Afinitor (Everolimus)

Afinitor (Everolimus) Medication Information

Uses

Afinitor is a kinase inhibitor indicated for the treatment of patients with: 

• advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. 
• subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of Afinitor is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. 

Dosage

There are oral tablets available in several different strengths:

• 2.5 mg
• 5 mg
• 10 mg

Side Effects

The most common side effects of Afinitor include:

• Stomatitis
• Upper respiratory tract infection
• Sinusitis
• Otitis media
• Pyrexia 

Speak with your doctor or pharmacist for a full list of side effects that applies to you.

Precautions

Consider a diagnosis of non-infectious pneumonitis in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. Patients should promptly report any new or worsening respiratory symptoms.

Afinitor has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections, including infections with opportunistic pathogens. While taking Afinitor, be vigilant for signs and symptoms of infection; if a diagnosis of an infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Afinitor.

Mouth ulcers, stomatitis, and oral mucositis have occurred in patients treated with Afinitor. If ulcerations develop, topical treatments are recommended, but alcohol- or peroxide-containing mouthwashes should be avoided as they may exacerbate the condition.

Interactions

Some of the common drug interactions with Afinitor:

• Amprenavir
• Aprepitant 
• Carbamazepine 
• Clarithromycin
• Diltiazem
• Fluconazole
• Itraconazole
• Phenobarbital 
• Phenytoin 
• Verapamil
• Rifampin

For a more complete list speak with your doctor or pharmacist 

Storage

Store at controlled room temperature (77ºF). It should be stored in the original container, protected from light and moisture. 

Pharmacist Tips

• There is a possibility of developing non-infectious pneumonitis
• Cases of hepatitis B reactivation have been associated with AFINITOR treatment
• There is a possibility of developing mouth ulcers, stomatitis, and oral mucositis
• You will need to monitor blood chemistry and hematology prior to the start of AFINITOR therapy and periodically thereafter
• It is important to inform their healthcare providers of all concomitant medications, including over-the-counter medications and dietary supplements
• Avoid the use of live vaccines and close contact with those who have received live vaccines

Afinitor FAQs

Can I take this with food?

Afinitor can be taken with or without food.

Can I take this if I am pregnant or breastfeeding?

Afinitor may cause fetal harm and that an effective method of contraception should be used during therapy with Afinitor and for 8 weeks after ending treatment.

It is not known if Afinitor passes into your breast milk. You and your healthcare provider should decide if you will take Afinitor or breastfeed. You should not do both.

Related Drug

• Anandron
• CeeNU
• Gleevec
• Xeloda

Reference:

Afinitor {package insert}. East Hanover, NJ: Novartis Pharmaceutical Corporation; 2010.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf