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SIROLIMUS Oral Solution (GREENSTONE LLC)

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SIROLIMUS Oral Solution (GREENSTONE LLC) Quick Finder

What is sirolimus?


  • if sirolimus is right for you, and
  • how to best use it with cyclosporine and corticosteroids after your transplant.
Who should not take...

What is sirolimus?


  • if sirolimus is right for you, and
  • how to best use it with cyclosporine and corticosteroids after your transplant.
Who should not take sirolimus?
Do not take sirolimus if you are allergic to sirolimus or any of the other ingredients in sirolimus. See the end of this leaflet for a complete list of ingredients in sirolimus.
Did you find an answer to your question? Yes No

What should I tell my doctor before taking sirolimus?

  • have liver problems
  • have skin cancer or it runs in your family
  • have high cholesterol or triglycerides (fat in your blood)
  • are pregnant or are a female who can become pregnant. Sirolimus can...

What should I tell my doctor before taking sirolimus?

  • have liver problems
  • have skin cancer or it runs in your family
  • have high cholesterol or triglycerides (fat in your blood)
  • are pregnant or are a female who can become pregnant. Sirolimus can harm your unborn baby. You should not become pregnant during treatment with sirolimus and for 12 weeks after ending treatment with sirolimus. In order to avoid pregnancy, a female who can get pregnant should use effective birth control during treatment and for 12 weeks after your final dose of sirolimus. Talk with your doctor about what birth control method is right for you during this time. Tell your doctor right away if you become pregnant or think you are pregnant during treatment with sirolimus or within 12 weeks after your final dose of sirolimus.
  • It is not known whether sirolimus passes into breast milk; however, there is a risk of serious side effects in breastfed infants. You and your doctor should decide about the best way to feed your baby if you take sirolimus.
Tell your doctor about all the medicines you take,
  • a medicine to lower your cholesterol or triglycerides
  • cyclosporine (including Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf) or other medicines that suppress the immune system
  • an antibiotic
  • an antifungal medicine
  • a medicine for high blood pressure or heart problems
  • an anti-seizure medicine
  • medicines used to treat stomach acid, ulcers, or other gastrointestinal problems
  • bromocriptine mesylate (Parlodel, Cycloset)
  • danazol
  • medicines to treat HIV or hepatitis C
  • St. John's Wort
Did you find an answer to your question? Yes No

How should I take sirolimus?

  • Read the Instructions for Use that comes with your sirolimus for information about the right way to take sirolimus oral solution.
  • Take sirolimus exactly as your doctor tells you to take it.
  • Your doctor will tell you how much...

How should I take sirolimus?

  • Read the Instructions for Use that comes with your sirolimus for information about the right way to take sirolimus oral solution.
  • Take sirolimus exactly as your doctor tells you to take it.
  • Your doctor will tell you how much sirolimus to take and when to take it. Do not change your dose of sirolimus unless your doctor tells you to.
  • If you also take cyclosporine (Gengraf, Neoral, Sandimmune), you should take your sirolimus and cyclosporine about 4 hours apart.
  • Do not stop taking sirolimus or your other anti-rejection medicines unless your doctor tells you to.
  • Your doctor will check the levels of sirolimus in your blood. Your doctor may change your dose of sirolimus depending on your blood test results.
  • Sirolimus is taken by mouth 1 time each day.
  • Take each dose of sirolimus the same way, either with or without food. Food can affect the amount of medicine that gets into your bloodstream. Taking each dose of sirolimus the same way helps keep your blood levels of sirolimus more stable. Do not take sirolimus with grapefruit juice.
  • Sirolimus oral solution can develop a slight haze when it is refrigerated. If this happens, bring the sirolimus oral solution to room temperature and then gently shake the bottle until the haze goes away.
  • If you get sirolimus oral solution on your skin, wash the area with soap and water.
  • If you get sirolimus oral solution in your eyes, rinse your eyes with water.
  • If you have taken more medicine than you were told, contact a doctor or go to the nearest hospital emergency department right away.
Did you find an answer to your question? Yes No

What should I avoid while taking sirolimus?

  • Avoid receiving live vaccines while taking sirolimus. Some vaccines may not work as well while you are taking sirolimus.
  • Limit your time in sunlight and UV light. Cover your skin with clothing and use a broad spectrum...

What should I avoid while taking sirolimus?

