Everolimus

What it is used for

1. INDICATIONS AND USAGE Everolimus tablets are a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.

Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

Everolimus tablets and everolimus tablets for oral suspension are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.

1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer Everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. 1.2 Neuroendocrine Tumors (NET) Everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.

Everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated, non-functional NET of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors.

1.3 Renal Cell Carcinoma (RCC) Everolimus tablets are indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. 1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma Everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.

1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) Everolimus tablets and Everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected.

1.6 Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures Everolimus tablets for oral suspension are indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.

The most important thing to know

Everolimus tablets can cause serious side effects, including: Increased risk of getting certain cancers. People who take everolimus tablets have a higher chance of getting lymphoma and other cancers, especially skin cancer. Talk to your doctor about your risk for cancer. Increased risk of serious infections. Everolimus tablets weakens the body’s immune system and affects your ability to fight infections.

Serious infections can happen with everolimus tablets that may lead to death. People taking everolimus tablets have a higher chance of getting infections caused by viruses, bacteria, and fungi (yeast). Call your doctor if you have symptoms of infection, including fever or chills. Blood clot in the blood vessels of your transplanted kidney.

If this happens, it usually occurs within the first 30 days after your kidney transplant. Tell your doctor right away if you: have pain in your groin, lower back, side or stomach (abdomen) make less urine or you do not pass any urine have blood in your urine or dark colored urine (tea-colored) have fever, nausea, or vomiting Serious problems with your transplanted kidney (nephrotoxicity).

You will need to start with a lower dose of cyclosporine when you take it with everolimus tablets. Your doctor should do regular blood tests to check your levels of both everolimus tablets and cyclosporine. Increased risk of death that can be related to infection, in people who have had a heart transplant. You should not take everolimus tablets without talking to your doctor if you have had a heart transplant.

See the section “

How to take it

Take everolimus tablets exactly as your doctor tells you to. Do not stop taking everolimus tablets or change your dose unless your doctor tells you to. Take everolimus tablets at the same time as your dose of cyclosporine or tacrolimus medicine. Do not stop taking or change your dose of cyclosporine or tacrolimus medicine unless your doctor tells you to.

If your doctor changes your dose of cyclosporine or tacrolimus, your dose of everolimus tablets may change. Take everolimus tablets 2 times a day about 12 hours apart. Swallow everolimus tablets whole with a glass of water. Do not crush or chew everolimus tablets. Take everolimus tablets with or without food. If you take everolimus tablets with food, always take everolimus tablets with food.

If you take everolimus tablets without food, always take everolimus tablets without food. Your doctor will do regular blood tests to check your kidney or liver function while you take everolimus tablets. It is important that you get these tests done when your doctor tells you to. Blood tests will monitor how your kidneys or liver are working and make sure you are getting the right dose of everolimus tablets and other transplant medications you may be on (cyclosporine or tacrolimus).

If you take too much everolimus tablets, call your doctor or go to the nearest hospital emergency room right away.

Side effects, and when to stop

” for information about other serious side effects. What are everolimus tablets? Everolimus tablets are a prescription medicine used to prevent transplant rejection (antirejection medicine) in people who have received a kidney transplant or liver transplant. Transplant rejection happens when the body’s immune system perceives the new transplanted kidney or liver as “foreign” and attacks it.

Everolimus tablets is used with other medicines called cyclosporine, corticosteroids and certain other transplant medicines to prevent rejection of your transplanted kidney. Everolimus tablets is used with other medicines called tacrolimus and corticosteroids to prevent rejection of your transplanted liver. It is not known if everolimus tablets is safe and effective in transplanted organs other than the kidney and liver.

It is not known if everolimus tablets is safe and effective in children under 18 years of age.

Who should not take it

Do not take everolimus tablets if you are allergic to: Everolimus (ZORTRESS/AFINITOR ® ) or any of the ingredients in everolimus tablets. See the end of this Medication Guide for a complete list of ingredients in everolimus tablets. sirolimus (Rapamune ® ) Before taking everolimus tablets, tell your doctor about all of your medical conditions, including if you: have liver problems have skin cancer or it runs in your family have high cholesterol or triglycerides (fat in your blood) have Lapp lactase deficiency or glucose-galactose malabsorption.

