking it at least 1 hour before or 2 hours after food. Always follow your individual prescription.
Is Xovoltib 50mg FDA approved in the USA?
Do not assume that Xovoltib 50mg has U.S. FDA approval simply because afatinib is an FDA-approved active ingredient. Current U.S. labeling lists afatinib tablet strengths of 20mg, 30mg, and 40mg. Therefore, customers should verify the regulatory status of the specific brand and strength before purchasing or using it in the United States.
Can afatinib cause serious side effects?
Yes. Afatinib can cause serious diarrhea, skin reactions, lung inflammation, liver toxicity, gastrointestinal perforation, keratitis, and fetal harm. Therefore, patients should remain under appropriate medical supervision during treatment.
Related Cancer Medicines
For additional oncology products, visit our Cancer Medicines category. You can also browse the complete medicine shop.
U.S. Purchase and Regulatory Disclaimer
U.S. customers: Xovoltib 50mg is a prescription cancer medicine. Availability, dispensing, importation, and use of prescription medicines in the United States are subject to applicable federal and state laws.
We do not represent that Xovoltib 50mg (Afatinib Dimaleate) Tablets are FDA-approved for sale or dispensing in the United States under the Xovoltib brand or 50mg strength.
FDA approval of an active ingredient or another afatinib product does not automatically establish FDA approval of every brand, manufacturer, formulation, or strength.
Customers should consult a licensed healthcare professional and verify the product’s regulatory status, prescription requirements, and legal eligibility before placing an order.
Do not purchase or use this medicine without appropriate medical advice and a valid prescription where required.
Medical Disclaimer
This product information is provided for educational purposes only. It does not replace professional medical advice, diagnosis, or treatment.
Always follow the instructions provided by your oncologist, doctor, or pharmacist. Product information, availability, pricing, packaging, and regulatory requirements can vary by country and may change over time.
If you experience severe diarrhea, difficulty breathing, severe skin reactions, vision changes, severe abdominal pain, yellowing of the skin or eyes, or another serious symptom, seek urgent medical attention.
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