Afinitor Disperz

Name: Afinitor Disperz

What special precautions should I follow?

Before taking everolimus,

  • tell your doctor and pharmacist if you are allergic to everolimus, sirolimus (Rapamune), temsirolimus (Torisel), any other medications, or any of the ingredients in everolimus tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors; aprepitant (Emend); certain antibiotics such as clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S., E-Mycin, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, in Rifamate, in Rifater), rifapentine (Priftin), and telithromycin (Ketek); certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); digoxin (Digitek, Lanoxicaps, Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) including amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (in Atripla, Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); nefazodone; nicardipine (Cardene); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with everolimus, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you have or have ever had diabetes or high blood sugar; high levels of cholesterol or triglycerides in your blood; liver disease; or any condition that prevents you from digesting foods containing sugar, starch, or dairy products normally.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant during your treatment with everolimus or for 8 weeks after your treatment. You must use birth control during this time. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while taking everolimus, call your doctor. Everolimus may harm the fetus.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking everolimus.
  • do not have any vaccinations without talking to your doctor. During your treatment with everolimus, you should avoid close contact with other people who have recently been vaccinated.
  • talk to your child's doctor about vaccinations that your child may need to receive before beginning his or her treatment with everolimus.
  • you should know that you may develop sores or swelling in your mouth during your treatment with everolimus. Tell your doctor if you develop sores or feel pain in your mouth. Your doctor may recommend a mouthwash or gel to relieve your symptoms. However, you should not use any mouthwash without talking to your doctor or pharmacist because certain types of mouthwash that contain alcohol, peroxide, iodine, or thyme can worsen the sores and swelling.
  • you should know that wounds or cuts, including the cut in the skin made during a kidney transplant may heal more slowly than normal or may not heal properly during your treatment with everolimus. Call your doctor right away if the cut in the skin from your kidney transplant or any other wound becomes warm, red, painful, or swollen; fills with blood, fluid, or pus; or begins to open.

What side effects can this medication cause?

Everolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • constipation
  • change in ability to taste food
  • weight loss
  • dry mouth
  • weakness
  • headache
  • difficulty falling asleep or staying asleep
  • nosebleed
  • dry skin
  • acne
  • problems with nails
  • hair loss
  • pain in the arms, legs, back or joints
  • muscle cramps
  • missed or irregular menstrual periods
  • heavy menstrual bleeding
  • difficulty getting or keeping an erection
  • anxiety
  • aggression or other changes in behavior

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • hives
  • itching
  • swelling of the hands, feet, arms, legs, eyes, face, mouth, lips, tongue, or throat
  • hoarseness
  • difficulty breathing or swallowing
  • wheezing
  • flushing
  • chest pain
  • extreme thirst or hunger
  • unusual bleeding or bruising
  • pale skin
  • fast or irregular heartbeat
  • dizziness
  • seizures

Everolimus may decrease fertility in men and women. Talk to your doctor about the risks of taking everolimus.

Everolimus may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Afinitor Disperz Overview

Afinitor Disperz is a prescription medication used to treat certain types of brain tumors seen with a genetic condition called tuberous sclerosis complex (TSC).

Afinitor Disperz belongs to a group of drugs called kinase inhibitors. It works by stopping cancer cells from reproducing and by decreasing blood supply to cancer cells.

Afinitor Disperz comes in tablet form for oral suspension and is usually taken once daily, with or without food.

  • If you take it with food, then take it with food all of the time.
  • If you do not take it with food, then do not take it with food all of the time.

Common side effects include constipation, mouth ulcers, nausea, vomiting, diarrhea, and headache.

Side Effects of Afinitor Disperz

Afinitor Disperz can cause serious side effects. See “Drug Precautions”.

Common side effects of Afinitor Disperz include:

  • Mouth ulcers. Afinitor Disperz can cause mouth ulcers and sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. Your doctor may tell you to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme. 
  • Infections
  • Nausea and vomiting
  • Diarrhea and constipation
  • Swelling of arms, hands, legs, and feet
  • Joint pain
  • Cough
  • Skin problems (rash, acne, or dry skin)
  • Fever
  • Feeling tired
  • Anxiety, aggression, and other abnormal behaviors
  • Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your doctor if this happens.
  • Low red blood cells, white blood cells or platelets
  • Increased blood cholesterol level and certain other blood tests
  • Decreased blood phosphate level
  • Increased blood sugar levels

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

These are not all the possible side effects of Afinitor Disperz. For more information, ask your doctor or pharmacist.

Inform MD

Before taking 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 Disperz. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. 

Tell your doctor if you are pregnant or breastfeeding.

Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Afinitor Disperz Usage

Your healthcare provider will prescribe the dose of Afinitor Disperz that is right for you.

Take Afinitor Disperz exactly as your healthcare provider tells you. Your healthcare provider may change your dose of 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.

If your healthcare provider prescribes Afinitor Disperz for you, see the “Instructions for Use” that come 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 Afinitor Disperz when preparing suspensions of Afinitor Disperz for another person.

Take Afinitor Disperz 1 time each day at about the same time.

