xovoltib 20mg tablet - Afatinib dimaleate (20mg) medicine

Xovoltib 20mg Tablet (Afatinib): Comprehensive Medicine Guide

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🏭 Boehringer Ingelheim 📦 Varies by brand 💊 Allopathy 📅 Updated: Oct 22, 2026
⚠️ Hepatotoxicity Risk ⚠️ Nephrotoxicity Risk 📋 Prescription Required 💊 Generic Available
Medically Reviewed
11 min read
Evidence: High
Reviewed by
SaathiMed Expert Panel | Oct 22, 2026
🩺
Medically Fact-Checked & Clinically Verified by SaathiMed Clinical Review Board
Clinical Reference Standards: CDSCO (Central Drugs Standard Control Organisation), Indian Pharmacopoeia (IP) & WHO | Last Updated: September 2026

When to Call Your Doctor IMMEDIATELY

  • Severe diarrhoea or vomiting leading to dehydration
  • New or worsening cough, shortness of breath, or fever
  • Yellowing of skin or eyes, dark urine, or abdominal pain
  • Eye pain, redness, blurred vision, or excessive tearing
  • Severe skin rash with blisters or peeling
  • Sudden severe abdominal pain, fever, and chills
  • Unusual bleeding or bruising
  • Swelling of face, lips, or throat

If experiencing severe symptoms, call emergency services immediately.

What is xovoltib 20mg tablet used for?

This medicine is a targeted therapy used to treat non-small cell lung cancer with specific EGFR mutations. It works by blocking proteins that help cancer cells grow. It is taken orally once daily.

  • Generic Name: Afatinib dimaleate (20mg)
  • Manufacturer: Boehringer Ingelheim
  • Form: Allopathy
  • Pregnancy Category: Consult doctor
  • Prescription Required: Yes

🇮🇳 xovoltib 20mg tablet के बारे में (Hindi Summary)

उपयोग: यह दवा एफिनिब (afatinib) नामक सक्रिय तत्व से बनी है और यह 20 मिलीग्राम की गोली के रूप में उपलब्ध है। यह मुख्य रूप से उन फेफड़ों के कैंसर (नॉन-स्मॉल सेल लंग कैंसर) के इलाज के लिए दी जाती है जिनमें EGFR जीन में विशिष्ट उत्परिवर्तन (म्यूटेशन) होता है। यह दवा कैंसर कोशिकाओं के विकास को रोकने में मदद करती है। यह केवल योग्य कैंसर विशेषज्ञ (ऑन्कोलॉजिस्ट) की देखरेख में ही ली जानी चाहिए।

साइड इफेक्ट्स: आम दुष्प्रभावों में दस्त, दाने, सूखी त्वचा, मुँह के छाले और नाखूनों में बदलाव शामिल हैं। गंभीर दुष्प्रभावों में गंभीर दस्त, निर्जलीकरण, फेफड़ों में सूजन, यकृत की समस्या और आंखों की समस्या हो सकती है। यदि आपको गंभीर दस्त, उल्टी, या निर्जलीकरण के लक्षण महसूस हों तो तुरंत डॉक्टर से संपर्क करें।

सुरक्षा सलाह: इस दवा को डॉक्टर के बताए अनुसार ही लें। गोली को पानी के साथ पूरा निगलें, चबाएं नहीं। इसे भोजन के साथ या बिना भोजन के ले सकते हैं, लेकिन हर दिन एक ही समय पर लें। चकोतरा (ग्रेपफ्रूट) और उसके जूस से बचें। अन्य दवाओं के बारे में डॉक्टर को बताएं। गर्भावस्था और स्तनपान के दौरान इस दवा का सेवन न करें। इसे बच्चों की पहुंच से दूर रखें।

💡 Did You Know? India is the largest provider of generic medicines globally, supplying over 50% of global vaccine demand.

