This is a Phase 2 trial examine the performance of a targeted cancer drug known as Xovoltib 50mg.
Xovoltib 50mg prohibits the EGFR protein, which is accepting to be included in driving the growth of chordoma tumors.
This study is plan specifically for chordoma patients 18 years or older with recurrent or metastatic tumors.
Xovoltib 50mg which is used as prescription drugs under the guidance of oncologist physician.
Xovoltib 50mg is used for the first-line treatment for patients with metastatic non-small cell lung cancer(NSCLC)
MECHANISM OF ACTION
Afatinib mechanism by preventing the activity of a group of proteins knowns as epidermal growth factor receptors (EGFR). Epidermal growth factor receptor is a protein which is included in the growth and spread of cancer cells; Afatinib works by inhibiting the action of this protein.
Afatinib should not be taken by people who having EGFR-negative tumors.
- Time to peak plasma time is 2-5 hr and bioavailability are 92 %
• Human plasma protein bound is 95%
• The major circulating metabolites are covalent adducts to proteins.
• The drug excretion through feces is 85% and urine 4% • Half-life is 37 hr.
For adult: 50mg taken once per day is the prescribed dose for adult patients with metastatic non-small cell lung cancer Age of 0-17 years prescribed dose is not being studied in children.
Avoid using of Xovoltib drug under 18 years of age
The prescribed dose for renal impairment is given 50mg taken once per day
Administer the drug Xovoltib on an empty stomach.
Take the drug Xovoltib 1 hour before or 2 hours after a meal
Avoid cutting or crushing the tablet
Overdosage:Overdose is reported in patients whom ingested 360mg of Xovoltib which causes in nausea, vomiting, asthenia, abdominal pain and hence provided supportive measurement for recovery.
Serious dehydration can occur with the use of Xovoltib 50mg. This may be leads to serious or persistent diarrhea, vomiting, or reduced fluid intake. Dehydration can result in kidney failure, if it is severe enough. While on treatment with this medication, you may be encouraged to drink extra water.
During treatment with Xovoltib 50mg will result in hepatotoxicity; monitor with periodic liver testing; withhold or stoptreatment for serious or worsening liver tests
The drug may result in Interstitial lung disease (ILD)
when administrated to pregnant women, Xovoltib 50mg will have foetus harm (embryo-fetal toxicity)
Discontinue the drug,if patients confirm with suspected keratitis or ulcerative keratitis
With Xovoltib 50mg have increased sunburn/phototoxicity; may aggravate rash or acne; patients use with caution to limit sun exposure and where sunscreen and protective clothing.
sometimes, Xovoltib 50mg has been bind to corneal perforation, a serious injury to the part of the eye which focuses light into the eye. If you have any persistent eye pain or changes in vision, inform your doctor immediately.
Common side effects caused :
• Mild diarrhae for 1 day or less
• Decreased appetite
• Nausea and vomiting
• Mouth ulcer
• Acne, itching, dry skin
• Red colour, tenderness, swelling or other signs of infection around your fingernails or toenails
Serious side effects :
• Eye problems – blurred vision, watery eyes, increased sensitivity to light
• Liver problem – stomach pain, feeling tried, dark urine
• Heart problem
• Urine colour changes to dark
• Bleeding or bruising
• Blurred vision
• Rapid heartbeat
• Breathing trouble
• Cough and fever
• Yellowing the skins
Co administration of Xovoltib 50mg with P-gp inhibitors (cyclosporine A, ketoconazole verapamil) will have high exposure to Afatinib
When interaction of Xovoltib 50mg with P-gp inducers (carbamazepine, phenytoin, phenobarbital) will lowers the exposure to Afatinib
Pregnancy category: c
During treatment with Xovoltib 50mg Pregnancy should avoid because the drug Xovoltib 50mg is administrated to a pregnant woman will harm the foetus.
Xovoltib 50mg Excretion into human milk is unknown or will have adverse reaction in a child who is breastfed. Hence decision can take whether to stop breastfeeding or discontinuation of medicine.
- Xovoltib 50mgStore at 25°C
• Keep Xovoltib 50mg away from children
• Protect away free from moisture and light.
If patient missed to take the dose of Xovoltib 50mg, then the missed dose must be skipped and follow the regular dosing schedule. Do not administerdouble the dose
Consult with doctor and follow the suggestions.