You should not take everolimus tablets if you have this disorder. are pregnant or could become pregnant. Everolimus tablets may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment and for 8 weeks after your last dose of everolimus tablets. Talk to your doctor about birth control methods that may be right for you during this time.

If you become pregnant or think you are pregnant, tell your healthcare provider right away. You should not become pregnant during treatment with everolimus tablets. are breastfeeding or plan to breastfeed. It is not known if everolimus passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take: antifungal medicine antibiotic medicine heart medicine high blood pressure medicine a medicine to lower cholesterol or triglycerides cyclosporine (Sandimmune ®, Gengraf ®, Neoral ® ) tuberculosis (TB) medicine HIV medicine St. John’s Wort seizure (anticonvulsant) medicine cannabidiol (Epidiolex ® )

What to say before you start

” What are the possible side effects of everolimus tablets? Everolimus tablets may cause serious side effects, including: swelling under your skin especially around your mouth, eyes and in your throat (angioedema). Your chance of having swelling under your skin is higher if you take everolimus tablets along with certain other medicines.

Tell your doctor right away or go to the nearest emergency room if you have any of these symptoms of angioedema: sudden swelling of your face, mouth, throat, tongue or hands hives or welts itchy or painful swollen skin trouble breathing delayed wound healing. Everolimus tablets can cause your incision to heal slowly or not heal well.

Call your doctor right away if you have any of the following symptoms: your incision is red, warm or painful blood, fluid, or pus in your incision your incision opens up swelling of your incision lung or breathing problems. Tell your doctor right away if you have new or worsening cough, shortness of breath, difficulty breathing or wheezing.

In some patients, lung or breathing problems have been severe and can even lead to death. Your doctor may need to stop everolimus tablets or lower your dose. increased cholesterol and triglycerides (fat in your blood). If your cholesterol and triglyceride levels are high, your doctor may want to lower them with diet, exercise and certain medicines.

protein in your urine (proteinuria). change in kidney function. Everolimus tablets may cause kidney problems when taken along with a standard dose of cyclosporine medicine instead of a lower dose. Your doctor should do blood and urine tests to monitor your cholesterol, triglycerides and kidney function. viral infections.

Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with everolimus tablets include BK virus-associated nephropathy. BK virus can affect how your kidney works and cause your transplanted kidney to fail. blood clotting problems. Talk to your doctor if this is a concern for you.

diabetes. Tell your doctor if you have frequent urination, increased thirst or hunger. infertility, male. Everolimus tablets can affect fertility in males and may affect your ability to father a child. Talk with your doctor if this is a concern for you. infertility, female. Everolimus tablets can affect fertility in females and may affect your ability to become pregnant.

Talk to your doctor if this is a concern for you. The most common side effects of everolimus tablets in people who have had a kidney or liver transplant include: These common side effects have been reported in both kidney and liver transplant patients: nausea swelling of the lower legs, ankles and feet high blood pressure The most common side effects of everolimus tablets in people who have had a kidney transplant include: constipation low red blood cell count (anemia) urinary tract infection increased fat in the blood (cholesterol and triglycerides) The most common side effects of everolimus tablets in people who have had a liver transplant include: diarrhea headache fever abdominal pain low white blood cells These are not all of the possible side effects of everolimus tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

What to avoid

Avoid receiving any live vaccines while taking everolimus tablets. Some vaccines may not work as well while you are taking everolimus tablets. Do not eat grapefruit or drink grapefruit juice while you are taking everolimus tablets. Grapefruit may increase your blood level of everolimus tablets. Limit the amount of time you spend in the sunlight.

Avoid using tanning beds or sunlamps. People who take everolimus tablets have a higher risk of getting skin cancer. See the section “What is the most important information I should know about everolimus tablets?” Wear protective clothing when you are in the sun and use a sunscreen with a high protection factor (SPF 30 and above).

This is especially important if you have fair skin or if you have a family history of skin cancer. Avoid becoming pregnant. See the section “

Storing it

Store everolimus tablets between 59°F and 86°F (15°C and 30°C). Everolimus tablets are packed in child-resistant blisters and bottles with a child resistant closure. Keep everolimus tablets out of the light. Keep everolimus tablets dry. Keep everolimus tablets and all medicines out of the reach of children.