💊 xovoltib 20mg tablet Uses & Benefits

[{"condition":"EGFR mutation-positive non-small cell lung cancer (NSCLC)","description":"First-line treatment for patients with locally advanced or metastatic NSCLC whose tumours have activating EGFR mutations (e.g., exon 19 deletions or exon 21 L858R substitution).","evidence":"Well-established"},{"condition":"Squamous cell carcinoma of the lung","description":"Treatment of patients with advanced squamous NSCLC that has progressed after platinum-based chemotherapy.","evidence":"Well-established"},{"condition":"Head and neck squamous cell carcinoma","description":"Sometimes used off-label for recurrent or metastatic head and neck cancer.","evidence":"Limited"}]

Off-label uses: [{"condition":"HER2-positive breast cancer","description":"Investigated in clinical trials for HER2-positive breast cancer, but not approved for this indication.","evidence":"Limited"},{"condition":"Other EGFR-mutated cancers","description":"Occasionally used in other cancers with EGFR mutations, such as glioblastoma, but evidence is limited.","evidence":"Limited"}]

Primary treatment for: EGFR mutation-positive non-small cell lung cancer (NSCLC)

Also treats: Squamous cell carcinoma of the lung

📋 Drug Information

Generic Name(s)Afatinib dimaleate (20mg)
Brand Namexovoltib 20mg tablet
ManufacturerBoehringer Ingelheim
Packaging / FormVaries by brand (Allopathy)
Therapeutic ClassANTI NEOPLASTICS
Action ClassTyrosine kinase inhibitors
Route of AdministrationOral
StorageStore at room temperature between 20°C and 25°C (68°F to 77°F). Keep in the original container to protect from moisture and light. Do not refrigerate or freeze.
Shelf LifeRefer to the packaging for the expiry date. Do not use after the expiry date.
WHO GuidelineNot established from the available information.
ICMR GuidelineNot established from the available information.

👨‍⚕️ Doctor's Practical Tips

Evidence-based practical advice from experienced clinicians

1
Take this medicine at the same time each day to maintain consistent blood levels.
2
Monitor for diarrhoea and stay well hydrated; report severe diarrhoea immediately.
3
Use moisturisers and sunscreen to manage skin rash and dryness.
4
Report any new or worsening cough, shortness of breath, or fever, as this may indicate lung inflammation.
5
Avoid grapefruit and grapefruit juice, as they can increase the levels of this medicine in your body.
6
Inform your doctor about all other medicines, including over-the-counter drugs and herbal supplements.
7
Use effective contraception during treatment and for at least 2 weeks after the last dose.

🔍 Is This Medicine Right for Your Symptom?

Educational reference. Always consult a doctor for diagnosis.

✅
Chronic cough and shortness of breath
This medicine is used for lung cancer that may cause these symptoms.
Likely Use
❌
Skin rash
This medicine can cause skin rash as a side effect, not as a treatment.
Not Primary

🔬 How This Medicine Works (Pharmacology)

Pharmacokinetics

AbsorptionFollowing oral administration, this medicine is absorbed slowly, with peak plasma concentrations typically occurring 2 to 5 hours after ingestion. The absolute bioavailability is approximately 59% in healthy volunteers. Food does not significantly affect the extent of absorption, but a high-fat meal can reduce the peak plasma concentration by about 50% and delay the time to peak concentration by about 1 hour. Therefore, it is recommended to take this medicine consistently with or without food.
DistributionThis medicine is widely distributed in the body. The apparent volume of distribution is approximately 4500 L, indicating extensive tissue distribution. It is highly bound to plasma proteins, primarily albumin and alpha-1 acid glycoprotein.
Protein BindingApproximately 95% bound to plasma proteins.
MetabolismThis medicine is metabolised primarily by cytochrome P450 enzymes, mainly CYP3A4, and to a lesser extent by CYP2D6. It undergoes extensive metabolism, with no single metabolite accounting for more than 18% of the total. The metabolites are excreted mainly in faeces and urine.
Half-LifeThe terminal elimination half-life is approximately 28 to 37 hours.
ExcretionThis medicine is excreted mainly in faeces (85%) and urine (4%). The majority of the dose is eliminated as metabolites.
BioavailabilityThe absolute bioavailability is approximately 59%.
Onset of ActionThe onset of action is not immediate; it may take several days to weeks for clinical effects to become apparent. Tumour response is typically assessed after several weeks of treatment.
Peak Plasma Time2 to 5 hours after oral administration.
Duration of ActionThe duration of action is related to the half-life, with steady-state plasma concentrations achieved after 8 days of once-daily dosing. The pharmacological effect persists as long as the medicine is taken.

