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AFINITOR
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 AFINITOR
 Package(a):
TABLETS: 30 x 5 mg.
Dosage(a):
Treatment should be initiated by a physician experienced in the use of anticancer therapies. The tablets should be administered orally once daily at the same time every day, either with or without food.
The tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Recommended dose for treatment of advanced renal cell carcinoma: 10 mg 1 x daily. Management of severe and/or intolerable suspected adverse reactions may require temporary dose reduction and/or interruption of therapy. If dose reduction is required, the suggested dose is 5 mg daily.
Pediatric patients: Not recommended for these patients.
Elderly patients (>65 years): No dosage adjustment is required.
Renal impairment: No dosage adjustment is required.
Hepatic impairment: For patients with moderate hepatic impairment (Child-Pugh class B), the dose should be reduced to 5 mg daily. Everolimus has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) and is not recommended for use in this patient population. See prescribing information for full details.

Prescribing Restrictions:  None

Package(b):
TABLETS: 30 x 10 mg.
Dosage(b):
Treatment should be initiated by a physician experienced in the use of anticancer therapies. The tablets should be administered orally once daily at the same time every day, either with or without food.
The tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Recommended dose for treatment of advanced renal cell carcinoma: 10 mg 1 x daily. Management of severe and/or intolerable suspected adverse reactions may require temporary dose reduction and/or interruption of therapy. If dose reduction is required, the suggested dose is 5 mg daily.
Pediatric patients: Not recommended for these patients.
Elderly patients (>65 years): No dosage adjustment is required.
Renal impairment: No dosage adjustment is required.
Hepatic impairment: For patients with moderate hepatic impairment (Child-Pugh class B), the dose should be reduced to 5 mg daily. Everolimus has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) and is not recommended for use in this patient population. See prescribing information for full details.

Prescribing Restrictions:  None


Indications:
Treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

Contra-Indications:
Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.

Special Precautions:
Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of non-infectious pneumonitis (including interstitial lung disease) have also been described in patients. See prescribing information. Treatment has immunosuppressive properties and may predispose patients to bacterial, fungal, viral or protozoan infections, including infections with opportunistic pathogens. See prescribing information for full details. Immunosuppressants may affect the response to vaccination and vaccination during treatment may therefore be less effective. The use of live vaccines should be avoided.
Pregnancy and lactation: Should not be given to pregnant women unless the potential benefit outweighs the potential risk to the fetus. Women should not breastfeed during treatment. Women of childbearing potential should be advised to use an effective method of contraception during treatment, and for up to 8 weeks after ending treatment. Male fertility may be compromised by treatment. See prescribing information for full details.

Side Effects:
Very common: Infections, decreased lymphocytes, decreased hemoglobin, decreased platelets, decreased neutrophils. Increased glucose, increased cholesterol, increased triglycerides, decreased phosphate, anorexia. Abnormal taste, pneumonitis, dyspnea, epistaxis, cough, stomatitis, diarrhea, mucosal inflammation, vomiting, nausea. Increased alkaline aminotransferase, increased aspartate aminotransferase. Rash, dry skin, pruritus. Increased creatinine, fatigue, asthenia, peripheral edema.
Common: Dehydration, insomnia, headache, conjunctivits, eyelid edema, hypertension. Hemoptysis, dry mouth, abdominal pain, dysphagia, dyspepsia. Increased bilirubin, palmar-plantar erythrodysethasia syndrome, erythema, skin exfoliation, nail disorder, acneiform dermatitis, onychoclasis. Chest pain, pyrexia, decreased weight. See prescribing information for full details.

Drug Interactions:
Strong inhibitors of CYP3A4 or P-glycoprotein (PgP): Co-administration should be avoided. Moderate CYP3A4 inhibitors or PgP inhibitors: Use caution when co-administered. Strong inducers of CYP3A4 or PgP: Co-administration should be avoided. See prescribing information for full details.

Taken from MEDIC