Zortress (Page 11 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

Zortress (everolimus) tablets are packed in child-resistant blisters.

Table 11. Description of Zortress (everolimus) Tablets
Dosage Strength 0.25 mg 0.5 mg 0.75 mg 1 mg
Appearance White to yellowish, marbled, round, flat tablets with beveled edge
Imprint “C” on one side and “NVR” on the other “CH” on one side and “NVR” on the other “CL” on one side and “NVR” on the other “CU” on one side and “NVR” on the other
NDC Number 0078-0417-20 0078-0414-20 0078-0415-20 0078-0422-20

Each strength is available in boxes of 60 tablets (6 blister strips of 10 tablets each).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Protect from light and moisture.

17 PATIENT COUNSELING INFORMATION

Administration

Inform patients that Zortress should be taken orally twice a day approximately 12 hours apart consistently either with or without food.

Inform patients to avoid grapefruit and grapefruit juice which increase blood drug concentrations of Zortress [s ee Warnings and Precautions ( 5.2 0 ) ].

Advise patients that Zortress should be used concurrently with reduced doses of cyclosporine and that any change in doses of these medications should be made under physician supervision. A change in the cyclosporine dose may also require a change in the dosage of Zortress.

Inform patients of the necessity of repeated laboratory tests according to physician recommendations while they are taking Zortress.

Development of Lymphomas and Other Malignancies

Inform patients they are at risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression. Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and using a sunscreen with a high protection factor [ s ee Warnings and Precautions (5.2) ] .

Increa s ed Risk of Infection

Inform patients they are at increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression. Advise patients to contact their physician if they develop any symptoms of infection [ s ee Warnings and Precautions (5.3, 5.1 3 ) ] .

Kidney Graft Thrombosis

Inform patients that Zortress has been associated with an increased risk of kidney arterial and venous thrombosis, resulting in graft loss, usually within the first 30 days posttransplantation [ s ee Warnings and Precautions ( 5.4 ) ] .

Zortress and Calcineurin Inhibitor-Induced Nephrotoxicity

Advise patients of the risks of impaired kidney function with the combination of Zortress and cyclosporine as well as the need for routine blood concentration monitoring for both drugs. Advise patients of the importance of serum creatinine monitoring [ s ee Warning s and Precautions ( 5. 6 ) ] .

Angioedema

Inform patients of the risk of angioedema and that concomitant use of ACE inhibitors may increase this risk. Advise patients to seek prompt medical attention if symptoms occur [ s ee Warnings and Precautions ( 5. 8 ) ] .

Wound Healing Complications and Fluid Accumulation

Inform patients the use of Zortress has been associated with impaired or delayed wound healing, fluid accumulation and the need for careful observation of their incision site [ s ee Warnings and Precautions ( 5. 9 ) ] .

Interstitial Lung Disease (ILD)/Non-Infectious Pneumonitis

Inform patients the use of Zortress may increase the risk of non-infectious pneumonitis. Advise patients to seek medical attention if they develop clinical symptoms consistent with pneumonia [ s ee Warnings and Precautions (5. 10 )] .

Hyperlipidemia

Inform patients the use of Zortress has been associated with increased serum cholesterol and triglycerides that may require treatment and the need for monitoring of blood lipid concentrations [ s ee Warnings and Precautions ( 5. 11 ) ] .

Proteinuria

Inform patients the use of Zortress has been associated with an increased risk of proteinuria [ s ee Warnings and Precautions ( 5.1 2 ) ] .

Pregnancy and Lactation

Advise women of childbearing age to avoid becoming pregnant throughout treatment and for 8 weeks after Zortress therapy has stopped. Zortress can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to a fetus. Also advise not to breastfeed while taking Zortress [see Use in Specific Populations (8.1, 8.2)].

Male and Female Fertility

Inform male and female patients that Zortress may impair fertility [see Warnings and Precautions (5.18), Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1)].

Medications that Interfere with Zortress

Some medications can increase or decrease blood concentrations of Zortress. Advise patients to inform their physician if they are taking any of the following: antifungals, antibiotics, antivirals, anti-epileptic medicines including carbamazepine, phenytoin and barbiturates, herbal/dietary supplements (St. John’s Wort), and/or rifampin [ s ee Warnings an d Precautions ( 5.1 4 )] .

New Onset Diabetes

Inform patients the use of Zortress may increase the risk of diabetes mellitus and to contact their physician if they develop symptoms [ s ee Warnings and Precautions ( 5.1 6 ) ] .

Immunizations

Inform patients that vaccinations may be less effective while they are being treated with Zortress. Advise patients live vaccines should be avoided [ s ee Warnings an d Precautions ( 5.1 9 )] .

Patient with Hereditary Disorders

Advise patients to inform their physicians that if they have hereditary disorders of galactose intolerance (Lapp-lactase deficiency or glucose-galactose malabsorption) not to take Zortress [ s ee Warnings and Precautions ( 5. 21 ) ] .