  • Avoid receiving live vaccines while taking sirolimus. Some vaccines may not work as well while you are taking sirolimus.
  • Limit your time in sunlight and UV light. Cover your skin with clothing and use a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer with sirolimus.
Did you find an answer to your question? Yes No

What are the possible side effects of sirolimus?


  • See " What should I tell my doctor before taking sirolimus?".
The most common side effects of sirolimus in people with renal transplant include:...

What are the possible side effects of sirolimus?


  • See " What should I tell my doctor before taking sirolimus?".
The most common side effects of sirolimus in people with renal transplant include:
  • high blood pressure
  • pain (including stomach and joint pain)
  • diarrhea
  • headache
  • fever
  • urinary tract infection
  • low red blood cell count (anemia)
  • nausea
  • low platelet count (cells that help blood to clot)
  • high blood sugar (diabetes)
The most common side effects of sirolimus in people with LAM include:
  • mouth sores
  • diarrhea
  • stomach pain
  • nausea
  • sore throat
  • acne
  • chest pain
  • upper respiratory tract infection
  • headache
  • dizziness
  • sore muscles
Other side effects that may occur with sirolimus:
  • Sirolimus 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.
  • Sirolimus 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 doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of sirolimus. For more information ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Did you find an answer to your question? Yes No

How should I store sirolimus?


  • Store bottles of sirolimus oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C). Protect from light.
  • If necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°F (25°C) for up...

How should I store sirolimus?


  • Store bottles of sirolimus oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C). Protect from light.
  • If necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
  • When a bottle of sirolimus oral solution is opened, it should be used within 1 month.
  • Use any diluted sirolimus oral solution right away.
Keep sirolimus and all medicines out of the reach of children.
Did you find an answer to your question? Yes No

General information about the safe and effective use of sirolimus.


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use...

General information about the safe and effective use of sirolimus.


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sirolimus for a condition for which it was not prescribed. Do not give sirolimus to other people even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about sirolimus. If you would like more information talk to your doctor. You can ask your pharmacist or doctor for information about sirolimus that is written for health professionals.

For more information about sirolimus call 1-800-438-1985.

Did you find an answer to your question? Yes No

What are the ingredients in sirolimus?


®

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What are the ingredients in sirolimus?


®

Logo

Did you find an answer to your question? Yes No

17 PATIENT COUNSELING INFORMATION

Advise patients, their families, and their caregivers to read the Medication Guide and Instructions for Use and assist them in understanding its contents. The complete text of the Medication Guide and Instructions for Use are reprinted at...

17 PATIENT COUNSELING INFORMATION

Advise patients, their families, and their caregivers to read the Medication Guide and Instructions for Use and assist them in understanding its contents. The complete text of the Medication Guide and Instructions for Use are reprinted at the end of the document.

See FDA-Approved Medication Guide and Instructions for Use.

Did you find an answer to your question? Yes No

17.2 Skin Cancer Events

Advise patients that exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer [...

17.2 Skin Cancer Events

Advise patients that exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer [see Warnings and Precautions (5.18)].

Did you find an answer to your question? Yes No

17.3 Pregnancy and Lactation

Advise female patients of reproductive potential to avoid becoming pregnant throughout treatment and for 12 weeks after sirolimus therapy has stopped. Sirolimus can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the...

17.3 Pregnancy and Lactation

Advise female patients of reproductive potential to avoid becoming pregnant throughout treatment and for 12 weeks after sirolimus therapy has stopped. Sirolimus can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to her fetus. Before making a decision to breastfeed, inform the patient that the effects of breastfeeding in infants while taking this drug are unknown, but there is potential for serious adverse effects [see Warnings and Precautions (5.15), Use in Specific Populations (8.1, 8.2, 8.3)].

Did you find an answer to your question? Yes No

INSTRUCTIONS FOR USE

Sirolimus
Oral Solution

Be sure that you read and understand the following instructions for the correct way to dilute and take sirolimus oral solution. Ask your pharmacist or doctor if you are not sure.

...

INSTRUCTIONS FOR USE

Sirolimus
Oral Solution

Be sure that you read and understand the following instructions for the correct way to dilute and take sirolimus oral solution. Ask your pharmacist or doctor if you are not sure.

Important:

  • Always keep the bottle in an upright position.
  • You may store sirolimus oral solution that is in a syringe at room temperature up to 77°F (25°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 24 hours. See "
    • Store bottles of sirolimus oral solution in the refrigerator at 36°F to 46°F (2°C to 8°C).
    • Protect from light.
    • Store sirolimus oral solution that is in a syringe at room temperature up to 77°F (25°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 24 hours.
    • If necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
    • When a bottle of sirolimus oral solution is opened, it should be used within 1 month.
    • Use any diluted sirolimus oral solution right away.

