Afinitor (Page 10 of 12)

15 REFERENCES

  1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16 HOW SUPPLIED/STORAGE AND HANDLING

AFINITOR

2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:

Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51

Each carton contains 4 blister cards of 7 tablets each

5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:

Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51

Each carton contains 4 blister cards of 7 tablets each

7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:

Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51

Each carton contains 4 blister cards of 7 tablets each

10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:

Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51

Each carton contains 4 blister cards of 7 tablets each

AFINITOR DISPERZ

2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in:

Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51

Each carton contains 4 blister cards of 7 tablets each

3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in:

Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51

Each carton contains 4 blister cards of 7 tablets each

5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in:

Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51

Each carton contains 4 blister cards of 7 tablets each

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.

Store in the original container, protect from light and moisture.

Follow special handling and disposal procedures for anti-cancer pharmaceuticals.1

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Non-infectious Pneumonitis

Advise patients of the risk of developing non-infectious pneumonitis and to immediately report any new or worsening respiratory symptoms to their healthcare provider [see Warnings and Precautions (5.1)].

Infections

Advise patients that they are more susceptible to infections and that they should immediately report any signs or symptoms of infections to their healthcare provider [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions

Advise patients of the risk of clinically significant hypersensitivity reactions and to promptly contact their healthcare provider or seek emergency care for signs of hypersensitivity reaction, including rash, itching, hives, difficulty breathing or swallowing, flushing, chest pain, or dizziness [see Contraindications (4), Warnings and Precautions (5.3)].

Angioedema with Concomitant Use of ACE Inhibitors

Advise patients to avoid ACE inhibitors and to promptly contact their healthcare provider or seek emergency care for signs or symptoms of angioedema [see Warnings and Precautions (5.4)].

Stomatitis

Advise patients of the risk of stomatitis and to use alcohol-free mouthwashes during treatment [see Warnings and Precautions (5.5)].

Renal Impairment

Advise patients of the risk of developing kidney failure and the need to monitor their kidney function periodically during treatment [see Warnings and Precautions (5.6)].

Risk of Impaired Wound Healing

Advise patients that AFINITOR/AFINITOR DISPERZ may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure [see Warnings and Precautions (5.7)].

Geriatric Patients

Inform patients that in a study conducted in patients with breast cancer, the incidence of deaths and adverse reactions leading to permanent discontinuation was higher in patients ≥ 65 years compared to patients < 65 years [see Warnings and Precautions (5.8), Use in Specific Populations (8.5)].

Metabolic Disorders

Advise patients of the risk of metabolic disorders and the need to monitor glucose and lipids periodically during therapy [see Warnings and Precautions (5.9)].

Myelosuppression

Advise patients of the risk of myelosuppression and the need to monitor CBCs periodically during therapy [see Warnings and Precautions (5.10)].

Risk of Infection or Reduced Immune Response with Vaccination

Advise patients to avoid the use of live vaccines and close contact with those who have received live vaccines [see Warnings and Precautions (5.11)].

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 8 weeks after the last dose. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 weeks after the last dose [see Warnings and Precautions (5.13), Use in Specific Populations (8.1, 8.3)].

Radiation Sensitization and Radiation Recall

Radiation sensitization and recall can occur in patients treated with radiation prior to, during, or subsequent to AFINITOR/AFINITOR DISPERZ treatment. Advise patients to inform their health care provider if they have had or are planning to receive radiation therapy [see Warnings and Precautions (5.12)].

Lactation

Advise women not to breastfeed during treatment with AFINITOR/AFINITOR DISPERZ and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].

Infertility

Advise males and females of reproductive potential of the potential risk for impaired fertility [see Use in Specific Populations (8.3)].

