Afinitor

Afinitor

everolimus

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Everolimus
Indications/Uses
In combination w/ exemestane for advanced hormone receptor +ve, HER2 -ve breast cancer (advanced HR+BC) in postmenopausal women. Advanced renal cell carcinoma (RCC) whose disease has progressed on or after VEGF-targeted therapy. Progressive neuroendocrine tumours of pancreatic origin or progressive, well-differentiated (grade 1 or 2) non-functional neuroendocrine tumours (NET) of GI or lung origin in patients w/ unresectable, locally advanced or metastatic disease. Subependymal giant cell astrocytoma (SEGA) associated w/ tuberous sclerosis complex (TSC) who require therapeutic intervention but not candidates for curative surgical resection in adult & ped patients ≥1 yr. Renal angiomyolipoma (AML) & TSC not requiring immediate surgery in adult patients.
Dosage/Direction for Use
HR+BC, NET, RCC, TSC-associated renal AML 10 mg once daily. Mild hepatic impairment (Child-Pugh class A) 7.5 mg once daily, may be decreased to 5 mg once daily if not tolerated. Moderate hepatic impairment (Child-Pugh class B) 5 mg once daily, may be decreased to 2.5 mg once daily if not tolerated. Severe hepatic impairment (Child-Pugh class C) Not to exceed 2.5 mg once daily. TSC-associated SEGA 4.5 mg/m2 once daily. Severe hepatic impairment (Child-Pugh class C) 2.5 mg/m2 once daily.
Administration
May be taken with or without food: Take at the same time each day consistently either always w/ or always w/o meals. Swallow whole w/ a glass of water, do not break/crush. Avoid grapefruit/grapefruit juice.
Contraindications
Hypersensitivity to everolimus or other rapamycin derivatives.
Special Precautions
Severe hypersensitivity reactions. Non-infectious pneumonitis, infections; stomatitis including mouth ulcers & oral mucositis; metabolic disorders eg, hyperglycemia, hypercholesterolemia, hypertriglyceridemia. Monitor CBC prior to, every 6 mth for 1st yr & annually thereafter; renal function prior to, annually thereafter & at least 6 mth in patients w/ additional risk factors for renal failure. Not to be administered at least 2 wk after major surgery & until adequate wound healing. Withhold treatment at least 1 wk prior to elective surgery. Avoid use w/ live vaccines & close contact w/ individuals who have received live vaccines during treatment. Avoid alcohol-, hydrogen peroxide-, iodine- or thyme-containing products; anti-fungal agents unless w/ diagnosed fungal infection. Concomitant use w/ ACE inhibitors. Concomitant or sequential use w/ radiation treatment. Hepatic impairment. May impair male & female fertility. Women of childbearing potential should use effective contraception during & 8 wk after last dose. Male patients must use effective contraception during & 4 wk after last dose. Pregnancy. Not to be used during lactation & for 2 wk after last dose. Childn <1 yr. Elderly ≥65 yr.
Adverse Reactions
Stomatitis, diarrhea, abdominal pain, nausea, vomiting, constipation, dry mouth; fatigue/malaise, general & peripheral edema, pyrexia, asthenia, fever, mucosal inflammation; infections, nasopharyngitis/rhinitis/upper resp infection, UTI, gastroenteritis, streptococcal pharyngitis; wt loss; decreased appetite, hyperglycemia, DM; arthralgia, back pain, pain in extremity, muscle spasms; dysgeusia, headache/migraine, dizziness; insomnia; cough/productive cough, dyspnea/exertional dyspnea, epistaxis, pneumonitis, oropharyngeal pain; rash, pruritus/generalized pruritus, alopecia, nail disorders, dry skin/xeroderma, acne; hot flush, HTN; anxiety, aggression or other behavioral disturbance; anemia, leukopenia, thrombocytopenia, lymphopenia, neutropenia, elevated partial thromboplastin time, hypercholesterolemia, hyperglycemia, increased AST, ALT, creatinine & alkaline phosphatase, hypertriglyceridemia, hypoalbuminemia, hypo- & hyperkalemia, decreased bicarbonate, hypophosphatemia, hypocalcemia, hyponatremia, hyperbilirubinemia.
Drug Interactions
Increased risk of angioedema w/ ACE inhibitors. Avoid concomitant use w/ P-gp & strong CYP3A4 inhibitors & strong CYP3A4 inducers.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EG02 - everolimus ; Belongs to the class of mammalian target of rapamycin (mTOR) kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Afinitor FC tab 10 mg
Packing/Price
3 × 10's
Form
Afinitor FC tab 5 mg
Packing/Price
3 × 10's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in