Afalino
Generic Name
afalino-25-mg-tablet
Manufacturer
Generic Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| afalino 25 mg tablet | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Afatinib, marketed as Afalino 25 mg Tablet, is a targeted therapy used for non-small cell lung cancer (NSCLC) that carries specific epidermal growth factor receptor (EGFR) mutations. It is an irreversible inhibitor of the ErbB family of receptors.
Uses & Indications
Dosage
Adults
The recommended dose is 40 mg once daily. For the 25 mg tablet, it may be used for dose reduction due to adverse reactions or in specific patient populations requiring a lower dose.
Elderly
No specific dose adjustment is needed based on age, but monitor for adverse reactions due to potential increased sensitivity in some elderly patients.
Renal_impairment
For mild to moderate renal impairment (CrCl 30-80 mL/min), no dose adjustment is required. For severe renal impairment (CrCl <30 mL/min), use with caution; consider dose reduction based on patient tolerability.
How to Take
Take Afalino tablet orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the tablet whole with water. Do not crush, chew, or split the tablet.
Mechanism of Action
Afatinib irreversibly binds to and inhibits the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and ErbB4. This blockade leads to inhibition of receptor autophosphorylation and downstream signaling, which can result in reduced proliferation of cancer cells expressing these receptors.
Pharmacokinetics
Onset
Clinical response typically observed within weeks of treatment initiation.
Excretion
Mainly excreted unchanged in feces (85%), with minor renal excretion (4%).
Half life
Terminal elimination half-life is approximately 37 hours.
Absorption
Oral administration; peak plasma concentration reached in 2-5 hours. Absolute bioavailability is approximately 92%. Food reduces exposure by approximately 50%.
Metabolism
Minimal hepatic metabolism by cytochrome P450 enzymes. Primarily metabolized by cysteine adduct formation.
Side Effects
Contraindications
- Known hypersensitivity to afatinib or any of its excipients.
Drug Interactions
P-glycoprotein (P-gp) Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin)
Co-administration may decrease afatinib exposure. Consider increasing afatinib dose if tolerated.
P-glycoprotein (P-gp) Inhibitors (e.g., Ritonavir, Cyclosporine, Ketoconazole)
Co-administration may increase afatinib exposure. Consider reducing afatinib dose if not tolerated.
Storage
Store below 30°C (86°F). Protect from moisture and light. Keep out of reach of children.
Overdose
There is no specific antidote for afatinib overdose. Management should consist of general supportive measures and symptomatic treatment of any adverse reactions.
Pregnancy & Lactation
Pregnancy Category D. Afatinib can cause fetal harm when administered to a pregnant woman. Avoid during pregnancy. It is unknown if afatinib is excreted in human milk, but due to potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment.
Side Effects
Contraindications
- Known hypersensitivity to afatinib or any of its excipients.
Drug Interactions
P-glycoprotein (P-gp) Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin)
Co-administration may decrease afatinib exposure. Consider increasing afatinib dose if tolerated.
P-glycoprotein (P-gp) Inhibitors (e.g., Ritonavir, Cyclosporine, Ketoconazole)
Co-administration may increase afatinib exposure. Consider reducing afatinib dose if not tolerated.
Storage
Store below 30°C (86°F). Protect from moisture and light. Keep out of reach of children.
Overdose
There is no specific antidote for afatinib overdose. Management should consist of general supportive measures and symptomatic treatment of any adverse reactions.
Pregnancy & Lactation
Pregnancy Category D. Afatinib can cause fetal harm when administered to a pregnant woman. Avoid during pregnancy. It is unknown if afatinib is excreted in human milk, but due to potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, depending on storage conditions.
Availability
Pharmacies, Hospitals
Approval Status
FDA approved
Patent Status
Patented by original innovator
Clinical Trials
Afatinib's efficacy and safety were primarily established through the LUX-Lung clinical trial program, which included several pivotal studies (e.g., LUX-Lung 3, LUX-Lung 6, LUX-Lung 7).
Lab Monitoring
- Liver function tests (baseline and periodically during treatment)
- Renal function (baseline and as clinically indicated)
- Electrolytes (especially potassium and magnesium, if diarrhea is severe)
- Skin and nail assessment for toxicities
Doctor Notes
- Counsel patients on proactive management of diarrhea, including hydration and use of antidiarrheal agents (e.g., loperamide).
- Monitor for signs and symptoms of interstitial lung disease (ILD) and advise patients to report new or worsening respiratory symptoms promptly.
- Regular dermatologic assessment is recommended for early detection and management of skin toxicities.
Patient Guidelines
- Report severe or persistent diarrhea, skin rash, or new or worsening breathing difficulties immediately to your doctor.
- Stay well hydrated, especially when experiencing diarrhea.
- Use moisturizers and wear protective clothing to manage skin and nail toxicities.
- Avoid direct exposure to sunlight as it can exacerbate skin reactions.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. Do not take two doses at once to make up for a missed dose. Continue with your regular dosing schedule the next day.
Driving Precautions
Afatinib may cause fatigue or dizziness. Patients should exercise caution when driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids throughout the day.
- Practice good skin care, including regular moisturizing and avoiding harsh soaps.
- Protect nails with gloves during household chores and keep them trimmed.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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