Distributed by:
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936

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This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: April 2021
PATIENT INFORMATION
AFINITOR® (a-fin-it-or)(everolimus)tablets AFINITOR DISPERZ® (a-fin-it-or dis-perz)(everolimus tablets for oral suspension)
Read this Patient Information leaflet that comes with AFINITOR or AFINITOR DISPERZ before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about AFINITOR and AFINITOR DISPERZ?AFINITOR and AFINITOR DISPERZ can cause serious side effects, including:
1. You may develop lung or breathing problems. In some people lung or breathing problems may be severe and can lead to death. Tell your healthcare provider right away if you have any of these symptoms:
  • New or worsening cough
  • Shortness of breath
  • Chest pain
  • Difficulty breathing or wheezing
2. You may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people (including adults and children) these infections may be severe and can lead to death. You may need to be treated as soon as possible. Tell your healthcare provider right away if you have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following:
  • Fever
  • Chills
  • Skin rash
  • Joint pain and swelling
  • Tiredness
  • Loss of appetite
  • Nausea
  • Pale stools or dark urine
  • Yellowing of the skin
  • Pain in the upper right side of the stomach
3. Severe allergic reactions. Call your healthcare provider or get medical help right away if you get signs and symptoms of a severe allergic reaction, including: rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness.
4. Possible increased risk for a type of allergic reaction called angioedema, in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ. Talk with your healthcare provider before taking AFINITOR or AFINITOR DISPERZ if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR or AFINITOR DISPERZ.
5. Mouth ulcers and sores. Mouth ulcers and sores are common during treatment with AFINITOR or AFINITOR DISPERZ but can also be severe. When you start treatment with AFINITOR or AFINITOR DISPERZ, your healthcare provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your healthcare provider’s instructions on how to use this prescription mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your healthcare provider. Your healthcare provider may tell you to re-start this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.
6. You may develop kidney failure. In some people this may be severe and can lead to death. Your healthcare provider should do tests to check your kidney function before and during your treatment with AFINITOR or AFINITOR DISPERZ.
If you have any of the serious side effects listed above, you may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Follow your healthcare provider’s instructions.
What is AFINITOR? AFINITOR is a prescription medicine used to treat:
  • advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer.
  • adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET), that has progressed and cannot be treated with surgery.
  • adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal), or lung that has progressed and cannot be treated with surgery.AFINITOR is not for use in people with carcinoid tumors that actively produce hormones.
  • adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked.
  • people with the following types of tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):
    • adults with a kidney tumor called angiomyolipoma, when their kidney tumor does not require surgery right away.
    • adults and children 1 year of age and older with a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.
What is AFINITOR DISPERZ? AFINITOR DISPERZ is a prescription medicine used to treat:
  • adults and children 1 year of age and older with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.
  • adults and children 2 years of age and older with a genetic condition called tuberous sclerosis complex (TSC) who have certain types of seizures (epilepsy), as an added treatment to other antiepileptic medicines.

It is not known if AFINITOR and AFINITOR DISPERZ are safe and effective in children to treat:

