Afinitor

The active ingredient in Afinitor is everolimus, which is a certain type of kinase inhibitor. It blocks a protein, mTOR (mammalian target of rapamycin). This protein can become more active in cancer cells, promoting tumor growth. By inhibiting this protein, cancer cells cannot grow and spread as effectively.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Afinitor. However, the following is a synopsis of the general guidelines for the use of Afinitor:

• Take Afinitor at the same time every day. You can take the drug with or without food, but you must do so consistently.
• Do not take a conventional tablet in conjunction with a dispersible tablet. Use only one form of this medication.
• Read and carefully follow any instructions for use that come with your medicine. If you don't understand these directions, ask your doctor or chemist.
• Afinitor may increase your risk of bleeding or infection by altering the way your immune system functions. You will require frequent medical examinations.
• If you have ever had hepatitis B, using Afinitor can make the virus active or worse. You may require frequent liver function tests while taking this medication and for several months after stopping.
• Surgical incisions and other wounds may take longer to heal when on Afinitor. You may need to stop taking this medication for one week before and two weeks following surgery. Follow your doctor's directions.
• Your healthcare provider may prescribe an alcohol-free mouthwash while you are taking Afinitor to help prevent mouth sores.

Some mild and most common side effects of Afinitor seen in clinical trials as compared to placebo include:

• Low red blood cells (anemia), white blood cells, and platelets.
• High cholesterol and lipid levels.
• Mouth sores (stomatitis).
• High blood glucose levels.
• Increased risk of infection.
• Weight loss.
• Joint pain.
• Back pain.
• Diarrhea.
• Headache.
• Nausea.
• Dizziness.
• Fever.
• Fatigue.
• Risk of impaired wound healing.

Some individuals may experience serious side effects while using Afinitor. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious viral infections include recurring fevers, chills, coughing, shortness of breath, severe diarrhea, vomiting, and painful or frequent urination.
• Serious bleeds include bleeding or bruising that does not stop or go away, vomiting blood, and bloody or black and tarry feces.
• Lung abnormalities (pneumonitis) include a new or worsening cough, chest pain, and breathing problems.
• Serious allergic reactions include throat tightness, problems breathing, flushing, swelling, hives, skin rash, and chest pain.
• Angiodema or swelling of the face, lips, and throat. Taking an angiotensin-converting-enzyme (ACE) inhibitor with Afinitor increases your risk of this side effect.

These are not all of the possible side effects of Afinitor. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Afinitor, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Allergies to everolimus, sirolimus (Rapamune), temsirolimus (Torisel).
• Active or chronic infections.
• Liver disease or hepatitis B.
• Kidney failure.
• Diabetes or high blood sugar.
• High cholesterol.
• High blood pressure.
• Avoid the use of live vaccines and close contact with individuals who have received live vaccines.

Boxed Warning

The Zortress version presents significant dangers, including an increased risk of infection, malignancies (such as lymphoma and skin cancer), kidney graft thrombosis, and increased death in heart transplant patients. It should only be prescribed by competent transplant physicians in well-equipped facilities, with careful monitoring of kidney function and medication levels, particularly when combined with cyclosporine. It is not recommended for heart transplantation.

Allergy to everolimus (Afinitor) or other rapamycins, including sirolimus (Rapamune) and torisel.

Afinitor (everolimus) does not act immediately; it often takes a few weeks to a few months for its effects to become apparent, depending on the ailment being treated. For cancer, doctors frequently assess response after 8-12 weeks of treatment. Improvements in disorders such as tuberous sclerosis (tumours or convulsions) can take several weeks, with continuous monitoring to track progress.

When Afinitor is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• An antibacterial or antifungal medication.
• Medications for the heart or blood pressure.
• Medicine for hepatitis C or HIV/AIDS.
• Seizure medication.
• St. John’s wort.
• Tuberculosis medicines.
• Sunitinib.
• Sorafenib.
• Anastrozole.
• Letrozole.
• Grapefruit juice.
• Other cancer medications, corticosteroids, and anti-rejection treatments - that weaken the immune system.

Breast cancer, neuroendocrine tumours, kidney cancer, or tuberous sclerosis complex (TSC)-related kidney tumor:

Afinitor and generic everolimus tablets: The normal dose is 10 milligrams taken orally once daily.

TSC-associated brain tumor treatment options include Afinitor, Afinitor Disperz, and generic everolimus tablets. Your dose will be determined by your provider based on your body surface area (BSA, in m2), which includes your weight and height. The typical starting dose is 4.5 mg/m2 administered orally once daily.

TSC-associated partial-onset seizures:

Afinitor Disperz (everolimus tablets for oral suspension), only: Your dose will be determined by your provider based on your body surface area (BSA, in m2), which includes your weight and height. The typical starting dose is 5 mg/m2 orally once daily.

Store at room temperature and keep out of reach of children.

Novartis Pharmaceuticals is the company that manufactures Afinitor.

There are lower-cost generic-name versions available of Afinitor.

You should not discontinue taking Afinitor (everolimus) without consulting your doctor. Because the medicine works by continuously inhibiting signals that enable tumors or abnormal cells to grow, discontinuing abruptly may worsen your cancer or disease.

If the mother or father takes Afinitor, the unborn baby may be harmed or have birth defects.

If you are a woman, do not use Afinitor while pregnant. You may require a negative pregnancy test before beginning this treatment. Use contraception to avoid conception while taking this medication and for at least 8 weeks following the final dosage.

If you are a man, use effective birth control if your sexual partner is capable of becoming pregnant. Continue using birth control for at least 4 weeks following your final dose.

You should not breastfeed while taking this medication or for at least two weeks after the last dose.