Take Afinitor Disperz the same way each time, either with food or without food.

  • If you take too much Afinitor Disperz contact your healthcare provider or go to the nearest hospital emergency room right away. Take the pack of Afinitor Disperz with you.
  • If you miss a dose of Afinitor Disperz, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your Afinitor Disperz, skip the dose for that day. The next day, take 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.

Commonly used brand name(s)

In the U.S.

  • Afinitor
  • Afinitor Disperz
  • Zortress

Available Dosage Forms:

  • Tablet for Suspension
  • Tablet

Therapeutic Class: Antineoplastic Agent

Uses For Afinitor Disperz

Everolimus is used to treat advanced (late-stage) cancers or noncancerous tumors, such as kidney and breast cancer, subependymal giant cell astrocytoma (SEGA, a brain tumor), renal angiomyolipoma (kidney tumor), tuberous sclerosis complex, and neuroendocrine tumors of the pancreas, intestines, and lungs. It is used for patients who have already received other medicines that did not work well or those who will not be treated with surgery.

Everolimus works by interfering with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. It belongs to the group of medicines known as antineoplastics (cancer medicines).

Everolimus is also used together with other medicines to lower the body's natural immunity in patients who receive kidney or liver transplants. When a patient receives an organ transplant, the body's white blood cells try to get rid of (reject) the transplanted organ. Everolimus works to suppress the immune system and prevents the white blood cells from getting rid of the transplanted organ.

This medicine is available only with your doctor's prescription.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Redness or irritation of the palms of hands or soles of feet.
  • A burning, numbness, or tingling feeling that is not normal.
  • Chest pain.
  • Any unexplained bruising or bleeding.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Seizures.
  • Very bad dizziness or passing out.
  • Muscle pain or weakness.
  • Period (menstrual) changes. These may include a missed period.
  • Mood changes.
  • Change in the way you act.
  • Swelling.
  • Very bad and sometimes deadly kidney problems have happened with this medicine. Call your doctor right away if you are unable to pass urine or if you have blood in the urine or a change in the amount of urine passed.

For the Consumer

Applies to everolimus: oral tablet, oral tablet for suspension

Along with its needed effects, everolimus (the active ingredient contained in Afinitor Disperz) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking everolimus:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody nose
  • chest pain or tightness
  • cough or hoarseness
  • decreased weight
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • fever or chills
  • general feeling of discomfort or illness
  • lower back or side pain
  • painful or difficult urination
  • rapid weight gain
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • tingling of the hands or feet
Less common
  • Bleeding gums
  • bloody urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coughing up blood
  • extreme fatigue
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst or urination
  • irregular breathing
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • nosebleeds
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • slow heartbeat
  • stomachache
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Agitation
  • confusion
  • depression
  • dizziness
  • hostility or irritability
  • lethargy
  • muscle twitching
  • seizures
  • stupor

Some side effects of everolimus may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • change in taste
  • dry skin
  • itching skin or rash
  • lack or loss of strength
  • loss of taste
  • pain in the arms or legs
  • unable to sleep
Less common
  • Back pain
  • blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
  • bumps on the skin
  • burning, dry, or itching eyes
  • discoloration of the fingernails or toenails
  • flushing or redness of the skin
  • full feeling
  • jaw pain
  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
  • passing gas
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sleepiness or unusual drowsiness

Usual Adult Dose for Renal Cell Carcinoma

10 mg orally once a day

Comments:
-Dose should be taken at the same time each day.
-Dose should be taken consistently with or without food.
-Afinitor (R) tablets should be swallowed whole with a glass of water and not chewed, broken, or crushed.

Uses:
AFINITOR(R):
1) Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC):
-Treatment of postmenopausal women with advanced hormone receptor positive, HER2 negative breast cancer in combination with exemestane, after treatment with letrozole or anastrozole has failed.
2) Advanced Neuroendocrine Tumors (NET):
-Treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.
-Treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.
3) Advanced Renal Cell Carcinoma (RCC):
-Treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
-Treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.
4) Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC):
-Treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

Dialysis

Data not available

How supplied

Dosage Forms And Strengths

AFINITOR

Tablets, white to slightly yellow and elongated with a bevelled edge:

  • 2.5 mg: engraved with “LCL” on one side and “NVR” on the other.
  • 5 mg: engraved with “5” on one side and “NVR” on the other.
  • 7.5 mg: engraved with “7P5” on one side and “NVR” on the other.
  • 10 mg: engraved with “UHE” on one side and “NVR” on the other.
AFINITOR

DISPERZ Tablets for oral suspension, white to slightly yellowish, round, and flat with a bevelled edge:

  • 2 mg: engraved with “D2” on one side and “NVR” on the other.
  • 3 mg: engraved with “D3” on one side and “NVR” on the other.
  • 5 mg: engraved with “D5” on one side and “NVR” on the other.

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 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

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

Follow special handling and disposal procedures for anticancer pharmaceuticals.1

REFERENCES

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

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: Mar 2018

Warnings

Included as part of the PRECAUTIONS section.

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