Description

Everolimus is indicated in advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC), Advanced Neuroendocrine Tumors (NET); Advanced Renal Cell Carcinoma (RCC); Renal Angiomyolipoma With Tuberous Sclerosis Complex (TSC); Subependymal Giant Cell Astrocytoma (SEGA) With Tuberous Sclerosis Complex (TSC) In combination with ciclosporin for microemulsion & corticosteroids for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In combination with tacrolimus & corticosteroids for the prophylaxis of organ rejection in patients receiving hepatic transplant.

CYP3A4 inhibitors &/or inducers, CYP2D6 substrates with narrow therapeutic index, PgP inhibitors, rifampicin, ACE inhibitors, grapefruit juice & live vaccines.

Stomatitis, Constipation, Infections, Asthenia, Fatigue, Cough, Diarrhea, Rash, Anemia, Nausea, Anorexia, Edema, peripheral, Dyspnea, Pyrexia, Vomiting, Headache, Epistaxis, Decreased lymphocytes, Grade 3, Increased glucose, Grade 3, Pneumonitis, Pruritus, Dry skin, Decreased Hgb, Grade 3, Menstrual irregularities, Dysgeusia, Hypertension, Hemorrhage, Tachycardia, CHF

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Lactation: Distribution into breast milk is unknown; not recommended

Patients taking concomitant ACE inhibitor therapy may be at increased risk for angioedema. Interstitial lung disease/noninfectious pneumonitis; monitor for clinical symptoms or radiological changes; fatal cases have occurred; manage by dose reduction or discontinuation until symptoms resolve, and consider use of corticosteroids; pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event reported Elicits immunosuppressive effects and may increase risk for infections; some infections have been severe or fatal; monitor for signs and symptoms and treat promptly. Pneumocystis jiroveci pneumonia, some with a fatal outcome, reported; this may be associated with concomitant use of corticosteroids or other immunosuppressive agents Mouth ulcers, stomatitis, and oral mucositis are common; management includes mouthwashes (without alcohol or peroxide) and topical treatments May delay wound healing and increase wound-related complications (eg, dehiscence, wound infection, incisional hernia, lymphocele, and seroma) Cases of renal failure (including acute renal failure), some fatal, have been observed May cause angioedema and fluid accumulation Decreases Hgb, lymphocytes, ANC, platelets; increases cholesterol, TG, glucose, creatinine Elevations of serum creatinine, urinary protein, blood glucose, and lipids may occur; decreases in hemoglobin, neutrophils, and platelets may also occur; monitor renal function, blood glucose, lipids, and hematologic parameters prior to treatment and periodically thereafter May impair male fertility Child-Pugh Class C hepatic impairment Avoid use of live vaccines during treatment and close contact with live vaccine recipients Can cause fetal harm when administered to a pregnant woman; advise female patients of reproductive potential to use highly effective contraception while receiving everolimus and for up to 8 weeks after ending treatment.

Immunosuppressant