Cabometyx Tablets / Film-coated
Cabozantinib
60mg
IPSEN PHARMA
| Pack size | 30’s HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | CITY MEDICAL STORE |
| Retail Price | 36818.00 AED |
Available as:
Indications
Cabometyx Tablets / Film-coated is used for:
For the treatment of metastatic medullary thyroid cancer and for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
- Medullary thyroid carcinoma,
- Advanced renal cell carcinoma,
- Hepatocellular carcinoma
Adult Dose
Oral
Metastatic medullary thyroid carcinoma, Unresectable locally advanced medullary thyroid carcinoma
Adult: As Capsule: Initially, 140 mg once daily.
Adjust dose in decrements of 40 mg daily, if necessary.
Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability.
This indication and dosage is specific for cap formulation. Do not use interchangeably with the tab formulation due to different bioequivalence.
Advanced renal cell carcinoma, Hepatocellular carcinoma
Adult: As Tablet: Initially, 60 mg once daily.
Adjust dose in decrements of 20 mg daily, if necessary.
Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability.
This indication and dosage is specific for tab formulation. Do not use interchangeably with the cap formulation due to different bioequivalence.
Hepatic impairment
Capsule
Mild-to-moderate (Child-Pugh A or B): Reduce starting dose to 80 mg/day
Moderate (Child-Pugh C): Not recommended
Tablet
Mild (Child-Pugh A): No dosage adjustment necessary
Moderate (Child-Pugh B): Reduce starting dose to 40 mg/day
Severe (Child-Pugh C): Avoid use
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl >30 mL/min): No dosage adjustment necessary
Severe (CrCl <30 mL/min): No experience
Administration
Should be taken on an empty stomach. Take at least 1 hr before or at least 2 hr after meals. Swallow whole, do not crush.
Contra Indications
History of haemorrhage or haemoptysis.
Lactation.
Precautions
Increases risk of treatment-emergent hypertension; discontinue for severe hypertension that cannot be controlled with antihypertensive therapy.
May impair wound healing; stop treatment at least 28 days prior to schedules surgery; withhold with dehiscence or wound healing complications requiring medical intervention.
GI perforations and fistulas reported; monitor patients for symptoms of perforations and fistulas, including abscess and discontinue therapy in patients who experience a Grade 4 fistula or a GI perforation.
Serious and fatal hemorrhage reported; do not administer to patients with risk for severe hemorrhage.
Renal and hepatic impairment. Pregnancy.
Pregnancy-Lactation
Pregnancy
Based on its mechanism of action, can cause fetal harm when administered to pregnant women
Verify pregnancy status of females of reproductive potential before initiation
Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the final dose
May impair male and female fertility
Lactation
Unknown whether distributed in breast milk
Because of potential for serious adverse reactions in a breastfed infant from cabozantinib, advise females of reproductive potential to not breastfeed during treatment and for 4 months after the final dose
Interactions
Increased plasma concentration with strong CYP3A4 enzyme inhibitors (e.g. ketoconazole, itraconazole). Decreased plasma concentration with strong CYP3A4 enzyme inducers (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine).
Adverse Effects
Side effects of Cabozantinib :
>10%
AST, ALT increased (86%)
Diarrhea (63%)
Hypertension, treatment-emergent (61%)
Increased TSH (57%)
Lymphopenia (53%)
ALP increased (52%)
Hypocalcemia (52%)
Stomatitis (51%)
Palmar-plantar erythrodysesthesia syndrome (50%)
Weight decreased (48%)
Appetite decreased (46%)
Nausea (43%)
Fatigue (41%)
Oral pain (36%)
Neutropenia (35%)
Thrombocytopenia (35%)
Dysgeusia (34%)
Hair color changes, depigmentation, graying (34%)
Hypertension (33%)
Hypophosphatemia (28%)
Constipation (27%)
Abdominal pain (27%)
Hypobilirubinemia (25%)
Vomiting (24%)
Asthenia (21%)
Dysphonia (20%)
Rash (19%)
Dry skin (19%)
Hypomagnesemia (19%)
Hypokalemia (18%)
Headache (18%)
Alopecia (16%)
Dizziness (14%)
Arthralgia (14%)
Palmar-plantar erythrodysesthesia syndrome, Grade 3 or 4 (13%)
Dysphagia (13%)
Muscle spasms (12%)
Dyspepsia (11%)
Erythema (11%)
1-10%
Hyponatremia (10%)
Hemorrhoids (9%)
Musculoskeletal chest pain (9%)
Anxiety (9%)
Paresthesia (7%)
Peripheral sensory neuropathy (7%)
Dehydration (7%)
Hyperkeratosis (7%)
Hypotension (7%)
Venous thromboembolism (6%)
Peripheral neuropathy (5%)
Non-GI fistula (4%)
GI perforation (3%)
Arterial thromboembolism (2%)
Proteinuria (2%)
GI fistula (1%)
Osteonecrosis of the jaw (1%)
Mechanism of Action
Tyrosine kinase inhibitor that targets RET, MET, VEGFR-1, -2, and -3, KIT, TrkB, FLT-3, AXL, and TIE-2 pathways; these tyrosine kinases are involved in both normal cellular function and pathologic processes (eg, oncogenesis, metastasis, tumor angiogenesis, and maintenance of tumor microenvironment).
Note
Cabometyx 60mg Tablets / Film-coated manufactured by IPSEN PHARMA. Its generic name is Cabozantinib. Cabometyx is availble in United Arab Emirates.
Farmaco UAE drug index information on Cabometyx Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.