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

    This Instructions for Use has been approved by the U.S. Food and Drug Administration.

    Logo

    LAB-0687-5.0

    Revised June 2021

Did you find an answer to your question? Yes No

Full Patient Information

...

Full Patient Information

This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: Aug 2019
MEDICATION GUIDE
Sirolimus Oral Solution
What is the most important information I should know about sirolimus?
Sirolimus can cause serious side effects, including:
1.
Increased risk of getting infections. Serious infections can happen including infections caused by viruses, bacteria, and fungi (yeast). Your doctor may put you on medicine to help prevent some of these infections.
Call your doctor right away if you have symptoms of infection including fever or chills while taking sirolimus.
2.
Increased risk of getting certain cancers. People who take sirolimus have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer.
Sirolimus has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take sirolimus after a liver or lung transplant. You should not take sirolimus if you have had a liver or lung transplant without talking with your doctor.
See the section " What are the possible side effects of sirolimus?" for information about other side effects of sirolimus.
What is sirolimus?
Sirolimus is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your body's immune system recognizes the new organ as a "foreign" threat and attacks it.
Sirolimus is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids. Your doctor will decide:
  • if sirolimus is right for you, and
  • how to best use it with cyclosporine and corticosteroids after your transplant.
It is not known if sirolimus is safe and effective in children under 13 years of age.
Sirolimus is a prescription medicine also used to treat lymphangioleiomyomatosis (LAM). LAM is a rare progressive lung disease that affects predominantly women of childbearing age.
Who should not take sirolimus?
Do not take sirolimus if you are allergic to sirolimus or any of the other ingredients in sirolimus. See the end of this leaflet for a complete list of ingredients in sirolimus.
What should I tell my doctor before taking sirolimus?
  • have liver problems
  • have skin cancer or it runs in your family
  • have high cholesterol or triglycerides (fat in your blood)
  • are pregnant or are a female who can become pregnant. Sirolimus can harm your unborn baby. You should not become pregnant during treatment with sirolimus and for 12 weeks after ending treatment with sirolimus. In order to avoid pregnancy, a female who can get pregnant should use effective birth control during treatment and for 12 weeks after your final dose of sirolimus. Talk with your doctor about what birth control method is right for you during this time. Tell your doctor right away if you become pregnant or think you are pregnant during treatment with sirolimus or within 12 weeks after your final dose of sirolimus.
  • It is not known whether sirolimus passes into breast milk; however, there is a risk of serious side effects in breastfed infants. You and your doctor should decide about the best way to feed your baby if you take sirolimus.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using sirolimus with certain medicines may affect each other causing serious side effects.
Sirolimus may affect the way other medicines work, and other medicines may affect how sirolimus works.
Especially tell your doctor if you take:
  • a medicine to lower your cholesterol or triglycerides
  • cyclosporine (including Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf) or other medicines that suppress the immune system
  • an antibiotic
  • an antifungal medicine
  • a medicine for high blood pressure or heart problems
  • an anti-seizure medicine
  • medicines used to treat stomach acid, ulcers, or other gastrointestinal problems
  • bromocriptine mesylate (Parlodel, Cycloset)
  • danazol
  • medicines to treat HIV or hepatitis C
  • St. John's Wort
How should I take sirolimus?
  • Read the Instructions for Use that comes with your sirolimus for information about the right way to take sirolimus oral solution.
  • Take sirolimus exactly as your doctor tells you to take it.
  • Your doctor will tell you how much sirolimus to take and when to take it. Do not change your dose of sirolimus unless your doctor tells you to.
  • If you also take cyclosporine (Gengraf, Neoral, Sandimmune), you should take your sirolimus and cyclosporine about 4 hours apart.
  • Do not stop taking sirolimus or your other anti-rejection medicines unless your doctor tells you to.
  • Your doctor will check the levels of sirolimus in your blood. Your doctor may change your dose of sirolimus depending on your blood test results.
  • Sirolimus is taken by mouth 1 time each day.
  • Take each dose of sirolimus the same way, either with or without food. Food can affect the amount of medicine that gets into your bloodstream. Taking each dose of sirolimus the same way helps keep your blood levels of sirolimus more stable. Do not take sirolimus with grapefruit juice.
  • Sirolimus oral solution can develop a slight haze when it is refrigerated. If this happens, bring the sirolimus oral solution to room temperature and then gently shake the bottle until the haze goes away.
  • If you get sirolimus oral solution on your skin, wash the area with soap and water.
  • If you get sirolimus oral solution in your eyes, rinse your eyes with water.
  • If you have taken more medicine than you were told, contact a doctor or go to the nearest hospital emergency department right away.
What should I avoid while taking sirolimus?
  • Avoid receiving live vaccines while taking sirolimus. Some vaccines may not work as well while you are taking sirolimus.
  • Limit your time in sunlight and UV light. Cover your skin with clothing and use a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer with sirolimus.
What are the possible side effects of sirolimus?
Sirolimus may cause serious side effects, including:
  • See " What should I tell my doctor before taking sirolimus?".
The most common side effects of sirolimus in people with renal transplant include:
  • high blood pressure
  • pain (including stomach and joint pain)
  • diarrhea
  • headache
  • fever
  • urinary tract infection
  • low red blood cell count (anemia)
  • nausea
  • low platelet count (cells that help blood to clot)
  • high blood sugar (diabetes)
The most common side effects of sirolimus in people with LAM include:
  • mouth sores
  • diarrhea
  • stomach pain
  • nausea
  • sore throat
  • acne
  • chest pain
  • upper respiratory tract infection
  • headache
  • dizziness
  • sore muscles
Other side effects that may occur with sirolimus:
  • Sirolimus 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.
  • Sirolimus 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 doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of sirolimus. For more information ask your doctor 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 sirolimus?
Sirolimus oral solution:
  • Store bottles of sirolimus oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C). Protect from light.
  • If necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
  • When a bottle of sirolimus oral solution is opened, it should be used within 1 month.
  • Use any diluted sirolimus oral solution right away.
Do not use sirolimus after the expiration date. The expiration date refers to the last day of that month.
Safely throw away medicine that is out of date or no longer needed.
Keep sirolimus and all medicines out of the reach of children.
General information about the safe and effective use of sirolimus.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sirolimus for a condition for which it was not prescribed. Do not give sirolimus to other people even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about sirolimus. If you would like more information talk to your doctor. You can ask your pharmacist or doctor for information about sirolimus that is written for health professionals.
For more information about sirolimus call 1-800-438-1985.
What are the ingredients in sirolimus?
Active ingredients: sirolimus
Inactive ingredients: Inactive ingredients: sirolimus oral solution: Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Sirolimus oral solution contains 1.5%–2.5% ethanol.
This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

