Introduction forErdanib 4 mg ( Erdafinitib 4 mg) :

Erdanib Tablet is manufactured by Drug International Limited. Each film-coated tablet of Erdafinitib contains Erdafitinib INN 4.00 mg. Erdanib-4: Each box contains 60 tablets of Erdanib in a container.

Indication:

Erdanib Tablet is intended for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), which has
1. Susceptibility to FGFR3 or FGFR2 genetic changes, and
2. Progressed after at least one course of platinum-containing treatment, including within 12 months after neo adjuvant or adjuvant chemotherapy.

Pharmacology of Erdanib:

Erdanib (Erdafitinib) is a kinase inhibitor that binds to and inhibits the enzymatic activity of FGFR1, FGFR2, FGFR3, and FGFR4, according to in vitro studies. Erdanib (Erdafitinib)  also interacts with RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT, and VEGFR2. Erdafitinib suppressed FGFR phosphorylation and signaling while decreasing cell viability in cell lines displaying FGFR genetic changes such as point mutations, amplification, and fusions. Erdafitinib had anticancer effect in FGFR-expressing cell lines and xenograft models derived from many tumor types, including bladder cancer. Pharmacokinetics: Following ingestion of 8 mg once daily, the average (coefficient of variation [CV%]).Erdanib (Erdafitinib)  steady-state maximum measured plasma concentration (Cmax), area under the curve (AUCTau).The lowest recorded plasma concentration (Cmin) was 1,399 ng/mL (51%), 29,268 ng-h/mL (60%), and 936 ng/mL (65%) respectively. Erdanib (Erdafitinib)  exposure (highest measured plasma concentration [Cmax] and area under the plasma concentration time curve [AUC]) rose proportionally between doses of 0.5 and 12 mg (0.06 to 1.3 times the maximum permitted recommended dose). After two weeks of once-daily dosage of Erdanib (Erdafitinib) , a steady state was attained, with a fourfold mean accumulation ratio. Absorption: The median time to peak plasma concentration (t max) was 2.5 hours (range 2 to 6 hours). Food Effect: In healthy volunteers, no clinically significant variations in Erdanib (Erdafitinib) pharmacokinetics were detected after administering a high-fat, high-calorie meal (800 calories to 1,000 calories, with fat accounting for roughly 50% of total caloric content).

Dosage and Administration of Erdanib:

Erdanib (Erdafitinib) ‘s suggested beginning dose is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and tolerability at 14 to 21 days. Whole pills should be consumed with or without food. If vomiting occurs during or after taking Erdanib (Erdafitinib), the next dose should be taken the next day. Treatment should continue until the condition progresses or intolerable toxicity occurs. If a dose is missed, it should be taken as soon as possible and on the same day. Erdanib (Erdafitinib) ‘s regular daily dosing regimen should continue the next day. Extra tablets should not be taken to compensate for the missing dosage or as recommended by the registered doctors.

Side Effects of Erdanib:

If you have symptoms of an allergic response such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat, get emergency medical attention.

Erdanib (Erdafitinib)  may have major side effects, such as eyesight issues, eyesight loss; eye discomfort or redness , itching rash, dry skin, or cracks in the skin .
Symptoms of elevated phosphate levels include numbness or tingling in the mouth, severe skin sores, or cramping.
If you experience specific adverse effects, your cancer treatments may be postponed or halted completely.
Erdanib (Erdafitinib)  may have the following common side effects when its overdosed: dry mouth, mouth sores , hair loss, dry skin, issues with your fingernails or toenails; redness, swelling, discomfort, or blisters on your palms or soles; tiredness etc.

Overdose of Erdanib:

For overdosing of Erdanib , the patient must seek emergency medical attention. If any dose of Erdafitinib is missed, take the missed dose of Erdanib the same day you remember it. Take your next dose of Erdafitinib at the scheduled time and stick to your once-daily regimen. Do not take two doses in the same day.

Use of Erdanib during pregnancy and lactation:

Erdafitinib  can cause fetal damage when given to a pregnant woman. Pregnancy testing is suggested for females with reproductive potential before beginning Erdanib  medication. Inform pregnant women and females of reproductive potential of the risk to the fetus. Males and females with reproductive potential should utilize effective contraception while taking Erdafitinib and for one month following the last dosage. According to animal research, Erdanib may affect fertility in females with reproductive potential. Lactation: Because Erdafitinib has the potential to induce serious adverse effects in breastfed children, breastfeeding women should not breastfeed during treatment or for one month after the final dosage.

Storage Conditions:
Erdanib should be kept between 25°C and 30°C at room temperature. When a medication is no longer needed or has expired, dispose of it safely. Protect Erdanib from sunlight and humidity. Keep Erdanib and all medicines out of the reach of children.

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