  • hormone receptor-positive, HER-2 negative breast cancer
  • a type of cancer called neuroendocrine tumors (NET)
  • kidney cancer (renal cell carcinoma)
  • a kidney tumor called angiomyolipoma, that can happen in children with a genetic condition called tuberous sclerosis complex (TSC).
Do not take AFINITOR or AFINITOR DISPERZ if you have had a severe allergic reaction to everolimus.Talk to your healthcare provider before taking this medicine if you are allergic to:
  • sirolimus (Rapamune®)
  • temsirolimus (Torisel®)
Ask your healthcare provider if you do not know.
Before taking AFINITOR or AFINITOR DISPERZ, tell your healthcare provider about all of your medical conditions, including if you:
  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high blood cholesterol levels
  • Have any infections
  • Previously had hepatitis B
  • Are scheduled to receive any vaccinations. You should not receive a “live vaccine” or be around people who have recently received a “live vaccine” during your treatment with AFINITOR or AFINITOR DISPERZ. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. For children with TSC and SEGA or certain types of seizures, work with your healthcare provider to complete the recommended childhood series of vaccines before your child starts treatment with AFINITOR or AFINITOR DISPERZ.
  • Are pregnant, can become pregnant, or have a partner who can become pregnant. AFINITOR or AFINITOR DISPERZ can cause harm to your unborn baby.Females who are able to become pregnant: ◦ Your healthcare provider will give you a pregnancy test before you start treatment with AFINITOR or AFINITOR DISPERZ.◦ You should use effective birth control during treatment and for 8 weeks after your last dose of AFINITOR or AFINITOR DISPERZ.Males with a female partner, you should use effective birth control during treatment and for 4 weeks after your last dose of AFINITOR or AFINITOR DISPERZ.Talk to your healthcare provider 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.
  • Are breastfeeding or plan to breastfeed. It is not known if AFINITOR or AFINITOR DISPERZ passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of AFINITOR or AFINITOR DISPERZ.
  • Are planning to have surgery or if you have had a recent surgery. You should stop taking AFINITOR or AFINITOR DISPERZ at least 1 week before planned surgery. See “What are the possible side effects of AFINITOR and AFINITOR DISPERZ?”
  • Have received radiation therapy or are planning to receive radiation therapy in the future. See “What are the possible side effects of AFINITOR and AFINITOR DISPERZ?”
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.AFINITOR or AFINITOR DISPERZ may affect the way other medicines work, and other medicines can affect how AFINITOR or AFINITOR DISPERZ work. Taking AFINITOR or AFINITOR DISPERZ with other medicines can cause serious side effects.Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take:
  • St. John’s Wort (Hypericum perforatum)
  • Medicine for:
    • Fungal infections
    • Bacterial infections
    • Tuberculosis
    • Seizures
    • HIV-AIDS
    • Heart conditions or high blood pressure
  • Medicines that weaken your immune system (your body’s ability to fight infections and other problems)
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your healthcare provider might need to prescribe a different medicine or your dose of AFINITOR or AFINITOR DISPERZ may need to be changed. You should also tell your healthcare provider before you start taking any new medicine.
How should I take AFINITOR or AFINITOR DISPERZ?
  • Your healthcare provider will prescribe the dose of AFINITOR or AFINITOR DISPERZ that is right for you.
  • Take AFINITOR or AFINITOR DISPERZ exactly as your healthcare provider tells you to.
  • Your healthcare provider may change your dose of AFINITOR or AFINITOR DISPERZ or tell you to temporarily interrupt dosing, if needed.
  • Take only AFINITOR or AFINITOR DISPERZ. Do not mix AFINITOR and AFINITOR DISPERZ together.
  • Use scissors to open the blister pack.
  • Take AFINITOR or AFINITOR DISPERZ 1 time each day at about the same time.
  • Take AFINITOR or AFINITOR DISPERZ the same way each time, either with food or without food.
  • If you take too much AFINITOR or AFINITOR DISPERZ, contact your healthcare provider or go to the nearest hospital emergency room right away. Take the pack of AFINITOR or AFINITOR DISPERZ with you.
  • If you miss a dose of AFINITOR or AFINITOR DISPERZ, you may take it if it is less than 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your AFINITOR or AFINITOR DISPERZ, skip the dose for that day. The next day, take AFINITOR or AFINITOR DISPERZ at your usual time. Do not take 2 doses to make up for a missed dose. If you are not sure about what to do, call your healthcare provider.
  • You should have blood tests before you start AFINITOR or AFINITOR DISPERZ and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels.
  • If you take AFINITOR or AFINITOR DISPERZ to treat SEGA or AFINITOR DISPERZ to treat certain types of seizures with TSC, you will also need to have blood tests regularly to measure how much medicine is in your blood. This will help your healthcare provider decide how much AFINITOR or AFINITOR DISPERZ you need to take.
