Indications
Axinix Tablet is used for:
Advanced renal cell carcinoma
Adult Dose
Oral
Advanced renal cell carcinoma
Adult: Initially, 5 mg bid (given approx 12 hrly), may be increased further to 7 mg bid, then 10 mg bid, if the initial dose is tolerated (patients w/ no AR above grade 2, w/ normal BP, and are not receiving antihypertensive therapy) for at least 2 consecutive wk.
Hepatic impairment
Mild (Child-Pugh A): No adjustment of initial dose is required
Moderate (Child-Pugh B): Decrease initial dose by ~50%; subsequent doses can be increased or decreased based on individual safety and tolerability
Severe (Child-Pugh C): Has not been studied
Child Dose
Renal Dose
Renal impairment
No dedicated renal impairment trial has been conducted
Based on population pharmacokinetic analyses, no significant difference in clearance observed in patients with pre-existing mild-to-severe renal impairment
Administration
May be taken with or without food
Contra Indications
Recent active GI bleeding, untreated brain metastases. Severe hepatic impairment (Child-Pugh Class C). Lactation.
Precautions
Patient w/ HTN, cardiac disease, history of or risk for thrombosis. Patients taking strong CYP3A4 inhibitors. Withhold treatment at least 24 hr prior to scheduled surgery. Moderate hepatic impairment (Child-Pugh Class B). Pregnancy.
Pregnancy-Lactation
Pregnancy
Based on mechanism of action and findings from animal studies, drug can cause fetal harm when administered to a pregnant woman; there are no available human data to inform drug-associated risk; in developmental toxicity studies in mice, axitinib was teratogenic, embryotoxic and fetotoxic at maternal exposures that were lower than human exposures at recommended clinical dose
When used in combination with avelumab or pembrolizumab, refer to full prescribing information of avelumab or pembrolizumab for pregnancy information
Animal data
Therapy administered twice daily to female mice prior to mating and through first week of pregnancy caused increase in post-implantation loss at all doses tested (greater than or equal 15 mg/kg/dose, approximately 10 times the systemic exposure (AUC) in patients at recommended starting dose)
Based on findings in animal studies, drug can cause fetal harm when administered to a pregnant woman; females of reproductive potential should have a pregnancy test prior to starting treatment
Contraception
Females: Therapy can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 1 week after last dose
Males: Based on findings in animal studies, advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after last dose
When is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for contraception information
Infertility
Based on findings in animals, therapy may impair fertility in females and males of reproductive potential
Lactation
There are no data on presence of drug in human milk, or effects on breastfed child or on milk production; because of potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment and for 2 weeks after final dose
When used in combination with avelumab or pembrolizumab, refer to full prescribing information of avelumab or pembrolizumab for lactation information
Interactions
Plasma concentration is increased by strong CYP3A4/5 inhibitors (e.g. ketoconazole, ritonavir, clarithromycin) and decreased by strong CYP3A4/5 inducers (e.g. rifampicin, phenytoin, carbamazepine). May enhance adverse effects (e.g. osteonecrosis of the jaw) of bisphosphonate derivatives.
Side Effects
Side effects of Axitinib :
>10%
Diarrhea (55%)
Hypertension (40%)
Fatigue (39%)
Decreased appetite (34%)
Nausea (32%)
Dysphonia (31%)
Palmar-plantar erythrodysesthesia syndrome (27%)
Weight decreased (25%)
Vomiting (24%)
Asthenia (21%)
Constipation (20%)
Hypothyroidism (19%)
Cough (15%)
Mucosal inflammation (15%)
Arthralgia (15%)
Stomatitis (15%)
Dyspnea (15%)
Abdominal pain (14%)
Headache (14%)
Extremity pain (13%)
Rash (13%)
Proteinuria (11%)
Dysgeusia (11%)
1-10%
Dry skin (10%)
Dyspepsia (10%)
Dizziness (9%)
Upper abdominal pain (8%)
Myalgia (7%)
Pruritus (7%)
Dehydration (6%)
Epistaxis (6%)
Hypercalcemia (6%)
Anemia (4%)
Alopecia (4%)
Hemorrhoids (4%)
Hematuria (3%)
Tinnitus (3%)
Increased lipase (3%)
Glossodynia (3%)
Pulmonary embolism (2%)
Rectal hemorrhage (2%)
Hemoptysis (2%)
Erythema (2%)
DVT (1%)
Retinal vein occlusion/thrombosis (1%)
Polycythemia (1%)
TIA (1%)
<1%
Reversible posterior leukoencephalopathy syndrome
Potentially Fatal: Cardiac failure, arterial thrombotic events (e.g. MI, TIA, CVA, retinal artery exclusion), venous thrombotic events (e.g. DVT, pulmonary embolism, retinal vein occlusion or thrombosis), hypertensive crisis, haemorrhagic events (e.g. GI or cerebral haemorrhage, haemoptysis, haematuria, melaena), GI perforation and fistula formation.
Mode of Action
Axitinib, a selective 2nd generation tyrosine kinase inhibitor, blocks angiogenesis, tumour growth, and cancer progression by inhibiting vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3).
Note
Axinix 5mg Tablet generic name is Axitinib. Axinix 5mg Tablet is manufactured by Beacon Pharmaceuticals Ltd.Axinix is availble in all over Bangladesh.
Mes BD drug index information on Axinix Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.