Vijayaganesh Kasinathan
Written & Compiled by Pharmacist Vijayaganesh Kasinathan, B.Pharm, M.Pharm
Suchitra Chari
Medically Reviewed by Suchitra Chari, M.S. M.Sc.
Last Updated on Jul 27, 2018
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General Information on Afatinib

Generic Name : Afatinib

Pronunciation : a-FA-ti-nib

Latest prescription information about Afatinib. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, warnings and its storage instructions . Also listed are the Indian trade name(s) of the drug and its price list.
Therapeutic Classification : Chemotherapy

Trade Names/Brand Names of Afatinib

Gilotrif, Xovoltib

Why is Afatinib Prescribed? (Indications)

• Afatinib is prescribed as a first-line treatment to treat non-small cell lung cancer, a specific type of lung cancer that has moved to nearby tissues or other body parts in patients who have specific non-epidermal growth factor receptor (EGFR) mutations detected by an FDA-approved test.

• It is a tyrosine kinase inhibitor that works by blocking the cancer cells from multiplication.

• Afatinib is also recommended to treat a particular squamous non-small cell lung cancer, a tumor that has gone to other parts of the body which has showed treatment failure with platinum-based chemotherapy or cancer drugs. 

When should Afatinib not to be taken? (Contraindications)

Afatinib should not be used in patients with-

• Allergy to afatinib
• Cancer with resistant EGFR mutations
• Pregnancy and breastfeeding
• Children (lack of data on safety and effectiveness)
• Patients undergoing fertility treatments

Caution is required while treating patients with-

• Eye disorders (dry eye or eye damage)
• Severe kidney or liver disease
• Lung disease
• Skin disorders

What is the dosage of Afatinib?

• The recommended adult dose of afatinib is 40 mg taken one time daily.

• Patients with severe kidney disease can be started initially with 30 mg of afatinib given once daily.

• The dose of afatinib can either be adjusted or modified based on the side effects experienced by the patients during the treatment, to avoid dangerous interactions with other drugs and in patients with a history of severe liver disease.

• The treatment with afatinib can be permanently discontinued if any serious or life-threatening side effects occur.

How should Afatinib be taken?

• Afatinib comes as a tablet which should be taken by mouth on an empty stomach preferably either two hours after a meal or one hour before a meal.

• Never take afatinib tablets in smaller or larger amounts but exactly as directed by the doctor.

• Do not take a missed dose of afatinib tablets if the next scheduled dose is within 12 hours.

• Take afatinib tablets at the same time every day and do not stop taking afatinib tablets without the doctor’s approval.

What are the warnings and precautions for Afatinib?

Severe diarrhea occurs during the treatment of afatinib and patients should be given anti-diarrheal medicines such as loperamide which can be taken until the loose stools stop.

If diarrhea does not stop after day 1 or 2, the dose of afatinib can be reduced, or treatment can be stopped temporarily and it is advised to treat the patient according to the symptoms.

Breastfeeding is not advised during afatinib treatment and should be avoided for at least two weeks after the last dose of afatinib to avoid complications to the baby.

Men with reproductive potential and women of childbearing age who wish to have a baby should store their sperm and egg in a sperm and egg or ova bank respectively as the infertility status may be irreversible in some cases.

Skin reactions such as blistering of skin and pimple like red-colored rashes or blemishes can occur during afatinib treatment that can last for weeks. In such cases, either dose reduction is advised or treatment can be stopped depending on the severity of skin disorders.

The treatment with afatinib can either be modified or stopped permanently if the patients show the following

• Pneumonitis and other respiratory illness
• Worsening of liver function
• Pain and swelling of the eye

What are the side effects of Afatinib?

•  Gastrointestinal: Diarrhea, indigestion, painful mouth sores, dryness and swelling of lips, nausea, vomiting
•  Nervous system: Headache, dizziness, sleeping difficulty, fever, abnormal weakness
•  Skin: Itching, dry skin, rashes looking like acne, nail disorders, hair loss
•  Eye: Swelling and pain, red eye, tear secretion, sensitivity to light, blurred vision, dry eye
•  Respiratory: Nose bleeding, pneumonitis, runny nose
•  Others: Kidney failure, urinary tract infection, muscle pain, dehydration, weight loss, lab abnormalities of liver enzymes, potassium, and white blood cells

What are the other precautions for Afatinib?

• Women of childbearing age should follow effective contraceptive measures during afatinib treatment and should continue contraception for at least 14 days after the last dose of afatinib.

• This effective contraception helps to avoid pregnancy and subsequent harm to the fetus.

What are the Drug Interactions of Afatinib?

The following drugs cause increased exposure to afatinib resulting in afatinib toxicity and should not be taken together.

• Anti-fungal drugs (e.g., Ketoconazole, Itraconazole)
• Erythromycin
• Anti-arrhythmic drugs (e.g., Quinidine, Amiodarone)
• Antiviral drugs (e.g., Nelfinavir, Saquinavir)
• Immune-suppressing drugs (e.g., Tacrolimus, Cyclosporine)
• Verapamil

In such cases, the dose of afatinib can be reduced by 10 mg and then resumed with the usual dose when the above medications are discontinued.

Some drugs reduce the concentration of afatinib leading to treatment failure or loss of response and should be avoided taken together.

• Anticonvulsant drugs (e.g., Phenytoin, Carbamazepine, Phenobarbital)
• Rifampicin
• St.John’s Wort

The dose of afatinib can be increased by 10 mg when the above medicines are given along with afatinib and then resume with the usual afatinib dose after 2 to 3 days of stopping those medicines.

What are the storage conditions for Afatinib?

• Store afatinib tablets at room temperature between 20°C and 25°C.

• Keep the tablets in the original container.

• Protect the tablets from excess heat and moisture.

Last Updated : 7/27/2018

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