AFINITOR:
  • Swallow AFINITOR tablets whole with a glass of water. Do not take any tablet that is broken or crushed.
AFINITOR DISPERZ:
  • If your healthcare provider prescribes AFINITOR DISPERZ for you, see the “Instructions for Use” that comes with your medicine for instructions on how to prepare and take your dose.
  • Each dose of AFINITOR DISPERZ must be prepared as a suspension before it is given.
  • AFINITOR DISPERZ can cause harm to an unborn baby. When possible, the suspension should be prepared by an adult who is not pregnant or planning to become pregnant.
  • Wear gloves to avoid possible contact with everolimus when preparing suspensions of AFINITOR DISPERZ for another person.
What should I avoid while taking AFINITOR or AFINITOR DISPERZ? You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR or AFINITOR DISPERZ. It may make the amount of AFINITOR or AFINITOR DISPERZ in your blood increase to a harmful level.
What are the possible side effects of AFINITOR or AFINITOR DISPERZ? AFINITOR and AFINITOR DISPERZ can cause serious side effects.
  • See “What is the most important information I should know about AFINITOR and AFINITOR DISPERZ?” for more information.
  • Risk of wound healing problems. Wounds may not heal properly during AFINITOR and AFINITOR DISPERZ treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with AFINITOR and AFINITOR DISPERZ.
    • You should stop taking AFINITOR and AFINITOR DISPERZ at least 1 week before planned surgery.
    • Your healthcare provider should tell you when you may start taking AFINITOR and AFINITOR DISPERZ again after surgery.
  • Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood. Your healthcare provider should do blood tests to check your fasting blood sugar, cholesterol, and triglyceride levels in the blood before you start and during treatment with AFINITOR or AFINITOR DISPERZ.
  • Decreased blood cell counts. AFINITOR and AFINITOR DISPERZ can cause you to have decreased red blood cells, white blood cells, and platelets. Your healthcare provider should do blood tests to check your blood cell counts before you start and during treatment with AFINITOR or AFINITOR DISPERZ.
  • Worsening side effects from radiation treatment, that can sometimes be severe. Tell your healthcare provider if you have had or are planning to receive radiation therapy.
The most common side effects of AFINITOR in people with advanced hormone receptor-positive, HER2-negative breast cancer, advanced neuroendocrine tumors of the pancreas, stomach and intestine (gastrointestinal) or lung, and advanced kidney cancer include:
  • Infections
  • Rash
  • Feeling weak or tired
  • Diarrhea
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Stomach-area (abdominal) pain
  • Nausea
  • Fever
  • Cough
  • Headache
  • Decreased appetite
The most common side effects of AFINITOR and AFINITOR DISPERZ in people who have SEGA, renal angiomyolipoma, or certain types of seizures with TSC include respiratory tract infections.
Other side effects that may occur with AFINITOR and AFINITOR DISPERZ:
  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your healthcare provider if this happens.
  • AFINITOR and AFINITOR DISPERZ may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.
  • AFINITOR and AFINITOR DISPERZ may affect fertility in males and may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR and AFINITOR DISPERZ. For more information, ask your healthcare provider or pharmacist.

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 AFINITOR or AFINITOR DISPERZ?
  • Store AFINITOR or AFINITOR DISPERZ at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep AFINITOR or AFINITOR DISPERZ in the pack it comes in.
  • Open the blister pack just before taking AFINITOR or AFINITOR DISPERZ.
  • Keep AFINITOR or AFINITOR DISPERZ dry and away from light.
  • Do not use AFINITOR or AFINITOR DISPERZ that is out of date or no longer needed. Keep AFINITOR or AFINITOR DISPERZ and all medicines out of the reach of children.
General information about the safe and effective use of AFINITOR and AFINITOR DISPERZ.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AFINITOR or AFINITOR DISPERZ for a condition for which it was not prescribed. Do not give AFINITOR or AFINITOR DISPERZ to other people, even if they have the same problem you have. It may harm them. This leaflet summarizes the most important information about AFINITOR and AFINITOR DISPERZ. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information written for healthcare professionals. For more information call 1-888-423-4648 or go to www.AFINITOR.com.
What are the ingredients in AFINITOR?
Active ingredient: everolimus.Inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.
What are the ingredients in AFINITOR DISPERZ?
Active ingredient: everolimus.Inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose.
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.© NovartisFor more information call 1-888-423-4648 or go to www.AFINITOR.com.

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