How It Works

This medicine is an irreversible inhibitor of the epidermal growth factor receptor (EGFR) family, including EGFR (ErbB1), HER2 (ErbB2), ErbB3, and ErbB4. It binds covalently to the ATP-binding site of these receptors, leading to irreversible inhibition of tyrosine kinase activity. This blocks autophosphorylation and downstream signalling pathways that promote cell proliferation, survival, and metastasis. By inhibiting these pathways, this medicine helps to slow or stop the growth of cancer cells that overexpress or have mutations in these receptors.

Mechanism Steps

1
Binding to EGFR family receptors: This medicine binds irreversibly to the ATP-binding site of EGFR, HER2, ErbB3, and ErbB4 receptors.
2
Inhibition of tyrosine kinase activity: The binding prevents autophosphorylation of the receptors and blocks downstream signalling.
3
Blockade of proliferation signals: This leads to inhibition of pathways such as MAPK and PI3K/AKT, which are involved in cell growth and survival.
4
Induction of apoptosis and reduced angiogenesis: Cancer cells undergo programmed cell death, and new blood vessel formation is suppressed.

💡 How to Take xovoltib 20mg tablet

Strength: 20 mg immediate-release tablet

1Take this medicine at the same time each day.
2Swallow the tablet whole with a glass of water.
3Do not crush, chew, or split the tablet.
4You can take it with or without food, but be consistent.
5If you miss a dose, follow the missed dose instructions.
6Do not take an extra dose to make up for a missed one.

Dosage Information

Adult DosageThe recommended dose of this medicine is 40 mg orally once daily for first-line treatment of EGFR mutation-positive NSCLC. For squamous NSCLC after platinum-based chemotherapy, the recommended dose is 40 mg once daily. For patients with severe renal impairment, the dose may be reduced to 30 mg once daily. Dose adjustments may be necessary for adverse reactions. The dose must be individualized by a qualified clinician based on indication, patient's condition, renal and hepatic function, and tolerability.
Pediatric DosagePediatric dosing is not established from available information. Consult a pediatric oncologist.
Elderly DosageNo specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients may be more susceptible to dehydration and renal impairment from diarrhoea. Monitor closely and adjust dose as needed based on tolerability and organ function.
Renal ImpairmentFor patients with severe renal impairment (creatinine clearance 15-29 mL/min), the recommended dose is 30 mg once daily. For patients with end-stage renal disease requiring dialysis, the dose is not established. Use with caution and monitor closely.
Hepatic ImpairmentNo dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. This medicine is not recommended for patients with severe (Child-Pugh C) hepatic impairment.
Maximum Daily DoseThe maximum recommended daily dose is 40 mg once daily. In case of severe renal impairment, the maximum dose is 30 mg once daily.

Dosage Timeline

🌅 Morning ❌ ☀️ Afternoon ❌ 🌆 Evening ❌ 🌙 Night ❌

🍽️ Food Timing Guide

With or without food
Take consistently
Food does not significantly affect absorption, but consistency helps maintain stable levels.
Grapefruit
Avoid
May increase drug levels and toxicity.

⏰ What to Do If You Miss a Dose

📌 Less than 12 hours since missed dose
→ Take the missed dose as soon as you remember.
💡 Continue with the regular schedule.
📌 More than 12 hours since missed dose
→ Skip the missed dose.
💡 Do not double dose to catch up.

⚠️ Side Effects of xovoltib 20mg tablet

✅ Common Side Effects

Diarrhoea (Very common (>10%))
Drink plenty of fluids and use anti-diarrhoeal medication as advised by your doctor. Contact your doctor if diarrhoea is severe or persistent.
Rash (Very common (>10%))
Use moisturisers and avoid sun exposure. Your doctor may prescribe topical steroids or antibiotics.
Dry skin (Common (1-10%))
Apply emollients regularly. Consult your doctor if it becomes severe.
Mouth sores (stomatitis) (Common (1-10%))
Maintain good oral hygiene and use alcohol-free mouthwash. Consult your doctor for pain relief.
Nail changes (paronychia) (Common (1-10%))
Keep nails clean and dry. Avoid trauma. Consult your doctor if signs of infection appear.

