XOVOLTIB 50MG

Description

Afatinib is a generic form of brand name Xovoltib 50mg, an orally bioavailable anilino-quinazoline derivative and inhibitor of the receptor tyrosine kinase (RTK) epidermal growth factor receptor (ErbB; EGFR) family, with antineoplastic activity. 

Xovoltib 50mg is a targeted therapy drug. Xovoltib 50mg is a prescription drugs which is used under the supervision of medical practioners.

Indication

Xovoltib 50mg is indicated for the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC)

Dosage and administration

For adult

The recommended dose for adult patients with metastatic non-small cell lung cancer is 40mg taken once per day.

For child

Dosage ages of 0-17 years is not being studied in children.

The drug should not be used age under 18 years of age

For renal impairment: prescribed dose is 30mg taken once per day

Administer the drug Xovoltib on an empty stomach. Consume the drug 1 hour before or 2 hours after a meal

Avoid cutting or crushing the tablet

Overdosage

overdose is resulted in patients whom ingested 360mg of Xovoltib which resulted in nausea, vomiting, asthenia, abdominal pain and hence provided supportive measurement for recovery.

Mechanism of action

Afatinib is a kind of cancer growth blocker called a protein tyrosine kinase inhibitor (TKI). Tyrosine kinases are proteins which trigger cells to grow. Afatinib inhibits tyrosine kinases and blocks epidermal growth factor receptor proteins in cancer cells. So Afatinib is also called an EGFR-TK inhibitor.

ADME Properties

Absorption: High plasma time is 2-5 hr and bioavailability are 92 %

Distribution: Human plasma protein bound is 95%

Metabolism: The major circulating metabolites are covalent adducts to proteins.

Elimination: The drug excretion through feces is 85% and urine 4%

Half-life is 37 hr.

Side effects

Common side effects caused

• Dry skin
• reduced appetite
• Nausea
• Vomiting
• Nail infection
• Diarrhoea
• Mouth sores
• Acne
• Itchiness
• Rash

Serious side effects

• Urine colour changes to dark
• Bleeding or bruising
• Weakness
• Blurred vision
• Rapid heartbeat
• Breathing trouble
• Cough and fever
• Yellowing the skins

Drug interaction

Xovoltib 50mg concomitant use with P-gp inhibitors (cyclosporine A, ketoconazole verapamil) with Xovoltib 50mg will have high exposure to Afatinib

When combination of Xovoltib 50mg with P-gp inducers (carbamazepine, phenytoin, phenobarbital) with Xovoltib 50mg will reduces the exposure to Afatinib

Precautions

The drug may cause diarrhea which leads in dehydration with or without renal impairment; some stated cases were fatal; withhold treatment for serious and extended diarrhea not responsive to antidiarrheal agents

Hepatotoxicity resulted; monitor with periodic liver testing; withhold or stop treatment for serious or worsening liver tests

The drug may result in Interstitial lung disease (ILD)

Embryo-fetal toxicity: Xovoltib 50mg will have risk to the foetus when administrated to pregnant women

Keratitis: if patients confirm with suspected keratitis or ulcerative keratitis then stop or discontinue the drug

May have high risk for sunburn/phototoxicity; may aggravate rash or acne; patients use with caution to limit sun exposure and where sunscreen and protective clothing

Pregnancy

While on treatment with Xovoltib 50mg Pregnancy should avoid because the drug Xovoltib 50mg is administrated to a pregnant woman will harm the foetus.

Lactation

Xovoltib 50mg Excretion into human milk is unknown or will have adverse reaction in a child who is breastfed. Therefore, decision should take whether to stop breastfeeding or discontinuation of medicine.

Storage

Xovoltib 50mg Store at 25⁰C

Keep Xovoltib 50mg away from children

Protect away free from moisture and light

Missed Dose

If patient forget to take the dose of Xovoltib 50mg, then the missed dose must be skipped and follow the regular dosing schedule. Do not have double the dose

Must consult with medical oncologist and follow the suggestions