Distributed by:
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936

© Novartis

T2021-02

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: January 2021
MEDICATION GUIDE ZORTRESS (ZOR-tres)(everolimus) Tablets

What is the most important information I should know about ZORTRESS?

ZORTRESS can cause serious side effects, including:

  • Increased risk of getting certain cancers. People who take ZORTRESS 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. ZORTRESS weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with ZORTRESS that may lead to death. People taking ZORTRESS 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 ZORTRESS. Your doctor should do regular blood tests to check your levels of both ZORTRESS and cyclosporine.
  • Increased risk of death that can be related to infection, in people who have had a heart transplant.You should not take ZORTRESS without talking to your doctor if you have had a heart transplant.
See the section “What are the possible side effects of ZORTRESS?” for information about other serious side effects.

What is ZORTRESS?

ZORTRESS is 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 as “foreign” and attacks it.

ZORTRESS is used with other medicines called cyclosporine, corticosteroids and certain other transplant medicines to prevent rejection of your transplanted kidney. ZORTRESS is used with other medicines called tacrolimus and corticosteroids to prevent rejection of your transplanted liver.

It is not known if ZORTRESS is safe and effective in transplanted organs other than the kidney and liver.

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

Do not take ZORTRESS if you are allergic to:

  • everolimus (ZORTRESS/AFINITOR®) or any of the ingredients in ZORTRESS. See the end of this Medication Guide for a complete list of ingredients in ZORTRESS.
  • sirolimus (Rapamune®)

Before taking ZORTRESS, 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 ZORTRESS if you have this disorder.
  • are pregnant or could become pregnant. ZORTRESS 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 ZORTRESS. 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 ZORTRESS.
  • are breastfeeding or plan to breastfeed. It is not known if ZORTRESS 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

How should I take ZORTRESS?

  • Take ZORTRESS exactly as your doctor tells you to.
  • Do not stop taking ZORTRESS or change your dose unless your doctor tells you to.
  • Take ZORTRESS at the same time as your dose of cyclosporine 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, your dose of ZORTRESS may change.
  • Take ZORTRESS 2 times a day about 12 hours apart.
  • Swallow ZORTRESS tablets whole with a glass of water. Do not crush or chew ZORTRESS tablets.
  • Take ZORTRESS tablets with or without food. If you take ZORTRESS tablets with food , always take ZORTRESS tablets with food. If you take ZORTRESS tablets without food, always take ZORTRESS tablets without food.
  • Your doctor will do regular blood tests to check your kidney function while you take ZORTRESS. It is important that you get these tests done when your doctor tells you to. Blood tests will monitor how your kidneys are working and make sure you are getting the right dose of ZORTRESS and other transplant medications they may be on (cyclosporine and tacrolimus).
  • If you take too much ZORTRESS, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking ZORTRESS?

  • Avoid receiving any live vaccines while taking ZORTRESS. Some vaccines may not work as well while you are taking ZORTRESS.
  • Do not eat grapefruit or drink grapefruit juice while you are taking ZORTRESS. Grapefruit may increase your blood level of ZORTRESS.
  • Limit the amount of time you spend in the sunlight. Avoid using tanning beds or sunlamps. People who take ZORTRESS have a higher risk of getting skin cancer. See the section “What is the most important information I should know about ZORTRESS?” 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 “What should I tell my doctor before taking ZORTRESS?”

What are the possible side effects of ZORTRESS?

ZORTRESS may cause serious side effects, including:

  • See “What is the most important information I should know about ZORTRESS?”
  • 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 ZORTRESS 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. ZORTRESS 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 ZORTRESS 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. ZORTRESS 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 ZORTRESS include BK virus-associated nephropathy. BK virus can affect how your kidney works and cause your transplanted kidney to fail.
  • blood clotting problems.
  • diabetes. Tell your doctor if you have frequent urination, increased thirst or hunger.
  • infertility, male. ZORTRESS 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. ZORTRESS 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 ZORTRESS 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 ZORTRESS 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 ZORTRESS 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 ZORTRESS.

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

How should I store ZORTRESS?

  • Store ZORTRESS tablets between 59°F and 86°F (15°C and 30°C).
  • Keep ZORTRESS out of the light.
  • Keep ZORTRESS tablets dry.

Keep ZORTRESS and all medicines out of the reach of children.

General information about the safe and effective use of ZORTRESS.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZORTRESS for a condition for which it was not prescribed. Do not give ZORTRESS to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about ZORTRESS that is written for healthcare professionals.

What are the ingredients in ZORTRESS?

Active ingredient: everolimus

Inactive ingredients: butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone and lactose anhydrous.

Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936

Rapamune® is a registered trademark of Pfizer Inc; Gengraf® is a registered trademark of Abbott Laboratories

For more information, call 1-888-669-6682 or visit www.zortress.com.

T2021-03

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