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For sirolimus oral solution:
LAB-0688-6.0

17 PATIENT COUNSELING INFORMATION

Advise patients, their families, and their caregivers to read the Medication Guide and Instructions for Use and assist them in understanding its contents. The complete text of the Medication Guide and Instructions for Use are reprinted at the end of the document.

See

17.1 Dosage

Patients should be given complete dosage instructions [see

17.2 Skin Cancer Events

Advise patients that exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer [see

17.3 Pregnancy and Lactation

Advise female patients of reproductive potential to avoid becoming pregnant throughout treatment and for 12 weeks after sirolimus therapy has stopped. Sirolimus can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to her fetus. Before making a decision to breastfeed, inform the patient that the effects of breastfeeding in infants while taking this drug are unknown, but there is potential for serious adverse effects [see

17.4 Infertility

Inform male and female patients that sirolimus may impair fertility [see Warnings and Precautions (5.16), Adverse Reactions (6.7), Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1)].

INSTRUCTIONS FOR USE

Sirolimus
Oral Solution

Be sure that you read and understand the following instructions for the correct way to dilute and take sirolimus oral solution. Ask your pharmacist or doctor if you are not sure.

Important:

  • Always keep the bottle in an upright position.
  • You may store sirolimus oral solution that is in a syringe at room temperature up to 77°F (25°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 24 hours. See " How should I store sirolimus?
    • Store bottles of sirolimus oral solution in the refrigerator at 36°F to 46°F (2°C to 8°C).
    • Protect from light.
    • Store sirolimus oral solution that is in a syringe at room temperature up to 77°F (25°C) or in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 24 hours.
    • If necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
    • When a bottle of sirolimus oral solution is opened, it should be used within 1 month.
    • Use any diluted sirolimus oral solution right away.

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

    This Instructions for Use has been approved by the U.S. Food and Drug Administration.

    Logo

    LAB-0687-5.0

    Revised June 2021

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event