🚨 Serious Side Effects

Severe diarrhoea and dehydration (Uncommon (0.1-1%))
Seek immediate medical attention if you have severe diarrhoea, vomiting, or signs of dehydration such as dizziness or reduced urination.
Interstitial lung disease (ILD) (Rare (<0.1%))
Report new or worsening cough, shortness of breath, or fever immediately. This may require discontinuation of the medicine.
Liver toxicity (Uncommon (0.1-1%))
Report yellowing of skin or eyes, dark urine, or abdominal pain. Regular liver function tests are required.
Eye problems (keratitis) (Uncommon (0.1-1%))
Report eye pain, redness, blurred vision, or excessive tearing immediately.
Severe skin reactions (Stevens-Johnson syndrome) (Rare (<0.1%))
Seek immediate medical attention if you develop a severe rash with blisters, peeling skin, or sores in the mouth or eyes.

⚠️ Rare Side Effects

Pancreatitis
Report severe abdominal pain, nausea, and vomiting immediately.
Gastrointestinal perforation
Seek emergency care for sudden severe abdominal pain, fever, and chills.
Cardiac disorders (e.g., reduced ejection fraction)
Report shortness of breath, swelling of legs, or fatigue. Regular cardiac monitoring may be needed.

Consult your doctor if you experience any unusual symptoms.

🔬 Drug Interactions

Drug Severity Effect
Ketoconazole Major
Rifampicin Major
Verapamil Moderate
Omeprazole Moderate
Ranitidine Moderate
Antacids Minor
Warfarin Moderate
CYP3A4 inducers (e.g., carbamazepine) Major
CYP3A4 inhibitors (e.g., ritonavir) Major
P-gp inhibitors (e.g., quinidine) Moderate

🚨 Major Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)
  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin)
  • P-glycoprotein inhibitors (e.g., verapamil, quinidine)

⚡ Moderate Interactions

  • Proton pump inhibitors (e.g., omeprazole)
  • H2 receptor antagonists (e.g., ranitidine)

🍷 Alcohol Interaction

Alcohol may increase the risk of liver toxicity and gastrointestinal side effects. It is advisable to avoid or limit alcohol consumption while taking this medicine.

🔎 Check Your Other Medicines

Educational tool. Always confirm with your doctor or pharmacist.

🛡️ Safety & Warnings

🚫 Contraindications

["Known hypersensitivity to afatinib or any component of the formulation.","Severe hepatic impairment (Child-Pugh C).","Severe renal impairment (creatinine clearance

⚠️ Warnings & Precautions

["Diarrhoea: May be severe and lead to dehydration, renal failure, and electrolyte imbalances. Monitor and treat promptly.","Skin reactions: Severe bullous, blistering, or exfoliative skin conditions have been reported. Discontinue if life-threatening.","Interstitial lung disease (ILD): May be fatal. Discontinue if ILD is suspected.","Hepatotoxicity: Monitor liver function. Discontinue if severe.","Ocular disorders: Keratitis may occur. Refer to ophthalmologist if symptoms develop.","Gastrointestinal perforation: Discontinue if suspected.","Cardiac toxicity: Monitor LVEF in at-risk patients.","Embryo-fetal toxicity: Use effective contraception. Avoid pregnancy during treatment."]

🤱 Lactation Safety

It is not known whether this medicine is present in human milk. Because of the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment and for at least 2 weeks after the last dose.

💊 Overdose Management

There is no specific antidote for overdose with this medicine. In case of suspected overdose, discontinue the medicine and provide supportive care. Monitor vital signs and treat symptoms as they occur. Gastric lavage may be considered if ingestion is recent. Contact a poison control center or emergency department immediately.

⏰ Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose (within 12 hours), skip the missed dose and continue with your regular schedule. Do not take two doses at the same time to make up for a missed dose.

Additional Safety Advice

General Safety

Take this medicine exactly as prescribed by your oncologist. Do not change the dose or stop taking it without consulting your doctor. Swallow the tablet whole with a glass of water; do not crush or chew it. You can take it with or without food, but taking it with food may help reduce stomach upset. If you miss a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose. Avoid grapefruit and grapefruit juice while taking this medicine, as it can increase the levels of the medicine in your body. Inform your doctor about all other medicines you are taking, including over-the-counter drugs and herbal supplements. Use effective contraception during treatment and for at least two weeks after the last dose, as this medicine can harm an unborn baby. Do not breastfeed while taking this medicine. Store at room temperature away from moisture and heat. Keep out of reach of children.

👴 Special Considerations for Elderly

💡 For Patients Above 65

Elderly patients may be more susceptible to dehydration and renal impairment from diarrhoea. Monitor closely and adjust dose based on tolerability and organ function. No specific dose adjustment is recommended based on age alone.

🤰 Pregnancy Planning (TTC)

This medicine can harm an unborn baby. Women of childbearing potential should use effective contraception during treatment and for at least 2 weeks after the last dose. If you are planning to become pregnant, discuss with your doctor before starting this medicine. Men with female partners of childbearing potential should also use effective contraception during treatment and for at least 2 weeks after the last dose.

🏥 Post-Surgery Considerations

This medicine may affect wound healing and increase the risk of bleeding. Inform your surgeon that you are taking this medicine before any surgery. Your doctor may advise you to stop the medicine temporarily before and after surgery.

🦷 Dental Procedures

This medicine can cause mouth sores and increase the risk of bleeding. Inform your dentist that you are taking this medicine before any dental procedure. Good oral hygiene is important to prevent infections.

💚 Lifestyle Tips for Better Results

🏃
Maintain a healthy diet rich in fruits and vegetables to support your immune system.
🥗
Stay well hydrated, especially if you experience diarrhoea.
😴
Use gentle skincare products and sunscreen to manage skin side effects.
💧
Engage in light exercise as tolerated to maintain strength and well-being.
🧘
Get adequate rest and manage stress through relaxation techniques.
🌞
Avoid smoking and limit alcohol consumption.

🏋️ Exercise Considerations

This medicine may cause fatigue, dizziness, or eye problems that could affect your ability to exercise. Avoid strenuous activities until you know how the medicine affects you. Consult your doctor before starting any new exercise regimen.

🥗 Diet Recommendations

Eat small, frequent meals if you have mouth sores or nausea.
Include soft, bland foods if you have diarrhoea.
Avoid spicy, acidic, or rough-textured foods that may irritate mouth sores.
Drink plenty of fluids to prevent dehydration.
Avoid grapefruit and grapefruit juice.

💼 Impact on Daily Work & Life

This medicine may cause fatigue, diarrhoea, and skin rash, which can affect your daily activities and work. You may need to take time off or adjust your schedule. Driving may be affected if you experience fatigue or vision problems. Discuss any work-related concerns with your doctor.

🛑 When to Stop This Medicine

Do not stop taking this medicine without consulting your doctor. If you experience severe side effects, your doctor may temporarily stop the medicine or reduce the dose. Stopping suddenly may cause the cancer to grow. Always follow your doctor's instructions.

📅 Long-Term Use Effects

Long-term use of this medicine may lead to chronic side effects such as persistent diarrhoea, skin changes, and nail problems. Regular monitoring of liver, kidney, and heart function is necessary. Some patients may develop resistance to the medicine over time, requiring a change in treatment. It is important to attend all follow-up appointments and report any new symptoms.

🌿 Non-Medicine Approaches

These can complement medicine but do not replace prescribed treatment.

Other EGFR tyrosine kinase inhibitors

Erlotinib, gefitinib, or osimertinib may be alternatives based on mutation type and prior treatments.

Evidence: Well-established
Chemotherapy

Platinum-based chemotherapy may be used if targeted therapy is not suitable or stops working.

Evidence: Well-established
Immunotherapy

Immune checkpoint inhibitors may be an option for some patients with lung cancer.

Evidence: Well-established

💉 Vaccination Considerations

💉 If You're Getting Vaccinated

Live vaccines should be avoided while taking this medicine due to the risk of infection. Inactivated vaccines may be given, but consult your doctor first. Ensure all age-appropriate vaccinations are up to date before starting treatment.

📦 Storage Guide

✅ DO

Store at room temperature (20-25°C)

❌ DON'T

Do not refrigerate or freeze

✅ DO

Keep in original container

❌ DON'T

Do not transfer to unmarked containers

✅ DO

Keep away from direct sunlight and moisture

❌ DON'T

Do not store in bathroom cabinet

✈️ Traveling with This Medicine

Carry this medicine in its original packaging with a copy of your prescription. Keep it in your carry-on luggage to avoid loss or temperature extremes. If crossing time zones, adjust dosing times gradually in consultation with your doctor. Store at room temperature and avoid direct sunlight. Check customs regulations for carrying prescription medicines.

💰 Cost Analysis & Savings

👥 Real Patient Stories

Educational, anonymized scenarios. Individual results may vary.

👤 A 58-year-old woman with EGFR mutation-positive lung cancer
She started this medicine after her diagnosis. Initially, she experienced diarrhoea and rash, which were managed with anti-diarrhoeal medication and moisturisers. After a few weeks, her cough and breathlessness improved, and scans showed a reduction in tumour size. She emphasizes the importance of staying hydrated and following the doctor's advice.
💡 Lesson: Early management of side effects helps patients continue treatment and achieve better outcomes.
👤 A 65-year-old man with squamous cell lung cancer
He was prescribed this medicine after chemotherapy. He experienced dry skin and nail changes, but with regular emollients and nail care, these were tolerable. He advises other patients to report any new symptoms to their doctor promptly.
💡 Lesson: Regular monitoring and prompt reporting of side effects can prevent complications and allow dose adjustments.

💬 Questions Patients Often Ask

Q: How long does it take to work?

A: It may take several weeks to months to see the full effect. Your doctor will monitor your response with regular scans.

Q: Can I take this medicine with food?

A: Yes, you can take it with or without food, but be consistent. Avoid grapefruit and grapefruit juice.

Q: What should I do if I miss a dose?

A: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

Q: Is this medicine safe during pregnancy?

A: No, this medicine can harm an unborn baby. Use effective contraception during treatment and for at least 2 weeks after the last dose. Do not breastfeed while taking this medicine.

🤔 Common Patient Concerns

💭 These are the concerns patients most commonly raise

  • Can I take this medicine long-term?
  • Will it affect my kidney function?
  • Can I drive after taking this medicine?
  • Does it interact with my blood pressure medicine?
  • What if I miss a dose?
  • Can I drink alcohol while taking this?

🔄 Substitutes for xovoltib 20mg tablet

View All

Alternative brands with exact same active ingredient:

Medical Note: Always consult your doctor before switching medications.

🛑 Myths vs. Facts

  • Myth: This medicine can cure lung cancer completely.
    Fact: This medicine can slow or stop cancer growth but does not cure cancer. It is used to control the disease and improve quality of life.
  • Myth: I can stop taking this medicine once I feel better.
    Fact: You should not stop taking this medicine without consulting your doctor. Stopping suddenly may cause the cancer to grow back.
  • Myth: This medicine has no side effects.
    Fact: This medicine can cause side effects, some of which may be serious. Regular monitoring and reporting of symptoms are important.

📊 Comparison with Similar Medicines

[{"medicine":"Afatinib","class":"2nd generation EGFR TKI","target":"EGFR, HER2, ErbB3, ErbB4","route":"Oral","common_side_effects":"Diarrhoea, rash, dry skin, mouth sores"},{"medicine":"Erlotinib","class":"1st generation EGFR TKI","target":"EGFR","route":"Oral","common_side_effects":"Rash, diarrhoea, fatigue"},{"medicine":"Gefitinib","class":"1st generation EGFR TKI","target":"EGFR","route":"Oral","common_side_effects":"Rash, diarrhoea, dry skin"},{"medicine":"Osimertinib","class":"3rd generation EGFR TKI","target":"EGFR (including T790M)","route":"Oral","common_side_effects":"Diarrhoea, rash, dry skin, nail changes"}]

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